Friday, January 15, 2016

Advancing the Agenda on How Healthcare is Delivered

Comments of CMS Acting Administrator Andy Slavitt at the J.P. Morgan Annual Health Care Conference, Jan. 11, 2016

Thanks for the introduction. Glad to be here and speak about the major policy areas that will affect the health care sector in 2016. I am particularly glad to be here with Jim from AMA, because between us we are working on an incredible amount of change across the health care sector.
When they put a private sector guy in charge at CMS, I made clear my intention to talk regularly to the health care investor community. From my not-so-distant past, I remember how CMS often felt opaque to me, and I probably said more than once how helpful it would be to know CMS’s agenda rather than divining them by poring through an often intricate set of regulations like they were Fed minutes.
I’m a believer in the maxim that it’s always 90 percent about implementation, and possibly to the annoyance of my colleagues, it’s a constant refrain from me. We only succeed if we bring the ideas behind the big legislation successfully to the kitchen table of the American family and the exam room of their physicians.
I’m blessed to be here now because in many ways the day-to-day work of CMS at this point in time is to start up new consumer and provider-facing capabilities and then scale them, nurture and mature them. It demands we change our culture and execute with clarity, with discipline, and with collaboration. Things we haven’t always been known for.
2015 was a meaningful year for execution on a number of fronts. From committing publicly to change how we pay for care, to leading the largest data transparency initiative in health care, releasing tens of millions of lines of data and new consumer websites, to investing in the growth of Medicare Advantage, to seeing record levels of quality, safety and continued low medical trend. To implementing the ICD-10 changeover, the biggest event no one heard about. And of course expanding Medicaid into three new states, and we’ve now crossed 17 million newly insured since the start of the ACA and have had a strong start to our third open enrollment.
Through the year, I developed a view I will share with you of how CMS operates and a new cultural focus to execute most effectively. CMS works on three important levels.
First, setting policy and acting as a regulator to make sure the laws of Congress and the rules we set advance the interests of consumers and taxpayers. Here our most important job is to listen and learn, policy is often a blunt instrument and in the real-world it takes continual adjusting.
Second, we act as an operator, providing service to our beneficiaries, technical support to health care providers, and partnering with states and commercial health plans to deliver our programs.  Our mantra here is to give people the tools they need to thrive in the face of significant change.
And third, we often operate as a market signaler, acting as a catalyst to bring together the disparate pieces of the health care to make improvement more rapidly and more efficiently such as how we pay for care.
So, 2016. Let me start with how we are advancing the agenda on how health care is delivered. To the 130 million Americans in the Medicare, Medicaid and CHIP programs, and by extension how care is paid for across all of health care, 2016 will be an enormous and pivotal year for progress and it’s starting off with a bang.
***
We announced today the participants in the Next Generation ACO model. In Next Gen, provider groups take full financial responsibility for a patient’s care and have innovative options like telemedicine, home visits, and direct consumer incentive and engagement options. It’s a model driven by all the lessons learned and feedback from previous participants and results. And the news is very good.
With 21 new Next Gen ACOs, there will be over 475 total ACOs with 30,000 physicians participating around the country, including 64 that are 2-sided or full risk, up from 19 just last year and of course zero before the Affordable Care Act.
My read of this news is that in 2016, we have not only more ACOs, but better ACOs. In total, 8.9 million Medicare FFS beneficiaries, or greater than 1 in 5, in 49 states and the District of Colombia, will now be a part of an ACO, with 1.6 million in better, more advanced models.
Many have wondered whether ACOs would succeed or would end up in the dustbin of health care’s three-letter acronyms. As a recovering entrepreneur, I can certainly tell you that the execution in the first stage is often the hardest part. But today’s news is strong evidence that ACO’s will be part of ushering in the new wave of alternative payment models. They have demonstrated improvements in quality, patient experience and have been certified to reduce costs.
But it’s important to remember where we are. Think of the Next Gen model like the second generation iPhone. There will still be progress and setbacks and we will continually improve.
***
The implementation of the bipartisan MACRA legislation is a major item squarely on our punch list that has everyone’s attention. At its most basic level it is a program that brings pay for value into the mainstream through something called the Merit-based incentive program, which compels us to measure physicians on four categories: quality, cost, the use of technology, and practice improvement.
The stakes are high for this program. As any physician will tell you, physician burden and frustration levels are real. Programs designed to improve often distract. Done poorly, measures are divorced from how physicians practice and add to the cynicism that people who build these programs just don’t get it. Over the next several months, we will be rolling out details, but for now a couple of themes.
At its core, we need to simplify. We have the opportunity to sunset three old programs and align them together in a single new program. That program needs to be streamlined and simple to use so physicians can focus where they need to – on their patients.
We are designing from the outside-in. We started by working with front-line physicians, tech companies, and practice managers over a four day session and through an RFI to garner direct feedback on the right measures for each specialty and how to implement the program most simply.  Jim and the AMA team were of significant help.
We are committed to building a program that is flexible and adapts around the goals of a provider’s individual practice and patient population.
I would be remiss if I didn’t add that like any good start up, we will start small and leave a lot of tool building opportunities to the private sector.
Let me dive a little deeper on the technology component. Now that we effectively have technology into virtually every place care is provided, we are now in the process of ending Meaningful Use and moving to a new regime culminating with the MACRA implementation.
The Meaningful Use program as it has existed, will now be effectively over and replaced with something better. Since late last year we have been working side by side with physician organizations across many communities — including with great advocacy from the AMA — and have listened to the needs and concerns of many. We will be putting out the details on this next stage over the next few months, but I will give you a themes guiding our implementation.
For one, the focus will move away from rewarding providers for the use of technology and towards the outcome they achieve with their patients.
Second, providers will be able to customize their goals so tech companies can build around the individual practice needs, not the needs of the government. Technology must be user-centered and support physicians, not distract them.
Third, one way to aid this is by leveling the technology playing field for start-ups and new entrants. We are requiring open APIs in order to the physician desktop can be opened up and move away from the lock that early EHR decisions placed on physician organizations so that allow apps, analytic tools, and connected technologies to get data in and out of an EHR securely.
And finally, we are deadly serious about interoperability. We will begin initiatives in collaboration with physicians and consumers toward pointing technology to fill critical use cases like closing referral loops and engaging a patient in their care. And technology companies that look for ways to practice “data blocking” in opposition to new regulations will find that it won’t be tolerated.
***
Medicaid is another significant item on our punch list this year. Over the last two plus years, over 13.5 million people have gained the security of Medicaid or CHIP coverage. But even as we are focused on helping interested states expand coverage, we are equally focused on rapidly modernizing Medicaid coverage so that it works as well or better than any insurance program.
This last year, we have released proposed or final rules to modernize how Medicaid managed care works, how states and CMS ensure access to care, and are working state by state on their plans to improve incentives for value-based care with delivery systems. Our priority this year is to attract new innovative companies to invest in the Medicaid IT space. From where I sit, investing in the future of Medicaid is one of the single best opportunities in the health care sector.
First, it’s big: Last month CMS permanently extended the 90 percent federal match for investments in Medicaid systems. Overall, CMS’ annual investment in state Medicaid IT is more than $5 billion. With over 30 states currently redesigning their Medicaid IT systems, 2016 will the most active year to date for Medicaid IT opportunities.
Second, the opportunity for innovation and differentiation is large and we are making it easier than ever: state investment is geared specifically towards technologies that are modular, reusable, and cloud-based. This opens up opportunities for innovative new entrants to disrupt this market. To assist potential new entrants in entering this solution space, today we are launching a one-stop-shop with a set of resources that will help private sector companies identify opportunities to participate in this important market. I will tweet this URL and a link to a blog with more details after this talk.
***
The final significant item on the punch list is the health and long term stability of the Health Insurance Marketplaces. Stepping back, the Marketplace is still in the early stages. Consumers are still getting educated and health plans are experimenting with the right product and network designs. Even as the market meets today’s needs and signs millions of new consumers up in record numbers, we also pay attention to adjustments that are needed as the Marketplace matures. And today I want to talk about steps we are taking to move from a startup stage to a more mature stage.
We have an experienced team of leaders and actuaries from the private sector and many who come directly from our Medicare Advantage and Part D operations where we have set up and operate very successful large marketplaces already. We study the data and meet regularly with all market participants and take a strategic view to determine what adjustments are warranted.  Our focus is simple – Marketplaces must be attractive to health plans to reach and build relationships with desirable consumers; the offerings need to be attractive to consumers so they come and shop; and we need a predictable set of underwriting and other rules that compensate fairly for risk and keep the risk pool stable and balanced.
On the first point, we are seeing the characteristics of an attractive customer base for health plans to serve: A growing market; a younger population; and with high levels of engagement and responsiveness to new offerings. This Open Enrollment period, we’ve seen a significant influx of new consumers making it clear there is still a large untapped market to serve.
And the tax penalty is bringing more young and healthy consumers into the market. We are using a large portion of our marketing resources to make sure that consumers are aware of the increasing fee for people that go without insurance.
41% of all new consumers this Open Enrollment are under 35, compared to 38% a year ago. And if past patterns continue to hold, the percentage of young people will climb throughout the rest of Open Enrollment.
There are also high levels of consumer engagement– as over 60% of Marketplace consumers have made active decisions about their health insurance choices.
And even at this early stage we are beginning to see health care look and feel like many other retail markets where consumer preferences are creating meaningful consumer improvements. 90% of consumers have an average of three insurance companies to choose from translating into 50 plan options. Consumers can now pick a plan based upon the insurance their doctor accepts or the drug they are looking for. And the vast majority are getting direct services like primary care and generic drugs outside their deductible.
The presence of federal subsidies has exploded the universe of consumers in the individual market. A truly retail market with these type of organic innovations should bring in even more consumers, including higher income individuals who will be attracted to better experiences and better services.
Finally, moving into the third year and beyond, we are focused on continually maintaining and improving a set of marketplace rules that create a healthy, stable and balanced risk pool. These changes will lead directly to a stable rate environment and more affordability for consumers. I want to lay out some of the specific steps we are taking over the next 45 days.
First, we think it is critical to enforce the integrity of the Open Enrollment period. In the first two years of the Marketplace, a number of Special Enrollment Periods or SEPs were created as consumers were learning how to enroll in coverage for the first time. SEPs play an important role for consumers but we are making changes so that as the Marketplace matures, SEPs serve the purpose they are intended.
Last month, we announced the elimination of the tax season special enrollment period; and this week, we will be announcing that we will be eliminating certain other select SEPs and making the language on others clearer to prevent bad actors from signing people up for insurance inappropriately. We have established an enforcement unit and have already terminated coverage for individuals who were improperly enrolled by certain brokers.
But lifting up, most importantly, consumers need to know that Open Enrollment– the next 20 days– is the time to get covered for potential illness and avoid the tax penalty.
Next, we are committed to making sure that risk adjustment works as it is intended to allow coverage of individuals with pre-existing conditions. This year we will be taking a number of steps. First, in response to health plan feedback, we will be providing early estimates of health plan specific risk adjustment calculations. Along with the newly launched backend automation, this will give plans more timely information in order to facilitate informed rate setting.
Second, on March 25, we are hosting a public conference to bring together all market participants to review the risk adjustment methodology so we can build in changes based on the first several years of experience. We have the tools to make certain the proper incentives exist to insure sicker populations.
And outside of risk adjustment, in the next 45 days you will see other announcements and more specificity intended to address the risk pool.
Overall, we’re taking steps to move from a start-up period to a more normalized set of operating rules. The start-up stage of anything has unique challenges. The Administration and Congress recognized the challenges that were placed on health plans with building a stable marketplace over the first few years and passed a one-year moratorium on the Health Insurance Tax to assist with that transition.
Just as the reinsurance program, which has paid out $7.9 billion, at a 25% higher level than expected, has been a stabilizing force to date; the one-year tax holiday, of $13.9 billion will help stabilize premiums next year.
The actions we are focused on, while targeting health plans, are aimed at directly benefitting consumers as they enhance predictability and affordability. That is a critical goal as we move to the next stage of Marketplace evolution.
***
Let me recap the themes in our 2016 agenda.
We maintain our cultural focus on listening and learning that we really launched in earnest this year. We have a number of start-up activities as well as areas where we must move to a more mature stage, which makes that focus even more important.
And we must execute in our role as a market catalyst and signaler– signaling that care delivery payments are changing, and reward people who provide the best care and we are pushing to a tipping point by 2018. Signaling that Medicaid, with the benefit of new innovation, will be a priority area of growth and innovation; and signaling that we have the focus, the tools and the experience to continue to make sure the Marketplace remains healthy.
On a personal note, it is a great honor and very energizing to serve as a leader in CMS at a time when there is such a significant amount to execute on. Taking this assignment on for me after my time in the private sector has been invigorating and inspiring so far, even when all the missiles appear to be pointed directly at us.
Quite simply, it’s because of the consumer — 130 million of them – many on fixed and low incomes who I wake up thinking about every day. When I took this job I decided to keep my email address public and I know now many of them wake up thinking about me.
I quickly realized how many people are just hoping for basic things, to have their family well taken care of when they’re sick, to have them home and to lead as productive and healthy life as possible. Whether living with a disability, trying to afford a prescription, or hoping to keep coverage as they look for a better job. Millions more of you are counting on us making smart decisions now so that these programs work for you when you need them. And it’s because of the people we serve that our punch list needs to be bold, clear and ultimately successful.
We are committed to continuing to working side-by-side with you to make this happen.

Sustaining a Habit of Service Excellence

In today's healthcare environment, new payment models have created a direct link between service, patient satisfaction scores, and reimbursement because value-based purchasing rewards high performers.

What is your organization doing to ensure a habit of service excellence?  
The quality of service your organization provides is one of the few variables that can differentiate your hospital or medical practice from the competition.

"Delivering great service is just a smart business practice for any organization in any industry. It builds loyalty and positive word of mouth," says Kristin Baird, president and CEO of Baird Group. "But in healthcare, service builds trust, creates a more positive experience, and drives up patient satisfaction scores."

When embarking on the journey to service excellence, it's critical to provide tools that build on annual training and assist employees in sustaining a habit of service excellence.

Playing for Change

Is your organization reaping the financial rewards of service excellence?

Changing behavior is never easy, but mHealth Games can help!

mHealth Games engages frontline staff with interactive activities that build essential communication skills and reinforce behaviors of service excellence.


Click the picture below to launch a demo:





Tuesday, January 5, 2016

CDPS Risk Adjustment



What is the CDPS Model?

The Chronic Illness and Disability Payment System was built to adjust capitated payments (based on estimated health burden) to health plans that involved Medicaid beneficiaries.


What is the Purpose?

  • To make equitable comparisons among health plans that take the health status of their enrolled members into consideration.
  • Minimize the incentives for plans and providers from selectively enrolling healthier members.
  • Provide adequate funding for those who treat individuals with higher than average health needs


Which States are Using CDPS?





How Does it Work?

CDPS is similar to models used for Medicare (CMS-HCC), but places a greater emphasis on less common, but costly chronic conditions that are more prevalent among disabled Medicaid beneficiaries.

The model maps ICD-9 / ICD-10 codes to 58 CDPS categories within 20 major categories corresponding to major body systems (e.g. cardiovascualar) or type of disease (e.g. diabetes).

CDPS includes weights for disabled, TANF Adults, and TANF Children, Prospective and Concurrent.


What are the 58 CDPS Categories?

 




Where Can I Download the Model?




Where Can I Learn More?

Test Your Skills and Play CDPS from mHealth Games Today!
  • Level 1 – Brief Overview and History of CDPS
  • Level 2 – Mechanics of CDPS Risk Adjustment
  • Level 3 – Application of Knowledge



    Click on the picture above to launch the game,

Or use one of the links below:







Thursday, December 17, 2015

Reducing Disparities and Improving Outcomes with Interactive Games


What are Health and Health Care Disparities?
Health disparity: A higher burden of illness, injury, disability, or mortality experienced by one population group relative to another group.
Health care disparity: Differences between groups in health insurance coverage, access to and use of care, and quality of care.

Why do Health and Health Care Disparities Matter?
Disparities in health and health care limit continued improvement in overall quality of care and population health and result in unnecessary costs. 
  • Addressing disparities in health and health care is not only important from a social justice standpoint, but also for improving the health of all Americans by achieving improvements in overall quality of care and population health. Moreover, health disparities are costly, resulting in added health care costs, lost work productivity, and premature death. 

    Recent analysis estimates that 30% of direct medical costs for Blacks, Hispanics, and Asian Americans are excess costs due to health inequities (Figure 1) and that, overall, the economy loses an estimated $309 billion per year due to the direct and indirect costs of disparities.


Figure 1: Excess Medical Expenditures Due to Health Inequities



What is Needed to Reduce Disparities?

To reduce health disparities, interventions are required that can be used again and again without losing their therapeutic power, that can reach people even if local health care systems do not provide them with needed health care, and that can be shared globally without taking resources away from the populations where the interventions were developed. 

Reducing Disparities with Interactive Games
Presenting information to patients and caregivers in the form of an interactive game reduces anxiety and improves engagement. 
Click either of the pictures below  to see how games can be used to improve screening rates.









Visit mHealth Games for more information....




Thursday, October 22, 2015

Medicare RACs Identified Almost $2.4 Billion in Overpayments in FY 2014



According to CMS, the Medicare Fee-For-Service (FFS) Recovery Auditor Program identified and corrected $2.57 billion in improper Medicare payments in FY 2014. The lion’s share of this amount — $2.39 billion — represented overpayments collected, compared to $173.1 million in underpayments repaid to providers. Considering all program costs (other than expenses incurred at the third and fourth levels of appeal), CMS concluded that the Medicare FFS Recovery Audit Program returned more than $1.6 billion to the Medicare Trust Funds. Note that the overall level of FY 2014 recoveries was down from FY 2013 levels, when Recovery Audit Contractors (RACs) identified $3.75 billion in improper payments. CMS attributes some of this decrease in RAC identification of improper payments to a prohibition on certain RAC inpatient hospital patient status reviews, along with reduced reviews during the close-out process of existing RAC contracts.



http://www.jdsupra.com/post/documentViewer.aspx?fid=2db04e5a-9976-4e7a-bec6-89d51d290ec7



Saturday, October 17, 2015

HHS-HCC Risk Adjustment Review


Open Enrollment starts November 1st.... Is your team ready?

Test your risk adjustment knowledge with this new game from mHealth Games.  Click the picture above to launch.

Quick Review of the ACA Commercial Model of Risk Adjustment, and HHS-HCC Codes in ICD-10.





Early Detection Saves Lives


The American Cancer Society estimates that 526 women in the US will be diagnosed with breast cancer today.
Add that up and that’s 192,200 women in the US diagnosed every year. What are the odds that one of them is someone you know?
If we are all doing our monthly self-exams and remembering to schedule a mammogram, the odds of surviving a fight with breast cancer increases greatly.

Why are self-exams so important?

Self-exams are an important first step because you can often feel a lump before it has caused any other symptoms. When was your last breast self-exam?

Click the picture above to play “Now Showing” and become a BSE expert!



View More On: www.mhealthgames.com



Tuesday, October 13, 2015

Computerized cognitive training improves childhood cancer survivors' attention and memory




Intensive, adaptive computer-based cognitive training presented as a video game helped improve working memory and other cognitive skills of childhood cancer survivors and holds hope for revolutionizing management of the late effects of cancer treatment. St. Jude Children's Research Hospital investigators led the study, which appears in the Journal of Clinical Oncology.
Working memory improved significantly, and attention and processing speed also improved for childhood cancer survivors who completed between 20 and 30 computer-based training sessions. Processing speed measures the speed at which the brain processes information. The sessions lasted 30 to 45 minutes and included verbal and visual-spatial exercises presented as games but designed to improve working memory.
The benefits to working memory and attention from the training were comparable to gains reported in previous studies of stimulant medications. The gains from cognitive training moved performance of the 30 survivors who completed the training into the normal range. Caregivers also reported significant improvement in the attention and executive functioning of survivors who completed the training compared to a similar group of survivors who had not. Executive functioning includes skills like planning and focus needed to juggle multiple tasks and get things done.
Changes in brain activity during brain imaging suggest the intervention might capitalize on neuroplasticity to train the brain to work more efficiently.
"These results suggest that computerized cognitive training may help fill a void in management of cognitive late effects that impact quality of life for childhood cancer survivors, such as the likelihood they will complete school and live independently," said first and corresponding author Heather Conklin, Ph.D., an associate member of the St. Jude Department of Psychology. "While medication and therapist-led interventions have shown some benefit for select survivors, online training marks a significant advance by giving survivors convenient access to an effective intervention."
Previous research from other investigators showed that individuals with developmental and acquired attention disorders benefited from intensive computer-based cognitive training using repetitive exercises of graded difficulty. This study used a commercially available program called Cogmed and is the largest yet involving cancer survivors. Currently, such programs are not covered by insurance.
This study included 68 childhood cancer survivors who had received cranial irradiation, intrathecal chemotherapy or both for treatment of acute lymphoblastic leukemia (ALL) or brain tumors. Intrathecal chemotherapy involves delivering anti-cancer drugs directly into the cerebrospinal fluid surrounding the brain and spine. The therapies leave survivors at an increased risk for cognitive declines that reduce academic, social and work-related achievement.
Study participants were 8 to 16 years old and had completed treatment and been disease-free for at least one year. Prior to joining the study, all scored below expectations on measures of working memory.
Half the participants were randomly assigned to begin the intervention immediately. The remaining survivors were offered the intervention about six months later. The training included weekly coaching by telephone for survivors and families.
Survivors who began training immediately also underwent functional MRI brain imaging before and soon after completing the intervention. The imaging tracked brain activity as the survivors completed a working memory exercise. Post-intervention imaging showed survivors decreased activity in specific prefrontal regions, which suggests their brains may be working more efficiently.
"That suggests the intervention exercised and strengthened the well-established working memory network. The implication is that the brain may operate more efficiently and have less need for compensatory strategies," Conklin said. "Such training-induced neuroplasticity suggests the benefits might be sustained going forward."
Researchers are now studying the possible benefits of starting brain training during treatment or combining it with other interventions. Investigators are also tracking whether the cognitive benefits are sustained and translate into the improved academic performance reported for other populations. In this study, gains in working memory, attention and processing speed did not translate into improved math or reading performance.
Conklin said that overall the results are good news for the nation's growing population of childhood cancer survivors, now estimated to include more than 420,000 individuals. "Computerized cognitive training is a more feasible, portable and efficient intervention than we've had in the past and is likely to result in meaningful improvement in the cognitive problems survivors experience," she said.









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



Purpose

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
Email: Letise.Williams@fda.hhs.gov
Phone: 301-796-8398

FDA Advisory Committee Information Line

1-800-741-8138
(301-443-0572 in the Washington, DC, area)
Please call the Information Line for up-to-date information on meetings