A Weekly Compilation of Clinical Laboratory and Related Information
from The Division of Laboratory Science and Standards
April 18, 2013
- Supreme Court Considers Gene Patents
- CDC Studying H7N9 Bird Flu From China
- Nationwide Shortage of Tuberculin Skin Test Antigens: CDC Recommendations for Patient Care and Public Health Practice
- Moving on From Traditional Biopsies, Blood Tests Found to Provide Fuller Picture of Mutations in Cancer
- DVD Player Modified to Test Blood
- Scientists Make 'Laboratory-Grown' Kidney
- Brains as Clear as Jell-O for Scientists to Explore
- Study of Babies Did Not Disclose Risks, U.S. Finds
- Health IT Needs to Prepare for 'omics'
View Previous Issues - Healthcare News Archive
Supreme Court Considers Gene Patents
The Supreme Court seemed skeptical that a human gene can be patented but also worried about what a decision to bar such patents would mean for private scientific inquiry and research. Even the normally confident justices expressed some trepidation as they considered the complexities of patent law and the mysteries of biochemistry. They talked about the introns and exons that are parts of genes, but spent more time on simpler illustrations: baseball bats, a hypothetical plant in the Amazon with miraculous powers, the recipe for chocolate-chip cookies. The justices’ caution is warranted: The decision could shape the future of medical and genetic research and have profound effects on pharmaceuticals and genetically modified crops.
What Obama’s Budget Means for Science
According to The Chronicle of Higher Education, overall Obama is proposing to increase science spending. The new budget includes $33.2 billion in total for basic science research (up by 4 percent over the fiscal year 2012 budget) and $143 billion for research and development (up by 1.3 percent since 2012).
The Centers for Disease Control and Prevention (CDC), meanwhile, is seeing its funds fall by $270 million to a total budget of $6.6 billion. Funds for prevention of chronic disease and public health preparedness are down. However, more money is proposed for fighting zoonotic disease and to the Advanced Molecular Detection Initiative, which aims to use gene sequencing and other techniques to speed up characterization of pathogens. Obama’s budget also includes increased money for injury prevention and control, including research into preventing gun violence.
President's New Budget Plan Extends Cuts for Lab Payments
President Obama's newly released fiscal year (FY) 2014 budget plan proposes a mix of cuts and tax increases to lower the deficit by $1.8 trillion over the next 10 years. Among the nearly $400 billion in proposed Medicare cuts is a $9 billion reduction in clinical lab payments. The budget backs policies to encourage electronic reporting of lab results, which are expected to amount to $9.5 billion in savings over 10 years.
Obama Budget Includes New Fee for EHR Vendors
Once again, the federal electronic health-record incentive payment program could take a financial hit due to government budget cutting. This time, EHR developers are being asked to take one for the team. The Office of the National Coordinator for Health Information Technology at HHS, as part of President Barack Obama's budget proposal, wants health IT vendors to pay an estimated $1 million in fees to help offset the cost of ONC's certification and standards activities.
Tavenner Draws Wide Bipartisan Support at Senate Confirmation Hearing
Marilyn Tavenner, acting administrator of the Centers for Medicare & Medicaid Services, received accolades from both sides of the aisle at a hearing to consider her nomination to head CMS. Senate Finance Committee leaders indicated a decision would come soon. Tavenner, who has been running CMS for more than a year on a temporary basis, was at last called in for a Senate Finance Committee vetting after being nominated twice for the position by President Obama.
Hoping to address the nation's imminent physician shortage, legislators in both chambers of Congress have introduced bills to create more medical residency slots for the growing number of U.S. medical graduates. In March, the Resident Physician Shortage Act was introduced in the U.S. Senate, and the bipartisan Training Tomorrow's Doctors Today Act was introduced to the U.S. House of Representatives. The bills aim to help meet the nation's increasing demand for new physicians by funding an additional 15,000 Medicare-supported graduate medical education (GME) positions over the next five years.
CMS and OIG Release Physician Referral, EHR Exception, and Safe Harbor/Anti-Kickback NPRMs
On April 10, the Centers for Medicare and Medicaid Services (CMS) and the HHS Office of the Inspector General (OIG) released two Notices of Proposed Rulemaking (NPRM). There is a 60-day public comment period, with responses due by June 10, 2013.
The CMS NPRM, outlines the following proposals, among others:
- Revising the exception to the physician self-referral prohibition for certain arrangements involving the donation of electronic health records (EHR) items and services.
- Extending the sunset date of the exception to December 31, 2016, remove the electronic prescribing capability requirement, and update the provision under which EHR technology is deemed interoperable.
Study of Babies Did Not Disclose Risks, U.S. Finds
A federal agency has found that a number of prestigious universities failed to tell more than a thousand families in a government-financed study of oxygen levels for extremely premature babies that the risks could include increased chances of blindness or death.
None of the families have yet been notified of the findings from the Office for Human Research Protections, which safeguards people who participate in government-financed research. But the agency’s conclusions were listed in great detail in a letter last month to the University of Alabama at Birmingham, the lead site in the study. In all, 23 academic institutions took part, including Stanford, Duke and Yale.
The letter stated that the study did have an effect on which infants died and which developed blindness, and that those risks were not properly communicated to the parents, depriving them of information needed to decide whether to participate.
HHS Charged With Bungling Preemie Study
Public Citizen, the watchdog group founded by Ralph Nader, demanded an apology from Kathleen Sebelius, secretary of the Department of Health and Human Services (HHS), for what it termed HHS mishandling of informed consent in a federally-funded study evaluating oxygen saturation targets in premature infants. The group claimed in a letter to HHS that the agency's Office for Human Research Protections (OHRP) failed to respond appropriately when it uncovered deficiencies in the consent forms used by the trial's participating centers; those problems are blamed for leaving the infants' parents uninformed about the potential risks of the trial and the actual purpose of the research. Public Citizen said the infants' parents should receive a formal apology.
Nationwide Shortage of Tuberculin Skin Test Antigens: CDC Recommendations for Patient Care and Public Health Practice
TUBERSOL®, a product of Sanofi Pasteur Limited, is in shortage nationwide until at least the end of May 2013. TUBERSOL® is one of two purified-protein derivative (PPD) tuberculin products that are licensed by the United States Food and Drug Administration (FDA).
CDC recommends any of three general approaches for addressing the shortages of tuberculin skin test antigens:
- Substitute IGRA blood tests for TSTs. The costs associated with using the blood tests can be greater than the cost of TSTs. The blood tests require phlebotomy, preparation of blood specimens, and specific laboratory services for analysis. Thus, these tests are not available in all practice settings. Clinicians who use the IGRA blood tests should be aware that the criteria for test interpretation are different than the criteria for interpreting TSTs (1).
- Allocate TSTs to priority indications, such as TB contact investigations, as determined by public health authorities. This might require deferment of testing some persons. CDC does not recommend testing persons who are not at risk of TB (4).
- Substitute APLISOL® for TUBERSOL®for skin testing. In cross-sectional studies, the two products give similar results for most patients. Shortages of APLISOL® are expected to become more widespread, thus limiting the feasibility of this approach.
CDC Studying H7N9 Bird Flu From China
There are no reported U.S. cases of H7N9 bird flu, but the Centers for Disease Control and Prevention are taking standard pandemic preparedness precautions. Officials at the CDC said they received the first H7N9 virus isolate from China which will support this process. The CDC began work on some preparedness measures based on the genetic sequences of the first three H7N9 viruses posted by China; the arrival of the actual isolate from China will allow this work to expand.
The virus isolate will be used to:
-- Continue to develop and evaluate a candidate vaccine virus against H7N9.
-- Further evaluate the CDC diagnostic test kit for detecting H7N9 infections in humans and make adjustments if needed.
FDA Issues Draft Guidance on Molecular Dx Instruments With Combined Functions
The US Food and Drug Administration is looking for feedback from the medical devices industry as it reviews its policies for handling how molecular diagnostic devices that have combination functioning, such as real-time thermocyclers, are used to perform multiple assays and may be best regulated. In a new draft guidance it has released for comments, the FDA has provided recommendations on how these combined-function molecular diagnostic instruments should be regulated. The document also covers the type of information that should be provided in a premarket submission for a molecular diagnostic instrument that measures human or microbial nucleic acid analytes and which also has combined functions.
Broad Recommendation for Molecular Testing Could Help Doctors Personalize Lung Cancer Care
Formal guidelines from professional medical societies now recommend that all patients with advanced lung adenocarcinomas should be tested for alterations in EGFR and ALK genes, which can help doctors then decide whether these patients will benefit from certain targeted tyrosine kinase inhibiting drugs. "The major recommendations are to use testing for EGFR mutations and ALK fusions to guide patient selection for therapy with an EGFR or ALK inhibitor, respectively, in all patients with advanced-stage adenocarcinoma, regardless of sex, race, smoking history, or other clinical risk factors, and to prioritize EGFR and ALK testing over other molecular predictive tests," wrote Neal Lindeman of Brigham & Women's Hospital and other colleagues from the three professional societies in the collaboratively developed, published guidelines.
Moving on From Traditional Biopsies, Blood Tests Found to Provide Fuller Picture of Mutations in Cancer
A new blood test revealed more of the gene mutations that sustain certain digestive-tract tumors than did a DNA analysis of a traditional tumor biopsy, Dana-Farber Cancer Institute investigators report at a special symposium of the American Association for Cancer Research annual meeting in Washington, April 6-10. The findings come from a study in which researchers used advanced amplification technology to search for abnormal DNA circulating in blood samples from patients in a clinical trial of a new therapy for gastrointestinal stromal tumor (GIST). GIST is a mutation-driven cancer of the digestive system that arises in approximately 5,000 people in the United States each year.
'Liquid Biopsy' More Precise in Detecting Cancer Mutations
A blood assay is much more successful than a traditional tissue biopsy for detecting key cancer mutations in patients with treatment-refractory gastrointestinal stromal tumors (GIST), new research shows. "Detecting drug-resistant mutations...can help clinicians choose therapies with more precision for patients," Dr. Demetri said at a meeting press conference. In the study presented by Dr. Demetri, the BEAMing blood biopsy tool was used. It is a digital technology that has "exquisite sensitivity," he said. "It can detect 1 mutant bit of DNA among 10,000 normal alleles," he told reporters.
An international research team has identified a new type of deadly intestinal lymphoma that is particularly common in Asia. The team, led by clinician-scientists from the SingHealth Academic Healthcare Cluster, also developed a new diagnostic test to accurately identify these patients. The study, carried out by the Singapore Lymphoma Study Group at Singapore General Hospital (SGH) and the National Cancer Centre Singapore (NCCS), has an immediate impact on patient care, with doctors now able to diagnose patients accurately and tailor more effective treatment strategies to improve outcomes. It will also impact the most recent WHO classification of haematolymphoid neoplasms. In addition, the team has identified a novel biomarker, known as MATK (megakaryocyte-associated tyrosine kinase), and developed a diagnostic test that enables clinicians to accurately diagnose patients suffering from this type of lymphoma. Requests for this test have come in from around the world, including China and the U.S.
Genomics May Help Identify Organisms in Outbreaks of Serious Infectious Disease Without Requiring Laboratory Culture
Researchers have been able to reconstruct the genome sequence of an outbreak strain of Shiga-toxigenic Escherichia coli (STEC) using metagenomics (the direct sequencing of DNA extracted from microbiologically complex samples), according to a study in the April 10 issue of JAMA, a Genomics theme issue. The findings highlight the potential of this approach to identify and characterize bacterial pathogens directly from clinical specimens without laboratory culture.
"The outbreak of Shiga-toxigenic Escherichia coli, which struck Germany in May-June 2011, illustrated the effects of a bacterial epidemic on a wealthy, modern, industrialized society, with more than 3,000 cases and more than 50 deaths. During an outbreak, rapid and accurate pathogen identification and characterization is essential for the management of individual cases and of an entire outbreak.
DVD Player Modified to Test Blood
DVD players are fast becoming obsolete with the rise of video streaming, but Swedish researchers have found something else to do with them. A team at the School of Biotechnology in the KTH Royal Institute of Technology in Stockholm has modified a DVD player to perform blood tests, including a check for HIV. The researchers converted a standard DVD player into a laser-scanning microscope, capable of detecting particular cells in a blood sample, says research highlighted in the journal Nature Photonics, and reported in Phys.org. The innovation opens up the possibility of cheaper blood tests in the developing world, senior lecturer at the institute and lead researcher Aman Russom told Phys.Org.
Cortisol Levels Predict Psychosis Risk
Cortical secretion is heightened in people at clinical high risk for psychosis, and it is associated with symptom severity and symptom progression, indicate initial findings from the North American Prodrome Longitudinal Study. Although the ongoing study and follow ups are not complete, researchers say the findings suggest that hypersecretion of cortisol may characterize an etiologic subgroup. Therefore, further study of the relationship between cortisol and brain abnormalities and the interplay between cortisol levels and receptor characteristics is warranted, they add.
Old Biomarker May Have New Role in Lung Ca
Bilirubin, which is considered a useful liver function marker, may also point to smokers at increased risk for lung cancer. In a large Taiwanese prospective cohort, male smokers with bilirubin in the lowest quartile lowest had a 69% higher risk for developing lung cancer, and a 76% higher rate of lung cancer mortality, compared with male smokers who had the highest bilirubin levels, said Xifeng Wu, MD, of the University of Texas MD Anderson Cancer Center in Houston. In men who had never smoked, bilirubin levels had no significant effect on health outcomes. The research showed that serum bilirubin is a potential biomarker for lung cancer risk prediction, Wu told MedPage Today at the annual meeting of the American Association for Cancer Research.
Tiny versions of the reflectors on sneakers and bicycle fenders that help ensure the safety of runners and bikers at night are moving toward another role in detecting bioterrorism threats and diagnosing everyday infectious diseases, scientists say. Their report on progress in using these innovative “retroreflectors” — the same technology that increases the night-time visibility of traffic signs — was among almost 12,000 on the agenda of the 245th National Meeting & Exposition of the American Chemical Society. “Our goal is the development of an ultrasensitive, all-in-one device that can quickly tell first-responders exactly which disease-causing microbe has been used in a bioterrorism attack,” says Richard Willson, who leads the research.
Many Breast Cancer Patients Do Not Receive Crucial Genetic Testing
Nearly half of breast cancer patients at high risk of carrying BRCA mutations do not receive genetic testing recommendations from their physicians. In fact, only 53% of newly diagnosed breast cancer patients who were at high risk of carrying a BRCA 1 or BRCA 2 mutation—based on age, diagnosis, and family history of breast or ovarian cancer—reported that their doctors urged them to be tested for the genes, according to a research team from the Perelman School of Medicine at the University of Pennsylvania.
The Key to Controlling Global Epidemic - HIV Self-Testing
A new international study has confirmed that self-testing for HIV is effective and could be the answer to controlling the global epidemic. This major systematic review, led by the Research Institute of the McGill University Health Centre (RI-MUHC), shows HIV self-testing removes much of the fear and stigma associated with being tested for the disease. This study, which is published in PLoS Medicine is the first of its kind and could pave the way for early detection and treatment
No Need for Genetic Testing for Most Thyroid Cancers
In the majority of patients with papillary thyroid cancer, the most common form of thyroid cancer, there is no need for genetic testing. However, there might be a role for such testing in the 7% of patients who present with an aggressive form of the disease. This finding comes from a study published in the April 10 issue of JAMA that explores the association between the BRAF V600E mutation and mortality in patients with papillary thyroid cancer.
Prostate Cancer: Call to Test Men in Their 40s
Men should be offered a screening test for prostate cancer in their late 40s, researchers say. The idea is controversial as prostate specific antigen (PSA) testing can be unreliable, throwing up false positive results that can cause undue worry and even treatment over something benign. But the Swedish team say, checking every man aged 45-49 would predict nearly half of all prostate cancer deaths. Their findings, in The BMJ, come from a study of more than 21,000 men.
Researchers have developed a simple new tool to help governments worldwide decide whether to screen airplane passengers leaving or arriving from areas of infectious disease outbreaks. The tool was developed by examining all international airplane traffic in the initial stages of the 2009 H1N1 pandemic. Researchers led by Dr. Kamran Khan of St. Michael's Hospital in Toronto found that a focused and coordinated approach to screening airplane passengers would generate the greatest public health benefits. Furthermore, they found that screening travelers as they leave an area where an infectious disease outbreak is under way is far more efficient than screening passengers when they land at their final destination.
Mayo Clinic Team Developing Predictive Gene Panel for Chemotherapy-induced Neuropathy
Researchers from the Mayo Clinic presented data at the annual meeting of the American Association for Cancer Research from their work using exome sequencing to identify gene mutations that could help gauge a patient's risk of developing peripheral neuropathy as a side effect of chemotherapy. Starting with a subset of genes known to be implicated in inherited forms of neuropathy and then expanding to examine larger portions of the exome, the team identified two promising predictive targets — the genes ARHGEF10 and PRX — in a study of 73 cases and 43 controls and also bookmarked a number of good candidates for future study.
FreeStyle InsuLinx Glucose Meter Voluntarily Recalled in United States
Abbott is voluntarily recalling its FreeStyle InsuLinx blood glucose meters in the United States due to a malfunction that could lead to a delay in the identification and treatment of severe hyperglycemia or incorrect treatment being given, which could potentially lead to serious injury or death. The problem is occurring at extremely high blood glucose levels of 1024 mg/dL and above, says the company. When this happens, the FreeStyle InsuLinx Meter will display and store in memory an incorrect test result that is 1024 mg/dL below the measured result. For example, at a blood glucose value of 1066 mg/dL, the meter will display and store a value of 42 mg/dL (1066 mg/dL - 1024 mg/dL = 42 mg/dL).
Thermo Fisher to Buy California Firm in $13.6 Billion Deal
Thermo Fisher Scientific Inc. agreed to buy diagnostics equipment maker Life Technologies Corp., in a $13.6 billion deal that will significantly expand Waltham-based Thermo Fisher and establish it as a major force in the emerging personalized medicine market. The definitive agreement caps a string of acquisitions over the past five years for Thermo Fisher, a leader in supplying medical instruments and technology to laboratories around the world.
Pathwork Dx Defunct; Future of Tissue of Origin Test Unclear
Pathwork Diagnostics has gone out of business as of April 2, PGx Reporter has learned. The company has "entered into a general assignment for the benefit of creditors," a message informs those who call Pathwork's offices. The company plans to issue an official notice in the next 30 days regarding "general assignment," the company states in the message. The company was based in Redwood City, Calif., and marketed a microarray-based gene expression diagnostic, called the Tissue of Origin test. Using proprietary algorithms, the test measures the gene expression levels of 2,000 genes, in order to help doctors determine the type of cancer a patient has in difficult-to treat cases.
At a time when healthcare costs continue to skyrocket, researchers have come up with a simple strategy for saving money in the hospital. "Showing physicians the price of diagnostic laboratory tests at the time they are ordered substantially cut the number of tests that were ordered, resulting in significant cost savings," said Leonard S. Feldman, MD, an assistant professor of medicine at the Johns Hopkins University School of Medicine. The study appears online in JAMA Internal Medicine.
- In the group in which the fee was displayed, the rates of ordering tests were reduced from 3.72 tests per patient day in the baseline period to 3.40 tests per patient-day during the intervention period. This corresponded to a 8.59% drop in tests ordered (95% CI -8.99% to -8.19%).
- In the control arm, ordering rose from 1.15 to 1.22 tests per patient-day from the baseline to the intervention period. This corresponded to a 5.64% increase in tests ordered (P < 0.001).
New Method Developed to Kill Pathogenic Bacteria Without Antibiotics or Chemicals
Engineering researchers at Rensselaer Polytechnic Institute have developed a new method to kill deadly pathogenic bacteria, including listeria, in food handling and packaging. This innovation represents an alternative to the use of antibiotics or chemical decontamination in food supply systems. Using nature as their inspiration, the researchers successfully attached cell lytic enzymes to food-safe silica nanoparticles, and created a coating with the demonstrated ability to selectively kill listeria Results of the study are detailed in the paper "Enzyme-based Listericidal Nanocomposites," * published in the journal Scientific Reports from the Nature Publishing Group.
Report on U.S. Meat Sounds Alarm on Resistant Bacteria
More than half of samples of ground turkey, pork chops and ground beef collected from supermarkets for testing by the federal government contained a bacteria resistant to antibiotics, according to a new report highlighting the findings. The data, collected in 2011 by the National Antimicrobial Resistance Monitoring System — a joint program of the Food and Drug Administration, the Agriculture Department and the Centers for Disease Control and Prevention — show a sizable increase in the amount of meat contaminated with antibiotic-resistant forms of bacteria, known as superbugs, like salmonella, E. coli and campylobacter.
Iron Deficiency Significance in Cancer Questioned
Researchers have uncovered an intriguing correlation between iron deficiency (ID) in patients with cancer and an increased likelihood of advanced disease and poor performance status. As reported in the Annals of Oncology, 45.9% of 1053 patients with solid tumors and 35.4% of 475 patients with hematologic malignancies were iron deficient, defined as a transferring saturation (TSAT) below 20%. In addition, 33.0% and 33.9% of the two groups, respectively, were anemic, defined as a hemoglobin level 12 g/dL or below.
Scientists Make 'Laboratory-Grown' Kidney
A kidney "grown" in the laboratory has been transplanted into animals where it started to produce urine, US scientists say. Similar techniques to make simple body parts have already been used in patients, but the kidney is one of the most complicated organs made so far. A study, in the journal Nature Medicine, showed the engineered kidneys were less effective than natural ones. But regenerative medicine researchers said the field had huge promise.
Brains as Clear as Jell-O for Scientists to Explore
Scientists at Stanford University reported that they have made a whole mouse brain, and part of a human brain, transparent so that networks of neurons that receive and send information can be highlighted in stunning color and viewed in all their three-dimensional complexity without slicing up the organ. Even more important, experts say, is that unlike earlier methods for making the tissue of brains and other organs transparent, the new process, called Clarity by its inventors, preserves the biochemistry of the brain so well that researchers can test it over and over again with chemicals that highlight specific structures and provide clues to past activity. The researchers say this process may help uncover the physical underpinnings of devastating mental disorders like schizophrenia, autism, post-traumatic stress disorder and others.
Biochemists Turn Flesh-Eating Bacteria Into Protein 'Superglue'
Biochemists at Oxford have adapted a protein from a species of flesh-eating bacteria into a kind of "superglue" that may improve cancer detection. Howarth, presenting the research to 245th meeting of the American Chemical Society in New Orleans, outlined exactly how strong that protein glue is: "We have engineered one of its proteins into a molecular superglue that adheres so tightly that the set-up we used to measure the strength actually broke. It resists high and low temperatures, acids and other harsh conditions and seals quickly." "With this material we can lock proteins together in ways that could underpin better diagnostic tests -- for early detection of cancer cells circulating in the blood, for instance," Howarth added. Cancerous tumours spread in the body by sloughing off cells into the bloodstream, and diagnostic tests rely on detecting when this happens.
Young Researcher Feels the 'Dance of the Dead'
Michael Xiao, 15, a student at Karl G. Maeser Preparatory Academy in Lindon, Utah, is the first high school student to present at the American Association for Cancer Research meeting, and maybe more importantly, among a very select group of scientists who show abilities far beyond their years. "I wanted to help better society. Maybe I wouldn't be as good as the other researchers, but I wanted to make an impact at this time," he said earnestly. Even his favorite piano pieces, he says, have an echo of cancer, like Liszt's "Totentanz," which translates to "The Dance of the Dead." Xiao, born in California, said he witnessed the grief of classmates in elementary school after a teacher died of cancer. He recalls a few years later thinking about cancer and exhaust pollution as he peered at the brown haze one day.
Tips From Former Smokers
In March 2012, the Centers for Disease Control and Prevention (CDC) launched the first-ever paid national tobacco education campaign — Tips From Former Smokers (Tips).
CDC is building on the success of the Tips campaign by launching a new round of advertisements in April 2013 to continue to raise awareness of the negative health effects caused by smoking, encourage smokers to quit, and encourage nonsmokers to protect themselves and their families from exposure to secondhand smoke. This campaign will expand upon the first campaign and feature additional health conditions (chronic obstructive pulmonary disease [COPD], asthma in adults, smoking-related complications in a person with diabetes) and population groups (American Indian/Alaska Native; Lesbian, Gay, Bisexual, and Transgender) that were not included in the first Tips campaign. The campaign also includes an ad focused on the effects of secondhand smoke exposure, as well as an emotionally impactful cessation ad.
HIE Workgroup: Reduce Program Variation, Extend Incentives
Micky Tripathi, Massachusetts eHealth Collaborative president and the workgroup chair, told the Policy Committee that although HIE "is advancing rapidly" in much of the country, "it is being held back by demand- and supply-side friction created by variation in federal and state programs and policies that give unequal and sometimes conflicting emphasis to interoperability." A CMS and ONC review of those areas of friction, and policy levers for reducing or eliminating it, "would do much to advance HIE adoption across the country," Tripathi said.
The workgroup also suggests providing laboratories safe harbor from certain federal clinical lab requirements, if providers are meaningful use compliant, and requiring or encouraging certification of technology used by providers not eligible for meaningful use, to help ensure interoperable exchange along the care continuum.
Health IT Needs to Prepare for 'omics'
Data systems in healthcare are lacking when it comes to the storage and handling of increasingly complex medical information, according to a new study published in the Journal of the American Medical Association. As genomics, epigenomics, proteomics and metabolomics and other so-called 'omics' advance, the study shows, the ability to store large-scale raw data for future reference with patients is critical – and existing EHRs are not up to the task. The study, "Crossing the Omic Chasm: A Time for Omic Ancillary Systems," was written by Starren with Marc S. Williams, MD, of Geisinger Health System, and Erwin P. Bottinger, MD, of Mount Sinai School of Medicine.
Doctor-Owned Hospitals Prosper Under Health Law
Some researchers say the doctors' financial interests encourage them to perform more tests and procedures, driving up the cost of care. The health law banned construction or expansion of these hospitals except in unusual circumstances. But physician-owned hospitals have emerged as among the biggest winners under two programs in the health law. One rewards or penalizes hospitals based on how well they score on quality measures. The other penalizes hospitals where too many patients are readmitted after they leave. There are more than 260 hospitals owned by doctors scattered around 33 states, according to Physician Hospitals of America, a trade group. They are especially prevalent in Texas, Louisiana, Oklahoma, California and Kansas.
Physician-Assisted Suicide Program Wins Praise
Patients, their families, and physicians have been satisfied with a "death with dignity" physician-assisted suicide program made available to terminal cancer patients at a Seattle clinic, clinicians there reported. Among 114 patients who asked about the program at the Seattle Cancer Care Alliance, the outpatient clinic for the city's major cancer treatment centers, 40 passed screening examinations and ultimately received lethal prescriptions for secobarbital, although only 24 actually took the drug, according to Elizabeth Trice Loggers, MD, PhD, and colleagues at the clinic and its affiliated centers.
US Cardiologist Admits to Ordering $19 Million in Unnecessary Testing
A New York area-based cardiologist has confessed to ordering unnecessary tests and procedures on patients to the tune of $19 million. Dr Jose Katz, the owner and chief executive officer of Cardio-Med Services and Comprehensive Healthcare and Medical Services, admitted to ordering diagnostic tests regardless of patient symptoms and falsely diagnosing a majority of his patients with angina to justify their treatment. The Record, a New Jersey newspaper, reports that Katz also admitted that he allowed unlicensed practitioners to treat and diagnose patients, including Mario Roncal, who obtained a medical degree in Puerto Rico but was never licensed to practice any US state. Katz also kept his wife on the payroll to make her eligible for Social Security benefits even though she did little or no work.
Clinical Laboratory President and New Jersey Doctor, Others Charged With Company in Multi-Million-Dollar Cash for Referral Scheme
Federal agents arrested the president and part-owner of Parsippany, New Jersey-based Biodiagnostic Laboratory Services LLC (BLS), a New Jersey physician, and two other BLS employees this morning on charges they participated in a long-running scheme to bribe doctors to refer patient blood samples to BLS and to order unnecessary tests, resulting in tens of millions of dollars in profit for the company. The charges were announced by New Jersey U.S. Attorney Paul J. Fishman.
Free Lab Tests for Charity Clinic
The Umbrella body of private laboratories said it was looking into offering free services to the Cyprus’ Volunteer Doctors’ weekend clinic and has suggested its members drop prices to beneficiaries of subsidised healthcare. The board of the association of clinical laboratory directors, biomedical and clinical laboratory scientists said it was looking to offer free services for necessary lab tests and nominal fees for other tests, its head Charilaos Charilaou said. He was referring to the free weekend clinic in Nicosia by the Volunteer Doctors to help the needy.
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