jueves, 10 de septiembre de 2015

DLS|HEALTHCARE NEWS|September 10, 2015

DLS|HEALTHCARE NEWS|September 10, 2015



A Weekly Compilation of Clinical Laboratory and Related Information
From The Division Of Laboratory Systems

September 10, 2015

News Highlights

  • House Passes Stem Cell Research Reauthorization
  • The Medicare Advisory Panel on Clinical Diagnostic Laboratory Tests Convenes Its Inaugural Meeting
  • HIV-preventing Drug Holds up under Study
  • The Case for FDA Regulation of Laboratory-Developed Diagnostic Tests
  • The Debate over Universal TSH Screening in Pregnancy Continues
  • Cutting-Edge Gene Tests May Improve Management of Autism
  • The Great Big Clean-Up
  • Scientists Map Genes at Work in Human Embryos' Earliest Days
  • Milder AKI Diagnoses Subject to Error, Warns Study
  • Medical Specialists Urge More Debate on Gene-Editing Technology
  • New Guidelines Call for Kids, Health Care Workers to Get Flu Shots
  • More Than Half of Asian Americans with Diabetes Are Undiagnosed
  • NIH Awards More Than $48M to eMERGE Project to Correlate Genomic Data with Health Records
  • AHRQ to Fund Research into How Health IT Can Boost Patient Safety
  • FDA Beefs Up Medical Device Adverse Event Data through API
  

View Previous Issues - Healthcare News Archive


Leading News

House Passes Stem Cell Research Reauthorization
The House passed legislation on Tuesday that would reauthorize programs to conduct medical research and transplants using stem cells from bone marrow and umbilical cord blood. Passed by voice vote after only about ten minutes of debate, the bill authorizes $23 million annually for the National Cord Blood Inventory Program and $30 million per year for the C.W. Bill Young Cell Transportation Program through fiscal 2020. The stem cells from bone marrow or umbilical cord blood collected after a birth can be used for transplants for blood-related diseases like leukemia.
The Medicare Advisory Panel on Clinical Diagnostic Laboratory Tests Convenes Its Inaugural Meeting
On August 26, 2015, the Medicare Advisory Panel on Clinical Diagnostic Laboratory Tests held its inaugural meeting.  The Panel was established by the Secretary of Health and Human Services under the authority of Section 216 of the Protecting Access to Medicare Act of 2014 (“PAMA”), which prescribes a new market-based payment system for laboratory tests paid under the Clinical Laboratory Fee Schedule.  PAMA, directs the Secretary to consult with the expert outside advisory Panel for (1) input on the establishment of payment rates under the new law for new clinical diagnostic laboratory tests, including whether to use crosswalking or gapfilling processes to determine payment for a specific new test, (2) input on the factors used in determining coverage and payment processes for new clinical diagnostic laboratory tests, and (3) recommendations under the new law.  See Charter for the Medicare Advisory Panel on Clinical Diagnostic Laboratory Test. With the first Panel meeting now complete, the pathology and laboratory communities continue to wait for CMS to publish regulations implementing PAMA’s new mandates.  The regulations will likely also provide additional information on the scope of the Panel’s role in addressing coverage and payment processes under the market-based pricing system.  Although PAMA required a final rule to be released by June 30, 2015, CMS has missed the deadline.  CMS announced this week that the proposed rule is almost completed and should be issued by the end of September.  The proposed rule can be tracked at the Office of Management and Budget website here.
HIV-Preventing Drug Holds Up under Study
Truvada, a daily pill that holds the hope of eliminating the risk of contracting HIV, appears to be living up to its promise. In the first real-world study of the prescription drug, Kaiser researchers found no new HIV infections among the more than 650 people they followed over nearly three years, beginning just after the drug was approved by the U.S. Food and Drug Administration in 2012. A clinical trial leading up to the FDA approval had shown that Truvada, made by Foster City’s Gilead Sciences, nearly eliminated the risk of getting infected by the AIDS virus. But no evaluations of the drug, also known as PrEP, for pre-exposure prophylaxis, had been published outside the tightly regulated clinical trial setting. In the new study, participants were sexually active. Many did not use condoms for prevention, and half of them were diagnosed with other sexually transmitted diseases within a year of starting the study. But no new HIV infections turned up, researchers said. “This is really compelling data that shows that PrEP works in a real-world setting,” said Dr. Jonathan Volk, a San Francisco Kaiser physician and epidemiologist and lead author of the study, which was published in the medical journal Clinical Infectious Diseases.

 

Laboratory Testing / Diagnostics

The Case for FDA Regulation of Laboratory-Developed Diagnostic Tests
Before they can be commercially available, high-risk, life-sustaining medical devices such as pacemakers, HIV tests, and automated external defibrillators (AED) must undergo the Food and Drug Administration’s (FDA) premarket approval process—an extensive series of steps involving rigorous testing for safety and efficacy. Until recently, however, a decades-old exemption enabled a subset of diagnostic devices called Laboratory-Developed Tests (LDTs) to bypass this process completely. As a result, more than 11,000 medical diagnostic tests on the market have never beentested for accuracy, risks, or side effects. But last July—in a move that drew both high praise and fierce opposition—the FDA announced that it would consider placing LDTs under federal oversight for the first time in history. In a recent article, Joshua Sharfstein—Associate Dean at the Johns Hopkins School of Public Health and former Secretary of the Maryland Department of Health and Mental Hygiene— argues that the agency’s proposal is a long-overdue victory for patients.
The Debate over Universal TSH Screening in Pregnancy Continues
Thyroid disease affects approximately 5% of U.S. women of reproductive age and has been associated with complications in pregnant women and their children. This relatively high incidence in part is driving a heated debate over whether there should be universal screening in pregnancy consisting of a thyroid-stimulating hormone (TSH) test—followed by measurement of free thyroxine (FT4) if TSH is abnormal. While a strong body of research points to a clear relationship between overt thyroid disease and pregnancy complications—including miscarriage, pre-eclampsia, anemia, placental ­abruption, and postpartum hemorrhage—evidence about the effects of subclinical thyroid disease, especially hypothyroidism, is less clear. Given this nuanced view of thyroid disease in pregnancy, it perhaps is not surprising that medical groups have taken different stances on universal screening. Overt hypothyroidism affects up to 1% of all pregnancies. But subclinical hypothyroidism, which has been estimated to affect between 3% and 15% of pregnancies, “is where the controversy lies,” said Alex Stagnaro-Green, MD, regional dean at the University of Illinois College of Medicine in Rockford, chair of the American Thyroid Association’s (ATA) Taskforce on Thyroid and Pregnancy, and lead author of 2011 ATA guidelines on thyroid disorders and pregnancy.
Cutting-Edge Gene Tests May Improve Management of Autism
A pair of genetic tests could help parents and doctors better understand the numerous challenges that a child newly diagnosed with autism might face throughout life, a new study suggests. The tests tracked down genes that could explain the nature of a child's autism susceptibility in nearly 16 percent of cases, according to findings published Sept. 1 in the Journal of the American Medical Association. That number increased to almost 38 percent when researchers used the cutting-edge tests to assess children with certain physical abnormalities. These birth defects are an indication that those children had suffered developmental problems stretching back to the womb, said senior study author Dr. Bridget Fernandez, chair of genetic medicine at Memorial University of Newfoundland in Canada. The two genetic tests are called chromosomal microarray analysis and whole-exome sequencing. "They are two very comprehensive tests that haven't been around for too long," Fernandez said.
Image Is Everything!
Quality issues remain as digital pathology enters the clinical lab.
Digital microscope images are used in reports, papers, publications, posters, laboratory notebooks, and all kinds of presentations. They provide data on and insight into specimens, cases, and procedures. But how can a laboratory professional be sure that a digital microscope image is consistent and reliable? What assurance is there that any given equipment captures a true representation of the specimen or that a computer monitor adequately displays the image? Nevertheless, digital imaging has become a standard practice in microscopy for research and teaching, and during the last several years, there has been a growing emphasis on the potential for digital microscopic images in clinical diagnostics in the United States. Digital pathology has grown in adoption and acceptance, as progress has been made in the validation and use of digital microscope images across a number of application areas. However, studies have revealed that current technology is not yet quite as good as the actual slide as viewed through a properly adjusted microscope. The old way is still viewed by most as “the gold standard.”
Universal BRCA Testing Slammed as Too Costly, Inefficient
—But BRCA1 discoverer disagrees
Universal screening for BRCA1/2 mutations would prevent few cancers and exceed generally accepted criteria for cost-effectiveness, authors of a decision-analysis study concluded. Universal screening would prevent four breast cancers and two ovarian cancers for every 10,000 women screened, increasing mean life expectancy among everyone screened by about 2 days. Even under favorable circumstances, universal screening would cost more than $1 million per quality-adjusted life year (QALY) gained, Elisa F. Long, PhD, and Patricia Ganz, MD, of the University of California Los Angeles, said in a perspective article published online in JAMA Oncology.
In BRCA Test Validation, Quest Says Off-the-Shelf NGS Assays Need Some Tweaks
Quest Diagnostics, while an adopter of clinical next-generation sequencing, has published research suggesting that laboratories should be careful when validating off-the-shelf kits for clinical use as they are likely not sufficient without substantial modifications. In the study, published in PLOS One, Quest researchers described the validation of the firm's NGS-based BRCAvantage test for analyzing the BRCA1 and BRCA2 genes for variants associated with increased breast and ovarian cancer risk. The firm launched the test in 2013 with a list price of $2,500, but had not disclosed the details of the assay. In the study, the firm described testing both the Illumina MiSeq instrument and Thermo Fisher's Ion Torrent PGM; a bait-based capture protocol; and analysis pipelines provided by the sequencing manufacturers as well as its own internally developed pipeline. The main take-home message, according to Charles Strom, VP of genetics and genomics at Quest Diagnostics, is that "neither of the machines' software/hardware combinations was sufficient for this particular application."
Focus Diagnostics Lands FDA Clearance for Herpes Test from Genital Swabs
Quest announced its subsidiary Focus Diagnostics has received 510(k) clearance from the US Food and Drug Administration for the Simplexa Herpes Simplex Virus (HSV) 1 & 2 Direct test from genital swab samples. In 2014, the FDA cleared the test for use with cerebrospinal fluid samples, the seventh HSV test — but the first molecular test — from Focus Diagnostics to receive clearance. Quest said in a statement that the Simplexa HSV 1 & 2 Direct test uses a proprietary process that eliminates nucleic acid extraction, allowing it to provide results in about an hour. "The added genital swab claim significantly broadens our test's potential clinical utility as an aid in diagnosing infection with one or both herpes simplex viruses," Michelle Tabb, Focus Diagnostics' VP of research and development, said in a statement.

 

Research and Development

The Great Big Clean-Up
From tossing out cross-contaminated cell lines to flagging genomic misnomers, a push is on to tidy up biomedical research.
Several years ago, a manuscript characterizing a cell line called RGC-5, which was derived from rat retina, came across the desk of Thomas Yorio, then an associate editor at Investigative Ophthalmology and Visual Science (IOVS). The line was commonly used in vision research; Yorio had used it in his own work at the University of North Texas Health Science Center, and researchers across the field had by then published more than 200 studies involving the cells. But the authors of the new paper had found that RGC-5 cells were not retinal ganglion cells after all. RGC-5 cells hadn’t even come from a rat. Suddenly, all of those published studies were called into question. The vision field isn’t the only scientific discipline making efforts to clean up its mess. From authenticating cell lines to identifying mislabeled genomic sequences and developing purer reagents, researchers across the life sciences are engaging in the fight against irreproducible research caused by contaminants.  “If we’re not using what we think were using, we’re not testing our hypotheses. We’re just gumming up the literature,” says Molecular Vision’s Boatright. “I’m not sure what we’re doing, but that’s not science.”
Scientists Map Genes at Work in Human Embryos' Earliest Days
A team of scientists in Sweden has broken open the genetic recipe for a human embryo's first three days of development, chronicling what happens in the crucial hours that follow the union of egg and sperm. The order in which a human's 23,000 genes awaken and start the process of building a person has never been charted before. But therein lie some momentous turning points -- moments that determine whether a fledgling embryo will grow and thrive or sputter and die, and moments at which the earliest seeds of disease can be sown. Twenty-four hours after a single egg cell has been penetrated by a sperm cell, it will split and become a two-cell zygote. At the end of two days, there will be four cells, and by day three, there will generally be eight cells. During the three-day initiation studied in the latest effort, an embryo is technically homeless: It has not yet implanted itself on the wall of a woman's uterus. This unformed mass will develop into billions of highly diverse cells by the time a fetus has reached full term. Each of those cells is hatched and sent forth to perform its function on the instruction of genes that are all present at the embryo's creation. But those genes are not all active at the creation; they are activated sequentially. Knowing which and how many of those genes go first could unlock a host of mysteries -- not least of which is, how do two simple cells create a human? Deconstructing the process could clarify whether some DNA long dismissed as "junk" has, in fact, a crucial function. It could make more efficient the process of turning the clock back on adult cells to create pluripotent stem cells for the treatment of diseases.
Milder AKI Diagnoses Subject to Error, Warns Study
—The 8% false-positive rate could affect trials and existing guidelines
Using small serum creatinine changes to diagnose acute kidney injury (AKI) is significantly limited by high false-positive rates, which may have important implications for existing studies of AKI and for clinical guidelines, according to a new modeling study. Researchers identified 2,267 adult patients with AKI who were admitted to the University of Pennsylvania hospital and used that data to create a simulation cohort. They then did seven simulated blood draws on an equal, but hypothetical population, and found an overall false-positive rate for diagnosis AKI of 8% (interquartile range 7.9%-8.1%). What's more, among patients who had a serum creatinine level of ≥1.5 mg/dL -- about 20% of the cohort -- there was a 30.5% (30.1%-30.9%) false-positive rate. At lower levels, though, the false-positive rate was 2.0% (1.9%-2.1%), according to co-author Perry Wilson, MD, assistant professor of medicine at the Yale School of Medicine, and colleagues. They published their results on Thursday in the Clinical Journal of the American Society of Nephrology.
New Medical Device Concept Could Reduce Time to Diagnose Infections
A new diagnostic device created by a collaborative team of University of Arizona engineers and scientists may significantly reduce the amount of time necessary to diagnose tissue infections. The device's novel approach to molecular diagnostics, called DOTS qPCR, is faster, more efficient and less expensive than alternatives currently being used in clinics. The work is described online in the journal Science Advances.  "With DOTS qPCR we are able to detect amplification and identify the infection after as few as 4 thermal cycles, while other methods are working with between 18 and 30," said Jeong-Yeol Yoon, a professor in the Department of Agricultural and Biosystems Engineering and a joint appointment in the Department of Biomedical Engineering. "We can get from sample to answer in as little as 3 minutes and 30 seconds." "It's easy to use, smartphone-integrated and saves money and labor using expensive equipment," explained Yoon. "This technology has a lot of commercial potential, and we'd be happy to work with industry to bring it to market."
Nanoporous Gold Sponge Makes DNA Detector
Sponge-like nanoporous gold could be key to new devices to detect disease-causing agents in humans and plants, according to UC Davis researchers. In two recent papers in Analytical Chemistry, a group from the UC Davis Department of Electrical and Computer Engineering demonstrated that they could detect nucleic acids using nanoporous gold, a novel sensor coating material, in mixtures of other biomolecules that would gum up most detectors. This method enables sensitive detection of DNA in complex biological samples, such as serum from whole blood. Rapid and sensitive detection of nucleic acids plays a crucial role in early identification of pathogenic microbes and disease biomarkers. Current sensor approaches usually require nucleic acid purification that relies on multiple steps and specialized laboratory equipment, which limit the sensors' use in the field. The researchers' method reduces the need for purification.
Researchers Identify Signature of Microbiomes Associated with Schizophrenia
In the most comprehensive study to date, researchers at the George Washington University have identified a potential link between microbes (viruses, bacteria and fungi) in the throat and schizophrenia. This link may offer a way to identify causes and develop treatments of the disease and lead to new diagnostic tests. The study helps to identify possible contributing factors to schizophrenia. With additional studies, researchers may be able to determine if microbiome changes are a contributing factor to schizophrenia, are a result of schizophrenia, or do not have a connection to the disorder.  Read the study at the Peer J website 

 

Public Health and Patient Safety

Medical Specialists Urge More Debate on Gene-Editing Technology
Medical researchers called on for detailed, thoughtful debate on future use of new genetic technology that has the potential to create "designer babies". The technology, called CRISPR-Cas9, allows scientists to edit virtually any gene they target, including in human embryos, enabling them to find and change or replace genetic defects. Describing CRISPR as "game-changing", the Wellcome Trust global medical charity and four other leading British research organizations urged the scientific community to proceed considerately, allowing time and space for ethical debate. "This raises important ethical and regulatory questions which need to be anticipated and explored in a timely and inclusive manner," they said in a joint statement. Wellcome's senior policy adviser Katherine Littler added: "It's essential we start these discussions early ... involving scientists, ethicists, doctors, regulators, patients and their families and the wider public."
New Guidelines Call for Kids, Health Care Workers to Get Flu Shots
All eligible children and health care workers should get flu shots, according to new policy statements from the American Academy of Pediatrics (AAP). "Parents must consider flu vaccine an essential vaccine for their children," Dr. Wendy Sue Swanson, an AAP spokeswoman, said in a news release from the pediatric group.  The AAP recommends that annual flu shots should be given to all people 6 months of age and older. Children aged 6 months to 8 years require two doses this flu season if they have received less than two doses of flu vaccine before July 2015. Flu shots are recommended for all people who have contact with children younger than 5 years of age and children with high-risk conditions. Pregnant women are at high risk for flu-related complications and can safely receive flu vaccination at any time during pregnancy. Getting a flu shot during pregnancy also protects infants for the first 6 months of life, the statements said.
More Than Half of Asian Americans with Diabetes Are Undiagnosed
More than half of Asian Americans and nearly half of Hispanic Americans with diabetes are undiagnosed, according to researchers from the National Institutes of Health and the Centers for Disease Control and Prevention. Their results were published Sept. 8 in JAMA, the Journal of the American Medical Association External Web Site Policy. Additionally, prevalence of diabetes for all American adults went up, from nearly 10 percent to over 12 percent between 1988 and 2012. Diabetes prevalence – how common the condition is – also went up in every age, sex, level of education, income and racial/ethnic subgroup. One bright spot: The proportion of people with diabetes that was undiagnosed decreased 23 percent between 1988-1994 and 2011-2012. The statistics account for age differences across the surveys.
Annual Influenza Vaccinations Help the Elderly
In years when the seasonal influenza vaccine is well-matched to the circulating strain, elderly patients have a lower incidence of pneumonia and influenza (P&I) hospitalizations and mortality. Aurora Pop-Vicas, MD, from Brown University in Providence, Rhode Island, and colleagues published the results of their retrospective cohort study online August 17 in the Journal of the American Geriatrics Society. The investigators tested the effect of vaccination in a population with uniformly high vaccination rates: more than 1 million Medicare New Hampshire nursing home residents between 2000 and 2009.The authors conclude from their results that influenza vaccination is an important primary prevention strategy in elderly adults. Moreover, they suggest that the effectiveness of seasonal influenza vaccines in healthier older individuals may be underestimated.
Rates of Survival Increasing for Extremely Preterm Infants, NIH Network Finds
Extremely preterm infants, those born before the 28th week of pregnancy, are surviving in greater numbers and escaping serious illness, according to a comprehensive review of births in a National Institutes of Health research network. The study, published in the Journal of the American Medical Association, reviewed the birth records of more than 35,000 premature infants born from 1993 to 2012 in 26 U.S. centers participating in the Neonatal Research Network, a program funded by NIH’s Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD). The lead author was Barbara J. Stoll, M.D., chair of pediatrics at Emory University School of Medicine.
Ryan White-Funded HIV Programs Offer More Complete Services
Low-income patients with HIV who received care at a facility funded by the Ryan White HIV/AIDS Program (RWHAP) were more likely to achieve viral suppression than those at non-RWHAP-funded facilities, according to a new study. RWHAP-funded facilities were also more likely than others to provide services such as case management and mental health and addiction services.
John Weiser, MD, MPH, from the Division of HIV/AIDS Prevention of the Centers for Disease Control and Prevention in Atlanta, Georgia, and colleagues report their findings online August 31 in JAMA Internal Medicine. The unadjusted rates of viral suppression favored the non-RWHAP-funded clinics, at 79.0%, compared with 74.4% of patients at RWHAP-funded facilities. However, after adjusting for patient characteristics, the likelihood of viral suppression among poor patients was higher at RWHAP-funded (hazard ratio [HR], 1.09; 95% confidence interval [CI], 1.02 - 1.16) clinics. The rates of antiretroviral therapy were similar among the two types of clinics (HR, 1.01; 95% CI, 0.99 - 1.03),
Ebola: Survey Says Physicians Are Too Confident in Their Ability to Assess Patients
A survey consisting of 23 questions was emailed to physicians between December 2014 and January 2015. Of the 202 primary care doctors who responded, 95% said they felt very prepared or somewhat prepared to diagnose a potential case of Ebola and 97% felt the same about informing patients about Ebola risk. Encouraging results? Yes. Accurate results? Not necessarily. Only about 50 to 70% participants gave answers to hypothetical situations that fit guidelines provided by the Centers for Disease Control and Prevention (CDC). According to the report published in the Journal of Internal Medicine, questions that related to Ebola transmission and incubation revealed that 20% would have gone with overly intense approaches. In addition, 75% of calls made to the CDC were about patients who had no risk of becoming infected with Ebola. The abundance of physician overreaction could be due in part to the heavy media coverage on the disease, the authors hypothesized. Additional findings determined that 88 percent of the participants viewed CDC guidelines regarding Ebola at least once during the past year. The CDC guidelines were the most common source of information for the clinicians, however, the team suggests having more resources available.


Health IT

NIH Awards More Than $48M to eMERGE Project to Correlate Genomic Data with Health Records
The National Institutes of Health has awarded over $48.6 million in research grants over the next four years to support groups working under the Electronic Medical Records and Genomics (eMERGE) project. The grants are administered by the National Human Genome Research Institute and represent the third phase of the eMERGE program. The funded projects focus on identifying the potential medical effects of rare genomic variants in about 100 clinically relevant genes. The National Advisory Council for Human Genome Research cleared phase III of eMERGE last year with the goal of performing targeted sequencing of around 25,000 individuals to study health outcomes of individuals with rare variants in medically important genes. "The newly funded projects are focused on discovering genes and gene variants with clinical implications by using the latest sequencing technologies to examine rare and common variants suspected to relate to disease risk and treatment effects," Rongling Li, program director for eMERGE in the Division of Genomic Medicine at NHGRI, said in a statement. The grants also focus on how to implement the information "into medical settings to improve patient care."
AHRQ to Fund Research into How Health IT Can Boost Patient Safety
Agency for Healthcare Research and Quality announced that it will make available millions of dollars in grants for ambulatory and long-term care facilities to research how health IT and other evidence-based tools can improve patient safety Health Data Management reports. The research projects will focus on understanding and eliminating disparities in patient and resident safety, according to Health Data Management. The funding will be used to support investigative research projects that:
  • Examine the epidemiology of patient safety in ambulatory and long-term care settings;
  • Collect evidence on strategies for bolstering patient safety; and
  • Develop tools for implementing such strategies.
According to Health Data Management, specific areas of interest include studies of:
  • Evidence-based intervention strategies;
  • Human, system and other factors that contribute to errors; and
  • Adverse events that result from medical errors in different types of ambulatory care.
FDA Beefs Up Medical Device Adverse Event Data through API
The U.S. Food and Drug Administration is expanding the data available on medical device-related adverse events and recalls through its OpenFDA initiative, according to a blog post at FDA Voice. The new data available through OpenFDA's Application Programming Interface (API) includes 6,000 device classification records, 24,000 registrations of device companies and establishments, and the companies' listings of more than 100,000 devices, write Taha A. Kass-Hout, M.D., chief health informatics officer and director of FDA's Office of Health Informatics; Roselie A. Bright, manager of OpenFDA; and Ann M. Ferriter, FDA's Director of Analysis and Program Operations in the Office of Compliance at the Center for Devices and Radiological Health. The agency unveiled the API in July 2014 as a new way to access FDA data--it already provided it through including an RSS feed, a Flickr stream and a search interface. The API was designed to be a common platform where developers could integrate data from various sources and build their own applications.
Extend Meaningful Use Reporting, Says MGMA
With little news on Stage 2 meaningful use updates since the proposed rule in April, the Medical Group Management Association is calling on CMS to extend the 2015 reporting period into the first quarter of 2016.  With less than four months left in this calendar year, the group is imploring CMS to extend the 2015 reporting period into the Q1 2016. "Even if the final rule came out today, the window of time that CMS is leaving medical groups and vendors to adjust workflows and update systems is both unacceptable and unrealistic," said Halee Fischer-Wright, MD, president and CEO of MGMA, in a press statement.
Meaningful use Rules in OMB for Review
The Centers for Medicare & Medicaid Services has handed the baton to the Office of Management and Budget, as the rules for Stage 3 meaningful use and the modifications to Stage 2 inch closer to finalization. The combined rules were delivered to OMB on September 3, the final step before publication. The much-requested 90-day 2015 reporting period is included in the Stage 2 modifications. That will have the biggest and most immediate impact for most health organizations. But so would a drastically reduced patient engagement requirement, and an alignment of hospital reporting to the calendar year.
Argonaut Interoperability Project Focuses on Testing
The Argonaut Project has entered Phase Two of its efforts to accelerate development and adoption of Health Level Seven International’s Fast Healthcare Interoperability Resources (FHIR), an interoperability framework leveraging the latest web standards. Many industry stakeholders are looking to FHIR—with its RESTful application programming interfaces (APIs) and OAuth-based security—as a solution to the complex challenge of health IT interoperability. They argue that RESTful APIs in particular, which are already widely used in other industries based on open/consensus-based standards, have the potential to serve as the core functionality to support data access in healthcare, becoming the enabler for health information exchange.
Telemedicine Offers 'Modest' Travel-Related Cost Savings, VA Study Finds
Certain patients under the Department of Veterans Affairs healthcare system qualify for travel reimbursement to get to and from appointments, which the government pays. According to a recent study in Telemedicine and e-Health, travel payments are projected to cost the VA approximately $1 billion in 2015, but telemedicine services may help reduce these costs. Researchers concluded that, though modest, telemedicine reduces VA travel payments as well as travel time for patients.
Cybersecurity Bill of Rights May Confuse Insurers, Consumers
Consumer and industry groups alike have expressed concerns about a "Cybersecurity Bill of Rights" proposed this summer by state insurance commissioners, InsuranceNewsNet reports. The National Association of Insurance Commissioners (NAIC) created the bill of rights to guide insurers' response to data breaches as well as explain how consumers can seek help if they are affected by a breach. The NAIC also is evaluating whether insurers are doing enough to protect customers' sensitive information. Yet the bill of rights' density is likely to discourage individuals from actually reading it, consumer advocates wrote in comments distributed at NAIC's Summer Meeting in Chicago, the article notes.


Other News
Report: Many e-Cigs Produce High Levels of Cancer-Causing Chemicals
In its report, A Smoking Gun: Cancer Causing Chemicals in E-cigarettes, the CEH said testing showed 21 products produced a level of one of the chemicals at more than 10 times the state safety standard, and that seven products produced one of the chemicals at more than 100 times the safety level. The report said that one nicotine-free product produced acetaldehyde at more than 13 times the state legal safety threshold and formaldehyde at more than 74 times the threshold, while the majority, 50 of the 97 products tested, showed high levels of one or both of the cancer-causing chemicals, in excess of the California standards.
Parents Protest R.I. Mandating HPV Vaccine for Teens
Seventh-graders in Rhode Island started school this year under a new mandate rarely seen in the country: Girls and boys must be vaccinated against HPV — the human papillomavirus — a sexually transmitted disease that can cause cancer. The move sparked protests from parents, who resented a school requirement to immunize against a disease that spreads through sex rather than anything that could be transmitted in the classroom. Despite the uproar, public health officials in Massachusetts are watching Rhode Island’s move. If it succeeds, Massachusetts may want to take the same route to boost the use of a vaccine that has long been a hard sell, said Kevin Cranston, director of the state’s Bureau of Infectious Disease. “We’re going to be very intrigued by the Rhode Island mandate experience,” Cranston said.
Sugary Drinks Affect Kids' Lipids
Study finds associations with triglycerides and HDL cholesterol
High consumption of sugary drinks including soda, fruit juice, and sweetened teas was associated with higher triglyceride levels in children, according to a study published in The Journal of Nutrition. However, kids who decreased their sugary drink intake over the course of a year didn't lower their triglycerides. Instead, their HDL cholesterol levels rose significantly, reported a team of researchers led by Maria Van Rompay, PhD, of Tufts University in Boston. In the cross-sectional analysis, the investigators found a significant linear trend between baseline sugary drink intake and triglyceride levels. The study's findings emphasize the importance of continuing to remove or replace sugary drinks in children's diets, especially children from lower socioeconomic backgrounds who tend to have more cardiovascular risk factors, Van Rompay said in an interview with MedPage Today. Milk and 100% fruit juices with no added sugar are other good options, she said.

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