Nicholas Valeriani Named to West Health

Gary and Mary West have announced that Nicholas J. Valeriani, with Johnson & Johnson for 34 years has been appointed Chief Executive of the collective West Health effort and CEO of the West Health Institute formerly called the West Wireless Health Institute. West Health brings together the Institute, West Health Policy Center, West Health Investment Fund, and West Health Incubator.

Valeriani as Chair the Executive Committee of the West Health Initiative will direct West Health’s efforts to lower healthcare costs through innovative, cost-effective technologies, and address medical research, policy issues, investments, and entrepreneurship.

The newly launched West Health Incubator located in La Jolla provides infrastructure, strategic guidance, and access to an extensive network of key partners, to permit the transfer to industry of research technologies developed at the Institute and elsewhere. Prior to acceptance or admission, companies in the Incubator must receive an investment commitment from the West Health Investment Fund.

“Early stage healthcare companies face multiple challenges in their efforts to develop and deploy innovative technologies,” said Gary West. “We are offering both significant intellectual and economic capital through our investment fund. At the same time, we are de-risking technologies and creating a lunch pad for disruptive cost-lowering technologies so they can reach the public.”

For more information, go to www.westhealth.org.

Marshfield Clinic Receives Grant

 Marshfield Clinic received a $39,675 grant to increase patient access to healthcare through telecommunications and videoconferencing. The grant was awarded by the Public Service Commission (PSC) of Wisconsin to fund new interactive videoconferencing technology to connect patients in rural areas to healthcare providers at Marshfield.

This funding will enable the Clinic to expand its telehealth capabilities within areas such as telepharmacy and telestroke according to Nina M. Antoniotti, Director of Telehealth at Marshfield Clinic.

The telepharmacy services allow pharmacists at Clinic locations to remotely oversee the mixing of drugs which includes chemotherapy drugs at other locations. The Clinic has eleven telepharmacy sites throughout the system. As for treating strokes, telehealth enables a neurologist to videoconference into a hospital to make urgent treatment decisions without delay.

The PSC grant is also going to support the Clinic’s initiative to incorporate mobile services into telehealth to allow physicians to video conference using mobile devices such as smart phones and tablets.

This grant is one of 23 grants awarded to healthcare providers in Wisconsin, and funded by the state’s universal service fund. The grants target projects that demonstrate the use of advance telecommunications services to extend medical care in rural areas and among underserved populations.

Allscripts Integrating Telehealth into EHR

Allscripts is integrating American Well Corporation’s Online Care telehealth platform into their EHR so that providers will be able to offer high quality online voice and video interactions. The University of South Florida Health, a partnership of USF’s colleges of medicine, nursing, public health, and pharmacy as well as the USF Physician Group is planning to use this new offering with “The Village”, the country’s largest over 55 residential community located near Tampa.

“Allscripts telehealth solutions will help provide convenient, safer and secure access to care and enable that care to be documented in the EHR so that providers can have up-to-date information. It will also give physicians an opportunity to get paid for telehealth, something that was a hurdle in the past,” said Glen Tullman, Chief Executive Officer of Allscripts. “Our open platform architecture enables this integration which we expect to be available in January.”

“The momentum behind the telehealth movement is growing at a remarkable pace. As patients demand improved access to care, providers are seeking alternative delivery methods to deliver care efficiently and effectively as payment models trend away from fee-for-service,” said Ido Schoenberg, MD, Chairman and CEO of American Well Corporation.

“Meanwhile legislative and regulatory barriers are being removed”, Schoenberg added. “Today forty state Medicaid plans reimburse for telehealth services and 16 states mandate private insurer coverage for telehealth including four states which have passed such laws since March.”

Reforming Device Databases

Representative Edward J. Markey (D-MA) and Senator Jeff Merkley (D-OR) sent a letter to FDA calling on the agency to streamline federal databases that provide information to the public on the safety of medical devices. However, these devices may not have undergone clinical trials in humans before being sold on the market.

In the absence of legislation that would close the current loophole in federal law that allows defective devices to enter the market, the lawmakers are urging reforms be made immediately to the FDA’s main medical device databases. The updates would provide device manufacturers, the public, and medical professionals better information about devices recalled for serious design flaws and help avoid future injuries.

Last February, a group of Representatives introduced the “Safety of Untested and New Devices Act of 2012” or referred to as the “SOUND Devices Act”. The legislation would close the major loophole in the 510(k) device approval process by allowing FDA to reject an application for a new device if it was modeled after an earlier product that was pulled from the market for causing serious harm to patients. The legislation is pending in the House of Representatives.

The federal loophole in the 510(k) device approval process requires the FDA to clear medical devices that demonstrate their similarity to an earlier model, even if that previous model was recalled for a major safety defect.

This loophole has enabled a number of defective products, such as bladder mesh implants, to enter the market and cause serious harm and in some cases even death. The updates to the 510(k) databases requested by the lawmakers would reflect if a medical device was subject to a recall due to a design flaw and if the medical device was cleared by FDA based on a previous design recalled for a serious flaw.

Go to http://markey.house.gov/document/2012/letter-fda-501k-database to view a copy of the letter sent to FDA.

Diagnosing & Treating TBI

The Department of Defense and the Veterans Administration are very concerned about brain injuries since so many service members are coming back from Iraq and Afghanistan with Traumatic Brain Injuries (TBI). The Army alone is involved in 472 active research TBI projects alone and is driving the science behind the public health problem that affects everyone from kids involved in sports to service members in Afghanistan.

Severe brain injuries aren’t difficult to diagnose, but it’s more difficult to diagnose mild to moderate TBI. To improve the spectrum of diagnosis-to-treatment of mild TBI, the Army is working with university researchers and organizations like the National Football League and the National Hockey League since their players are a risk for concussions.

The Army and the NFL are both interested in developing helmet sensors that can be used to evaluate concussive events that could lead to TBI. The sensors would be able to measure the severity of impact to a soldier’s head and the data could be collected and incorporated into further TBI research and medical reports.

The current TBI research being funded includes a range of research on neuroimaging or brain scanning technologies, a quantitative electroencephalography or brain mapping, blood tests for biomarkers for brain injury, and drugs that could prevent injuries from mild brain trauma.

The Veterans Administration’s Office of R&D is very actively pursuing ways to help veterans with TBI. The VA has established a VA Rehabilitation Research Center of Excellence at the Michael E. DeBakey VA Medical Center in Houston Texas to focus on mild TBI.

At the center, researchers in the Genetics Core Program are studying the possible link between genetics and the effects of blast exposure during combat. Individuals who meet certain criteria may be asked to participate in studies using a functional MRI to view their brain as they complete computer tasks.

NIH is actively funding and involved in brain research. Researchers at NIH’s Center for Neuroscience and Regenerative Medicine have developed a prototype for a hematoma detector with a motion based sensor. The device images the brain by using near-infrared light to penetrate the skull and characterizes the amount of blood pooling by measuring how much the changing light is absorbed.

An existing handheld device called the InfraScanner developed by the Office of Naval Research has been FDA approved and is used in Europe but this device differs from the NIH device in that the patient has to remain motionless. 

NIH scientists have developed a device to simulate the effects of pressure waves resulting from explosions or blasts on biological tissue. This device would permit real-time monitoring of tissue damage while it is occurring and be able to track the secondary effects of pressure damage after tissue insult. The device is in the prototype stage but for more information, email Michael Shmilovich at shmilovm@mail.nih.gov at the NIH Office of Technology Transfer.

David Hage, a Professor of Chemistry at the University of Nebraska at Lincoln (UNL) is developing a handheld tool to diagnose TBI on the spot to yield critical and in some cases life-saving information to guide triage decisions from the battlefield to the football field.

SFC Fluidics, a Fayetteville Arkansas based-biotechnology company recently entered into a licensing agreement with UNL’s nonprofit affiliate NUtech Ventures to use the technology developed by Hage.

Hage a bioanalytical chemist has developed the technology to separate and measure specific compounds in complex fluids at a rapid rate. Hage’s methods can measure specific proteins in blood serum released by the brain which would enable the severity of brain injury to be diagnosed with a simple blood test.

Hage has spent two decades designing separation and measurement techniques, many of which are patented for a wide range of applications. These applications have ranged from new clinical tests to improved methods for forensic testing, drug development, and environmental monitoring.

The research is being supported by NIH, EPA, the Nebraska EPSCoR program, the Nebraska Center for Nanohybrid Functional Materials, and DOD. Clinical trials for the device are expected to begin in spring 2014. For more information, call (402) 472-2744.  

In other research, BrainScope Company Inc, a privately held medical neurotechnology company is developing a new generation of handheld, portable simple to use, non invasive tools to rapidly and objectively assess brain function and TBI at the point-of-care.

Clinical studies have been conducted over three years with collegiate and high school football players who sustained concussions. The findings indicate that BrainScope’s technology may be able to detect TBI, categorize the severity of TBI, and provide an indication of the length of time needed for recovery before the players can return to play. For more information, go to www.brainscope.com.   

NIH to Help Newborns

Newborn screening programs currently genetically screen more than 4 million U.S. infants per year due to the passage of the 2008 Newborn Screening Saves Lives Act. This screening program saves lives by identifying infants who are at risk for congenital disorders so that early interventions and treatments can be started.

NIH released a Funding Opportunity Notice “Genomic Sequencing and Newborn Screening Disorders” (RFA-HD-13-010) on August 9, 2012. The project will be a five year program with $25 million in funding co-funded by NICHD and the National Human Genome Research Institute within NIH. Pilot studies will be funded to determine whether or not having genome sequence information contributes to improved clinical care of newborns.

Funds will be used to stimulate research in three component projects specifically applicable to newborn screening. These component projects would provide for the acquisition and analysis of genomic datasets, perform clinical research, and perform research related to the ethical, legal, and social implementation of genomic sequencing of newborns.

Whole genome sequencing is a laboratory method that can determine the entire DNA sequence of a person’s genetic material or genome from a DNA sample. In recent years, genomic technologies have advanced sufficiently so that it may be possible to use individuals’ whole genome information to enhance medical care, including the care and treatment of newborns.

Eligible organizations to apply for the funding include public, state, and private state institutions of higher education, nonprofits, for-profits to include small businesses, and state and local governments.

The letter of Intent is due October 19, 2012 with the application due November 19, 2012. The earliest start date will be July 1, 2012.

Go to http://grants.nih.gov/grants/guide/rfa-files/RFA-HD-13-010.html for more information.

Tech Helps Nurse Practitioners

A project initiated to serve seniors has twenty full time cross-trained nurse practitioners employed by a Medicare Advantage plan called CareMore running twenty disease-specific clinics supported by high technology.

Using technology helps the nurse practitioners work with the patients to educate them on how to self-manage and coordinate their care as it relates to diabetes, wounds, CHF, hypertension, pulmonary disease, and CAD. Although caseloads vary across conditions, the typical nurse practitioner takes responsibility for roughly 1,500 patients.

CareMore operates network-model Medicare Advantage plans for seniors in Northern and Southern California, Arizona, and Nevada. The nurse-practitioner-led clinic program developed after one nurse practitioner with expertise in diabetes and wound care began seeing seniors with diabetes on a regular basis in one CareMore center.

CareMore’s IT systems include EMRs that support the nurse practitioners as they see patients, while other groups of four nurse practitioners monitor incoming data and then are able proactively to reach out to patients with CHF and hypertension if they require in-home monitoring.

For select CHF, hypertensive, and diabetics members, nurse practitioners have access to additional data provided by in-home monitoring and biometric telemetry devices. Members with diabetes receive a home glucometer to periodically measure blood glucose levels that are automatically stored in the device and can be downloaded by diabetes clinic staff to help monitor the patient.

Members with high blood pressure regularly use biometric telemetry devices to measure blood pressure and then transmit this information over the internet. CHF patients have a similar device to monitor weight. All of these systems tie into an internet-based interface which has built-in applications to provide real-time alerts and decision support to nurse practitioners and other clinicians.

A team of nurse practitioners and medical assistants regularly review the data and the alerts from the CHF and hypertension monitoring devices. If necessary, phone calls are made to encourage members who may be at risk to come to the nurse practitioner-led clinics. A separate call center reaches out to at-risk members with diabetes who register two consecutive hemoglobin A1C tests over eight percent.

To further help guide visits, nurse practitioners through CareMore’s EMR system have access to disease and condition-specific templates based on established guidelines and protocols related to self-management, education, and treatment. For a patient suffering from more than one disease/condition, the nurse practitioner can call up multiple templates during the visit so that all health issues can be addressed. As protocols are updated, IT staff updates the corresponding templates.

The results in the program show significantly improved outcomes and reductions in blood pressure, lower blood glucose levels, lower readmission rates for CHF patients, and lower amputation rates for those suffering from vascular and other types of wounds.

For more information, go to www.innovations.ahrq.gov or email Henry Do, MD, Senior Medical officer at CareMore at Henry.Do@caremore.com.