Sunday, October 30, 2011

BioSense 2.0 Coming Soon

The CDC BioSense program tracks health problems as they evolve and provides public health officials with data, information, and the tools needed to better respond to potential bioterrorism-related illnesses. The CDC BioSense Program launched in 2003 was to establish an integrated national public health surveillance system to provide nationwide and regional situational awareness for all-hazard health related threats that go beyond bioterrorism.

In 2010, RTI was awarded a $16.3 million contract to redesign the BioSense program under CDC’s Office of Surveillance, Epidemiology and Laboratory Services. In the first year, the team developed a BioSense Redesign website at and held a number of stakeholder input sessions, webinars, focused groups, and one-on-one interviews.

The Redesigned BioSense or BioSense 2.0 will be governed by ASTHO, in coordination with the Council of State and Territorial Epidemiologists, National Association of County and City Health Officials, and the International Society for Disease Surveillance.

Key components of the BioSense 2.0 will:

• Strengthen the health monitoring infrastructure and workforce capacity where needed at the state, local, tribal, and territorial levels

• Coordinate responses and be able to monitor health-related outcomes routinely and during an event

• Build on existing state and local health department systems and programs to maintain the original purpose of BioSense to detect and characterize events

• Expand BioSense data usage beyond early event detection and provide public health awareness, improve outcomes, and increase local and state participation in BioSense

• Expand the utility of BioSense data to multi-use and all-hazard detection

• Improve the ability to detect emergency health-related threats by supporting systems capable of providing alerts

The new BioSense system will take advantage of novel and proven data storage and processing technology to allow users to control their data and will encourage collaboration in a social network-style environment.

CDC will still continue to examine the stakeholder requirements and perform a needs assessment, determine limitations of participating sites, assess Meaningful Use readiness, and work collaboratively with external partners on how to best meet the needs of state and local health departments.

Go to to view the draft BioSense Strategic Plan available for comments until November 4, 2011. For more information, contact Taha A. Kass-Hout, MD at

Be sure to attend the Capitol Hill Steering Committee on Telehealth and Healthcare Informatics session on Wednesday November 16th from 12:00 to 1:45 to hear officials from CDC discuss progress on the BioSense program plus other panelists will discuss how biosurveillance technologies can improve public health. Representative Phil Gingrey (R-GA) will kick off the program. To receive an announcement, email Neal Neuberger at or call (703) 508-8182.

Improving Licensure Portability

On October 13, 2011, HRSA’s Office of Rural Health Policy, the Office for the Advancement of Telehealth, issued a funding announcement for the “Licensure Portability Grant Program” (LPGP). The deadline for applications is January 17, 2012. The primary purpose for the grant program is to support State professional licensing boards to enable them to carry out their programs and help develop and implement policies to reduce statutory and regulatory barriers to the use of telemedicine.

The program is designed to leverage the experience of State licensing boards that have a strong record in implementing cross-border activities to help the states overcome licensure barriers that exist that still prevent telemedicine services from being provided across many states.

The grant competition will seek projects that can serve as national models. Contingent upon reauthorization, this program will provide funds for FY 2012 to 2014. Approximately $700,000 is expected to be available annually to fund up to two grantees limited to State professional licensing boards. The estimated average size of awards is expected to be $350,000.

Previously funded LPGP projects have worked to reduce the redundancies that complicate and delay obtaining medical licensure in multiple jurisdictions. Nineteen state medical boards have been involved so far and include Connecticut, Idaho. Iowa, Kansas, Maine, Massachusetts, Michigan, Minnesota, Missouri, New Hampshire, North Carolina, New Mexico, Ohio, Oklahoma, Oregon, Rhode Island, South Dakota, Virginia, and Wyoming.

These states are now using multiple models and tools developed under the LPGP to promote physician licensure portability, including an online uniform application, participation in a centralized credentialing verification program, and states are being helped to endorse physicians outside of their own state.

To view the grant announcement (HRSA-12-091), go to then click on New Grants. For more details, email Carlos Mena, Program Coordinator for the Office for the Advancement of Telehealth, in the Office of Rural Health Policy at or call (301) 443-3198.

mPhones Helping Diabetics

In a study supported by AHRQ, researchers affiliated with the University of Washington and a local HMO enables patients to wirelessly upload blood-glucose values through mobile phones, communicate through email with a care manager, and access their shared medical record from a system at home. Participants were trained to access the system through a smart phone, personal computer, and through the web.

After interviews with eight patients to discuss their experience, several themes emerged. The researchers concluded that connecting with nurse practitioners was valuable, some individuals are very receptive to using web-based and mobile communication services to help manage their diabetes, uploading data from wireless glucose meters was easy, but using the technology could sometimes be frustrating to self-managing diabetes.

The University of Maryland’s School of Medicine reports in a study published in ‘Diabetes Care” that an interactive computer software program appears to be effective in helping patients’ mange their Type 2 diabetes using their mobile phones.

The study one of the first to scientifically examine mobile health technology found that a key measure of blood sugar control was lowered by an average of 1.9 percent over a period of one year in patients using the mobile health software. The findings support further exploring mobile health approaches to use to manage many chronic conditions including diabetes.

The study enrolled 163 patients with the help of 39 primary care doctors in Baltimore County, Baltimore City, Montgomery County, and Anne Arundel County in Maryland. Patients were divided into four groups based on the research assignment of their physician. Three patient groups received mobile phones loaded with diabetes management software and the fourth group served as a control group. All patients in the study received a free blood glucose meter and testing supplies.

The software examined provided real-time feedback, displayed medication regimens, and served as a “virtual coach”. The system analyzed blood sugar levels and other patient information, sent computer-generated logbooks, and suggested treatment plans to the patients’ primary care doctor.

A clinical trial listed on sponsored by the University of Southern California is looking at using text-messaging based mHealth with emergency department diabetic patients. The trial referred to as “TExT-MED”, uses unidirectional daily text messages consisting of educational materials, trivia questions, and challenges to promote healthy lifestyle choices, along with reminders to check blood sugar and take medications.

The trial is currently recruiting up to 200 participants ages 18 to 80 that have Type 2 diabetes, have a text message capable mobile phone, and speak and read English or Spanish. The study is expected to be completed July 2012.

The principal contact is Sanjay Arora, MD at (323) 226-6667. The identifier is (NCT01403831).

In another program sponsored by the McKesson Foundation $1.4 million in research funding was awarded to the second generation of “Mobilizing for Health” grant recipients. The funding will help researchers from six institutions investigate how mobile phones can be used to improve the lives of underserved populations suffering from chronic diseases but the program is especially geared to helping diabetics.

The 2012 grants recipients include:

• Baystate Medical Center is going to field test an integrated mHealth solution to improve daily adherence to medications and blood glucose and blood pressure monitoring among older Type 2 diabetes patients

• Albert Einstein Medical Center will examine how doctors and nurses with regular feedback from their diabetic patients use integrated mobile phone technology to improve blood sugar control

• Center for Connected Health, Partners HealthCare in Boston will integrate a text-messaging program with the existing DSME program at 3 MGH community health centers representing medically underserved and low income populations. The goal is to assess the effect of personalized text messages on clinical outcomes and physical activity in patients with Type2 diabetes. Personalized text messages will include coaching to improve activity levels and reminders and will be offered in English and Spanish

• Medic Mobile will develop and pilot an SMS-based appointment validation tool to automate the process of confirming and rescheduling appointments for low-income diabetic patients

• Scripps Whittier Diabetes Institute will test the effectiveness of using a mobile health application to improve the management of diabetes in a recently diagnosed diabetic Latino population

• Vanderbilt University Medical Center will design and test a mobile assessment and intervention system for low-income adults with Type 2 diabetes

Letters of Intent for the next “Mobilizing for Health” grant cycle will be accepted beginning in January 2012. For further information, go to

Multitasking is Distracting

“Fragmented attention is the norm—people today are continually multitasking”, reports Clifford Nass PhD, Thomas M. Storke Professor at Stanford University and Director for the Communication between Humans and Interactive Media Lab. In our present media saturated environment, media multitasking which is a person’s consumption of more than one item at the same time is very popular among the young.

He continued to tell the attendees at the Partners Healthcare Center for Connected Health Symposium held in Boston in October 2011 that more and more young people listen to music, text, chat, check email, use tablets, tend to be socially connected 24/7, and therefore are considered chronic multitaskers. However, studies show that heavy media multitaskers are poor at number of cognitive control processes.

Researchers have studied whether chronic heavy multitaskers process information differently than individuals who do not multitask on a frequent basis. In other words, has chronic multitasking changed our brains and affected top down thinking and produced a society less concerned with task completion.

People today are bombarded with several streams of electronic information and as a result, they do not always pay adequate attention, are easily distracted, have difficulty controlling their memory, and have difficulty switching from one job to another as compared to those individuals who prefer to complete one task at a time.

In an experiment, two groups were shown sets of two red rectangles alone or surrounded by two, four, or six blue rectangles. Each configuration was flashed twice, and the participants had to determine whether the two red rectangles in the second frame were in a different position than in the first frame. They were told to ignore the blue rectangles and the low multitaskers had no problem doing that, but the high multitaskers were constantly distracted by the irrelevant blue images.

The issue today is how to communicate health issues to chronically distracted users. Researchers will probably have to present information to multitaskers in different ways such as scattering information across windows, using product placement for multiple hits, using asides to present key information, continually update social networking software, and always present the newest information first since multitaskers are focused on the idea that new is better.

Clifford Nass PhD is the author of “The Man Who Lied to his Laptop: What Machines Teach Us About Human Relationships” published in 2010. For more details on the Connected Health Symposium, go to

Experts Speak at AMIA 2011

AMIA’s 35th Annual Symposium “Improving Health: Informatics and IT Changing the World” opened with NIH Director Dr. Francis S. Collins addressing more than two thousand professionals engaged in translational bioinformatics, clinical research informatics, clinical informatics, public health, and consumer health informatics.

Dr. Collins discussed plans for the planned National Center for Advancing Translational Sciences (NCATS), designed to speed up the process of “rescuing and repurposing” drug therapies out of the laboratories and into advanced clinical trials.

The expectation is for NCATS to continue the work of the Clinical and Translational Science Awards (CTSA) which are required to leverage informatics as a core component of their scientific structure.

Dr. Collins reported “In the ten years since the genome sequence was completed, the economic return has resulted in a return on investment of 141:1 a $3 billion investment leading to $790 billion in economic growth. He continued to point out that that medical research is not only a wonderful way to plan for revolutionizing more effective medicine, but also gives people a chance to live healthy lives and at the same time helps nurture the American economy.

The proposed NCATS Working Group held a meeting in September to make suggestions for some of the key areas ideally suited for NCATS activities. These suggestions include supporting innovative research, new partnerships, and regulatory science and its applications. It is also important to encourage the dissemination of research outcomes, harness the power of the CTSA program and form a strong national CTSA consortium, develop educational programs in translational sciences especially in under-represented fields, and streamline the administrative process to overcome roadblocks to rapid and effective funding and management.

Discussing other new ideas in the health technology field, Gregory Abowd, PhD, Distinguished Professor, School of Interactive Computing at Georgia Tech, told the attendees how his research interests are centered on finding how to use advanced information technologies of “ubiquitous computing” or referred to as (ubicomp). The researchers are looking at how ubicomp can and will impact ordinary lives when technology is seamlessly integrated into daily living spaces.

Dr. Abowd is very involved with researchers working with body sensors, cameras, microphones, and sensors embedded in objects along with using mobile phones and text messaging to better manage chronic illnesses. His chief goal is to tap into a home’s infrastructure to sense and learn as much as possible about human activity to help manage health activities from a distance. Dr. Abowd projects that within five years, the majority of clinically relevant data will be collected in non-clinical settings.

Biomedical Computing FOA

NIH released a Funding Opportunity Announcement (FOA) seeking projects from individuals or small groups to collaborate with the National Centers for Biomedical Computing (NCBC). The objective is to enable researchers to build a better biomedical computing environment using computational tools along with biological and behavioral application drivers.

These partnerships are designed to produce, validate, and disseminate the tools and computational environments for the use of a broad spectrum of biomedical researchers in the U.S. The NCBCs operate as the hubs of a networked national effort to build the computational infrastructure for biomedical computing in the nation.

The NCBCs are partnerships bringing together a number of scientists such as:

• Computational scientists to work on inventing and developing efficient and powerful languages, data structures, software architectures, hardware, and algorithms for solving biomedical computing problems

• Biomedical computational scientists to adapt and deploy resources from computational science to solve significant biomedical problems

• Experimental and clinical biomedical and behavioral scientists to generate data that can be transformed into knowledge by computational simulation, analysis, modeling, data mining, and visualizations.

The FOA (PAR-12-001) was posted October 7, 2011. Proposals can be submitted up to September 8, 2014 with the number of awards contingent on NIH appropriations.

For more information, go to

Advancing Regulatory Science

FDA just awarded $2 million to support two regional “Centers of Excellence in Regulatory Science and Innovation” (CERSI). The Centers to be located at the University of Maryland and Georgetown University will focus on strengthening science and training needed to modernize and improve the ways drugs and medical devices are reviewed and evaluated.

Working closely with FDA scientists, CERSI researchers will assist FDA in driving innovation in medical product development as well as advance laboratory, population, behavioral, and manufacturing sciences. The agency will pilot the CERSIs in the Washington D.C. area to allow for the greatest possible face-to-face collaboration and training with FDA staff.

Starting in August 2011, the agency released the strategic plan for “Advancing Regulatory Science at FDA”. In October, the agency released the blueprint “Driving Biomedical Innovation: Initiatives for Improving Products for Patients”. The biomedical blueprint addresses concerns on how to sustain the medical development pipeline which is slowing down despite record investments in research and development.

The focus of the blueprint is to rebuild FDA’s small business outreach services, drive personalized medicine, create a rapid drug development pathway for important targeted therapies, harness the potential of data mining and information sharing, improve the clarity in the medical device review process, train the next generation of innovators, and streamline and reform FDA regulations.

In 2010, FDA entered in a partnership agreement with the University of Rochester to form the Analgesic Clinical Trial Innovations, Opportunities, and Networks (ACTION) Initiative. The initiative is designed to streamline the discovery and development process for new pain-reducing drug products and will establish a scientific and administrative infrastructure to support a series of projects.

Tuesday, October 25, 2011

OSEHRA Takes Important Step

The “Open Source Electronic Health Record Agent “(OSEHRA), a not-for-profit foundation established by the VA will facilitate open source EHR software development. Conrad Clyburn responsible for the development of the open source community announced that the launch of the “Code Repository and Software Quality Certification Process” has officially taken place. The VA is still an active participant in the OSEHRA community.

Seong K. Mun Ph.D Acting President and CEO said, “The repository and software quality certification process will ensure that the Open Source EHR codebase, based on VA’s contribution of VistA software is suitable for modernization and distribution. Certification is ultimately the verification that all executable artifact managed by OSEHRA are safe, compliant, and functional.”

He added, that there are a number of additional tools of value to all community members such as an architecture reference for the existing open source EHR codebase, guidelines for making code contributions, tools for reviewing code, bug tracking tools, and a community Wiki.

Dr. Mun hosted a 45 minute webinar on October 19, 2011 titled “OSEHRA: Open for Business” where he provided a progress report on OSEHRA activities and discussed the strategic direction of the organization while encouraging community participation.

Membership is now open to all and according to Clyburn membership is currently operating with over 350 members with about 60 from industry, 50 or so drawn from the VA VistA software development community, and a dozen academic institutions.

For more information on OSEHRA, go to or email Conrad Clyburn at or call (571) 858-3205.

Vodafone Seeks Innovative Ideas

The Vodafone Americas Foundation and mHealth Alliance have announced a call for submissions for their annual “Vodafone Americas Foundation Wireless Innovation Project” and the “mHealth Alliance Award”. The goal is to identify and support wireless-related technologies with high potential to solve critical global issues.

Applicants compete for first, second, and third-place prizes worth $300,000, $200,000, and $100,000. Additionally, the mHealth Alliance award winner will receive a prize package worth $50,000 which will include strategic and networking support from the mHealth Alliance.

A panel of judges from the fields of wireless engineering, international development, social entrepreneurship, and business will evaluate the applications for their potential to solve issues in the fields of health, education, access to communication, economic development, and the environment.

Project proposals must demonstrate significant advancement in the field of wireless-related technology to be applied to social benefit use. The competition is open to projects from universities and nonprofit organizations based in the U.S but projects may operate and help people outside of the U.S. Many of the past award winners are now running field tests in developing countries in Africa, Asia, and Central America.

The project must be at a stage of research where an advanced prototype or field market test can occur during the award period, have the potential for replication and large scale impact, and teams need to submit a business plan or develop a basic framework for financial sustainability and rollout.

The previous 2011 winners included:

• First prize—NETRA originating in the MIT Media Lab is a clip-on eyepiece for mobile phones that can instantly screen for eye conditions and transmit data to an optometrist allowing for early treatment of common refractive eye disorders and cataracts

• Second prize—Smart Diaphragm from UC San Francisco is a wireless monitoring and early warning system for high-risk pregnancies that can be easily administered by a patient at a low cost. The technology can detect decreasing levels of collagen in the cervix—an indicator of impending preterm labor and then transmit results to a cloud database monitored by physicians

• Third price—CoolComply a collaboration between Massachusetts General Hospital, Innovations in International Health at MIT, and the Global Health Committee produced a solar-powered wireless detection system to monitor the dose and temperature for medications for patients undergoing treatment for Multiple Drug Resistant Tuberculosis. The technology relays readings via wireless technology to local healthcare workers to enable them to track the treatment and intervene when necessary

To submit a proposal, applicants must first successfully complete an Eligibility Questionnaire. Proposals were accepted starting October 10, 2011 but will be received through December 31, 2011, with winners to be announced April 2012.

For more information, go to

Telemedicine Center Opens

Dr. Sali Berisha, Prime Minister of Albania, and Alexander Arvizu U.S. Ambassador to Albania, attended the opening of the USAID funded National Telemedicine Center of Albania located at the Mother Theresa University Hospital Center (TUHC). In addition there are five regional telemedicine centers located in Kukes, Shkoder, Durres, Korce, and Vlore.

The Center will serve as the foundation for a national telemedicine and e-health network covering Albania that will directly address the issue of rural access to patients and their care along with medical education for health professionals.

The U.S. based International Virtual e-Hospital (IVeH) developed and built the National Telemedicine Center of Albania as part of the Integrated Telemedicine and e-Health Program of Albania.

The establishment of the Center was conducted in partnership with USAID, the Albanian Ministry of Health, the U.S. Department of Defense’s Office of Defense Cooperation, and the U.S. Army Corp of Engineers.

Charles Doarn IVeH Executive Director and Professor of Public Health Sciences, at the University of Cincinnati served as Master of Ceremony at the inaugural opening event where an unveiling of a plaque took place by Dr. Petrit Vasili, the Albanian Minister of Health, Visho Ajazaj, Deputy Minister of Innovation and Communication and Technology, and Salmir Ivziku, Director of TUHC.

The delegation participated in a program linking sites with the U.S and telemedicine centers in Albania. Dr. Rifat Latifi, Project Director, President and Founder of IVeH and Professor of Surgery at the Unversity of Arizona, in Baltimore Maryland and Dr. Ronald Merrell, Vice President for IVeH and Professor of Surgery at Virginia Commonwealth University located in Richmond Virginia participated. IVeH’s Dr. Erion Dasho provided a demonstration of ViteNet’s telemedicine unit which was linked live to offices in McLean Virginia.

For more information, go to

NIH's UDP Solving Mysteries

After two years, the NIH supported “Undiagnosed Diseases Program” (UDP) reports attaining success in patients whose cases have stumped specialists at leading medical institutions around the country. UDP researchers have reviewed, evaluated, and diagnosed 23 patients with rare diseases, where 15 cases reflected extremely rare diseases affecting fewer than 10,000 people. The researchers published the program’s first retrospective analysis in an online issue of “Genetics in Medicine”.

The UDP report focuses on 160 patients of the 326 cases accepted into the program. More than half of the accepted patients had undiagnosed neurological problems. Other prominent disorder categories include gastrointestinal disease, fibromyalgia and chronic fatigue syndrome, immune and rheumatic illnesses, psychiatric conditions, pain, dermatologic disorders, and cardiovascular disease.

The program has also delved into unknown maladies. In February 2011, the UDP announced in the “New England Journal of Medicine” that a new disease called ACDC or arterial calcification due to deficiency of CD73 was discovered. CD73 is a protein that produces a small molecule adenosine, which protects arteries from calcifying.

The siblings whose cases led to discovery of ACDC continue to experience pain while walking more than a short distance. NIH researchers have obtained approval to start a drug treatment protocol that could improve their condition which is due to be initiated within months.

UDP researchers had a patient with an unexplained muscle condition and diagnosed with a rare form of amyloidosis, a condition where the bone marrow produces excess immunoglobulin proteins that accumulate in the patient’s muscle tissue. The NIH team referred the patient for a stem-cell bone marrow transplant using healthy donor stem cells. The patient has subsequently experienced progressive improvement in her condition.

A typical UDP patient visits the NIH Clinical Center for one week. The case is evaluated by specialists from several of NIH’s institutes and centers with expertise in neurology, radiology, dentistry, and rheumatology. A key component of the program is genetics, so researchers collect DNA from blood or tissue samples from all participating patients, and often from family members to support the genomic analyses.

Up to 60 healthcare providers at NIH participate in UDP with up to 60 healthcare providers screening the applications. Patients are accepted based on the availability of clinical and research resources. The program currently has a backlog of applications and since July 2011 has suspended acceptance of new applications until November 2011.

For more information, go to

Coordinated Care Developments

CMS launched an initiative to help people with chronic mental illnesses, substance abuse disorders, and other chronic conditions receive a new level of coordinated healthcare. The Affordable Care Act now provides new flexibility and resources for State Medicaid programs to provide new health home services for people with chronic conditions.

Using new tools and resources, Missouri will be the first state to create the health home model that will go into effect January 1, 2012. As a health home, Missouri’s community mental health centers will serve as the central source of care for patients with mental health issues and will coordinate all medical needs including primary, acute, behavioral health, and long term services and support for persons with chronic illnesses.

States with approved proposals will receive enhanced 90 percent federal matching funds to support this initiative for two years. The state has worked closely with both CMS and SAMHSA in developing the health home model. Currently, two other states such as Rhode Island and Oregon have applied for a similar Health Home State Plan Amendment

Two other CMS initiatives were launched to include the Medicare Shared Savings Program and the Advance Payment Model to help providers from ACOs. The Medicare Shared Saving Program will provide incentives for participating healthcare providers who agree to work together and become accountable for coordinating care for patients.

Providers, who band together through this model and meet certain quality standards based upon, patient outcomes and care coordination among the provider team, may share in savings they achieve for the Medicare program.

The Advance Payment Model will provide additional support to physician-owned and rural providers participating in the Medicare Shared Savings Program so they would also benefit from additional start-up resources to build the necessary infrastructure, such as new staff or IT systems. The advanced payments would be recovered from any future shared savings achieved by the ACO.

Detecting Hospital Adverse Events

An invention available from the NIH Office of Technology Transfer could benefit public health and patient care. The technology can be used commercially by medical centers, hospitals, and commercial developers of hospital information systems. The technology could be used successfully as part of the NIH Clinical Center Clinical Research Informatics System now operating in the NIH Clinical Center in Bethesda Maryland.

It is basically a computer science-based technology that can detect untoward events such as:

• A patient crisis
• Individual clinic adverse occurrences
• Adverse reactions related to new medication lots
• Inconsistencies in ordered and delivered patient medications

The technology has a dedicated computer server that executes specially designed software with input data from a main hospital information system and other relevant patient data sensors and systems.

The technology also includes design specifications for constructing a “patient registration system”, an untoward event specification catalogue, intelligent software for detecting untoward events, a light and sound panel design for signaling untoward alerts, and includes a report listing untoward alerts.

For more information contact Michael Shmilovich at (301) 435-5019 or email

Addressing Online Therapy

A recent article “When Your Therapist is Only a Click Away” appeared in the New York Times featuring Marlene M. Maheu Ph.D Executive Director for the TeleMental Health Institute. The Institute provides telehealth and online therapy training for professionals and as a result of the publication of the article professionals throughout the world have been flooding Dr. Maheu’s inbox with email inquiries.

In response, Dr. Maheu created a video to address some of the pivotal questions raised by the article outlining some of the primary legal and ethical issues for both practitioners and consumers desiring to connect online. The video addresses concerns that involve audio, email, text messaging, video conferencing, as well as the use of smart phones. The video is available at

“In mental health, new technologies are very exciting, allowing mental health professionals to responsibly deliver needed services to people who otherwise would not get help. By using the right videoconferencing technology, telehealth has been proven to be safe and effective, client satisfaction is high, and insurance companies are starting to pay for such services including Medicare and Medicaid in limited circumstances,” explains Dr. Maheu.

She points out that unfortunately, a large number of mental health professionals have not been heeding their legal or ethics codes, largely because they don’t understand how existing codes are relevant. “Professionals need to be properly trained because many have already begun serving consumers online without thinking through key issues, including professional licensing, the need for an initial in-person assessment by a trained professional, possible abuse, security and fraud, plus technical complications that can all too easily interfere with clinical care.”

For more information, call Dr Maheu at (619) 255-2788.

Tuesday, October 11, 2011

Managing the Influx of Data

According to the top experts in the field of data management, our society will need to deal with mammoth amounts of health and medical data in the coming years. To prepare for this influx of data means that professionals in the field will need to be equipped with up-dated management skills and specialized expertise to effectively be able to transform the medical and healthcare fields. Discussion on this important topic took place at the October 5th HIT Lunch Briefing held as part of the Capitol Hill Steering Committee on Telehealth and Healthcare Informatics Series.

Neal Neuberger, Executive Director for the Institute for e-Health Policy coordinator for the event as well as moderator, stressed the importance of making valuable research data accessible but yet there are still a number of issues to resolve in order to effectively cope with this huge influx of data.

He mentioned that the National Library of Medicine provides the world with the largest collection of data in all areas of biomedicine and healthcare and is able to deliver trillions of bytes of data to millions of users every day.

Speaking from a historical perspective, Dr. Gary Christoph, HHS Client Executive at Northrop Grumman said, “Medicare is a large source for claims data and most of it on magnetic tape. The Integrated Data Repository (IDR) was planned to be sourced from the Medicare claims data and then make the data available on a daily basis.

In 2003-2004 when Medicare began building the IDR, the aim was to have the last three years of data on disk and on a Teradata platform optimized for Online Analytical Processing (OLAP). In 2011, GAO soundly criticized the IDR for still not being complete since claims are being submitted 18 months afterward with the result that the information is more than a year out of date.

Christoph described how the Center for Program Integrity (CPI) is in place to handle fraud, waste, and abuse issues, and is building a new data warehouse sourced from claim processors. However, the HHS Office of Inspector General uses a separate data warehouse for its own investigations of fraud, waste, and abuse but even that data is now about a year out of date.

Christoph emphasized that with the new health IT environment, the data collected will expand from purely administrative data and will add vast amounts of clinical data. As Christoph sees it, the IDR will rapidly outgrow its current size as more state HIEs are established, as the NwHIN becomes more accepted, and as exchangeable EHRs become more prevalent.

Some of Christoph’s other thoughts are that states will become the hotbed of innovation—not the federal government. Also, industry will have to settle on standards without federal government intervention, security and privacy will need to be better enforced, and the Universal ID needs to be in place so people can be correctly matched to records.

For clinical trials and the resulting data to greatly contribute to the development of lifesaving therapies and cures, more patients need access to clinical trials, providers need to be made more aware of clinical trials, and costs need to be reduced for clinical trial recruitment and retention, according Jim Bialick, Vice President, Technology and Public Policy, for the Health IT Now Coalition.

He reports that clinical trials consume nearly 40 percent of pharmaceutical R&D funding. It has also been shown that a good percentage of pharmaceutical research studies are delayed for more than a month partly because people are not always informed about clinical trials and not because they don’t want to participate. It has been found that for every day that a drug is delayed, the sponsors lose up to $8 million.

In surveying patient participation in trials, it was found that 87 percent of patients are willing to share medical information that is included in their EHRs with researchers as long as it can’t be linked back to them personally. However, 91 percent of patients want to give approval before the information is shared among healthcare providers.

Cloud-based services although new to healthcare are in our future according to Jonathan Bush, CEO and Chairman, Athena Health. As Bush explained, cloud-based services must operate with a business model and provide enough incentives to use the services.

According to Bush, individuals and organizations exchanging data should have to pay in some way for this service. As he indicated, health IT has not progressed as fast as it should not because there isn’t appropriate technology, but due to the fact that there is no financial market for healthcare information as currently exists in other industries such in banking.

David Hartzband, D.Sc. Director for Technology Research at the RCHN Community Health Foundation and associated with MIT pointed out it is important to not only manage enormous amounts of data, but at the same time, be able to use ultra-large data sets efficiently. Today, the amount of data that needs to be analyzed is limited but increasing every year and as a result, analysts will be forced to work with more and more data on a huge scale.

A number of possibilities exist to analyze vast amounts of data from many sources. For example in the future, data could be used to determine how many patients in an EHR system had flu-like symptoms, be able to correlate the length of an acute respiratory infection while administering doses of specific medicines, and determine how effectively seasonal respiratory infections respond to different drug therapies.

As Hartzband said, “If we are going to be able to aggregate huge amounts of data, then new skills are needed to design and interpret the results. We are only at the beginning of using ultra-large data sets but eventually outcomes will improve, enable greater control of costs, and enable public health information to be better analyzed.”

Sandeep Purao, Ph.D., Research Director for the Center for Enterprise Architecture at Penn State University continued by adding his thoughts on handling the influx of data in the field and how important it is to add structure to deal effectively with the information explosion facing society today.

As he said, “Today, primary data comes from institutions and from public sources to support administrative and clinical tasks and systems. Since data is available everywhere in different formats this means that the entire life cycle of data has to make sense to be useful in healthcare.”

Critical areas to think about when working with data are scale, interoperability, security, and making sense of the data. Specifically, the tasks involve:

• Scale—Working with healthcare data can involve moving from gigabytes, to Terabytes, and then to Petabytes, working with cloud-based data, and then extracting the data

• Interoperability—Means doing important work on voluntary and consensus standards including HL7

• Security—Means dealing with malicious users, working with measures such as Role-Based Access, and preventing unlawful access to EHRs

• Sense-making—Means measuring data quality in crowd-based forums, searching for patterns and user behaviors, and delivering data to be used for e-health

For more information, email or

New Ideas to Spur Innovation

FDA Commissioner Margaret A. Hamburg M.D., released the document “Driving Biomedical Innovation: Initiatives for Improving Products for Patients” to address the sustainability of the medical product development pipeline which is slowing down despite record investments in R&D.

The blueprint focuses on:

• Rebuilding FDA’s small business outreach services
• Building the infrastructure to support personalized medicine
• Creating a rapid drug development pathway for important targeted therapies
• Harnessing the potential of data mining and information sharing while protecting privacy
• Improving consistency and clarity in the medical device review process
• Training the next generation of innovators
• Streamlining and reforming FDA regulations

Go to to view the document.

In another move, affecting medical device development, FDA and CMS have launched a parallel review pilot program to use when reviewing medical devices for FDA approval and Medicare coverage. Often device sponsors focus solely on obtaining FDA approval, only to find that Medicare coverage is not automatically forthcoming.

Both agencies rely on clinical data in reaching their decisions and while the two agencies have distinctly different regulatory responsibilities, parallel review can reduce the time between FDA approval and Medicare national coverage determinations.

The pilot program is voluntary and will not change the existing separate and distinct review standards for FDA device approval and CMS coverage determination. The review pilot is only available for qualifying new medical device technologies.

The pilot program will last for up to two years with possibilities for extension will focus on innovative technologies that can benefit from the efficiencies of parallel review. The pilot program will accept no more than three to five submissions per year.

“The pilot program will help FDA and CMS streamline the parallel review process so that it works efficiently for expedient patient access to safe and effective medical devices,” said Jeffrey Shuren, M.D., Director of the FDA’s Center for Devices and Radiological Health.

Go to to view the Federal Register notice. For questions, email Marham C. Luke at

Reaching Out to Patients

A $265,000 grant was recently awarded to the University of Nebraska Medical Center’s Munroe-Meyer Institute to help improve access to specialized epilepsy services while expanding telehealth technologies in rural areas in the state. Epilepsy clinics are now being offered to pediatric patients in rural Nebraska via telemedicine.

Currently, all of Nebraska’s pediatric neurologists and neurologist specializing in epilepsy have established practices in Omaha. This means that parents of children with epilepsy who live in rural Nebraska sometimes wait between four to six months for an appointment. When they do manage to schedule a visit with a specialist, many families have to travel 60 to 250 miles to the pediatric neurologist.

Project Access is a national program originally established in 2004 to help children and youth with epilepsy receive care in medically underserved and rural areas. The program is now in its third phase and has established state teams that are collaborating with the Epilepsy Foundation.

Recently the state’s Project Access initiative entered a partnership with the Epilepsy Foundation covering North/Central Illinois, Iowa, and Nebraska to link rural epilepsy patients from birth to age 18 with urban specialists using telemedicine.

The process is simple. Patients check in at either good Samaritan Hospital in Kearney or at a telemedicine site approved by Medicaid close to their hometown. Nurses set up the visit via telemedicine technology, so patients are face-to-face with a pediatric neurologist located in a specially designed telemedicine examination room at UNMC’s Munroe-Meyer Institute in Omaha.

“These clinics have the potential to bring top-notch epilepsy care to the remote areas of our state,” said Joseph Evans Ph.D, Director of Project Access-Nebraska. “Not only are we using telemedicine for actual medical visits, but we are also delivering support group services and epilepsy education via the Nebraska State Telehealth Network.”

For more information, email or contact Laura Neece-Baltaro at (402) 559-3014.

CMS Center Accepting LOIs

The CMS Center for Medicare and Medicaid Innovation led “Comprehensive Primary Care” (CPC) initiative is a new multi-payer initiative to foster collaboration between public and private healthcare payers.

The CPC initiative offers a way for payers to join with Medicare to invest in primary care in 5 to 7 selected locations across the country with approximately75 practices in each market serving up to 330,750 Medicare and Medicaid Beneficiaries over four years.

The CPC initiative will test two models such as a service delivery model and a payment model simultaneously. The service delivery model will test comprehensive primary care while providing planned care for chronic conditions and preventative care, engage patients and caregivers, and coordinate care.

The payment model includes a monthly care management fee paid to the selected primary care practices on behalf of their fee-for-service Medicare beneficiaries and in years 2 to 4 examine the potential to share in any savings to the Medicare program.

Building in the “medical home” concept, the CPC initiative aligns multi-payer reform with practice transformations while holding practices accountable for total cost of care. Practices will be able to engage in systematic data sharing and collaborative learning experiences and share savings achieved at the market level.

Practices will also receive compensation from other payers participating in the initiative that will include private insurance companies and other health plans to enable them to integrate multi-payer funding streams.

The first step for public and private payers including states if interested is to submit a nonbinding Letter of Intent (LOI) and a completed Geographic Service Area Worksheet by November 15, 2011 sent via email to

Final applications are to be completed only after the LOI has been submitted with final applications due by January 17, 2012. Once CMS evaluates the proposals and selects the markets, a second solicitation will be issued recruiting and selecting primary care practices in those markets.

Go to to view the solicitation.

NIH Issues Several FOAs

Concerns about high and ever-rising healthcare expenditures, efficiency, and quality of health care have accelerated in recent years. The Affordable Care Act has motivated public and private insurers, large employers, healthcare providers, and various research and policy centers to devise and examine new ways to structure, organize, and pay for healthcare.

However, a research study focused on a service delivery innovation intended to reduce costs may not provide enough data scientifically and may not examine cost or economic efficiency questions thoroughly. Valid replicable findings and studies considering the full range of outcomes relevant to these studies and innovations are needed.

On October 7th NIH issued Funding Opportunity Announcement (FOA) (RFA-RM-11-023) developed as a Common Fund initiative, to solicit high-quality, health economic research projects associated with large-scale federal and non-federal pilots, demonstrations, or other experiments in healthcare payment structure.

One of the areas of concern to researchers concerns studying innovations in the use of health information technology. This includes studying electronic health records for care coordination, especially across multiple healthcare organizations to examine the effect on efficiency, delivery, costs, and quality of care.

Eligible applicants can include higher education institutions, nonprofits, for-profits to include small businesses, and state and county governments.

NIH intends to commit approximately $2 million across this FOA and $2 million to its companion FOA (RFA-RM-11-024) also issued October 7th seeking economic studies to show how to increase the value of healthcare in projects that are currently in the planning stages but have not yet been implemented.

The plan is to fund 5 awards contingent on NIH appropriations and the submission of a sufficient number of scientifically meritorious applications. The application deadline for (RFA-RM-11-023) is February 9, 2012 and for (RFA-RM-11-024) the deadline is February 8, 2012.

Go to to view (RFA-RM-11-023) and go to to view (RFA-RM-11-024).

Medicaid Contract Awarded

The Florida Agency for Health Care Administration (AHCA) has signed a renewal service agreement with HP Enterprise Services to manage the state’s Medicaid Management Information System. The $172 million three-year renewal extension contract will help the state transition to a managed care environment and prepare for pending program changes. HP administers $95 billion in benefits a year and also serves as the fiscal agent or principal IT provider for Medicaid in 22 states.

HP helps Florida manage Medicaid benefits for more than 3.1 million beneficiaries in the state. The company processes more than 150 million claims worth more than $20 billion a year for about 114,000 Florida healthcare providers.

Through HP’s interChange Medicaid Management Information System, the company has provided fiscal agent support and business process outsourcing services to AHCA since 2008. Today, HP is helping the agency prepare for pending healthcare changes by assisting through the mandatory managed care transition, helping to implement HIPAA 5010 requirements, and help to support the move to ICD-10 procedure coding.

Since AHCA switched to the HP interchange Medicaid system, the company has implemented web-based provider enrollment, claims authorization and file exchange, and supported various agency initiatives. These include Medicaid reforms, the National Correct Coding Initiative to support claims coding standards, and the Medicare and Medicaid EHR Incentive Programs. To help in the adoption of EHRs, HP has implemented a low-cost, high efficiency decision support system to support health policy decision making.

HP plans to enhance Florida’s federally certified interchange MMIS with several new advances. From its facilities in Tallahassee, Florida, HP provides real-time claims processing, call center services, and oversees pharmaceutical support provided by a third party.

According to Susan Arthur, Vice President, U.S. Healthcare Industry, HP Enterprise Services, “HP built and manages a system for Florida based on the most advanced proven technology to streamline Medicaid procedures while providing the state with vital information on healthcare trends and the medical needs of Florida’s Medicaid beneficiaries.”

For more information, go to

Wednesday, October 5, 2011

DOD Seeks CCCRP Applications

The Department of Defense seeks applications for the “Combat Casualty Care Research Program” (CCCRP). The funding notice “Forward Surgical Enroute Care, Shock, and Tissue Stabilization” posted September 23rd requires applications by March 22, 2012. The funding is going to be used to address advances in biotechnology research.

The U.S. Army Medical Research Acquisition Activity (USAMRAA) issued the program announcement and will be negotiating all resulting awards while the Telemedicine and Advanced Technology Research Center (TATRC) located at Ft. Detrick will be administering the application process.

The four research priority areas to benefit both the civilian and military communities for FY 2012:

• Research on Forward Surgical/Intensive Critical Care to include physiological monitoring, closed loop controls, remote triage, non-invasive monitoring, treating vascular injuries and severe trauma

• Research on enroute care to study the impact of moving patients, study the patient’s physiology, study non-invasive methods for patient monitoring during transport, and develop life saving interventions for enroute care

• Research on mechanisms for immune-modulatory protection after hemorrhagic shock using complement inhibition, T-cell depletion, or T-cell sequestration

• Pre-clinical development of one or more pre-hospital resuscitation fluid strategies

Applicants must be independent investigators at any academic level from government, academia, research institutions, industry, and private foundations.

USMRMC will implement this research program through grants and cooperative agreements. The amount available for the four priority areas is approximately $19.5 million over three years and the maximum amount of funding for any award for all years is $3 million and is expected to result in 7 investigator-initiated awards.

For more information, go to

New York Issues Solicitation

New York State was awarded an “Early Innovator Grant” for $27.4 million to help the state design and implement the IT infrastructure needed to operate their Health Insurance Exchange. The state is to deploy their Health Benefit Exchange beginning July 2012 with the system to be fully implemented by January 1, 2014.

The NY Department of Health’s Office of Health Insurance Programs on September 26, 2011 posted a Funding Availability Solicitation (FAS) seeking bidders with demonstrated Quality Assurance (QA) expertise to oversee the work of the primary contractor selected to implement the New York State Health Benefit Exchange (NY-HX).

The QA contractor must be able to demonstrate expertise in health policy, public benefit eligibility systems, maximizing federal reimbursement, and be able to monitor the operations of a project the size of NY-HX. The system is to be built upon a Medicaid Information Technology Architecture (MITA) and also be able to integrate New York’s CHIP into the NY-HX.

The NY-HX will be designed to interoperate with other social benefit programs such as the Supplementary Nutrition Assistance Program, Temporary Assistance for Needy Families, and with parts of the Social Security Act relating to foster care.

The FAS is due on November 3, 2011 with all questions due by October 7, 2011. To view the FAS, go to For additional information, email Pamela Petrie Baldasaro at

Reducing Hospital Readmissions

Philips introduced their latest telehealth software at the annual meeting of the National Association for Home Care & Hospice held in Las Vegas October 1-5, 2011. The new telehealth clinical application includes features enabling customers to more efficiently care for chronically ill patients.

The software to be broadly available in December will help to improve workflow by building on intervention management capabilities to provide for closer collaboration among care team members. The system will also help to keep patients under closer watch by multiple clinicians until the patient is stable.

Specifically, the software expands disease management capabilities to include diabetes, hypertension, and co-morbidities, enhances higher levels of patient workflow tracking and analysis, improves clinical data collection, and provides clinical outcome and patient population reports.

Philips in trying to help leading providers find ways to reduce hospital readmissions and healthcare costs has just signed new remote patient monitoring contracts with eight large healthcare providers. These health organizations include Advanced Home Care, Atrius Health, Catholic Healthcare West, HealthPartners, Henry Ford Home Healthcare, Jewish Hospital & St. Mary’s Healthcare (VNA Nazareth Home Care), South Shore Visiting Nurse Association, and THA Group.

The health organizations agree that telemonitoring can reduce hospital readmissions. According to Gerrie Leppert, President/CEO of VNA Nazareth Home Care, “Telemonitoring is a key component for our success. Philips technology delivers patient education and monitoring devices like ECG and the steady scale. Results to date show a dramatic reduction in re-hospitalization rates.”

To contact Philips Healthcare in Andover MA, call 1-800-934-7372 or go online at

NQF Introduces New Tool

The National Quality Forum (NQF) launched the beta version of the “Quality Positioning System” (QPS), a web-based tool for finding and exploring ways to use NQF endorsed measures. QPS was developed with support from the Robert Wood Johnson Foundation to help users search in a variety of ways, such as by measure names, numbers, or key search terms as well as by condition, care setting, or data sources.

Each measure within QPS describes the numerator denominator and any exclusions plus the name of the measure developer, the endorsement date, whether it has been risk-adjusted, and whether eMeasures are available. Up to three measures can be selected at a time for side-by side comparison.

Additionally, QPS will allow users to create their own lists of NQF-endorsed measures in customized portfolios to fit specific interests or needs, share portfolios with others, and view and copy portfolios that others have generated. This function is designed to help users see other real-world application of measures in public reporting and in other programs.

“Use of standardized measures in healthcare is fundamental to promoting better, more affordable care, and to improve the health of individuals and their communities,” said Janet Corrigan, PhD, President and CEO of NQF. “QPS will make it easier to find nationally vetted and endorsed measures, so that organizations can more confidently build their public reporting and quality programs to produce comparable and useful performance results.”

Go to for more information, on NQFs state and community-based efforts.

PCORI Announces Funding

The Patient-Centered Outcomes Research Institute (PCORI) created by the Affordable Care Act as a non-profit governmental organization, released their PCORI Funding Announcement (PFA) to focus on PCORI Pilot Projects. PCORI is going to commit up to $13 million in 2012 in support of 40 awards. Funding may be requested for up to $250,000 in direct costs per year for up to two years.

The PCORI Pilot Projects will help PCORI develop national research priorities for patient-centered outcomes research. The pilots will support collecting preliminary data to be used in ongoing and future research.

Eligible projects under this PFA must address:

• Methods to bring together patients, caregivers, clinicians, and stakeholders in all of the stages in the research process

• Develop decision support tools for translating evidence-based care into healthcare practices, identify gaps in comparative evidence knowledge, develop predictive tools, and develop tools to assess the patient perspective when researching behavior and lifestyles with the patient’s control

• Studying the patient care team’s interaction in situations where multiple options for wellness, prevention, diagnosis or treatment exist

• The advancement of analytical methods for CER

Eligible applicants can be higher education institutions, nonprofits, for-profit organizations, government, and others such as regional organizations, faith-based or community-based organizations, Native American Tribal organizations, non-domestic entities, and foreign components of U.S. organizations.

A webinar will be held October 18, 2011, letters of intent are due November 1, 2011, and applications are due December 1, 2022. Go to to view the funding announcement.

ONC Awards Contract

The Office of the National Coordinator awarded a contract to App Design Inc. located in Itasca Illinois to work with ONC’s E-Consent Trial pilot project. The program is in place to find an effective, efficient, and innovative way to help patients understand their choices regarding privacy issues.

Patients today need to know when and how their healthcare provider can share their health information electronically. They also need to know what rules apply when sharing the information with a health information exchange organization.

The App Design project team will develop and pilot innovative ways to electronically implement existing patient choice polices while improving the business processes for healthcare providers. The formal launch for the E-Consent Trial project will take place this month.
Go to to view the Statement of Work.

Sunday, October 2, 2011

Secretary Speaks at AdvaMed2011

The need to sustain U.S leadership in medical technology was voiced at the “AdvaMed2011: The MedTech Conference” held September 26-28 in Washington D.C. “For decades, the medical device industry has been a shining example of American innovation and creativity” said Kathleen Sebelius, HHS Secretary speaking at the conference luncheon on September 28th.

She praised the development of medical products from coronary stents to dialysis technology to cutting edge imaging. Other technology recently cleared by FDA, includes the first test to diagnose the early stages of Q fever, an emerging infectious disease among U.S. soldiers serving in Iraq and worldwide and the first ever mammography device to provide 3D images for breast cancer screening and diagnostic purposes.

The Secretary pointed out that the medical device sector is one of the few areas of the American economy that consistently runs a trade surplus and exports are expected to continue to grow. The Department of Commerce projects that the growth of exports will continue to grow at an annual rate of 5 to 10 percent.

Secretary Sebelius discussed FDA’s plans for the future. The government needs to work with the medical device industry to ensure the timely approval of safe and effective medical devices. To does this, the agency must continue to streamline and modernize FDA processes and procedures and make device approval and clearance not just scientifically rigorous but also clear, consistent, and predictable.

As announced, FDA is creating a network of external experts to help resolve complex scientific issues related to the development of medical devices and to improve the business process for information technology. The agency plans to establish an “Innovation Pathway” to streamline the regulatory pathway for breakthrough medical devices

FDA is also working with Medicare and Medicaid to establish a process for doing premarket evaluations and reduce the time and uncertainty surrounding coverage decisions for these programs.

According to the Secretary, steps taken by FDA in 2011 so far include:

• In January 2011 FDA announced 25 steps the agency will take in 2011 to improve the predictability, consistency, and transparency in their programs

• FDA has established an internal Center Science Council to actively monitor quality and performance in the agency

• FDA has published a series of draft guidances for both industry and staff to help address confusion and uncertainty about key parts of the premarket review, clinical trial programs, and how the agency should make benefit-risk determinations

• FDA has launched a new training program for new reviewers

To specifically address mobile medicine applications, Bakul Patel, Policy Advisor on mHealth and Medical Devices for the Center for Devices and Radiological Health at FDA took part in an AdvaMed panel on wireless health.

The recent FDA public workshop on September 12-12, 2011 was held to listen to comments on mobile medicine applications. With the FDA Guidance document on Mobile Medicine Applications released July 2011, FDA is examining what their regulatory authority should be concerning software applications for use on mobile platforms.

As Patel explained, FDA held the workshop to hear various approaches on not only mobile medical applications but also to discuss the issue of accessories related to mobile medical applications. The FDA also has to give consideration to Clinical Decision Support (CDS) in terms of defining stand-alone CDS software.

For more information on the AdvaMed2011 Conference, go to

Senate Approves FY 2012 Bill

The Senate Labor, Health and Human Services, and Education, and Related Agencies, Appropriations Subcommittee approved a FY 2012 bill that would provide $158 billion in funding. The bill provides $30.5 billion, a decrease of $190 million to fund biomedical research at the 27 Institutes and Centers that comprise NIH. The bill also provides funds through several new initiatives called “Race for the Top” to provide for education reform, and the “Workforce Innovation Fund” to provide training,

The bill creates the National Center for Advancing Translational Sciences (NCATS) but the bill would terminate the NIH National Center for Research Resources. A new program within NCATS called the Cures Acceleration Network (CAN) is included in the bill to help speed the translation and application of discoveries that have shown signs of success at the laboratory level but have not advanced far enough to attract significant investments from the private sector.

The bill provides $20,000,000 for CAN to make grants to biotech companies, universities, and patient advocacy groups, and will also help FDA review for the high-need cures that are funded by this initiative.

The bill includes $4 billion to operate CMS while the FY 2011 level was $3.6 billion. Additional funding is needed to accommodate an increase in the Medicare population, as 2011-2012 are the first years that the baby boom generation will begin enrolling in this program.

The bill includes $581 million for the Health Care Fraud and Abuse Control activities at CMS. For fraud and abuse activities throughout Medicare and Medicaid, the Federal government saves or recovers $6 for every $1 spent.

The bill includes $1.6 billion for Community Health Centers (CHC). The FY 2012 program level for CHCs is $2.8 billion, an increase of $200 million. This level will enable base grant adjustments for all existing CHCs and the expansion of the national network of clinics. The bill also includes $678.6 million for Community Services Block Grants to help ensure a safety net at the local level for vulnerable Americans.

For more information, go to

NIH Center Using Biograph mMR

Researchers have a new weapon in their arsenal to diagnose and treat service members and civilians diagnosed with TBI and PTSD. NIH’s Health Clinical Center, a research hospital began imaging patients on a first-of-its-kind on the whole-body using both PET and MRI scans simultaneously.

The new technology referred to as “Biograph mMR” offers a more complete picture of abnormal metabolic activity in a shorter time frame than separate MRI and PET scans and eliminates the need for two separate tests. Researchers at the NIH Clinical Center will also use the “Biograph mMR” to study patients with other brain disorders, cardiovascular disease, and cancer.

David Bluemke, M.D., Ph.D., Director of the NIH Clinical Center for Radiology and Imaging Sciences said, “The MRI points us to the abnormalities in the body, and the PET tells us the metabolic activity of that abnormality be it a damaged part of the brain or a tumor.”He also said, “The new device makes patient care swifter and safer. The faster turnaround time and more comprehensive results will help diagnose patients at an earlier stage of disease.”

The purchase of the “Biograph mMR” was made possible through the Center for Neuroscience and Regenerative Medicine (CNRM), a Department of Defense-funded collaboration between NIH and the Uniformed Services University of the Health Sciences.

The CNRM does research on TBI and PTSD at the Walter Reed National Navy Medical Center now located in Bethesda Maryland. The CNRM is developing innovative approaches to use to diagnose and prevent long term consequences resulting from TBI. Under the CNRM Diagnostics and Imaging Program, researchers characterize each patient’s injury to optimize diagnosis and inform the patient on the plan of treatment.

Opportunities at USTDA

The U.S Trade and Development Agency (USTDA) invests in infrastructure and industrial projects in middle-income and developing counties. The agency contracts with U.S. companies to advise the agency on funding proposals plus the agency contracts with U.S. firms for products and services. Almost all contracts with USTDA are reserved for small businesses.

The agency seeks technical experts qualified in health, telecommunications and information technology, manufacturing, finance and in other areas such as energy, transportation, and environment.

To meet their needs, USTDA has developed a “Consultant Database” for Small U.S. Businesses. Consultants can receive contract assignments lasting anywhere from several days to several weeks based on the complexity of the assignment.

USTDA uses consultants and contractors to provide technical advice to the staff so that the staff may evaluate potential investments in feasibility studies and other project planning services. Consultants and contractors are then required to write detailed technical reports supporting their views.

USTDA awards small business contracts called “Desk Studies”. Contractors do research in the U.S to develop information on a project and with “Desk Studies” no overseas travel is required. Another type of small business contract is called “Definitional Missions” to develop the technical information needed but “Definitional Missions” requires a short-term visit overseas. Requests for “Definitional Missions” are posted on

USTDA now requires all small businesses interested in working with the agency to register in two places. The first place is to be included in the Consultant database. The second place to register is the Central Contractor Registration at By registering in CCR, your organization will not only be of value to USTDA but also to other government agencies and private companies. Registration is free for both registrations.

As an example of an USTDA contract awarded this past spring, USTDA awarded the Vi Na Group Corporation (VNG) a grant to examine the feasibility of establishing a cloud computing business in Vietnam.

The $402,675 feasibility study project awarded to Pathway Systems LLC in St. Louis Missouri, involves examining the growing demand for data center services, while minimizing costs and filling the infrastructure gaps that exist in the growing Vietnam internet and ICT market. In addition, the study will look at information technology applications services to customers who lack the financial resources or justification to maintain their own computer systems.

The study will define the market opportunity, strategy, size, scope, implementation plan, and tendering process for the cloud computing data center and provide procurement documents required for VNG to acquire all of the facility’s components.

Go to for more small business information or Contact Walter Knott, Small and Disadvantaged Business Utilization Contracting Officer at (703) 875-4357.

NIDDK Supports CKD Research

Chronic Kidney Disease (CKD) is an important public health problem which affects more than 26 million people in the U.S. However, racial/ethnic minority groups and low income populations bear a disproportionate burden of CKD particularly with End Stage Renal Disease (ESRD).

Researchers in the field hypothesize that public health systems which disproportionately care for diverse populations do not consistently identify or provide recommended care to persons with CKD who are at the highest risk for progressive disease.

Dr. Yoshio Hall, Assistant Professor in Nephrology at the University of Washington is the lead investigator for a project initiated in 2010 and supported by grant (K23DK087900-01) awarded from the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) to study CKD in medically underserved populations.

The research to be completed in 2015 will help to discover which patient-centered interventions could be used to improve the delivery of care to diverse populations and decrease the growing burden of CKD and ESRD to society

The research project will include recruiting and maintaining a patient cohort, performing and validating diagnostic tests, developing and maintaining a CKD registry from multiple data sources, provide training in health IT and advanced statistical and epidemiologic methods, and design pilot intervention studies.

The researchers will analyze data from Harborview Medical Center, the largest public hospital system in Northwestern U.S and from the Community Health Network, a large safety net health system in Northern California.

For more information, email or call (206) 277-3202.