Sunday, October 31, 2010

NIH Issues RFP

Recently, NIH’s Information Technology Acquisition and Assessment Center (NITAAC) issued RFP (NIHJT2010002) for the new Chief Information Officer-Solutions and Partners (CIO-SP3) Government Wide Acquisition Contract (GWAC) that includes a set-aside for small businesses.

This GWAC is the successor to NIH’s current (CIO-SP2i) and the Image World 2 New Dimensions GWACs which will expire in December 2010. This successor GWAC was put in place to support government IT efforts with a focus on health and biomedical-related IT services.

The NAICS code for this procurement is (541512) with a size standard of $25 million. This procurement has been issued as a total small business set-aside with further set-asides for Section 8(a) vendors, HUBZ vendors, and Service Disabled Veteran-Owned Small Businesses.

The specific task areas listed in the RFP are:

• IT services for biomedical research, health sciences, and healthcare
• Chief Information Officer support
• Imaging
• Outsourcing
• IT operations and maintenance
• Integration services
• Critical infrastructure protection and information assurance
• Digital government
• Enterprise resource management
• Software development

To download the solicitation due by January 14, 2011, go to HHS at www.fbo.gov for the solicitation released October 26, 2010. For background information on the solicitation, go to the September 17, 2010 “Federal Telemedicine News” article “NIH Issues RFP” http://telemedicinenews.blogspot.com/2010/09/nih-issues-rfp.html and to the August 24, 2010 article “NIH Issues Pre-Solicitation Notice” at http://telemedicinenews.blogspot.com/2010/08/nih-issues-presolicitation-notice.html.

For more information, contact Ed Wigus, Contracting Officer at wilguse@od.nih.gov or call (301) 402-8360.

Tissue Banking in the "Cloud"

NCI’s Cancer Biomedical Informatics Grid (caBIG®) is an information network enabling everyone in the cancer community such as researchers, physicians, and patients to share data and knowledge. NCI’s goal is to connect science and practitioners through a shareable and interoperable infrastructure.

By establishing the information network, NCI is transforming biospecimen management operations at their NCI Community Cancer Centers Program (NCCCP) using a combination of caBIG® and cloud computing technology. Cloud computing is a concept relying on computer networks harnessed together by the internet to handle computer data.

NCI’s October “caBIG Links” newsletter reports how a team at St. Joseph Hospital in Orange California, a participant in NCI’s CCCP, is working with caBIG® support on a ground breaking effort to manage tissue samples in the “cloud.”

St Joseph Hospital knew that they wanted to work with NCI’s knowledge in this area and implement a biospecimen repository in the “cloud”. However, the startup costs and labor needed to manage biomedical samples and related information was initially too great for the hospital but fortunately additional funding came in 2009 through a local family foundation. The foundation’s family had a son who was treated for cancer at St Joseph and was so impressed with their dedication to developing a Biospecimen Repository that the family foundation donated $100,000 to support the project.

At that point, St Joseph’s Executive Medical Director, Dr. Lawrence Wagman and Chief of Pathology Dr. Aaron Sassoon, assembled a biospecimen team. The team included the pathology manager, a colorectal surgeon, anesthesiologist, and IT architect Joshua Mann. The team discussed their needs, the planning process, and how they were going to accurately annotate the specimens to ensure compliance with NCI.

To answer critical questions, the team turned to Christiana Care Health Services headquartered in Wilmington Delaware for some guidance since Christiana was developing a similar model for the kind of biospecimen repository needed at St. Joseph. At this point, Christiana was customizing their “ca Tissue” module supplied by NCI.

Leveraging the policies and procedures already well established by Christiana Care, the team set out to launch a similar biobanking effort. Joshua Mann’s plan was to implement St. Joseph’s own “ca Tissue” with one major difference. The system would not be installed at St Joseph’s but would be hosted offsite and access to data and information would occur “in the cloud” to make it simple for all sites to access.

“The implementation of “caTissue” at St. Joseph’s marks the beginning of a broader effort to digitize all of health information collected and stored onsite. We started off with a completely manual process to manage specimens collected onsite but when “caTissue” is fully online, we will be able to use a bar-coding system to track the specimens and be able to link to clinical and other information associated with a given sample,” reports Maria Gonzalez, Cancer Research Manager at St Joseph’s Center for Cancer Prevention and Treatment.

"Early Innovator Grants" announced

HHS just announced new competitive funding for “Early Innovator” grants so that states will be able to design and implement the information technology infrastructure needed to operate health insurance exchanges. The grants will reward states that demonstrate leadership in developing cutting-edge and cost effective consumer-based technologies to help develop the models needed for the exchanges to deal effectively and efficiently with insurance eligibility and enrollment issues.

“States are focused on implementing the health insurance exchanges because they know the exchanges will empower their citizens by forcing health insurers to compete,” said Secretary of Health and Human Services Kathleen Sebelius. “Consumer-friendly information technology is the backbone of that effort which is why we are creating an incentive for states that are willing and able to lead the way to do so.”

Although exchanges are not scheduled to launch until 2014, work is already underway to design and implement them across the country. Two year grants will be awarded by February 15, 2011, for up to five states or coalitions of states that have ambitious yet achievable proposals that will yield IT models and best practices to benefit all the states.

Additionally, all states including recipients of the awards will be eligible to apply for a future funding opportunity that will support ongoing exchange implementation. HHS expects this funding opportunity to be announced in February. 2011.

“States are developing cutting-edge innovative systems to deliver cost-effective and consumer friendly care to families and small businesses,” said Joel Ario, Director of the Office of Consumer Information and Insurance Oversight. “By encouraging and rewarding states for their innovation, we can build and leverage models that can be adopted and tailored by other states and generate taxpayer savings across the board.”

NSF Grant to Help State

The National Science Foundation (NSF) awarded the Nebraska “Experimental Program to Stimulate Competitive Research” (EPSCOR) a $1.7 million grant over the next two years to invest in a statewide cyber backbone for high-speed data and video transfer.

The NSF investment will expand the Nebraska University Region Optical Network (NURON), a high bandwidth fiber ring operating between Lincoln and Omaha campuses of the University of Nebraska. Eventually, NURON will be connected to the University of Nebraska at Kearney, Creighton University, Wayne State College, and several smaller institution and tribal colleges in the eastern part of the state.

Expanding Nebraska’s cyber infrastructure resources will facilitate interdisciplinary academic research collaborations across the state and more fully connect Nebraska Education to the Nebraska Statewide Telehealth Network.

Connecting the telehealth network to NURON will provide integration among nearly all of the hospitals and public health departments in the state. Several years ago, it was found that when 8,000 participants used video conferencing from a hospital or public health department site, over one million was saved in travel time and over one million in mileage costs.

“All of Nebraska stands to gain by this investment,” said University of Nebraska President James B. Milliken. “With this project, our colleges and universities will have enhanced opportunities for advanced research and collaborations so that our rural residents will have greater access to education and specialized healthcare.”

Ohio Program Issues RFP

The Ohio Third Frontier Wright Projects Program (OTFWPP) issued their FY 2011 Request for Proposals on October 20, 2010. OTFWPP’s purpose is to provide funding for capital equipment to serve a commercial purpose in the short-term and in the long term, help train and educate the current and future workforce in the state. OTFWPP funding helps support commercialization collaborations at Ohio universities and colleges, other non-profit research institutions, and at Ohio companies.

Biomedical proposals must address areas such as drug development, diagnostics and therapeutics, or medical devices. Information technology is considered an enabling technology area to supports research and commercialization in technology areas therefore, information technology is only eligible to the extent that it supports the biomedical proposal.

At the end of three years, the commercialization project included in the RFP must be mature enough to have completed demonstrations of commercial market products or processes and achieve market entry for the products and process.

To meet the commercialization requirements, the proposal must include information on achieving market entry, potential for the products, size opportunity in the market, markets that are of sufficient size, have growth potential, customer readiness, long term financing to support the commercialization, ability to compete globally, a sustainable competitive advantage, and the existence of the workforce to support the commercialization effort.

The Lead Applicant must either be an Ohio college or university or non-profit public or private research organization or public body in Ohio. Proposals must include collaborations between institutions or organizations meeting the eligibility requirements and at least one Ohio for-profit company.

OTFWPP anticipates awarding up to $21 million in grants through FY 2011. Funding of $18 million will come from the Wright Capital Fund and $3 million from the Third Frontier Research and Development Fund. Six to ten grants are to be awarded with each grant to be in the range of $1 to $3 million. Project funds requested are not to exceed $500,000.

A bidder’s conference will be held November 10, 2010, letters of intent are due November 30, 2010, and the proposal is due by January 20, 2010. To download the proposal, go to www.thirdfrontier.com/Documents/FY2011OTFWPP-RFP.pdf. The RFP is administered by the Ohio Department of Development, Technology, and Innovation Division in Columbus Ohio. For more information, call (614) 466-2480 or go to www.development.ohio.gov.

Wednesday, October 27, 2010

State Conducts Telehealth Survey

The state of Maryland held several roundtables to discuss improving access to primary and specialty care in rural areas and how to implement the Maryland Rural Health Plan released by the State Office of Rural Health in 2007.

In 2009, it was decided to do a statewide inventory of current telehealth/telemedicine projects so that the state could move forward. The Maryland Rural Health Association (MRHA) was put in charge to administer the survey in cooperation with the Rural Maryland Council (RMC).

In 2010, the Upper Shore Regional Council and a member of the RMC’s Health Care Working Committee and the Telehealth Subcommittee received grant funding to do the telehealth/telemedicine survey. A roundtable discussion will be held December 6, 2010 to review the results.

However, in the meantime, a review draft or interim report based on the results gathered from the survey as of September 2010 was compiled and released. According to the draft Report, 95 facilities were surveyed. So far, four major conclusions can be drawn from the information and the comments received so far.

First of all, there is a need for reimbursements by state Medicaid and other third-party payers for telehealth/telemedicine services along with other funding streams to support the cost of buying, setting up and maintaining equipment plus funds are needed for related administrative costs.

Maryland is one of only 18 states that Medicaid does not reimburse for telemedicine services. Twenty six states have private payers reimbursing for telemedicine but Maryland is not one of them. Recently the Department of Health and Mental Hygiene (DHMH) approved regulations to allow Medicaid reimbursement for telemental services delivered in areas DHMH designate as underserved.

In addition, although federal funding for telemedicine has expanded in the last few years, Maryland has lagged behind other states in securing funds. For example, the USDA Distance Learning and Telemedicine program has not funded Maryland since 2003 when Sheppard Pratt received funding to start a telemental service.

The FCC Rural Healthcare Pilot Programs awarded 69 statewide or regional broadband telehealth networks in 43 states, but none in Maryland. Some projects have been funded to develop telemedicine/ telehealth projects, but have not been included in a coordinated statewide plan.

The survey reports that there is a lack of state leadership surrounding telehealth coordination. Services are not coordinated through any one agency or organization and so at the present time, multiple state and federal agencies are funding telehealth and telemedicine projects. As a result, the state continues to miss out on federal funding opportunities because of this lack of coordination. This also means that individual facilities have started projects on their own and indicate that they do not have an accurate inventory of the projects within their own systems.

Also, poor access to high speed broadband services in rural areas deprives some rural residents access to state-of-the-art medical care. In addition, with so many projects being started in isolation, there is a real risk that the technological infrastructure being developed and implemented in one facility will be incompatible with other facilities.

The University of Maryland, School of Law held a roundtable on the legal impediments to telemedicine in April 2010. The attendees looked at the legal questions that are still unresolved involving licensing and credentialing across state lines. The Law School has prepared a White Paper, “Legal Impediments to the Diffusion of Telemedicine” clearly laying out the conflicts and the questions that still remain.

For more information email Michelle Clark Executive Director of the MRHA at mrha@allconet.org. Go to www.rural.state.md.us/Publications/Interim_Telehealth_Report.pdf to download the Interim Report. For details on the “Maryland Telehealth Telemedicine Survey Roundtable” to be held December 6, 2010 in Annapolis Maryland go to www.rural.state.md.us/Roundtables/RRT10_Telehealth.htm. The School of Law’s White Paper is available on that site.

DOD Awards Grant

The Department of Defense awarded a $5 million grant to the Feinstein Institute for Medical Research and to the University of Cincinnati to develop a “lab-on-a-chip” device to use to monitor patients suffering from severe brain injury.

In order to manage severe brain trauma, cutting-edge tools need to monitor patients during the critical first few hours and days after an injury. The Feinstein Institute neurosurgeons at the North Shore-LIJ Health System are collaborating with engineers and neurosurgical colleagues at the University to design a device to provide continuous monitoring of key biochemical and physiological parameters.

Tools to measure intracranial pressure have been available for over 25 years, but there are also many other changes going on inside the brain that are difficult to monitor. The device under development is a “lab-on-a-chip” designed to measure other parameters in addition to intracranial pressure such as brain temperature, brain tissue oxygen levels, glucose, and potentially other biochemical markers.

DOD is interested in the device for wounded soldiers in the theater. “When soldiers are injured, there is a great need for this kind of monitoring and it is critically important during transport,” said Raj K. Narayan, M.D, Chairman of Neurosurgery at North Shore University Hospital and LIJ Medical Center.

Dr. Narayan started work on the device during his tenure as Chair of Neurosurgery at the University of Cincinnati, College of Medicine, and the Mayfield Clinic. He recently recruited Chunyan Li, PhD from the University of Cincinnati’s Department of Computer Science and Engineering to help oversee the project. The grant funding will enable the team to complete the engineering on the device and then test it in laboratory models.

MIT's Technology Research

The Deshpande Center for Technological Innovation at MIT awarded $800,000 in grants to ten MIT research teams currently working on early stage technologies. The projects may contribute to diagnostics, medical procedures, diabetes treatment, vision correction, software, high power electronics, and solar energy efficiency.

Specifically, some of the grants were awarded to:

• Develop an on-chip diagnostic device for use in clinical settings to use at the point-of-care
• Develop a drug delivery device to treat cerebral edema to reduce the systemic side-effects typical for conventional treatments
• Develop tissue specific adhesive materials to match tissue types so that leakage can be reduced after surgery
• Develop a low cost mobile diagnostic tool for self-evaluation of eye refractive disorders
• Develop a robotically steered electrode for image-guided thermal ablation of tumors that could eliminate the need for open or laparoscopic surgery for some patients.
• Develop a wearable sensor to use to continuously monitor diabetic patients

The Deshpande Center’s goal is to move technologies from the MIT laboratories to the marketplace. The Center helps grantees assess and reduce the technical and market risks associated with their innovations.

In addition to financial support, the Center’s network of entrepreneurs, venture capitalists, and academic and legal experts help recipients assess the commercial potential of their innovations so they can develop their business plans or licensing strategies.

The Center has provided $11,000,000 in grants to more than 70 MIT research projects since 2002. Twenty two projects have spun out of the center as independent start-ups, and collectively raised over $180 million in outside financing from investors.

In the Harvard-MIT Health Sciences and Technology program, a graduate student Ming-Zher Poh is working on developing a new system to continuously check a person’s vital signs, pulse, respiration, and blood pressure. He wants to make it possible for a person to be positioned in front of a low-cost camera such as a laptop computer’s built-in webcam and be monitored. The concept of using a camera to detect health information is not entirely new, but the ability to use low-cost camera equipment to achieve the result is new.

Poh suggests that such noninvasive monitoring could prove useful where attaching sensors to the body would be difficult or uncomfortable particularly when monitoring burn victims or newborns. It could also be used for initial telemedicine screening tests over the internet using a patient’s own webcam or cell phone camera.

Poh’s project won third place and a prize of $50,000 in the second annual Primary Healthcare Competition run by the Center for Integration of Medicine and Innovative Technology (CMIT). CMIT was created by a group of physicians at Boston-area hospitals in collaboration with the mechanical engineering faculty at MIT to develop new devices to meet clinical needs.

Telepsychiatry to Treat Youths

An initial pilot study sponsored by Oregon Health and Science University will examine how best to use telepsychiatry (TP) to treat rural youths 6 to 17 years old. The study will explore how offering telepsychiatry care to kids who live in rural areas will help them.

The problem our country faces is that it is difficult to provide kids who live in rural areas good psychiatric care. There are only about 7000 pediatric psychiatrists in the entire country. Even when adding nurse practitioners who specialize in mental healthcare for children there still isn’t enough help available for everyone that needs care.

The pilot specifically addresses children and adolescents with Attention Deficit/Hyperactivity Disorder (ADHD) and especially children and adolescents with co-occurring psychiatric conditions because of high co-morbidity rates in ADHD. Co-morbidity is present in as many as two-thirds of children with ADHD including up to 50 percent for other disruptive disorders, 15 to 20 percent for mood disorders, 20 to 25 percent for anxiety disorders, and 15 to 20 percent for learning disorders.

The researchers will find study subjects when parents seek care at clinics in rural Oregon. The physicians will be aware of the study and will refer the children to the study when they think a child or youth needs care from a specialized mental health professional that is either a pediatric psychiatrist or a nurse practitioner with extensive experience in pediatric mental health.

At the first visit, the mental health profession will determine if the diagnosis is correct and if so, the parent and child will then be given an exam to confirm the ADHD diagnosis. If accepted into the study, the youth will then be assigned to the mental health professional.

The subjects will be split into two study groups. As subjects are identified, they will be assigned a screening number according to a randomization table. The study will then use TP for one group and face-to-face (F2F) care for the other group.

Since this is an initial pilot study, the information collected will mainly offer a better understanding of whether or not a larger study is possible or needed. The researchers will look at how many of the youths stayed in the study or dropped out. The plan is to also study whether those subjects part of the TP group did as well or nearly as well, as those in the F2F group.

The study with an estimated enrollment of 50 to start in 2010 and be completed in 2011 was first received March 2010 but was updated in October 2010. The contact for the clinical trial identified as (NCT02096953) is Eric D. Colling at collinge@oshu.edu.

Alaska Provides Dental Care

Dental therapists with two years of intensive training provide safe, competent, and appropriate dental care, according to an independent evaluation of a pilot program in Alaska designed to expand access to dental care. The two year evaluation just completed is the first independent evaluation of its scale to assess care provided by dental therapists practicing in the U.S. It confirms that dental therapists are able to provide safe care for underserved populations.

In Alaska, dental therapists under the general supervision of dentists have been providing preventive and basic dental care to families in remote Alaska Native villages since 2006. The program evaluation conducted by RTI International of Research Triangle Park, in North Carolina, and funded by the W.K Kellogg Foundation, the Rasmuson Foundation, and the Bethel Community Services Foundation, found that dental therapists in Alaska are clearly providing safe dental services.

Severe shortages of dentists disproportionately affect low income communities and communities of color which has resulted in putting sorely needed dental services out of reach for nearly 50 million Americans, particularly in rural and underserved areas. There are 60,000 Alaska Natives living in small rural Alaska communities that are accessible only by air or water. In most villages, a dentist is available for only one week a year.

The evaluation revealed that of the 405 Alaska Natives surveyed, it was found that over half of all children have had untreated dental decay as do 60 percent of adolescents and 77 percent of adults. Tooth decay rates among American Indian and Alaska Native children are five times the national average for children from two to four years old.

“Dental therapists in Alaska are performing well and operating safely within their scope of work,” said Scott Wetterhall, M.D., RTI’s principal investigator and lead author of the evaluation report. He noted, however, that the evaluation did not assess the overall impact of dental therapists work and that there is still a tremendous amount of dental diseases and unmet dental need.

Mary Willard, Clinical Director of the Dental Health Aide Therapist Training Program in Alaska, reported that the students spend 40 hours a week in clinical training for a year on top of an intensive year of classroom training.

It was found that four of the five communities receiving dental care successfully provided preventive treatment children at high risk for cavities and adults overwhelmingly reported a positive experience with dental therapists. Although the study did not attempt to quantify changes in access to care, the survey of Alaska village residents felt that access to care had improved.

“The survey findings clearly indicate that alternative providers such as dental therapists can successfully provide good, quality dental care in areas where people can’t gain access to dentists,” said Sterling K. Speirn, the W.K. Kellogg Foundation’s President and CEO. He continued to say “Other states and tribal areas should explore the dental therapist model as a way to expand the reach of dentists.”

Internationally, dental therapists have a long history of successfully expanding high quality care to underserved children and families as part of a comprehensive system of care managed by dentists. Dental therapy has been well established for decades in more than 50 countries including those countries with advanced dental care systems similar to the U.S.

Go to www.wkkf.org/what-we-support/healthy-kids/dental-therapy.aspx for a copy of the full report and videos of the Alaska dental therapist program. For more details, email Fiona Brosnan, Alaska Native Tribal Health Consortium at fmbrosnan@anthc.org.

Sunday, October 24, 2010

Conference Showcases Global Markets

“There are few subjects more important than the dramatic developments taking place in the medical technology industry,” reports Commerce Secretary Gary Locke keynote speaker at the AdvaMed2010 Medical Technology Conference held October 18-20 in Washington D.C. Over 1,700 medical device and diagnostics leaders were on hand to listen to the Secretary’s assessment that the U.S. med tech industry is strategically positioned to remain a vibrant, progressive industry and a dominant player in the global market for the foreseeable future.

The Secretary reported that the President’s National Export Initiative (NEI) is working to increase exports in general but is also expanding opportunities for med tech companies. Several promotional export efforts are underway. For example, NEI is planning a series of med tech seminars in 2011, working to improve access to credit especially for small and medium-sized businesses, and in addition, the Export-Import Bank has devised a Medical Technologies Initiative to enable more buyers to qualify for Export-Import support.

The Department of Commerce is actively engaged in working with key emerging markets to promote trade for med tech companies in countries such as:

• China—U.S med tech exports to China are projected to increase by 5 to 10 percent annually over the next five years as China implements healthcare reforms and expands health insurance coverage. Last year, U.S. medical device exports to China including Hong Kong exceeded $1.2 billion

• India—Medical product imports in India have increased by a compounded annual growth rate of 12 percent over the past 20 years. This pace of growth is expected to continue, because high-quality healthcare products are sought after by India’s growing middle class with a population around 300 million that has rising disposable income and increasing medical expectations

• Brazil—Compounded annual growth rate for total market size and med tech imports in the country have exceeded 20 percent from 2004 to 2009. The Commerce Department is concerned about recent proposals to restrict market access and these issues are being addressed though U.S. / Brazil Commercial Dialogue. “Brazil Trade Net” is the trade promotion web site for Brazil’s Ministry of External Relations and is in place to stimulate exports and to attract direct investment to the country

• South Korea/ASEAN—South Korea is one of the largest markets for medical devices with a market value expected to exceed $3 billion in 2010. Within the ASEAN countries, healthcare is a priority with plans to modernize and integrate healthcare sectors across the region. A number of Southeast Asian countries including Malaysia, Indonesia, Singapore, and Thailand have compounded annual growth rates exceeding 10 percent over the past five years

To attract businesses to Puerto Rico, Salvatore Casale-Villani, Esq. an exhibitor at AdvaMed 2010, explained that Puerto Rico now has 15 top selling medical device manufacturers located on the island. He reports that medical device companies have invested over $600 million on the island since FY 2007. Building on 40 years plus of experience as a worldwide hub for the manufacture of pharmaceuticals, Puerto Rico is looking forward to the next wave of life sciences development.

Doing business in Puerto Rico enables companies to operate within a U.S. jurisdiction while taking advantage of a foreign tax structure. An R &D incentive provides incentives based on increased R& D corporate spending and/or working with an academic researcher on the island.

Also, researchers from Puerto Rico’s universities and research centers have access to federal research funding from federal agencies such as NSF, NIH, NCI, NOAA, and NASA. There are more than 30 federally funded research programs currently underway in the biosciences area on the island and today there are over 150 clinical trials being conducted on cancer, HIV, metabolic disorders, and infectious diseases.

For more information on doing business in Puerto Rico, go to www.pridco.com or contact Salvatore Casale-Villani,Esq at (787) 764-1175 ext (4009) or email scasale@pridco.com.

For more information on AdvaMed2010 or on the future 2011 AdvaMed Conference to be held September 26-28, 2011 in Washington D.C., go to www.advamed.org.

VA Seeks Teleaudiology Carts

The Veterans Administration is developing a teleaudiology pilot to determine if it is feasible to provide audiology services to program hearing aids over the VA’s intranet. On October 21, 2010, the VA posted the solicitation (VA79110RP0027) on www.fbo.gov. Phase I of the pilot will focus on remote programming for hearing aids and Phase II will target remote audiometry.

The solicitation calls for the development of an integrated telemedicine cart. The cart needs to contain various peripheral equipment to cover a wide range of applications including the remote sharing of patient educational materials, visualization of the external auditory canal and tympanic membrane, as well as displaying a macro-view of an inserted ear mold or hearing aid, plus a probe tube reference microphone. Close-up views of various hearing aid landmarks will also be critical for troubleshooting hearing aid problems and to help read identifying items such as a serial number.

In the pilots, an estimated 10 small Community Based Outpatient Clinics (CBOC) will be equipped with the mobile carts containing video teleconferencing equipment, computer equipment, computer-based diagnostic equipment, and related software.

In addition, five VA Medical Centers will be equipped with corresponding video teleconferencing equipment to allow two-way interactions with the CBOCs. The carts will enable interactive audio/video communications with an audiologist at a host VA Medical Center while remotely controlling the computer and the software on the cart.

The contractor will also provide the desktop video teleconferencing workstation needed by the audiologist. The audiologist will control the equipment on the cart to conduct the patient examination, provide consultation, and if necessary reprogram or refit the patient’s hearing aid.

The solicitation response is due November 4, 2010 and the point of contact is Steve Wilson at (720) 227-0359.

Looking for Partners

The National Institute of Standards and Technology (NIST) and the National Telecommunications and Information Administration (NTIA) are looking for partners in the telecommunications industry to help create a demonstration broadband communications network for the nation’s emergency services agencies. The network will use a portion of the 700 megahertz radio frequency spectrum freed up by last year’s transition of U.S. broadcast television from analog to digital technologies.

The demonstration network currently being developed by the joint NIST/NTIA Public Safety Communications Research (PSCR) program is in place to provide a common site for manufacturers, carriers, and public safety agencies to test and evaluate advanced broadband communications equipment, and provide software tailored specifically to the needs of emergency first responders.

The PSCR program is a partnership of the NIST Law Enforcement Standards Office and NTIA’s Institute for Telecommunication Sciences. PSCR provides needed technical support, research, development, testing, and evaluation.

Alcatel-Lucent is the first vendor for public safety broadband equipment to formally join the PSCR demonstration network project by signing a Cooperative Research and Development Agreement (CRADA) with NIST and NTIA in September 2010. The company has supplied the demonstration network with Long Term Evolution (LTE) Bandclass 14 equipment.

The two agencies hope that other companies will follow to create a multi-vendor environment to test and evaluate the demonstration network and also to help build the system. Partners may participate in many ways by donating equipment, providing access to infrastructure, or supporting tests.

Vendors and other telecommunications companies that want to become CRADA partners on the demonstration network project may email Dereck Orr at dereck.orr@nist.gov or Jeff Bratcher at jbratcher@its.bidrdoc.gov for more information.

Strategic Plan Published

FDA recently published their draft document outlining their Strategic Priorities for 2011 to 2015. Information technology will play an important role as FDA plans to implement an IT modernization program to support present and future state-of-the-art networked information and also to share data resources.

FDA plans to develop modernized data centers to support their IT needs. These data centers will provide for high performance and data storage needed today but they will also be designed to accommodate growth.

Specific goals are to:

• Partner with programs and industry to provide innovative IT to make it possible to collaborate across government and globally
• Maintain a secure environment where security, privacy, and confidentiality are addressed
• Manage IT projects and investments in order to demonstrate progressive incremental improvements

In the public health area, FDA’s key priority is to advance the safety and effectiveness of medical products. To do this, FDA is working to develop a new generation of information collection and analysis methods to fully understand real-world health outcomes resulting from medical products.

The report discusses how advances in science and technology show great promise for the development of new safe and effective biological products and relevant scientific discoveries. These include newly identified clinical biomarkers, adaptive clinical trial designs, and genomics but will also require new regulatory guidance documents for industry. To meet this need, FDA is working on improving connectivity of agency databases and how to simplify storage procedures.

The FDA’s National Center for Toxicological Research is researching new computational approaches and technologies to use to evaluate human health outcomes, as well as to find new methods to identify, quantify, and characterize potential microbial and chemical contaminants in foods and other FDA-regulated products.

In addition, FDA is planning a series of workshops to address important and difficult rare disease research issues and developing a rare disease database to establish the natural history of rare diseases to assist with planning trials that will be able to test rare disease therapies.

To download the draft of the report, go to www.fda.gov.

NIH Awards SBIR Grant

NIH has awarded a $1.25 million SBIR grant to the Indiana University School of Informatics and to “My Health Care Manger”, Inc, a leader in managing the issues and options of aging. The grant will be used to enhance “My Health Care Manager’s” suite of software and decision support system referred to as the “Senior Care Navigation System or SCANS®.

The NIH SBIR grant follows the Indiana Economic Development Corporation’s $1.9 million grant from Indiana’s 21st Century Research and Technology Fund to initially develop SCANS® in 2008.

The information technology system was originally created by experts in geriatric medical health informatics, engineering, and computer science and forms the foundation for “My Health Care Manager’s” holistic, personalized, and comprehensive approach to geriatric management services for seniors and families.

The test laboratory being led by Mathew Palakal, PhD, at the IU School of Informatics, will be able to add increased functionality to SCANS® by developing an automated knowledge acquisition system. The system will then be able to mine large, text-based literature databases to allow senior care agencies and providers access the latest research on geriatric health issues.

For more information on “My Health Care Manager” go to www.myhealthcaremanager.com or call 1-800-499-8020.

Wednesday, October 20, 2010

Studying Health Networks

A new research study at West Virginia University is examining formal and informal health networks in rural areas that are serving people with multiple long term chronic health issues. These individuals often move back and forth from their homes to hospitals and nursing homes for treatment. They also interact with a wide variety of health professionals, health institutions, and social agencies over the course of their illnesses.

These transitions become more common and more complex as their conditions worsen and they approach the end of their lives. With their caregivers help, they often struggle to navigate multiple healthcare providers and programs while experiencing symptoms such as shortness of breath, fatigue, and depression.

Joy Buck, Ph.D., R.N., in the WVU School of Nursing based at the University’s Eastern Division in Martinsburg is leading a research team that includes social work and public health professionals, along with WVU medical, nursing, and social work students.

Volunteers with more than one serious health problem will be recruited over the next several months and the research team will conduct in-depth interviews. Participants and their caregivers will be followed for about 18 months with monthly follow-up calls to check in with the study participants on how they are doing and any changes in their condition. Researchers will also talk with nurses, social workers, family members, and others involved with the patient’s care to get a well rounded picture of how well the care is working.

“We want to understand more on the types of care and services received and learn whether the services were received at home, at their healthcare providers’ offices, in hospitals, or elsewhere to see if they are receiving what they need and prefer,” Dr. Buck said. “It’s been our observation that the transition from one setting to another is often done poorly and that there are gaps in communication among the primary care providers, the specialists, the families, and the patients.”

The researchers have found that many of the symptoms the patients experience are not well managed. The study will provide a more comprehensive understanding of the socio-cultural context of living with and caring for adults with complex chronic illnesses in rural areas. According to the research team, this study is needed in order to see the true impact of care on patients and identify points where the system can be improved to better serve rural populations.

States Seek Solutions

Louisiana Medicaid issued a Request for Innovation (RFI) seeking information and ideas from vendors. The RFI responses received at the beginning of October are going to be used for planning purposes only. The RFI was issued to find the best ways to integrate state and federal initiatives into the state’s Medicaid Management Information System (MMIS) and/or possibly create a replacement for the MMIS.

The Department of Health and Hospitals (DHH) in the state operates an MMIS to process claims and makes provider payment for medical claims. DHH contracts with a fiscal intermediary for Medicaid and maintains data on approximately 32,450 qualified Medicaid providers in the MMIS.

The RFI sought comments on such topics as coordinated care networks, EHRs, HIEs, health insurance exchanges, fraud prevention, master patient index, and electronic case management. The vendor needed to indicate whether the system would be COTS with customization, or if the system would be fully customized, if there were any licensing requirements, any barriers to the state owning the system, the estimated costs for the system and implementation, and the costs for operating the system and for staffing and programmers. For more information on the RFI, email Janith Miller at Janith.miller@la.gov.

The State of Vermont, Department of Vermont Health Access (DVHA), in partnership with the Vermont Department of Banking, Insurance, Securities, and Health Care Administration seeks to contract with one or more vendors and will have them assist with the first year of planning for designing and implementing a health benefits exchange in the state. However, the bid award is dependent on the state receiving the grant funding needed.

The RFP is due October 22, 2010. Go to http://dvha.vermont.gov/administration/rfp-health-benefits-exchange.pdf to download the RFP. For more information, email Betsy Forrest at betsy.forest@ahs.state.vt.us.

South Dakota Governor's Office on October 8th issued solicitation notice #25429 seeking vendors to do research and to conduct a survey to provide information on how to develop the South Dakota state-based health insurance exchange. the bids are due by November 5th.

It is necessary to register in order to view the solicitation document. To register, go to www.state.sd.us/boa/opm/register_to_bid_online.htm.

MEPI Grants to Help Africa

HHS is partnering with the President’s Emergency Plan for AIDS Relief (PEPFAR) and plans to invest $130 million over five years to transform African medical education to dramatically increase the number of healthcare workers. The project called the Medical Education Partnership Initiative (MEPI) will work towards PEPFAR’s goal to train and retain 140,000 new healthcare workers and will help sub-Saharan nations expand their abilities to provide healthcare.

The vast region in Africa has around 15 physicians for every 100,000 people and shoulders nearly one-quarter of the global burden of disease. Much of the funding will focus on medical education and research training related to HIV/AIDS while other grants will cover the training of researchers and clinicians on other issues such as maternal and child health, cardiovascular disease, cancer, and mental illness.

The George Washington University Medical Center in Washington D.C. was awarded $12.5 million to be the coordinator for the health initiative grants in sub-Saharan Africa. GW received the funding to establish a coordinating center to evaluate the progress of the programs through data collection, site visits, and to help establish communication between the institutions.

The GW initiative will form a network to include about 30 regional partners, country health and education ministries, and more than 20 U.S. collaborators. GW will also be working with the African Centre for Global Health and Social Transformation to provide grantees with technical expertise and links to further resources.

GW will establish a web-based platform to enable participating institutions to strengthen their IT infrastructure, provide for virtual and face-to-face meetings plus an annual symposium, support distance education, data sharing, and establish clinical registries to help research and healthcare decision-making on national levels.

The GW project is being led by researchers Fitzhugh Mullan, the Murdock Head Professor of Medicine and Health Policy, and Seble Frehywot, an assistant research professor of health policy and global health, both from the School of Public Health and Health Services.

Go to www.fic.nih.gov/programs/training_grants/mepi/awards.htm for a complete list of MEPI awards and collaborating partners.

Social Media in Emergencies

A recent American Red Cross survey asked 1,058 adults about their use of social media sites in emergency situations. They found that if people needed help and couldn’t reach 911, one in five would try to contact responders through a digital means such as email, websites, or social media. If web users knew of someone else who needed help, 44 percent would ask other people in their social network to contact authorities, 35 percent would post a request for help directly on a response agency’s Facebook page, and 28 percent would send a direct Twitter message to responders.

In the five years since Hurricane Katrina, social media has exploded and is used very effectively in crises situations. This was made clear after the Haiti earthquake. According to Patrick Meier, Director of Crisis Mapping at Ushahidi, is a platform that unifies data gathered from multiple sources such as SMS, email, and the web, and then distributes this information into a visual map or timeline. This system was used after the earthquake to map actionable information using the volunteer efforts of thousands or people around the world.

According to Craig Fugate, Administrator of FEMA, the rapid exponential growth of social media and the bells and whistles of new technology are here, and the public’s use of social media in crises is growing One of the many challenges is the need and the ability of first responders and governments to be able to monitor this information and be able to act on it in a timely manner. For example, Merni Fitzgerals, Public Affairs Director for the Fairfax County Virginia government, notes that while her county’s 911 system operates 24/7, no one is monitoring social media 24/7.

In a June 2020, survey of the DomPrep40, an advisory board of disaster response practitioners and opinion leaders, nine out of ten respondents report they are not staffed to monitor social media applications and respond to a major event. Furthermore, 90 percent of respondents also felt that the public expects some action performed based on social media applications.

MMA Help for Specialists

The Minnesota Medical Association (MMA) Foundation received a $150,000 grant from the Physicians Foundation to develop a toolkit to help specialty care providers implement health information technology. The Foundation helps physicians navigate the challenges of new and expensive technology, changes in reimbursements, and information overload.

The MMA Foundation working on the toolkit expects it to be released in two parts. The Foundation expects to have the first material available April 2011 and the second section will be released July 2011.

Although there are many resources available to general care practices looking to adopt HIT, there is a distinct lack of resources that focus on implementing HIT in specialty care practices. The Foundation will be tailoring the “Stratis Health’s Health Information Technology Toolkit for Physician Offices” to be used by specialty care providers.

The HIT toolkit will have three distinct sections for various types of specialty providers. For example, there will be a section tailored to surgical specialties like general surgery and cardiovascular surgery. There will also be a section customized for diagnostic specialties like radiology and pathology with a segment in the toolkit to be devoted to medical specialties such as neurology or gastroenterology.

The toolkit will focus on the specific needs of the specialty office such as limited resources, differences in hardware and software needs, differences in work flow, and greater clinical exam and documentation needs.

Studies of EHR adoption have shown that smaller and specialty care practices are often slower to adopt and implement EHRs because not only do they have fewer resources but they also have insufficient technical support. Also the process for selecting and implementing an EHR is often much more complex for these practices due to specialized technical and clinical requirements.

The MMA Foundation will be compiling input from Minnesota’s health IT leaders, stakeholders, and physicians in their effort to create this web-based tool. They will complement rather than duplicate the efforts of the Minnesota and North Dakota Alliance Regional Extension Assistance Center for Health Information Technology (REACH) program.

The Foundation will also be subcontracting with MedLinX Consulting, LLC, a St. Paul-based management consulting firm to help small and specialty practice care providers understand and navigate the HIT marketplace and then help them develop strategies to implement electronic health records.

Sunday, October 17, 2010

Advancing Regulatory Science

“We’re more poised than ever to deliver science to serve patients but to do so requires advanced and more effective application of regulatory science—the discipline at the very heart of our mission at FDA,” said FDA’s Commissioner Dr. Margaret Hamburg.

Speaking at a National Press Club luncheon on October 6th, , she said “We’ve witnessed the discoveries that hold major promise for therapeutic advances in fields as diverse as genomics, synthetic biology, stem cells, and nanotechnology.”

She continued to say, “However, we lack the ability to effectively translate many of these developments into vital products to help those who need them. The number of new therapies is on the decline while the costs to bring the therapies to market have soared. Because of the troubling gap between advances in science and available patient care, we need to build a bridge across this gap and that bridge is referred to as regulatory science.”

Dr. Hamburg announced that the FDA white paper “Advancing Regulatory Science for Public Health”, a framework for FDA’s regulatory science initiative is now available. Section IV in the white paper, points out that the FDA at the present time does not have the right infrastructure, tools, and resources available to organize and analyze all of the large data sets across the multiple studies and data streams.

The report also explains how the vast data stored at FDA needs to be transformed into a harmonized format and organized in a common database so that it can be queried by topic and analyzed to address key questions. These goals require investments in informatics hardware and software but at the same time, standardized data models need to be developed for relational databases and scientific computing.

Also, FDA needs to concentrate on real-time monitoring of safety data using healthcare data. The goal for the agency is to expand and harmonize FDA’s electronic systems to receive, process, store, and analyze adverse event reports and other safety information for FDA-related products while at the same time ensuring patient privacy.

In addition according to the whitepaper, investments in new software tools are needed along with collaborative projects that bring together the latest technologies and approaches for mining complex data from clinical trials, healthcare settings, and biological studies.

Dr. Hamburg gave an example of how FDA and NIH, foundations, and industry have been working hard to develop an artificial pancreas for juvenile diabetes. The artificial pancreas is designed to continuously monitor blood sugar levels and inject the right amount of insulin automatically. This is a complex task, so scientifically solid testing path has to be developed to insure that the device controls blood sugar levels without risking hypoglycemia. Next month, FDA will be holding a meeting on establishing standards needed for approval of the artificial pancreas.

Dr. Hamburg described FDA efforts for 2011. As she sees it, the agency will continue to make strategic targeted investments in areas that support regulatory science. There are plans to establish pilots and feasibility studies and to expand these activities in the next few years to establish centers of excellence in regulatory science funded by FDA. The plan is to focus on collaborative, multidisciplinary, and multi-sector research activities that most likely will be housed in academic settings.

In addition, FDA is working with NIH on a new regulatory science initiative to collaboratively encourage research in the field. Last week, FDA/NIH awarded more than $9 million to go to four projects to research nanoparticles, develop a heart/lung model to test the safety of new drugs, develop innovative clinical trial design strategies, and to develop a novel strategy to predict eye irritation.

Dr. Hamburg concluded by saying, “We are living in the century of biology where scientific advances are ripe. With a collective effort, these advances can be transformed into therapies to alleviate or prevent much suffering, and enhance our quality of life.”

Go to www.fda.gov/ScienceResearch/SpecialTopics?RegulatoryScience/default.htm to download the whitepaper.

Data Tool Needed

The National Organization of State Offices of Rural Health (NOSORH), a membership association of all 50 State Offices of Rural Health (SORH) realizes that state offices must be able to document the impact of the state offices and their services. According to NOSORH, the 50 SORHs all have different organizational structures and each has been using a different a web-based performance tool.

A Request for Proposals has been issued and NOSORH and the contractor will work together to offer all 50 SORHs the same basic performance measurement tool to collect data on five core measures of performance and at least ten custom measures.

The goal is to have all 50 SORHs input data into the same web-based data collection tool. Nearly all the work will be done electronically via teleconferences, emails, webinars, and with the use of web-based workspaces. There will be some opportunities to meet face-to-face with the SORH at national and regional meetings.

The web-based data collection tool needs to provide these services:

• A web-based data collection system linked from the NOSORH website
• A system to handle a large number of users simultaneously and available on a real-time basis for a large number of users
• Security, back-up, and retrieval of lost data for each user
• A diverse selection of reports
• A system that is easy to use and allows for simple user registration, do validity checks, and provide for clear definitions
• Provide ongoing maintenance of the system
• Training and continuing education

Funding is available through August 31, 2011 with ongoing funding expected to go through at least 2012. The services to be provided by the contractor will be funded in part by a Cooperative Agreement from the Federal Office of Rural Health Policy. Other funding may be provided by fees collected from enrolled SORHs. The development of a contracting and pricing strategy may allow for some revenue sharing.

Go to www.nosorh.org/events/files/performance_measures_tracking_tool_rfp.pdf to download the RFP. A notice to bid is required and proposals must be submitted by October 29, 2010. For more details, email donnap@nosorh.org or call NOSORH at (586) 739-9940.

GAO Publishes Report

After obligating $2 billion over 13 years to acquire an EHR system, so far, DOD has delivered capabilities for outpatient and dental care documentation but scaled back on other capabilities. In addition, users continue to experience significant problems such as speed, usability, and availability in deployed portions of the system. DOD plans to acquire a new EHR system and is working to have the “Armed Forces Health Longitudinal Technology Application” (AHLTA) system operate as a bridge to the new EHR system.

GAO just published the report “Information Technology: Opportunities Exist to Improve Management of DOD’s EHR Initiative” that looks at the status of AHLTA, determines DOD’s plans for acquiring a new system, and evaluates DOD’s acquisition management of the system.

According to the report, DOD”s new EHR system to be known as “EHR Way Ahead” is to be a comprehensive, real-time health record for service members, families, and beneficiaries to use. The system is expected to address performance problems, provide unaddressed capabilities such as comprehensive medical documentation, be able to capture and share medical data electronically within DOD, and improve existing information sharing with the Department of Veterans Affairs.

As of September 2010, the department has established a planning office to analyze alternatives for meeting the new system requirements. Completion of this project is expected in December 2010. Following completion, DOD expects to select a technical solution for the system and release a delivery schedule. DOD’s FY 2011 budget request includes $302 million for the EHR initiative.

The Military Health System (MHS) Chief Information Officer (CIO) has the primary responsibility for overseeing the acquisition, development, testing, and deployment of AHLTA. Key offices within the Office of the MHS CIO perform information management and information technology functions to support AHLTA. The Joint Medical Information Systems Office is responsible for testing, implementing, training, fielding of system components, operations, maintenance, and the ultimate disposal of system components.

To acquire the present EHR system, DOD used several contractors and different types of contracts that included fixed-price, time-and-material, and cost-plus-fixed-fee contracts. The prime developer and lead integrator for CHCS II, Integic (acquired by Northrop Grumman in 2005), was awarded a time-and-materials contract for $65.4 million in 1997.

DOD also used noncompetitive contracts to develop the system. According to the program office, eleven noncompetitive contracts and task or delivery orders, totaling $44.6 million were awarded from FY 2004 through FY 2012. Program official stated that the noncompetitive contracts were awarded since DOD’s need for the supplies and services was so urgent.

The GAO report makes several recommendations for the MHS CIO to:

• Develop and maintain a comprehensive project plan to include the project’s scope, cost, schedule, risks, and then update the plan to provide key information for stakeholders on the project’s plans and status
• Develop a systems engineering plan to address the technical complexities involved in delivering a worldwide EHR
• Make sure that the requirements development process involves system users throughout the development
• Establish bidirectional traceability for all system requirements
• Prioritize improvement projects, resources, include schedules for improvement efforts including a user feedback survey, and use the information to link measurable outcomes and specific user needs
• Include identifying milestones and a completion date for the external evaluation

For more information, go to www.gao.gov/products/GAO-11-50.

CCHP Telehealth Projects

Surprisingly, 13 percent of Californians live in rural communities according to Mario Gutierrez, Policy Advisor for Connected Health Policy (CCHP), a non-profit planning and strategy organization based in Sacramento. The organization supported by the California Health Care Foundation with $2 million in funding, is working to remove the policy barriers that prevent the integration of telehealth technologies into California’s healthcare system.

Gutierrez recently spoke at the “Alliance for Health Reform” briefing held October 13th on Capitol Hill to emphasize that telehealth is one solution that is needed and vital to use in California. Services highly needed in the state include dermatology, neurology, endocrinology, hepatology, orthopedics, and psychiatry.

The situation is critical. For example, Merced County in the rural section of the San Joaquin Valley is almost entirely dependent on out-of-town specialist referrals. A 2009 survey done by the University of California Merced found that 80 percent of the patients received referrals but less than 25 percent actually followed through with appointments.

One of the major problems in California is the need to link University of California specialists with safety net clinics. Gutierrez explained that CCHP has initiated a telehealth demonstration project that connects safety net clinics across the state with medical specialists at the University of California Schools of Medicine at Davis, Irvine, Los Angeles, San Diego, and San Francisco that will run through early 2012. For Phase 1 there are 12 safety net clinics statewide, and for Phase 2 another 36 clinics have applied to join.

CCHP purchases specialty clinic time from all five of the UC medical schools. Specialty telemedicine clinics are reserved exclusively for the patients of SCSNI partner clinics allowing access to care for patients regardless of insurance eligibility.

CCHP is also very involved in a yearlong research project that is examining the state’s telederamatology workforce as relates to issues such as teledermatology reimbursement for the Medi-Cal program and overall dermatology practice patterns. The plan is to produce baseline data on teledermatology practitioners, analyze viable practice models, and identify key policy issues facing telederamtology in California. The project is scheduled to run through May 2011.

CCHP is working to improve past legislation (Telemedicine Development Act of 1996) to meet today’s needs. To do this, CCHP formed the Telehealth Model Statute Work Group with 26 members representing a diverse group of prominent stakeholders. These stakeholders include telehealth and health policy experts, telehealth providers, consumer representatives, payers, telehealth industry representatives, and telehealth law experts. A model statute is scheduled for completion in early 2011.

For more information on CCHP, go to www.ConnectedHealthCA.org or call (916) 285-1857. Go to www.allhealth.org to find out more information on the briefings and the documentation available.

VA to Award Contract

The Technology Acquisition Center within the Department of Veterans Affairs is planning to award a sole source firm-fixed price contract to Knowesis Inc. in Gainesville Virginia. The company a Service-Disabled Veteran-Owned Small Business will develop prototype software capable of creating custom reports from the VistA EHR system.

The contractor will develop a Graphical User Interface program to run queries that will identify patients with a specified diagnosis and patients receiving a specified therapy. The prototype will also generate customized patient reports that will include demographic, laboratory, treatment, and outcomes data for each patient.

The notification “D-TAC 473 MC OED Innovation Initiative: #226 Prototype Software for Creating Custom Reports from VistA” (Solicitation number VA 11810RP0866) appeared in www.fbo.gov on October 15th. The estimated date for the award is December 30, 2010. For more information, email Summer Spalliero at summer.spalliero@va.gov or call (732) 578-5458.

HIE Goes Live

The Maryland “Chesapeake Regional Information System for our Patients” (CRISP) has gone live with a statewide HIE. The infrastructure supports the private and secure flow of health information among physician practices, hospitals, labs, radiology centers, and other healthcare institutions.

Organizations participating in the HIE include Holy Cross Hospital, Suburban Hospital, Montgomery General Hospital, Community Radiology (a RadNet partner), American Radiology Services, Quest Diagnostics, and Laboratory Corporation of America.

“We at Holy Cross Hospital believe a statewide health information exchange can help make care safer and more efficient for Marylanders,” said Kevin J. Sexton, President and CEO of Holy Cross Hospital. “We are delighted to join CRISP, state government, and other healthcare providers in getting Maryland to this important milestone.”

Additionally, all 48 Maryland hospitals have recently committed to sharing data with the statewide HIE. This commitment covers 11,175 in-patient beds from Garret County to the Eastern Shore.

Other hospitals, physician practices, and clinics will be coming online before the end of the year, including many of the state’s federally qualified health clinics, which predominantly serve Medicaid, uninsured, and other underserved patients.

CRISP will also be expanding the data that the HIE is able to exchange as participation grows, to include hospital discharge summaries, lab and radiology results, to medical documents with more complete medical information, sometimes referred to as continuity of care documents or “CCDs”.

As David Horrocks, President of CRISP said, “The HIE is the beginning of a process which will give physicians new and more effective tools to provide the best care to their patients.”

Monday, October 11, 2010

Views on CER

A national push on comparative effectiveness research is underway as a result of the federal stimulus and health reform legislation. The research aimed at answering critical questions about what works and what doesn’t in health care, was the subject for the “Health Affairs” briefing “New Era of Comparative Effectiveness Research” (CER) held October 5th in Washington D.C.

The speakers presented their views related to CER concerning the national strategy needed, how the research needs to be designed, the data, and methods to be used, cost effectiveness of care, methods to disseminate research findings, moving CER into clinical practices, how to obtain public support, and how to address the research differences related to a variety of population groups. The speakers ideas presented appear in the numerous articles published in the October “Health Affairs” thematic issue.

What concerns many is how the federal funding available for CER will be spent not only today but in the future. Susan Dentzer, Health Affairs Editor-in-Chief reports that the federal funding for $1.1 billion allocated for CER under the ARRA 2009 stimulus funding has paved the way for a fierce debate over whether any additional backing for the research should be incorporated into the national health reform legislation enacted this year.

Joshua Benner, Pharm.D., Sc.D, Research Director, Engelberg Center for Health Care Reform, at Brookings and his colleagues Marisa R. Morrison, Erin K. Karnes, S. Lawrence Kocot, and Mark McClellan authors of the article “An Evaluation of Recent Federal Spending on Comparative Effectiveness Research” offer early insights into how the new CER funds are being spent along with the priorities and gaps that need to be addressed.

The authors found that nearly 90 percent of the funding allocated for CER will be spent on evidence development and synthesis plus on improving research capacity. More than half of the funds were spent on improving capacity to do CER with projects including evidence development and synthesis, infrastructure and methods development, translation and dissemination, priority setting, and stakeholder engagement.

So far, according to Benner and his colleagues as of August 4th, nearly all of the $1.1 billion was spent, but one of the biggest problems is tracking the grants, contacts, and administrative spending which has proven to be very challenging.

According to the article, the authors consulted several sources for specific information such as:

www.grants.gov —to examine all open, closed, and archived recovery act funding among HHS sub agencies
www.fbo.gov —to examine all recovery act funding opportunities listed
www.ahrq.gov —to consult the section titled “AHRQ and the Recovery Act and also the AHRQ Grants On-line Database (GOLD)
www.nih.gov —to download summaries of comparative effectiveness projects funded by the NIH Research Portfolio Online Reporting Tools Expenditures and Results (RePORTER). Also reviewed the research, condition, and disease categorization (RCDC) system
www.recovery.gov —to identify project summaries and implementation plans

The authors were able to account for $910.3 million (82.8 percent) of the $1.1 billion available recovery act funds. Breaking the amount down, $298.9 million (99.6 percent) was allocated for AHRQ, $330 million (82.5 percent) for NIH, and $282 million (70.4 percent) for the Office of the Secretary. Of the total, $464.3 million (51 percent) reflects the awarded amounts. However, $446.1 million (49.0 percent) in funding was allocated for specific grant opportunities but these grants have not yet been awarded

Benner reports that this analysis doesn’t account for (17 percent) of the full $1.1 billion in funding because all of the funds have not yet been committed for specific projects. In addition, NIH Grand Opportunity Grants and Challenge Grants are both multiyear projects, but only FY 2009 and some FY 2010 budget information was publicly available.

To complicate the picture, some of the grant information was not available at the time of the publication of the article. In addition, waivers have been approved allowing agencies to spend some of the funds after FY 2010.

As a result, Benner and the other authors, emphasize that since the information is not reported in any central publicly accessible location, it is not always possible to identify all of the funding for the projects. What the authors want to see is a timely comprehensive “dashboard” to provide information on opportunities and ongoing projects, specific aims with priority areas addressed, information on methods and data sources, and budget information with information on the granting agency...

After completing the research, Benner and his colleagues see areas where more funding is still needed to do additional experimental research, to evaluate system-level reforms, to identify the effects in subgroups, and do more research on understudied populations.

The October issue of “Health Affairs” was funded by the National Pharmaceutical Council, WellPoint Foundations, and the Association of American Medical Colleges. For more information, go to www.healthaffairs.org or email Sue Ducat at Health Affairs at sducat@projecthope.org.g.

RFP for HIE Issued

In Alabama, medical communities such as hospitals have all developed some limited levels of data exchange. Most are linking their internal systems, and in some isolated cases, hospitals are exchanging data with physicians who are part of their system. Currently, there are no systems in the state communicating with other systems outside their own medical community nor are there any functioning RHIOs although at least one is underway.

Since 2007, the Alabama Medicaid Agency has established basic HIE through a Medicaid Transformation Grant. As a result, the state has a web-based system that compiles claims-based information from both Alabama Medicaid and Blue Cross and Blue Shield of Alabama as well as certain physician-entered clinical information.

This information is available through an end use application known as Q-Tool or through one directional CCD exchange. The state’s current HIT system is a hybrid model with Medicaid data centralized and other data sources pulled in at the time of query. The state wants to move to the next level for statewide HIE by building on the work currently underway.

The Alabama Medicaid Agency on behalf of the Alabama HIE (AHIE) Advisory Commission has issued a Request for Proposals (RFP) for vendor services and expertise in construction, operation, and support of the AHIE to be available to physicians, hospitals, mental health providers, healthcare organizations, and consumers.

In addition vendors will be required to provide support services to include resource consultations, help in the planning for implementation, be available to speak to stakeholder groups, do further research, and keep the state appraised of national changes.

The overall project plan for the development and operation of the AHIE will follow the ONC approved AHIE Strategic Plan and Operational Plan and the State Medicaid HIT Plan. In addition, the state must complete the planning for adoption of meaningful use criteria.

To be a registered vendor with the state, interested vendors must complete an on-line registration at www.purchasing.alabama.gov. As part of the registration, vendors are required to summit $200 in payment to allow for two years access to view, print, bid, and/or be awarded a solicitation to bid.

The RFP issued October 1, 2010, titled “Alabama Statewide HIE Development and Operation” (RFP Number 2010-HIE 04) is due November 12, 2010 with work to begin February 2011.

Go to www.medicaid.alabama.gov/news/rfps_rfis.aspx to download the RFP. For more information, email Gary D. Parker, AHIE IT project coordinator gary.parker@mh.alabama.govv or call (334) 242-3940.

Standards Update

The House Committee on Science and Technology’s Subcommittee on Technology and Innovations held a hearing to discuss the integration of IT with healthcare as a means to improve patient care and lower escalating healthcare costs.

Subcommittee Chairman David Wu (D-OR) stated, “We still have a ways to go in promoting interoperability, coordinating the many health IT projects underway, governing the standards development process, and providing direction on privacy and security.”

David Blumenthal, MD., National Coordinator, HHS Office of the National Coordinator for HIT, briefed the Subcommittee on the standards work needed beyond Meaningful Use Stage 1. As Dr. Blumenthal explained, the HIT Standards Committee will focus on the standards implementation specifications and certification criteria necessary for future stages of meaningful use. The Committee will work to achieve agreement on vocabularies and on code sets for particular exchange purposes.

He said the Standards Committee plans to issue recommendations on strengthening the security capabilities of EHR technology and issue standards for electronic health information exchange in support of meaningful use.

ONC has issued a final rule establishing a temporary certification program for HIT that outlines how organizations can become ONC-Authorized Testing and Certification Bodies (ONC-ATCB). Dr. Blumenthal said a final rule for a permanent certification program is expected to be published later this year and is expected to be fully operational in early 2012.

He expects that this program will be more rigorous than the temporary certification program and will achieve greater incorporation of international standards and best practices through requirements such as accreditation and surveillance.

Kamie Roberts, Associate Director, Information Technology Laboratory at NIST, appearing before the Committee, described NIST’s role in developing standards. Currently, NIST plays a critical role by participating early in the development process and by helping to ensure that the infrastructural standards are complete and unambiguous. NIST priorities are to develop security, usability, along with medical device and terminology standards.

NIST’s standards role for HIT is to:

• Collaborate with organizations and federal agencies including HL7, IEEE, ISO, and Integrating the Healthcare Enterprise, to refine current standards and develop future standards needed for the next stages of meaningful use criteria in 2013 and 2015

• Play an important role in testing activities including developing test tools and associated testing infrastructure and also study how to reduce costs in developing health IT systems

• Collaborate with HHS and the ONC to help develop a program for the voluntary certification of health IT systems that will be in compliance with applicable certification criteria to meet meaningful use.

Roberts made suggestions as to where longer-term health IT standards development, research, and outreach activities are needed:

• Standards need as the use of emerging technologies such as body sensors, implants, and medical equipment are used for routine monitoring of chronic conditions. Current research is being done to analyze the impact of interference from such devices and to study how energy obtained from human movement can be used to power the devices

• Standards and guidelines are required so that medical records can be retrieved regardless of the format and medium where they are first created or stored. Having the ability to preserve records will enable doctors to create medical records for children and be able to access the same medical records when the children are adults.

• Standards and terminologies are needed to accommodate changing technologies and advances in biomedical knowledge

• Standards are important when information needs to be retrieved from notes in EHRs where data is not formatted or structured

• Standards are needed to control image quality so that colors viewed on a digital image by a medical practitioner are representative of the actual colors when viewed in person

The organization HIMSS has some concerns regarding standards. Joyce Sensmeier HIMSS Vice President for Informatics, testifying at the hearing, urges HHS to publish criteria pertaining to Meaningful Use Stage 2 at least 18 months before the beginning of Stage 2. This will enable sufficient time to develop, test, and deploy software conforming to these standards and implementation guides.

She also explained that beyond the specific concerns associated with the Standards, Implementation Specifications and Certification Criteria for Meaningful Use Stage 1, HIMSS is concerned that meaningful use and interoperability will be hindered without addressing the patient identity solution and security needed for personal health information.

Richard Gibson M.D., PhD, President, Oregon Health Network made suggestions on some new national standards that are needed. For example, standards to transmit provider text notes, to export and import patient information directly between EHRs and between provider-to-provider, for document transfer to help providers using paper records, a standard EHR functionality requirement for quality measure reporting, plus a national model is needed for privacy and patient consent, access control, and availability of the entire health record.

New Survey Released

A new survey finds that 70 percent of the public and 65 percent of doctors agree with the concept of a “blue button” to enable individuals to download their own medical information online with just one click, according to Carol Diamond, M.D. Managing Director at the non-profit New York based Markle Foundation.

The Markle Foundation survey offers a first ever comparison of public and physician views on key issues surrounding HIT, including their views on the new federal incentives to stimulate the use of health IT. The “Markle Survey on Health in a Networked Life 2010” is the first of its kind to compare public and doctor priorities for health IT.

Despite the strong support for downloading personal health information, 83 percent of the public reports that they never ask for their information in electronic format. The vast majority of doctors said requests from patients for information in electronic format are received either rarely (24 percent) or never (67 percent).

In the federal sector, Medicare and the VA are preparing this fall for beneficiaries and veterans to have a blue button to download their claims or medical information from the MyMedicare.gov and My HealtheVet web sites.

The new federal rules require healthcare providers and hospitals to give patients electronic copies of their lists of medication, after visit summaries, lab results, and other pertinent information in order to qualify for an estimated $27 billion in federal subsidies for using health IT. The program, now being rolled out as required by the Recovery Act, is designed to make the sharing of patient information more efficient.

Sixty two percent of the public and 49 percent of the doctors surveyed said that if the billions in federal incentives are to be well spent, it’s important to set the requirements needed for participating doctors and hospitals to be able to supply patients with electronic copies of their personal health information.

Only 8 percent of the public and 21 percent of the doctors felt that providing electronic copies to patients was not an important requirement for the program. Overwhelming majorities of the public and doctors also want to be sure that the money comes with privacy and security safeguards.

In response to the need for privacy, the Markle Connecting for Health collaborators recently published a set of privacy practices for the blue button download capability. Support for the privacy practices is supported by 50 organizations representing technology companies, insurers, and provider groups, along with consumer and privacy advocates. These practices are part of the Markle Common Framework for Networked Personal Health Information which recommends policy and technology safeguards to encourage individual access to information and privacy.

The Markle survey was conducted in August 2010 by Knowledge Networks (KN). The general population survey of 1,582 adults age 18 and older was conducted using KN’s KnowledgePanel®, a probability-based panel of 50,000 individuals designed to be representative of the U.S. population. The survey of 779 physicians was conducted using KN’s Physicians Consulting Network and invitation only list of more than 45,000 practicing physicians.

Go to www.markle.org/downloadable_assets/20101007_bluebutton_summary.pdf to download the survey.

Grant Opportunity Announced

In September, the Office of Massachusetts Attorney General (AGO) Martha Coakley announced grant funding is available for up to $1.5 million to reduce health disparities in the state. The AGO expects to issue the grants in varying amounts to multiple applicants with the maximum grant amount of $250,000 over a 2 year period. Proposals are due by October 22, 2010 and grants will be awarded from January 3, 2011 to December 2012.

The AGO is looking to help municipal government agencies, boards, and non-profit organizations within the state understand the issues involved in helping the underserved populations by reducing health disparities, managing chronic diseases, and promoting wellness.

Applicants must be a municipal government agency or board, or a non-profit organization and seek to expand or provide new programs for underserved populations that are in alignment with the AGO strategic health care priorities for underserved populations. Applicants are encouraged to develop programs in partnership with other non-profit organizations, including but not limited to hospitals or community health centers.

This grant opportunity is part of a series of competitive health-related grant opportunities offered by the AGO using the settlement funds obtained as a result of the investigation of pharmaceutical manufacturers.

Go to www.mass.gov/cago/docs/Community/AGO_Health_Care_Grant_RFP.pdf to download the grant opportunity referred to as “Promoting Health and Reducing Health Disparities Grants”. For more information, email Aaron Kravitz at AGOgrants@state.ma.us.

Home Assistance for Vets

Veterans of all ages with disabilities will gain additional support in 28 states under a new program designed to help them live independently with more choice and control over the services they receive in their homes.

Currently, 21 VA Medical Centers in 14 states have a fully operational Veteran Directed Home and Community-Based Service (VD-HCBS) Program. This program enables veterans to live independently and manage their flexible spending budgets, decide for themselves what mix of goods and services can best meet their needs, hire and supervise their own workers, and purchase items or service to help them live more independently. This approach is called “Participant Direction.”

Through a contract with the Veterans Health Administration (VHA), the National Resource Center for Participant-Directed Services (NRCPDS) at Boston College in a new effort is going to provide training and assistance to VA Medical Centers to help them implement participant-directed services for veterans.

“We are proud to help America’s veterans maintain their independence and preserve their quality of life,” said Kevin J. Mahoney, PHD, Director of the NRCPDS at BC and Professor in the Graduate School of Social Work at Boston College.

“This new partnership will help VHA expand the VD-HCBS Program and enable VA Medical Centers to be better equipped to provide participant-directed services to veterans”, said James F. Burris, M.D., Chief Consultant for the Office for Geriatrics and Extended Care at the VHA.

Currently, 21 VA Medical Centers in 14 states have a fully operational VD-HCBS Programs with more than 450 veterans enrolled including young and severely injured veterans. The states with active VD-HCBS programs include Arkansas, Connecticut, Florida, Illinois, Maine, Massachusetts, Michigan, New Jersey, New York, Texas, Washington, Wisconsin, and Virginia. The VHA anticipates expanding the VD-HCBS Program to an additional 14 states by 2011.

For more information, email Elizabeth Maguire at Elizabeth.Maguire@bc.edu.

Wednesday, October 6, 2010

HIT for All Communities

The “Steering Committee on Telehealth and Healthcare Informatics” and the “National Health IT Collaborative for the Underserved” collaboratively held a briefing September 30th, on Capitol Hill to discuss the status of HIT efforts for underserved and minority communities.

Neal Neuberger, Executive Director, Institute for e-Health Policy, assembled the experts to discuss the impact of federal and state health investments, the increasing need and importance to use health IT in these communities, successes achieved, challenges ahead, and the next steps to take.

Last week, NIH announced that the National Center on Minority Health and Health Disparities will now transition into the National Institute on Minority Health and Health Disparities (NIMHD. This re-designation elevates the Center’s program to the NIH Institute level.

Garth Graham, M.D., M.P.H., Deputy Assistant Secretary for Minority Health at HHS, moderator for the panel, said “When there are disparities in the population, it is very important to work together to decrease the gaps in care in minority communities and to find workable solutions.”

Ruth Perot, Managing Director for the NHIT Collaborative for the Underserved & in addition, the Executive Director/CEO for the Summit Health Institute for Research and Education (SHIRE), explained that the National Health IT Collaborative for the Underserved (NHIT) was formed with SHIRE operating as the Program Management Office for NHIT.

NHIT was established as a public private community partnership to use HIT to expand healthcare access, improve quality, promote consumer self-management, provide education, training and outreach, and find ways to finance and sustain projects.

NHIT is actively supporting pilot projects to demonstrate how innovative and existing information technology can be used effectively in underserved communities. Presently, NHIT is working with pilot programs in South Carolina, Georgia, and Florida.

“Wellpoint believes that health IT benefits should be available across health delivery systems nationally, particularly in rural or underserved communities where health inequalities are greatest and adoption of health IT is often the lowest,” said Charles D. Kennedy, M.D., Vice President Health Information Technology, at WellPoint Inc.

As Kennedy told the group, “WellPoint is implementing an investment program to support HIT in rural critical access hospitals in medically underserved communities. Many of these hospitals cannot access capital or access capital at suboptimal interest rates which can limit their ability to take advantage of federal incentives. The program is starting to roll out and will begin in California and Georgia in 2011 to allow qualifying hospitals to borrow short term funding to pursue HIT.”

Andrea Anderson M.D. a bilingual Family Physician with Unity Health Care, a non-profit organization provides healthcare services to the poor and underserved in Washington D.C. She is also Assistant Medical Director, at the Upper Cardozo Health Center in Washington D.C. that treats an ethnically and economically diverse community and now takes care of about 80,000 patient visits annually

Dr. Anderson emphasized how invaluable health IT has proven to be when treating vulnerable populations. She described how a Spanish speaking male collapsed, was diagnosed with a heart condition, and given a pacemaker. He has a family and children to support but because he couldn’t work for awhile, he was depressed and did not feel on top of his healthcare.

Today, he is benefiting from all that health technology offers. The EHR system in use at the health center enables him to use technology to communicate with his doctors, plus he receives reminders by telephone but also by texts. Using health technology at the Center has enabled patients to feel empowered and feel that they are an important part of the program.

The North Carolina AHEC has nine regional centers and has the structure to create highly successful REC centers reports Ann Lefebvre, Associate Director of the program at the University of North Carolina at Chapel Hill.

With the support of collaborating partners, NC AHEC is going to use their existing regional infrastructure to hire and train over 40 positions in the nine regions to provide on-site technical assistance to primary care providers. The goal is to help providers adopt EHRs, help providers optimize their use of EHRs, and provide the on-going educational resources needed.

In some cases, Lefebvre reports that REC technicians are able go into the community especially when there is just one primary care physician in a town. For example, a doctor in Southeast North Carolina was unable to leave town easily because if he left, then the emergency room in the town would not have a doctor. The REC technicians went to his office to help him manage better and help him upgrade his EHR to meet the new requirements of “meaningful use”.

The state of Pennsylvania has cities like Philadelphia and Pittsburgh with vast populations but the rest of the state has huge underserved and large rural areas, according to Philip Magistro, Deputy Director & State HIT Coordinator for Pennsylvania. In meeting the needs of the rural parts of the state, Magistro see the immediate need for doctors to make the best use of technology to maintain quality, reduce hospital readmission rates, and to implement a workable chronic care model.

Presently, the state’s working with the University of Pittsburgh Medical Center and the Geisinger Health System with the goal to help expand basic exchange capabilities. In addition, the state is working on connectivity issues with smaller community providers.

Scharmaine Lawson-Baker, DNP, FNP-BC, President and CEO for Advanced Clinical Consultants, LLC located in New Orleans, recounts how she was able to provide medical records during Katrina. All of the information on the patients was accessible electronically even when Lawson-Baker was in San Antonio for awhile.

Back in New Orleans, she sees the tremendous value of supplying information electronically. Most of the patients she sees are elderly can be homebound or bed bound, but they are much more involved in their care since the EHR has been put in place. Lawson-Baker is now able to show information to patients, pull up lab reports, x-rays, and use e-prescribing.

She’s lobbying for Congress to pass (S 2814) the “Home Health Care Planning Improvement Act” introduced by Senator Susan Collins and a companion bill on the House side (H.R. 4993) introduced by Representative Allyson Schwartz. As she explained, both bills would provide more timely access to home health service for Medicare beneficiaries.

For more information on future briefings, go to www.e-healthpolicy.org or contact Neal Neuberger at (703) 562-8870.

VA's Teledermatology Project

The VA’s VISN 20 “NW Network News”, reports that a year ago no teledermatology services existed in VISN 20. Survey results showed that over 5,000 rural veterans in the VISN went without care due to the low number of dermatologists available.

Dr. Gregory Raugi, MD, PhD, and Gayle Reiber, PhD submitted a proposal to address the problem. VISN 20 made their proposal a 2009 clinical priority and entered the proposal in a VA National Competition for Rural Health Funds.

As a result, the Tele-Dermatology Project was awarded a grant in 2009. However, one of the conditions for the grant award required both Dr Raugi and Dr. Reiber to implement tele-dermatology services at a rural VA within one month. The Walla Walla VAMC accepted the challenge in June 2009, and became the first medical center in the VISN to provide rural tele-dermatology service.

In the past year, there have been a number of accomplishments. Twenty three rural sites now have primary care providers and teledermatology technicians. Primary care providers work in partnership with Board Certified dermatologists who recommend and teach dermatology patient care. The providers receive training in supervised dermatology skill development, problem solving, and one-on-one training is provided with a surgical dermatologist. The technicians have learned to take and upload images, facilitate patient follow-up, and assist the primary care providers with patient care.

The system works by having the teledermatology consults forwarded through the Computerized Patient Record System to Board Certified Dermatologist readers. Care is recommended based on the patient’s history and the primary care provider’s assessment and accompanying images. The turn-around time between receipt of the consultation and the time needed to provide recommendations is two days.

The goal by the end of FY 2010 is for the tele-dermatology primary care providers to complete their training and be able to manage up to 80 percent of dermatology problems locally. The plan is to have providers identify conditions beyond their scope of practice by continuing to refer to the dermatologist readers.

So far, 23 primary care providers and technician teams have served over 2,000 veterans with over 3,000 skin problems including malignancies identified in 17 percent of those served. Follow-up skin problem outcomes are carefully monitored by the core team and there are plans to expand to additional rural sites.