A Weekly Compilation of Clinical Laboratory and Related Information
from The Division Of Laboratory Programs, Standards And Services
April 17, 2014
- DNA Alternative to Pap Smear Sparks Medical Debate
- AACR Panel Discusses Challenges of Reporting Incidental Findings
- Choosing Wisely Lists Dominated by Cost Considerations
- Most Hospital Pregnancy Tests Found to Be Unreliable After First Few Weeks of Pregnancy
- Blood Test Could Provide Rapid, Accurate Method of Detecting Solid Cancers, Study Finds
- New Method for Prostate Cancer Detection Can Save Millions of Men Painful Examination
- New Blood Group Typing Technique Reduces Transfusion Risks and Blood Bank Costs
- Artificial Blood 'Will be Manufactured in Factories'
- Doctors Implant Lab-grown Vagina
- Defensive Medicine Accounts for One-third of Health Costs, Hospital Execs say
- EHR Meaningful Use Penalty Will Not Apply to Independent Laboratories
- OIG Reverses Course on Referral Arrangement Involving EHR Data Exchange
View Previous Issues - Healthcare News Archive
A high-tech screening tool for cervical cancer is facing pushback from more than a dozen patient groups, who warn that the genetic test could displace a simpler, cheaper and more established mainstay of women's health: the Pap smear. The new test from Roche uses DNA to detect the human papillomavirus, or HPV, which causes nearly all cases of cervical cancer. While such technology has been available for years, Roche now wants the FDA to approve its test as a first-choice option for cervical cancer screening, bypassing the decades-old Pap test. But a number of women's groups - including the American Medical Women's Association and Our Bodies Ourselves - warn that moving to a DNA-based testing model would be a "radical shift" in medical practice that could lead to confusion, higher costs and overtreatment.
Blood Glucose Monitoring Test Systems for Prescription Point-of-Care Use; Draft Guidance for Industry and Food and Drug Administration Staff; Extension of Comment Period
The Food and Drug Administration (FDA) is extending to May 7, 2014, the comment period for the notice that appeared in the Federal Register of January 7, 2014 (79 FR 830). In the notice, FDA requested comments on a draft guidance document entitled ``Blood Glucose Monitoring Test Systems for Prescription Point-of-Care Use.'' The Agency is taking this action in response to requests for an extension to allow interested persons additional time to submit comments.
Self-Monitoring Blood Glucose Test Systems for Over-the-Counter Use; Draft Guidance for Industry and Food and Drug Administration Staff; Extension of Comment Period
The Food and Drug Administration (FDA) is extending to May 7, 2014, the comment period for the notice that appeared in the Federal Register of January 7, 2014 (79 FR 829). In the notice, FDA requested comments on the draft guidance document entitled ``Self-Monitoring Blood Glucose Test Systems for Over-the-Counter Use.'' The Agency is taking this action in response to requests for an extension to allow interested persons additional time to submit comments.
EU Eyes Genetic Test Regulation
A skirmish is brewing in Europe over several proposals that would regulate genetic testing as part of an overhaul of the European Union's In Vitro Diagnostic Devices directives. The European Society of Human Genetics has a big problem with an amendment that would require that counseling be provided in certain situations and enact other rules on genetic testing. On the whole, ESHG supports the EU's medical devices reform, but in a new legal opinion the society says the genetic counseling amendment is burdensome, bad for patients, unworkable, and that the EU doesn’t have the legal authority to enact it anyway.
Reporting incidental or secondary findings may pose a challenge for the cancer field, a panel at this year's American Association for Cancer Research meeting said. The panelists particularly focused their discussion on recommendations the American College of Medical Genetics and Genomics issued last year and updated about a week ago. Those guidelines list a set of some 56 genes for which variants should be reported back to patients undergoing clinical sequencing. Many of the genes on that list are linked to increased cancer risk, as well as susceptibility to cardiac conditions.
Healthcare costs figured highly in specialty medical societies' decision-making processes in determining what to include in their Choosing Wisely Top 5 lists, according to a research letter published in the April 9 issue of JAMA. To learn more about how specialty medical societies were developing their Choosing Wisely lists, Catherine Gliwa, BA, and Steven D. Pearson, MD, PhD, from the Department of Bioethics, National Institutes of Health, Bethesda, Maryland, analyzed the "evidentiary rationales provided by specialty societies" when they issued their lists. They conclude, "Specialty societies can enhance trust in the Choosing Wisely campaign by defining more clearly the types of potentially wasteful medical care they seek to eliminate, and by providing a clear evidentiary justification for the selection of each service."
Overweight/Obese Youth May Not Receive Needed Lab Screening
Maryland Medicaid/Children's Health Program providers are inadequately coding diagnoses of overweight and obesity in children and adolescents, according to a CDC study published in the April 11 issue of the Morbidity and Mortality Weekly Report. Furthermore, at-risk overweight and obese children and adolescents are not receiving recommended laboratory screening tests for obesity-related conditions. "Expert Committee recommendations for the prevention, assessment, and treatment of childhood obesity were released in 2007 that update the 1998 guidelines published by the American Academy of Pediatrics," write Lee Hurt, DrPH, from the Armed Forces Health Surveillance Center in Silver Spring, Maryland, and the Maryland Department of Health and Mental Hygiene in Baltimore, and colleagues. "The recommendations included screening laboratory tests (lipid panel and fasting glucose) for children and adolescents with a body mass index (BMI) at or above the 85th percentile for age and sex, as well as dietary and physical activity assessment and screening for a family history of obesity risk factors."
Though the 11 most popular hospital urine pregnancy tests perform well in the first month after conception, a new study published in Clinical Chemistry, the journal of AACC, reveals the alarming statistic that nine of these tests become significantly more likely to produce false-negative results after the 5th to 7th week of pregnancy. When a human egg is fertilized, it begins producing the hormone human chorionic gonadotropin (hCG), which can be detected in either urine or blood. This is what healthcare providers test for to determine if a woman is pregnant. Around the 5th to 7th week of gestation, however, urine concentrations of an hCG variant known as the hCG beta core fragment rise dramatically, interfering with hCG detection and causing false-negative test results. In a hospital setting, this failure to detect pregnancy can lead to major consequences such as administration of medications that cause birth defects, fetal radiation exposure, or failure to diagnose ectopic pregnancy, which is the leading cause of first-trimester pregnancy-related maternal death.
A blood sample could one day be enough to diagnose many types of solid cancers, or to monitor the amount of cancer in a patient’s body and responses to treatment. Previous versions of the approach, which relies on monitoring levels of tumor DNA circulating in the blood, have required cumbersome and time-consuming steps to customize it to each patient or have not been sufficiently sensitive. Now, researchers at the Stanford University School of Medicine have devised a way to quickly bring the technique to the clinic. “We set out to develop a method that overcomes two major hurdles in the circulating tumor DNA field,” said Maximilian Diehn, MD, PhD, assistant professor of radiation oncology. “First, the technique needs to be very sensitive to detect the very small amounts of tumor DNA present in the blood. Second, to be clinically useful it’s necessary to have a test that works off the shelf for the majority of patients with a given cancer.” The researchers describe their findings in a paper published online April 6 in Nature Medicine.
Each year prostate tissue samples are taken from over a million men around the world - in most cases using 12 large biopsy needles - to check whether they have prostate cancer. This medical procedure, which was recently described by an American urology professor as 'barbaric', shows that 70% of the subjects do not have cancer. The examination is unnecessarily painful and involves risk for these patients, and it is also costly to carry out. A patient-friendly examination, which drastically reduces the need for biopsies, and may even eliminate them altogether, has been developed at Eindhoven University of Technology (TU/e), together with AMC Amsterdam. The results will be presented at the European Association of Urology Congress in Stockholm.
Large Clinical Trial Suggests NIPT Better at Detecting Fetal Trisomy Than First Trimester Screening
In a head-to-head comparison of noninvasive prenatal testing to standard first trimester screening for detecting Down syndrome, researchers found that analyzing cell-free DNA from maternal plasma comes out on top. The study, which was led by researchers from the University of California, San Francisco and Columbia University and sponsored by Ariosa Diagnostics, compared Ariosa's Harmony test to standard of care first trimester screening in women of average risk for fetal aneuploidy.
UNC Reports Data from First Year of Non-Invasive Prenatal Testing Using Verinata and Sequenom Tests
Researchers from the University of North Carolina's department of obstetrics and school of medicine have published a report on the center's first year offering non-invasive prenatal fetal aneuploidy tests from both Illumina-owned Verinata Health and Sequenom. Overall, the report, published late last month in Genetics in Medicine, found that between January and September 2012, noninvasive prenatal testing showed a combined sensitivity of about 85 percent and a specificity of 99 percent at UNC. Rates of both false-positive and false-negative results were higher than anticipated based on earlier published data. And unclassified results, reported by the Verinata test, were also more numerous than previous trials have suggested. According to the study authors, the team's experiences, especially the one false positive "highlight the importance of confirming abnormal results with invasive testing."
Each year, nearly five million Americans need a blood transfusion. Transfusions are performed on a number of different patients, such as those coming out of surgery, cancer patients, those suffering from infections or severe burns, or patients with certain blood disorders. For the many that need a blood transfusion, a successful procedure could mean the difference between life and death. Scientists in France have designed a new breakthrough technology that can dramatically reduce the negative complications associated with blood transfusions, and in turn, save many lives. The new system is based on a flexible DNA microarray platform for molecular blood group typing. Two robotic workstations process the blood samples into genotypes. In previous test runs, the results have been very promising, showing to be both simple to use and highly cost efficient. It is four times lower than the per-antigen cost using serologic methods.
Rapid Screenings Detect Previously Unreported HCV Infections
The combination of being able to take needle-stick blood samples outside of the typical clinical setting and rapid screening tests has revealed previously unreported hepatitis C virus (HCV) infections in Wisconsin. These are techniques that could be leveraged across the nation as the number of young drug users with HCV infections has spiked, according to a new study. Some 3.2 million people in the United States have chronic HCV, an infection that can go unnoticed for years, Lauren J. Stockman, MPH, from the Wisconsin Division of Public Health, Madison, and coauthors write in an article published in the April 11 issue of the Morbidity and Mortality Weekly Report. Yet lifelong HCV infections can have serious consequences, including liver cancer or a need for liver transplantation.
Bio-Rad Acquires Sequencing Technology Developer GnuBio
Bio-Rad Laboratories has purchased next-generation sequencing technology firm GnuBio for an undisclosed price in order to give it capabilities in the NGS space, especially for clinical applications, Bio-Rad said. Cambridge, Mass.-based GnuBio is developing a droplet-based sequencing platform that uses "picoinjector" technology developed in co-founder David Weitz’s physics laboratory at Harvard University.
Wellcome Trust-funded stem cell research has produced red blood cells fit for transfusion into humans, paving the way for the mass production of blood. But the production of blood on an industrial scale could become a reality once a trial is conducted in which artificial blood made from human stem cells is tested in patients for the first time. It is the latest breakthrough in scientists’ efforts to re-engineer the body, which have already resulted in the likes of 3d-printed bones and bionic limbs. Prof Turner has devised a technique to culture red blood cells from induced pluripotent stem (iPS) cells – cells that have been taken from humans and ‘rewound’ into stem cells. Biochemical conditions similar to those in the human body are then recreated to induce the iPS cells to mature into red blood cells – of the rare universal blood type O. “Although similar research has been conducted elsewhere, this is the first time anybody has manufactured blood to the appropriate quality and safety standards for transfusion into a human being,” said Prof Turner.
Proteins Discovered in Gonorrhea May Offer New Approach to Treatment
Researchers at Oregon State University have discovered novel proteins in, or on the surface of the bacteria that causes gonorrhea, which offer a promising new avenue of attack against a venereal disease that is showing increased resistance to the antibiotics used to treat it. Only a single, third-generation cephalosporin antibiotic still shows good efficacy against gonorrhea, creating a race against time to find some alternative way to treat this disease that can have serious health effects. It’s the second most commonly reported infectious disease in the United States. The new findings were just published in Molecular and Cellular Proteomics, by researchers from OSU and the Fred Hutchinson Cancer Research Center. The research has been supported by OSU and the Medical Research Foundation of Oregon.
How Niffy Nappies Could Help Develop New Weapons in Fight Against Bacteria
At a time when there is growing concern about rising antibiotic resistance, the results – published in the journal PLOS ONE – could lead to new ways of combatting dangerous bacteria. For many years, people thought bacteria worked by simply consuming resources until they ran out, and then entering a stationary, non-growing, phase. Working with physicists from the Cavendish Laboratory, Hannah Gaimster and David Summers from the Department of Genetics showed that as resources decline, bacteria switch to austerity mode, individually deciding to consume less until conditions improve. “Our results have many applications because indole plays such an important role in how bacteria respond to stress, including antibiotics. If we can understand how they use signaling systems to cope with the drugs we’re throwing at them, that should help us find new ways to get around their defences,” she said.
How Mouse Studies Lead Medical Research Down Dead Ends
Most experimental drugs fail before they make it through all the tests required to figure out if they actually work and if they're safe. But some drugs get fairly far down that road, at the cost of hundreds of millions of dollars, based on poorly conducted studies at the outset. Medical researchers reviewing this sorry state of affairs say the drug-development process needs serious improvement.So Steve Perrin, who runs the ALS Therapy Development Institute in Cambridge Mass., decided to take a close look at the mouse studies that had initially suggested these drugs were promising. "We tried to replicate those findings precisely by talking to the authors and trying to repeat the experiments in an identical fashion," Perrin says. "And what we found was that we couldn't replicate a lot of the experiments." Perrin says that if scientists had been more careful with their initial mouse studies, they would have realized that these drugs were never good candidates and that it made no sense to try them in people.
Obesity-Related Enzyme Targeted in Mouse Study
An enzyme in the fat and liver of mice could take a key role in future attempts to battle obesity and type 2 diabetes, according to a new study. The enzyme – nicotinamide N-methyltransferase, or NNMT – appears to help regulate the ability of cells to burn energy efficiently, researchers report. Controlling levels of this enzyme could potentially help people reach and maintain a healthy weight by prompting the body to burn excess energy rather than store it, Kahn suggested. "Diet and exercise will always be very key, but this opens up the possibility of a new way to speed up cellular metabolism so people don't store as much fat," she said. Results of animal research do not necessarily apply to humans, however.
Platelet Management Occurs via Progenitor Cells
A study has found that the production of platelets involves the direct action of thrombopoietin, an essential blood-making hormone, on progenitor stem cells several generations before the platelets. The platelets themselves, and their immediate ‘parent’ megakaryocyte cells, manage the levels of thrombopoietin to maintain platelet numbers in the blood. Platelets are essential for stopping bleeding and are small disc-shaped fragments that derive from the fragmentation of their parent megakaryocytes. The discovery, made by Dr Ashley Ng, Dr Maria Kauppi, Professor Warren Alexander, Professor Don Metcalf and colleagues at the Walter and Eliza Hall Institute, also shows how bone marrow cells could become overstimulated and produce too many platelets.
Four women have had new vaginas grown in the laboratory and implanted by doctors in the US. A tissue sample and a biodegradable scaffold were used to grow vaginas in the right size and shape for each woman as well as being a tissue match. They all reported normal levels of "desire, arousal, lubrication, orgasm, satisfaction" and painless intercourse. Experts said the study, published in the Lancet, was the latest example of the power of regenerative medicine.
Too Much Protein May Kill Brain Cells as Parkinson’s Progresses
Scientists may have discovered how the most common genetic cause of Parkinson’s disease destroys brain cells and devastates many patients worldwide. The study was partially funded by the National Institutes of Health’s National Institute of Neurological Disorders and Stroke (NINDS); the results may help scientists develop new therapies. “This may be a major discovery for Parkinson’s disease patients,” said Ted Dawson, M.D., Ph.D., director of the Johns Hopkins University (JHU) Morris K. Udall Center of Excellence for Parkinson’s Disease, Baltimore, MD. Dr. Dawson and his wife Valina Dawson, Ph.D., director of the JHU Stem Cell and Neurodegeneration Programs at the Institute for Cell Engineering, led the study published in Cell.
Gene Variant May Double Alzheimer's Risk for Women: Study
Having a copy of a certain gene variant increases women's risk for Alzheimer's disease much more than it does for men, a new study indicates. Stanford University researchers analyzed data from more than 8,000 people, most older than 60, who were tracked over a long period of time at about 30 Alzheimer's centers across the United States. Overall, having a copy of the ApoE4 gene variant increased the risk of Alzheimer's. But further analysis showed that women with a copy of this gene variant were about twice as likely to develop Alzheimer's as those who did not have the variant. Men with the ApoE4 variant had only a slightly increased risk of developing Alzheimer's, according to the study in the April 14 issue of the Annals of Neurology.
3D Model of Human Parasite to Help Curb Malaria
A research team at University of California, Riverside has generated a 3D model of the human malaria parasite genome at three different stages in the parasite's life cycle. The parasite that causes malaria in humans is Plasmodium falciparum. To understand the biology of an organism, scientists need to understand the information encoded in the genome sequence. They also need to know how the sequence is compacted and physically organised in each cell/tissue and how changes in the 3D genome architecture can play a critical role in regulating gene expression. "Understanding the spatial organisation of chromosomes is essential to comprehend the regulation of gene expression in any eukaryotic cell," said lead author Karine Le Roch, an associate professor of cell biology and neuroscience at University of California.
Simple, Short HCV Regimen Has High Cure Rate
A single pill once a day for 8 weeks is enough to cure more than 90% of hepatitis C virus (HCV) patients with relatively uncomplicated disease, a researcher said. In a large phase III open-label trial, 94% of patients with HCV genotype 1 and no cirrhosis were able to clear the virus after just 8 weeks of sofosbuvir (Sovaldi) and ledipasvir co-formulated in a single once-daily pill, according to Kris Kowdley, MD, of Virginia Mason Medical Center in Seattle.
Flu Drugs May do More Harm Than Good, Researchers Find
Tamiflu and Relenza, antiviral drugs stockpiled by governments to tame influenza outbreaks, haven’t been proven to prevent pandemics and may cause more harm in some patients than good, researchers said after reviewing 170,000 pages of clinical-trial data. The findings, published today in the journal BMJ, came from the Cochrane Collaboration, a nonprofit U.K. research organization, using information obtained from Roche Holding AG (ROG), maker of Tamiflu, and GlaxoSmithKline Plc (GSK), which sells Relenza.
Virtually All Touchscreens Are Contaminated With Pathogens
Virtually all smartphones and tablet computers used by healthcare workers are contaminated with at least 1 organism, research from a German hospital shows. "We might be transferring these pathogens to patients, increasing their risk for infection," said investigator Romy Wendler, a medical student at Klinikum St. Georg in Leipzig, Germany. "Nurses and physicians use their private phones while working in high-risk areas, such as in operating rooms and ICUs," she told Medscape Medical News. "Our behavior might be putting patients at risk because we are not thinking about good hygiene in these critical settings." The study results were presented at the 16th International Congress on Infectious Diseases.
Are You Programmed to Enjoy Exercise?
It’s possible that some of us are born not to run. According to an eye-opening new genetics study of lab rats, published in The Journal of Physiology, the motivation to exercise — or not — may be at least partly inherited. For years, scientists have been bedeviled by the question of why so few people regularly exercise when we know that we should. There are obvious reasons, including poor health and jammed schedules. But researchers have begun to speculate that genetics might also play a role, as some recent experiments suggest.
Boston Considers Banning Deadliest Pathogens From new Biolab
Boston is set this week to debate whether to ban a new, downtown biodefense laboratory from studying some of the world's deadliest disease agents. A city council hearing is expected to consider a proposed citywide prohibition on so-called "Biosafety Level 4" research, which can involve diseases for which there are no known cures. The initiative marks the latest local pushback against Boston University's effort to pursue the sensitive pathogen studies at its recently completed National Emerging Infectious Diseases Laboratories.
Pentagon Seeks More Funds to Counter Bio Weapons
The Pentagon wants to spend more money on a secret program to track weapons of mass destruction because of new information showing an increased need to locate chemical and biological weapons, military budget plans show. The increased funding for the Nimble Elder program of the Defense Threat Reduction Agency (DTRA) is "driven by recent classified DoD guidance," according to DTRA's budget plans, which were released in March. The threat from biological weapons is real and growing, said Gerald Parker, vice president for public health preparedness and response at Texas A&M University's Health Science Center. "Biological weapons are a considerable threat that we need to pay attention to and develop new capabilities that are able to respond to bio threats," said Parker, a former deputy assistant secretary of Defense for chemical and biological defense. "Bio threats can emanate from state-sponsored and non-state-sponsored programs."
Drop in Federal Funds Squeezes Public Health
The state budget recently delivered good news for Georgia public health: an overall increase in funding. But behind those numbers are other numbers that have alarmed public health officials. About 70 percent of the overall budget for the Department of Public Health comes from federal grants. And that federal money has seen significant reductions. From fiscal 2012 to fiscal 2013, across all programs, Public Health lost about $25 million in federal money. And that drop has continued. Almost all Health and Human Services and Homeland Security grants have been cut, said Dr. Patrick O’Neal, director of health protection for the Georgia Department of Public Health. All states have suffered federal reductions to public health programs, according to the American Public Health Association. But some states, such as Georgia, that are much more dependent on federal dollars have been hit hardest.
Congress Passes Law Changing How Medicare Sets Prices for Clinical Laboratory Tests; Lab Industry Groups Differ on Which Labs Will Be Winners and Losers
Clinical laboratories will face new financial challenges following passage of a new federal law two weeks ago that makes deep changes in the way Medicare officials will establish prices for the Medicare Part B Clinical Laboratory Fee Schedule (CLFS). Many medical laboratory administrators, hospital lab managers, and pathologists remain unaware of the significant negative financial impact this law will have on their lab’s revenue and fiscal stability.
Hospital administrators estimate that one-third of healthcare costs are the result of tests and treatments that aren't medically necessary and ordered defensively to prevent lawsuits, according to a new survey by Atlanta-based Jackson Healthcare.
Other highlights of the survey, which 106 hospital executives completed in early 2014, included the following:
- Ninety-four percent of respondents said they believe the practice of defensive medicine drives up healthcare costs, while 62 percent said it protects hospitals from litigation.
- Executives estimated that 57 percent of physicians practice defensive medicine (in a separate Gallup survey in 2010, 73 percent of physicians stated they practiced some form of defensive medicine during the previous year).
- Sixty-five percent of hospital executives said defensive medicine hurts hospitals' financial performance, while 27 percent reported a positive impact.
- Respondents were almost evenly divided on how defensive medicine affects patient care quality, with 31 percent citing a positive impact, 32 percent reporting a negative impact, 30 percent claiming no impact and 7 percent stating they didn't know.
Pathologists at independent laboratories will not be penalized under the Medicare Electronic Health Record (EHR) Incentive Program beginning in 2015, according to the College of American Pathologists (CAP). Pathologists billing only the professional component of Medicare services and Provider Enrollment, Chain and Ownership System code 22 on claims will automatically be granted a hardship and will not be penalized in 2015, says CAP, which sought clarification on this issue.
Big Data Bummers
Big data is "suddenly everywhere" these days, say New York University Professors Gary Marcus and Ernest Davis in the New York Times. "Everyone seems to be collecting, it, analyzing it, making money from it and celebrating (or fearing) its powers," they write. But is it time to fire all the researchers and let the machines take over? Nope. Marcus and Davis have some bones to pick with big data, nine bones at least. Turns out that there are some sticky issues that crop up when vast volumes of number get crunched. "Molecular biologists, for example, would very much like to be able to infer the three-dimensional structure of proteins from their underlying DNA sequence…. But no scientist thinks you can solve this problem by crunching data alone, no matter how powerful the statistical analysis," they write. Big data also can be gamed. Take the example of programs used in grading student essays, which examine sentence length and word sophistication and have correlated well with the grades given by humans. If those programs replaced humans, what would stop students from simply writing essays that are full of long sentences fancy words, but otherwise poorly written?
It appears that there may be uses for Google Glass beyond wearing them to attract mates and to make everyone not wearing them feel like outsiders. In what amounts to a teaser for how Glass and similar tools may one day be used in medicine, an inventive group of UCLA scientists have worked up an app that uses the space-age specs to make it much faster and easier to get the results of medical diagnostic tests. The application reads dozens of types of lateral flow diagnostic tests for malaria, prostate cancer, and HIV, among others, and could be adapted for any number of other tests, and it uploads the results to secure servers and provides anonymous data to epidemiologists. The project, headed by UCLA's Aydogan Ozcan, enables Glass wearers to capture photos of rapid diagnostic test results, upload them in about 8 seconds, and receive analyses that are more accurate than the human eye can provide.
The U.S. Department of Health & Human Services Office of Inspector General has taken the rather unusual step of terminating an advisory opinion originally in favor of a data exchange arrangement created by an electronic health record vendor. OIG initially approved the arrangement in 2011, in which physicians who purchase the "Coordination Service Package" received a discount on their monthly EHR service subscription fees. Each time the physician used the coordination service to make a referral to a "non-trading partner," the discount was reduced by an amount equal to or less than $1.00, until it disappeared entirely. "Trading partners" paid a per-order fee for each test order the vendor transmitted to the trading partner. OIG approved the arrangement because, among other things, the network was large, the arrangement was intended to facilitate the exchange of information among providers, fees were at fair market value and were unlikely to include referrals because they were low and capped. In its notice of termination of the opinion, dated April 8, OIG has reconsidered its position, and now concludes that the arrangement could implicate the anti-kickback statute in the event that the "trading partner" is one that a physician may refer to frequently.
HIT Policy Committee Approves Best Practices for Proxy Access to EHR Data
The Health IT policy committee gave a green light to recommendations from its privacy and security Tiger Team that empower patient personal representatives (proxies) for adults with view/download/transmit (VDT) permissions for protected health information. Such permissions as they pertain to adolescent patients will be discussed at a future meeting.
Cost Remains a Barrier to e-Prescribing, Despite Benefits
While e-prescribing has the potential to increase patient safety and medication adherence while save money, implementation costs remain one of the biggest barriers to adoption in ambulatory practices, according to research published at Perspectives in Health Information Management. Sending prescriptions electronically to pharmacists has the potential to save the U.S. healthcare system an estimated $27 billion a year, the article points out. It potentially can help prevent more than two million adverse drug events a year, 130,000 of them life-threatening.
Researchers Develop Bacterial 'FM Radio'
Programming living cells offers the prospect of harnessing sophisticated biological machinery for transformative applications in energy, agriculture, water remediation and medicine. Inspired by engineering, researchers in the emerging field of synthetic biology have designed a tool box of small genetic components that act as intracellular switches, logic gates, counters and oscillators. The key that enabled this breakthrough is the use of frequency, rather than amplitude, to convey information.
UCLA, Chinese Firm to Create Lab Offering MDx, Genetic Tests in China
The University of California, Los Angeles announced an agreement with a Chinese firm creating a new company to offer molecular diagnostic, genetic, and other "sophisticated" tests in China. UCLA, the UCLA Department of Pathology, and Centre Testing International — which offers product testing, inspection, certification, and consulting services in China — reached the deal to create CTI-Pathology/UCLA Health, a new company that will operate a 25,000-square-foot facility in Shanghai. The lab, which is expected to open in September, will support clinical trials "and enhance medical care" for patients in China with cancer and other illnesses, UCLA said, adding that pathologists from the school will train Chinese lab specialists in interpreting test results.Source: http://www.genomeweb.com/
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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