A Weekly Compilation of Clinical Laboratory and Related Information
from The Division of Laboratory Science and Standards
August 15, 2013
View Previous Issues - Healthcare News Archive
Senators Hagan and Hatch Introduce Newborn Screening Measure
Senators Kay Hagan (D-NC) and Orrin Hatch (R-UT) recently introduced legislation, S.1417, the Newborn Screening Saves Lives Reauthorization Act, which would preserve recent advances in state newborn screening programs. Since the enactment of earlier legislation, the number of states testing for 29 of the 31 treatable core conditions has increased four-fold.
In addition to expanding access to newborn screening, S.1417 would:
- help state screening programs better assess and coordinate newborn treatments;
- continue research towards identifying treatments for conditions that can be detected through early testing;
- ensure the quality of testing provided by newborn screening laboratories;
- renew the Secretary’s Advisory Committee on Heritable Disorders in Newborns and Children; and
- Create a fast track process for reviewing conditions where drug treatment is available.
Baldwin Says Bill Would Strengthen US Research
Sen. Tammy Baldwin said she plans to sponsor legislation that would strengthen America's commitment to research, science and innovation. The Wisconsin Democrat said she grew concerned after hearing Dr. Francis Collins, the director of the National Institutes of Health, bemoan a decade of funding reductions along with this year's sequestration cuts that slash $1.5 billion from the NIH budget. Continued cuts would disproportionately affect younger researchers, putting an entire generation of new scientists at risk, Baldwin said.
Baldwin said her bill is intended to determine how to maintain research funding at levels that keep the U.S. competitive with other science-focused countries. She plans to introduce the measure next month when the Senate reconvenes.
Medicare SGR Reform Bill Passes Key House Committee
Legislation to repeal the Medicare sustainable growth rate formula and revamp the physician payment system so it rewards high-quality care has garnered unanimous approval from a key House committee and constructive criticism from organized medicine groups The SGR is scheduled to cut pay rates by 24.4% in 2014, but the measure would stop that reduction and future SGR cuts by repealing the payment formula. Instead, pay rates would increase 0.5% annually for five years. This period of stability is designed to give physicians and other stakeholders time to help develop and test quality measures and improve their practices. The legislation would institute a quality incentive program at the end of the transition period in 2019, using an enhanced version of the Medicare physician quality reporting system.
FDA Proposes Fiscal 2014 User Fee Rates
The FDA proposes new rates for the user fees medical device companies pay to have their products reviewed by the federal watchdog agency. The FDA wants to raise the user fees paid by medical device companies for the watchdog agency's review by 4.2% across the board. The FDA's Center for Devices & Radiological Health said today that it proposes to boost the fees for both small businesses making less that $100 million annually and for their larger brethren. The increases would cover applications for 510(k) clearance, the more stringent pre-market approval process and a raft of other applications to the FDA.
LDT Guidance Unlikely in Near Future
The Food and Drug Administration’s (FDA’s) Director of the Center for Devices and Radiological Health (CDRH), Alberto Guiterrez, PhD, mentioned at the AACC Annual Meeting that the agency has not, at this time, notified Congress of its intent to publish the long-awaited guidance documents regulating laboratory developed tests (LDTs). Under the medical device user fee law enacted last year, Congress stipulated that the agency notify the legislative body 60 days prior to releasing the LDT documents. Also joining the debate was former CDRH Director Steve Gutman, MD, who posted a blog asserting that behind-the-scenes politics is the cause of the delay and the future issuance of the guidance is unclear. To view Dr. Gutman’s blog, please go to the Myraqa website.
New Guidelines: HIV Exposure at Work, Treat ASAP
Healthcare workers exposed to HIV at work should immediately begin four weeks of post-exposure prophylaxis with three antiretroviral drugs, according to new recommendations. The three-drug guideline is a change from the 2005 recommendations of the U.S. Public Health Service, which suggested prescribing the number of drugs based on an assessment of the risk of infection, according to David Kuhar, MD, of the CDC, and colleagues.
FDA Is Developing a 'Cybersecurity Laboratory'
Federal healthcare regulators have solicited bids from security group Codenomicon Defensics to help build a "cybersecurity laboratory" where regulators can take a closer look at software bugs and weaknesses in medtech systems. Codenomicon's systems will subject devices to "fuzz testing," barraging the software in search of defects or vulnerabilities that could leave a system open to attack.
Laboratory Medicine Plays a Key Role in Genetic and Genomic Testing
At a briefing in Capitol Hill on the current innovations in genetic and genomic testing. U.S. Rep. Jackie Speier (D-Calif.) was the keynote speaker at the meeting, which was hosted by the American Clinical Laboratory Association’s branch, Results for Life. “Thanks to the results of the human genome project and genomic testing, we’re seeing results that allow for real personalized medicine,” Rep. Speier said. Clinical laboratory testing allows for a more targeted diagnosis and treatment that benefits the patients, clinicians, and the health system. Steven Shak, MD, Chief Medical Officer and Executive Vice President of Research and Development at Genomic Health, indicated the value of genomic testing by providing data on breast, colon, and cancer patients who received treatment aided by the results of their genomic tests.
5 SURE-FIRE METHODS Complying With QSA.01.03.01 for Laboratories
In addition to compromising patient safety, failure to comply with proficiency testing standards can lead to serious sanctions. Quality System Assessment for Nonwaived Testing (QSA) Standard QSA.01.03.01 requires that laboratories have a process for handling and testing proficiency testing samples.
- Develop a written policy and procedure for testing of proficiency testing samples.
- Educate staff.
- Treat proficiency testing samples as you would patient samples.
- Develop a method for ensuring that attestations are signed.
- Assign someone to thoroughly review documentation before it is submitted.
The laboratory has a process for handling and testing proficiency testing samples.
Elements of Performance for QSA.01.03.01
1. The laboratory has written policies and procedures for testing proficiency testing samples.
2. The laboratory tests proficiency testing samples according to its policies and procedures.
3. The laboratory performs proficiency testing for each test method used as the primary method under each Clinical Laboratory Improvement Amendments of 1988 (CLIA ’88) certificate for each regulated analyte.
Note: Proficiency testing for secondary analyzers is not required. (See also QSA.02.08.01, EP 1, for correlation study requirements between primary and secondary methods)4. Proficiency testing samples are tested along with the laboratory’s regular patient testing workload by staff who perform the laboratory’s testing.
5. The laboratory rotates proficiency testing samples among the staff who perform patient testing.
6. The laboratory’s staff tests the proficiency testing samples the same number of times that they test patient samples.
7. The laboratory staff who performed the proficiency testing and the laboratory director or technical supervisor sign attestations documenting that proficiency testing samples were tested in the same manner as patient specimens. Source: http://www.jointcommission.org/
Interim Guidelines for Collecting, Handling, and Testing Clinical Specimens from Patients Under Investigation (PUIs) for Middle East Respiratory Syndrome Coronavirus (MERS-CoV) – Version 2
This is an updated version of the interim guidance document issued by the Centers for Disease Control and Prevention (CDC) on June 7, 2013. CDC has revised the interim guidance based on comments received from public health partners, healthcare providers, professional organizations, and others. CDC will continue to update the document as necessary to incorporate new information that increases our understanding of MERS-CoV.
- Modified the title of the document to reflect additional testing guidelines
- Expanded the “Specimen Type and Priority” section to better describe what specimens are preferred for testing
- Expanded the “Blood Components – Serum” section to better describe available testing options based on time between symptom onset and serum collection
- Revised “Summary of MERS-CoV rRT-PCR Testing Guidelines for Respiratory Specimens” that describes reporting MERS-CoV test results and testing for other respiratory pathogens
International Consortium for Harmonization of Clinical Laboratory Results (proposal)
Results from clinical laboratory measurement procedures should be comparable irrespective of the laboratory, method or time when measurements are made. Comparable results are necessary to allow meaningful interpretation of a patient’s condition over time, to allow clinical practice guidelines to be implemented, to allow data from clinical research to be used to develop guidelines, and for results to be aggregated into electronic health records. A lack of recognition that results are neither standardized nor harmonized may lead to erroneous clinical, financial, regulatory, or technical decisions. To address these problems, an international conference recommended that an international infrastructure be developed to provide: a systematic approach for prioritization of measurands to be harmonized based on clinical importance and the technical feasibility to achieve harmonization; an information portal on global harmonization activities to avoid duplication of effort; and procedures to implement harmonization for measurands for which no reference measurement procedure was likely to be developed. (Roadmap for harmonization of clinical laboratory measurement procedures. Clinical Chemistry 2011;57:1108-17.)
The Next Big Thing in Pregnancy: Sequencing Your Baby's Genome
Every year, the U.S. welcomes 4 million new babies into the world, the result of roughly 4 million pregnancies that in large part go through the same battery of prenatal health checks 4 million times: analyses of the mother's blood and urine, of the mother's blood pressure, of the mother's weight, of the mother's blood sugar -- even of the mother's genetic makeup if she's deemed a risk for certain inheritable disorders. Ultrasound imaging being the obvious exception, doctors generally measure an unborn baby's health via the mother -- a kind of science by proxy that offers only a rough approximation of the baby's developmental health. But if parents could know more about their child's health before birth, wouldn't they want to? And if a bounty of health information -- even the unborn child's entire genome and all the data contained therein -- could be accessed via nothing more than a simple blood draw from the mother, wouldn't parents want to have that option? A handful of medical diagnostics companies think so, and a new generation of non-invasive prenatal tests (NIPT) they have brought to market over the past couple of years have positioned them to completely transform the way clinicians perform routine prenatal care -- a full 4 million times annually in the U.S. alone.
Microfluidic Chip Captures Live Tumor Cells in the Blood
Tumor cells circulating within a patient's bloodstream can carry cancer from a primary tumor site to distant sites of the body, spreading the disease. Many currently available devices for detecting CTCs in patients' blood are either too slow for clinical use or have other problems, such as a reduced ability to distinguish between the rare CTCs and more common white blood cells and other non-tumor cells. The new system captures more than 90 percent of the CTCs, which makes it highly efficient. Overall processing time has also been shortened, thanks in part to a step in which red blood cells are selectively lysed, or broken apart. Lysing the red blood cells diminishes the tendency of blood to clog the system, a common problem that slows processing time in similar CTC filtering devices.
Face Recognition Test May Predict Early Dementia
Patients who were unable to name or recognize culturally-relevant and age appropriate famous faces may be at risk for various deficits in early-onset dementias, researchers found. Compared with age-matched controls, patients with primary progressive aphasia "displayed significant impairment" at a famous face identification task, with greater naming impairment associated with left anterior temporal lobe atrophy, and with greater recognition impairment associated with bitemporal atrophy, according to Tamar Gefen, MS, of the Cognitive Neurology and Alzheimer's Disease Center at Northwestern University Feinberg School of Medicine in Chicago, Ill., and colleagues.
FDA Approves First Rapid Diagnostic Test to Spot Antibodies to Both HIV Types 1 and 2 as Well as the HIV-1 p24 Antigen
The US Food and Drug Administration (FDA) approved the first rapid diagnostic test to spot antibodies to both HIV types 1 and 2 as well as the HIV-1 p24 antigen. The new test will enable HIV testing to expand to regions without traditional healthcare facilities and speed up treatment, according to the agency. The Alere Determine HIV-1/2 Ag/Ab Combo test, manufactured by Orgenics of Yavne, Israel, can detect HIV antibodies and the HIV-1 p24 antigen in human serum, plasma, and venous or fingerstick whole-blood specimens. The HIV-1 antigen is an earlier tip-off to HIV-1 infection than HIV-1 antibodies by themselves. The new test can tell the difference between acute vs. established HIV-1 infections when the blood specimen tests positive for the p24 antigen, but negative for HIV-1 and HIV-2 antibodies.
FDA Recognizes Med Device Interoperability Standards
Voluntary medical device standards for interoperability were recognized this week by the U.S. Food and Drug Administration, as outlined in an Aug. 6 post in the Federal Register. The recognition, according to Bakul Patel, senior policy advisor to the director of the Center for Devices and Radiological Health at FDA, is a "first step" toward helping manufacturers to create medical devices that can "work well" with each other
Quest Diagnostics Introduces Comprehensive Opioid Therapy Genetic Test
The test is based in part on gene variants owned by Transgenomic, Inc. (OTCBB: TBIO) through a non-exclusive licensing agreement between the two companies. Quest Diagnostics developed, validated and now offers the test service through its advanced Nichols Institute facility in San Juan Capistrano, Calif. Additional terms were not disclosed. More than 100 million Americans in the United States suffer from chronic pain. Opioids, which include oxycodone and methadone, are widely used in the management of moderate to severe pain. While opioids are the most widely prescribed class of medications in the United States, they are also implicated in high rates of drug addiction and overdose.
DIATHERIX Laboratories Receives Diagnostic Testing Patent
DIATHERIX Laboratories, Inc. announced that it has acquired the patent to Tem-PCR, a diagnostic testing technology that allows for rapid identification of multiple infectious disease organisms. With the patent acquisition, DIATHERIX plans to expand its business model to begin manufacturing and distributing diagnostic testing products to healthcare providers for on-site use.
Theragenics Agrees to $68M Buyout Offer From Juniper
Juniper Investment has agreed to pay about $68 million in cash to acquire Atlanta based Theragenics, which specializes in wound-closure systems and brachytherapy products. Theragenics Chief Financial Officer Frank Tarallo will become the company's CEO upon completion of the deal, which could come during the fourth quarter.
Texas A&M Plans Bioinformatics, Genomics Engineering Center
Texas A&M University plans to establish a new center to conduct genomics and computational biology research into human and animal health and agriculture. The Center for Bioinformatics and Genomics Systems Engineering, for which the Board of Regents approved plans late last week, will be a joint program run by the Texas A&M Engineering Experiment Station (TEES) and Texas A&M AgriLife Research.
Stanford Researchers Announce ‘Living Computers’ Made From DNA and RNA That Function Inside Human Cells and Could Be Used to Diagnose Cancer
Researchers at Stanford University are another step closer to understanding how to make DNA and RNA function like computer chips fabricated from silicon. Their work could eventually form the basis for new types of diagnostic services that could be offered by clinical laboratories and anatomic pathology groups. Bioengineers at Stanford University have engineered a genetic circuit to behave like a transistor in individual living cells, according to a story published by the San Jose Mercury News. The achievement represents the final component of a simple biological computer that functions within individual cells of the body.
Antibiotic Resistance Among Hospital-Acquired Infections Is Much Greater Than Prior CDC Estimates
The rise of antibiotic resistance among hospital-acquired infections is greater than the Centers for Disease Control and Prevention (CDC) found in its 2008 analysis, according to an ahead-of-print article in the journal, Antimicrobial Agents and Chemotherapy. The article also finds that the Food and Drug Administration's (FDA) promise to "reboot" antibiotic development rules a year ago to combat the rise in resistance has fallen short. "With antibiotic-resistant microbes infecting more than 2 million Americans every year and killing more than 100,000 annually, we must act to find new weapons in the global battle against deadly Superbugs," said Dr. Spellberg, M.D., who authored "Rising Plague," a book on antibiotic resistance.
Gene Combo May Predict Alcohol Treatment Outcomes
Specific gene combinations may predict the success or failure of an experimental medication for the treatment of alcohol dependence, new research suggests. A study of nearly 300 alcohol-dependent participants showed that the effectiveness of ondansetron for treating their disorder, including a reduction in severe drinking and an increase in abstinence, was strongly associated with whether they had 1 of 3 specific HTR3 gene variants. Ondansetron is a serotonin-3 (5-HT3) antagonist that is commonly used to treat postchemotherapy nausea and vomiting.
Blood Clots Could Be Sucked Out of the Brain by a Robotic Device
Intracerebral hemorrhaging is what occurs when a blood vessel in the brain bursts, and the blood which subsequently leaks out of that vessel forms a clot that places pressure on the surrounding brain tissue. It’s not that uncommon of an occurrence, it’s difficult to treat, and is fatal in about 40 percent of cases. Help may be on the way, however. A team from Nashville’s Vanderbilt University has created a robotic device that is designed to remove those clots, in a safe and minimally-invasive fashion.
Tumor-Targeting T Cells Engineered
Scientists genetically modify T cells derived from pluripotent stem cells to attack lymphatic tumors.
Scientists have combined the ability to reprogram stem cells into T cells with a recently developed strategy for genetically modifying patients’ own T cells to seek and destroy tumors. The result is the capacity to mass-produce in the laboratory an unlimited quantity of cancer-fighting cells that resemble natural T cells, a type of white blood cell that fights cancer and viruses. In a study published (August 11) in Nature Biotechnology, researchers show that the genetically engineered cells can effectively wipe out tumors in a mouse model of lymphoma. “To put these two techniques together is really groundbreaking,” said Pam Ohashi, a cell biologist at the Ontario Cancer Institute, who was not involved in the study. “The idea that you can make unlimited numbers of tumor-killing cells is very exciting.”
Canada Launches C$10.5M Prenatal Testing Comparative Effectiveness Project
Researchers at Canada's CHU de Quebec and the University of Laval will use C$10.5 million (US$10.2 million) in government funding to work with Ariosa Diagnostics to run a comparative study of non-invasive prenatal testing techniques for screening for chromosomal conditions such as Down syndrome. The project, funded by the Canadian Institutes of Health Research, Genome Quebec, and other partners will try out currently available prenatal screening methods, including Ariosa's Harmony Prenatal Test, which is already commercially available, Genome Quebec said.
Brazilian Scientists Test New AIDS Vaccine, Hoping 'HIVBr18' Ends Global Pandemic
Scientists in Brazil plan to test a new vaccine for acquired immune deficiency syndrome (AIDS) that may prevent the spread of human immunodeficiency virus (HIV) and the development of AIDS. Researchers at the University of Sao Paulo say that although the HIVBr18 vaccine won't eradicate the virus from its host, the disease would be beaten back sufficiently to prevent transmission or to develop immunodeficiency, thereafter maintaining equilibrium.
Test of PfSPZ Malaria Vaccine Encouraging
An experimental malaria vaccine is safe and effective, researchers said, performing better in early trials than any vaccine tested so far in the fight against the disease. In a small clinical trial involving 40 U.S. adults, 12 of the 15 people who received doses of the PfSPZ vaccine were protected from malaria, according to a study published in the journal Science. Though preliminary, the results represent hope in the battle against an illness contracted by hundreds of millions of people every year. "It's an exciting result," said Dr. Robert Seder, an immunologist at the National Institutes of Health in Bethesda, Md., who led the study. But he and others cautioned that more research, and possibly improvements in methods of delivering the vaccine, are needed before it would be practical to administer PfSPZ on a broad scale.
Researchers Suspect That Camels Are Linked to a Middle East Virus
Camels may be a carrier of the mysterious virus that has infected at least 94 people in the Middle East and killed half of them, scientists are reporting. The virus, first detected last year in Saudi Arabia, causes Middle East respiratory syndrome, or MERS, which begins with flulike symptoms and can progress to severe pneumonia. Because the virus belongs to a family called coronaviruses, often found in bats, researchers suspect that it originally came from bats. The bats might infect people through droppings or saliva, but they might also infect other animals that could then transmit the virus to humans. But which animals? Researchers have been scrambling to find out. Now, a scientific team from a dozen universities is reporting that dromedary camels (the kind with one hump) from Oman and the Canary Islands show signs of past infection with the MERS virus or one very much like it.
New Ground Broken in Epilepsy Research
The largest genetic study of children with certain debilitating types of epilepsy has uncovered dozens of mutations associated with the disease and two genes that have never before been linked to epilepsy, opening new avenues of research into potential treatments. The results - published in the journal Nature - are the first from an extensive nationwide project, led by researchers at UCSF and Duke University, to analyze the genomes of children with epilepsy. The findings focused on children with the most severe forms of epilepsy, which often are untreatable and cause major cognitive and developmental disabilities.
Autism Linked to Induced or Augmented Labor, Study Says
As scientists struggle to understand the causes of autism, a potential new pattern has emerged: The condition is associated with induced or augmented labor, according to a new study. Induction means stimulating contractions before spontaneous labor begins. Augmentation means helping contractions become stronger, longer or more frequent. Both of these methods of expediting deliveries have helped mothers who have health conditions that could be detrimental to them or their child. The researchers did not prove that these treatments cause autism. Women should not read the new study, which is published in the journal JAMA Pediatrics, and decide against expediting labor on that basis, said Simon Gregory, researcher at Duke University Medical Center and lead author of the study. "It’s a decision between them and their healthcare provider," Gregory said, but the data do not "outweigh the risks that would come with just not wanting to be induced or augmented at all, because then you’re the placing the mother and the infant’s life at risk."
Cocoa 'Might Prevent Memory Decline'
Drinking cocoa every day may help older people keep their brains healthy, research suggests. A study of 60 elderly people with no dementia found two cups of cocoa a day improved blood flow to the brain in those who had problems to start with. Those participants whose blood flow improved also did better on memory tests at the end of the study, the journal Neurology reported. Experts said more research was needed before conclusions could be drawn
Sugar Consumption Fuels Tumor Growth in Fruit Flies
Sugar consumption fueled tumor growth in fruit flies, possibly explaining why people with metabolic syndrome have an increased risk for certain cancers, according to a new study. Putting Drosophila engineered to express the oncogenes Ras and Src on a high-sugar diet resulted in small, localized tumors growing much larger and metastasizing, reported Ross Cagan, from the Icahn School of Medicine at Mount Sinai in New York City, and colleagues. The sugary diet caused the flies to develop insulin resistance, but it also promoted tumor cell-specific insulin sensitivity by increasing the activity of the canonical signaling pathway Wingless/Wnt, the researchers wrote in the journal Cell.
High Blood Sugar Linked to Dementia
People with diabetes face an increased risk of Alzheimer’s disease and other forms of dementia, a connection scientists and physicians have worried about for years. They still can’t explain it. Now comes a novel observational study of patients at a large health care system in Washington State showing that higher blood glucose levels are associated with a greater risk of dementia — even among people who don’t have diabetes. The results, published in The New England Journal of Medicine, “may have influence on the way we think about blood sugar and the brain,” said Dr. Paul Crane, the lead author and associate professor of medicine at the University of Washington
Mediterranean Diet Could Influence Genetic Risk for Stroke
A new study further strengthens the notion that what you eat can have an impact on your genetic risk for disease. The research, published in the journal Diabetes Care, shows that for people who carry two copies of a specific gene variant known to raise disease risk, eating a Mediterranean diet seems to lower their risk of developing stroke -- to the level of someone who possesses just one copy, or no copies, of the gene variant. A Mediterranean diet is one that is high in olive oil, fish and produce. On the other hand, for people who carry two copies of this gene variant and eat a low-fat diet, their risk of stroke is nearly three times higher than people with one or no copies of the gene variant. "Our study is the first to identify a gene-diet interaction affecting stroke in a nutrition intervention trial carried out over a number of years in thousands of men and women," study researcher José M. Ordovás, Ph.D., director of the Nutrition and Genomics Laboratory at the USDA Human Nutrition Research Center on Aging at Tufts University, said in a statement.
CDC State Data Shows High Costs due to Excessive Alcohol Use
Costs mainly due to binge drinking
Excessive alcohol use causes a large economic burden to states and the District of Columbia, according to a new study released by the Centers for Disease Control and Prevention. Excessive alcohol use cost states and D.C. a median of $2.9 billion in 2006, ranging from $420 million in North Dakota to $32 billion in California. This means the median cost per state for each alcoholic drink consumed was about $1.91.
“Excessive alcohol use has devastating impacts on individuals, families, communities, and the economy,” said CDC Director Dr. Tom Frieden, M.D., M.P.H. “In addition to injury, illness, disease, and death, it costs our society billions of dollars through reduced work productivity, increased criminal justice expenses, and higher healthcare costs. Effective prevention programs can support people in making wise choices about drinking alcohol.”
Report: Nationwide Medicaid Expansion Would Boost Enrollment by 18.1M
Medicaid and Children's Health Insurance Program enrollment would go up by about 37.4 percent if all states expanded their benefit programs under the Patient Protection and Affordable Care Act, rising from 48.3 million before the expansion to an estimated 66.4 million after full implementation, according to a Kaiser Family Foundation report. If all states expanded their Medicaid coverage under the PPACA, enrollment would increase by about 18.1 million people nationwide, and the uninsured population would shrink by 23.1 million, according to the analysis, which used the Urban Institute's American Community Survey-Health Insurance Policy Simulation Model. It may take until 2016 or longer for enrollment to reach the levels projected by the model, depending on how long it takes enrollment to ramp up, according to the Urban Institute. It's still unclear how many states will decide to expand Medicaid coverage, according to the report. As of July 1, 2013, 22 states were moving forward with the Medicaid expansion and six were debating it, according to the Kaiser Family Foundation.
Kentucky Sees Rise in Number of Doctors Offering Telemedicine, Greater Expansion Expected
The expanding number of doctors offering appointments through videoconferencing, called telemedicine, is expected to see a sharp increase. The Courier-Journal reports telemedicine is seen as a way to help deal with doctor shortages, especially in rural areas and especially with another 600,000 people in the state who are expected to join insurance rolls in health exchanges and or through expanded Medicaid coverage. "I see the future of medicine as a progressive use of technology," said Dr. Greg Jicha, a neurologist at the University of Kentucky's Sanders-Brown Center on Aging. "Riding the wave of telemedicine is really going to increase access to care."
A Limit on Consumer Costs Is Delayed in Health Care Law
In another setback for President Obama’s health care initiative, the administration has delayed until 2015 a significant consumer protection in the law that limits how much people may have to spend on their own health care. The limit on out-of-pocket costs, including deductibles and co-payments, was not supposed to exceed $6,350 for an individual and $12,700 for a family. But under a little-noticed ruling, federal officials have granted a one-year grace period to some insurers, allowing them to set higher limits, or no limit at all on some costs, in 2014.
8 Maine Hospitals Sue Sebelius Over Payments for Low-income Patients
Eight Maine hospitals have joined forces in a lawsuit against U.S. Department of Health & Human Services Secretary Kathleen Sebelius over a long-simmering dispute over payment calculations for dual eligibility patients, the Bangor Daily News reported. The lawsuit, filed in U.S. District Court in Portland, claims Sebelius arbitrarily and improperly ruled against them in a dispute over millions of dollars in payments to care for the elderly, poor and disabled.
Mostashari Ends Tenure at ONC
In one week, Farzad Mostashari, MD, twice made national news. He announced his unanticipated departure as national coordinator for Health Information Technology (HIT) for Health and Human Services this fall, and he authored new research in Health Affairs showing that the exchange of health information jumped 41 percent between 2008 and 2012. Mostashari joined ONC in 2009. And while healthcare groups issued statements lauding Mostashari’s service and his “tireless pursuit” of electronic health record (EHR) adoption and use, perhaps this new report is a kind of fitting requiem for his service as national coordinator of ONC.
Obamacare Months Behind in Testing IT Data Security
The federal government is months behind in testing data security for the main pillar of Obamacare: allowing Americans to buy health insurance on state exchanges due to open by Oct. 1. The missed deadlines have pushed the government's decision on whether information technology security is up to snuff to exactly one day before that crucial date, the Department of Health and Human Services' inspector general said in a report. "Several critical tasks remain to be completed in a short period of time," the report concluded. Any additional delays could mean CMS would not have the information it needs to authorize use of the system by Oct. 1, the inspector general found. The final component is an assessment by an independent testing organization that proper security controls have been implemented correctly, are operating as intended, and are meeting security requirements.
Workgroup: Don't Subject Health IT to FDA Pre-market Requirements
The Food and Drug Administration Safety and Innovation Act workgroup—tasked with developing a report that contains a proposed strategy and recommendations on a regulatory framework for health IT—submitted draft recommendations for that strategy at a Health IT Policy Committee meeting in Washington, D.C. Specifically, the workgroup said that health IT should not be subject to the FDA's pre-market requirements, except in the case of:
- Medical device accessories
- Certain forms of high-risk clinical decision support to be defined more clearly by the FDA
- Higher risk software use cases
Novant’s New Iris Scan Connects Patients to Records
Like something out of a science fiction movie, a new system at Presbyterian links patients to their medical records by scanning their eyes. The system, which the hospital introduced last month, is designed to combat identity mix-ups and theft. “Someone can steal a driver’s license or a social security number,” said Veronica Rose, a registrar at Presbyterian, “but they can’t get your eyes.” Hospitals across the country are turning to electronic means of recording medical information and verifying patient identity. One of the key benefits is that there’s nothing for patients to remember to bring, such as a driver’s license or insurance card.
Pathologist Creates Open Source Software
A pathologist at Taunton and Somerset NHS Trust has created open source, web-based pathology reporting software. Dr Fred Mayall, a consultant histopathologist at the trust, got involved in the Free Diagnostic Pathology Software Project after being frustrated that the existing IT in the NHS was not up to scratch. Cancer laboratory reporting software often lacks the technology medical staff need to accurately report complex cases, said Dr Mayall. “So we came up with the idea that we just created our own IT system. If we want the world’s best cancer pathology system, we know what needs to be in it, so we came up with what we needed and built it ourselves.”
Tackling the Greatest Digital Divide
What’s the most persistent digital divide in America? It isn’t by race, income or educational attainment, studies show, but by age. Just 56 percent of Americans over 65 are online, according to a May study by the Pew Internet and American Life Project, compared with 83 percent of people aged 50 to 64, 92 percent of people 30 to 49 and 98 percent of 18-to-29 year olds. The 2013 study represented the first time the percentage of America’s online elderly tipped over the 50 percent mark. Disconnected seniors are more likely to feel isolated and sink into depression, Sarmiento said, especially if they’re housebound by physical ailments or have lost much of their nondigital social circle to death, disease or dementia. A 2009 report by the Phoenix Center for Advanced Legal and Economic Public Policy Studies found a 20 percent reduction in depression among seniors who are online compared with those who are not.
Reporting Time Cut in Half by EHR-Automated Quality Measures, Study Says
The use of electronic health records for automating publically reported quality measures reduced the time required to update those quality measures by 50 percent, according to a case report in Journal of the American Medical Informatics Association. The report examined Oakland, Calif.-based Kaiser Permanente's automated quality reporting for the surgical care improvement project, one of six Joint Commission measure sets the organization has automated to date.
UNC-Malawi Cancer Pathology Laboratory Is a Model for Sub-Saharan Africa
Since 2011, the University of North Carolina has partnered with the government of Malawi to establish a pathology laboratory in the nation's capital, building on an existing decades-long collaboration. In July of 2011, UNC and the Malawi Ministry of Health established a pathology laboratory at Kamuzu Central Hospital in Malawi's capital city of Lilongwe. Relying on a largely Malawian staff (Fred Chimzimu, Coxcilly Kampani, Prof. George Liomba), supported by UNC collaborators, the lab has now assessed more than 3,600 specimens. The lab became one of only two pathology labs in the nation of 16 million, helping to relieve diagnostic delays that contributed to late diagnoses and early deaths for Malawians suffering from cancer.
Disclaimer- The information provided in this news digest is intended only to be general summary information. It does not represent the official position of the Centers for Disease Control and Prevention and is not intended to take the place of applicable laws or regulations.
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