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DLPSS|HEALTHCARE NEWS|May 1, 2014 ▲ Laboratory Science, Policy and Practice Program Office

DLPSS|HEALTHCARE NEWS|May 1, 2014





Healthcare News

A Weekly Compilation of Clinical Laboratory and Related Information 
from The Division Of Laboratory Programs, Standards And Services

 

May 01, 2014


News Highlights 

 

View Previous Issues - Healthcare News Archive

 

Alternative to Pap Test is Approved by F.D.A.

The Food and Drug Administration approved the first alternative to the long-used Pap test as a primary screening method for cervical cancer, in the face of opposition from some women’s groups and health organizations. The new test, developed by Roche, detects the DNA of the human papilloma virus, which causes almost all cases of cervical cancer, in a sample taken from the cervix. Pap testing involves examining the cervical sample under a microscope to detect abnormalities. A committee of outside advisers to the F.D.A. unanimously endorsed the Roche test in a meeting last month.
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Individualized Quality Control Plan for CLIA Laboratory Non-Waived Testing — Registration Now Open

To Register: Visit MLN Connects™ Upcoming Calls. 
How will the new Individualized Quality Control Plan (IQCP) affect my laboratory? This MLN Connects™ National Provider Call will educate laboratories on IQCP, the new quality control option for Clinical Laboratory Improvement Amendments (CLIA) laboratories performing non-waived testing. IQCP will provide laboratories with flexibility in customizing Quality Control (QC) policies and procedures, based on the test systems in use and the unique aspects of each laboratory. IQCP is voluntary. Laboratories will continue to have the option of achieving compliance by following all CLIA QC regulations as written. The IQCP Education and Transition Period began on January 1, 2014 and will conclude on January 1, 2016. This education and transition period gives laboratories the opportunity to learn about IQCP and implement their chosen QC policies and procedures. Prior to the call, providers are encouraged to review IQCP: A New QC Option and other IQCP educational materials on the CLIA website.
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Stop Using GenStrip Blood Glucose Test Strips, FDA Warns

GenStrip blood glucose test strips, sold by Shasta Technologies LLC, may give incorrect blood glucose readings and should not be used, the US Food and Drug Administration (FDA) warned. This recall was issued after extensive quality control violations were found during a recent inspection of the company. Shasta's GenStrip test strips are "third-party" blood glucose monitoring test strips not made by the same company as the meter with which they are used, the FDA noted in a safety communication.
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Minn. Senate Passes Bill to Restore Newborn Screening Bloodspot, Data Retention Policy

The Minnesota Senate has passed a bill that would enable the state's Department of Health (MDH) to retain newborn bloodspot samples and related data indefinitely, a change that would restore a state policy that was overturned by a state court three years ago. The Newborn Screening Program Modifications bill (SF 2047), which passed on a 41 to 22 vote, has strong support of screening advocacy groups, but it has drawn fire from others who worry that it will undercut genetic privacy and take choice from parents and give it to the state. Minnesota had been retaining blood spots indefinitely for use in screening research, follow-up care, and other research programs until 2011, when the Minnesota Supreme Court ruled that the MDH was against the law in holding blood spots indefinitely. To comply with the court, the state was eventually forced to destroy the blood spots for 1 million children who were born before 2011. Under the current policy, MDH retains normal blood spots (those testing negative) for 71 days before they are destroyed. Samples with abnormal results and the test results for all babies are kept for 24 months before being destroyed. During these retention periods, MDH may only use blood spots for basic program operations, and not for research, public health studies, or to develop new screening tests without the written consent of a parent or guardian. The new bill would enable the state to retain these spots indefinitely again, and to use them and test results in research related to newborn screening and to develop new tests, although parents would be able to choose if they do not want their child's samples and results stored. 

 

Putting the Patient First – Using the Expertise of Laboratory Professionals to Produce Rapid and Accurate Diagnoses

The test menu in the clinical laboratory continues to increase dramatically in size, complexity, and cost. There is a growing recognition that errors in test selection and results interpretation can have significant adverse clinical consequences to patients and painful financial consequences to healthcare institutions. A survey is now in progress of all U.S. medical schools to understand how our newly graduating physicians are learning the appropriate use of the clinical laboratory. Preliminary results from nearly three-quarters of American medical schools indicate some startling facts (personal communication, Brian Smith, MD, PhD). Keep in mind that in practice, physicians are required to order the correct laboratory tests, with thousands of tests from which to choose, largely from what they have learned. On the other hand, however, there are experts in anatomic pathology who systematically interpret every case, and test selection is not an issue because all tests involve the same thing—gross and/or microscopic examination of tissue collected from the patient.
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How POC Testing is Pushing the Envelope

Today, whether for blood gas and electrolytes, glucose, coagulation, cardiac markers, drugs of abuse, food pathogens, hemoglobin, or infectious diseases, hundreds of tests once considered too complex for point of care are routinely performed outside the laboratory. But some of the nation’s experts in point-of-care testing say that developments on the near horizon could make previous advances in POC testing look tame. “A number of tests are on the cusp of being available at point of care, from the realm of infectious disease biomarkers, all the way up to PCR and molecular testing right at the bedside,” says Timothy R. Hamill, MD, vice chair of the CAP Point-of-Care Testing Committee.
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'Magical' Gene Expression Tests

Gene expression profiling tests can help patients avoid unnecessary chemotherapy treatments, but a new study of breast cancer patients in Canada suggests that many patients have a muddled understanding of how these tests work and may be likely to put faith in the results they want to hear. According to a new study in Current Oncology, many women place great importance on and trust in gene expression profiling tests, but have mixed levels of understanding about their function and "misapprehensions" are common.

 

Largest Prostate Screening Trial Still Shows it Saves Lives

For the first time, updated results from the European Randomized Study of Screening for Prostate Cancer (ERSPC), the largest randomized prostate cancer screening trial in the world, show a significant survival advantage with prostate-specific antigen (PSA) screening for men from 50 to 74 years of age. The new data come from a follow-up of 13 years, and were presented during the European Association of Urology 29th Annual Congress.

 

New Prostate Cancer Blood Test Now Available in the US

The most widely used screening test for prostate cancer is currently the PSA test, which measures the blood's level of PSA—a protein that is naturally produced by the prostate gland and is typically increased when cancer is present. However, it is widely recognized that PSA results can often indicate the possibility of prostate cancer when none is present. "The PSA test is based on the fact that men with higher levels of the PSA protein are more likely to have prostate cancer," said William Catalona, MD, principal investigator on the Prostate Health Index clinical study and urologist at Northwestern Medicine and director of the Clinical Prostate Cancer Program at the Robert H. Lurie Comprehensive Cancer Center of Northwestern University, where they began using the phi test on patients in February. Dr. Catalona, who was the first physician in the U.S. to run the phi test, added, "However, the problem is that higher levels of PSA can also be caused by a benign enlargement or inflammation of the prostate, leading to many false-positives for cancer and ultimately unnecessarily invasive biopsies and an increased potential for patient harm." The substantial increase in accuracy of the phi test over PSA addresses this concern. Results of a multi-center clinical study found a 31 percent reduction in unnecessary biopsies due to false-positives as a result of using the phi test.
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Scientists Create Take-home Fertility Test for Men

Two former Sandia National Laboratories scientists have come up with what they say is a take-home fertility test for men, the Albuquerque Journal reported. Researchers Greg Sommer and Ulrich Schaff have created a portable test kit for gauging a man's sperm quality that could be available to consumers as early as 2015. "It allows men to test and track their fertility from the comfort and privacy of their own homes," Sommer said. "It's a portable, easy-to-use diagnostic system with the accuracy of a clinical lab test." The test would give results within a few minutes, the scientists said.

 

Blood Test Spots Recurrent Breast Cancers and Monitors Response to Treatment

The test, called the cMethDNA assay, accurately detected the presence of cancer DNA in the blood of patients with metastatic breast cancers up to 95 percent of the time in laboratory studies. The findings were described in the April 15 issue of the journal. Currently, there is no useful laboratory test to monitor patients with early stage breast cancer who are doing well, but could have an asymptomatic recurrence, says Saraswati Sukumar, Ph.D., who is the Barbara B. Rubenstein Professor of Oncology and co-director of the Breast Cancer Program at the Johns Hopkins Kimmel Cancer Center. Generally, radiologic scans and standard blood tests are indicated only if a woman complains of symptoms, such as bone aches, shortness of breath, pain, or worrisome clinical exam findings. Otherwise, routine blood tests or scans in asymptomatic patients often produce false positives, leading to additional unnecessary tests and biopsies, and have not been shown to improve survival outcomes in patients with early stage breast cancer who develop a recurrence.
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A Breathalyzer for Lung Cancer May be on Its Way

Researchers haven't made a cancer-testing breathalyzer reality yet, but a doctor in Kentucky has reported success in scanning exhalations for four cancer compounds that can distinguish between lung tumors and benign growths. Testing for cancer is an invasive – not to mention frightening – process. So wouldn’t it be great if you could breathe your way to a diagnosis? Researchers aren’t quite there yet, but they’re making progress. Dr. Michael Bousamra II at the University of Louisville School of Medicine reported that he’s had success in scanning exhalations for four cancer compounds that can distinguish between lung tumors and benign growths. The test is also more specific than expensive PET scans for distinguishing between the two types of growths.
Source: http://time.com/External Web Site Icon 

Scientists at University of Washington Discover a Second Language in DNA, PossiblyGiving Pathologists a New Source of Diagnostic Information

The discovery of dual-purpose condons, called ‘duons’ opens the door to creation of more precise diagnostic and medical laboratory tests, as well as better treatment choices. New insights into the human genome have led to the discovery of a second “code” or “language” within human DNA. Pathologists performing genetic testing will be particularly interested in the implications of this discovery, which the researchers have dubbed “duons.” It was a research team at the University of Washington (UW) that discovered evidence of a second type of DNA code overlying the protein code that controls transcription factors (TFs). TFs regulate flow of genetic information from DNA to messenger RNA, which manages the synthesis of proteins described by the DNA. 

 

Scientists Find MERS Virus Antibodies That May Lead to Treatments

Scientists have found natural human antibodies to the newly-emerging Middle East Respiratory Syndrome (MERS) virus and say their discovery marks a step towards developing treatments for the often fatal disease. Antibodies are proteins made by the immune system that recognize foreign viruses and bacteria. A neutralising antibody is one that not only recognizes a specific virus but also prevents it from infecting host cells, eventually meaning the infection is cleared from the person or animal. In one study in the Science Translational Medicine journal, a Chinese-led team found that two antibodies, called MERS-4 and MERS-27, were able to block cells in a lab dish from becoming infected with the MERS virus.
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CSF Tau May Help Diagnose ALS

Tau protein levels in cerebrospinal fluid (CSF) may help distinguish amyotrophic lateral sclerosis (ALS) from other disorders with similar clinical presentations, researchers said here. A low ratio of phosphorylated tau to total tau (P/T-tau) in CSF showed more than 90% sensitivity and specificity for identifying patients with ALS versus progressive supranuclear palsy and other so-called four-repeat tauopathies (4R-tau) in a 74-person study, according to Corey McMillan, PhD, of the University of Pennsylvania in Philadelphia, and colleagues.

 

Athena Diagnostics Unveils New Lab-developed Tests for Epilepsy Diagnosis

Athena has developed nine sequencing test panels according to epilepsy type to aid the diagnosis of discrete forms of epilepsy ranging from generalized to syndromic. The panels, called Epilepsy Advanced Sequencing Evaluations, are arranged by clinical phenotype and EEG test findings, with testing performed only on genes associated with a specific epilepsy type. Physicians may therefore select a panel and receive a test report with clinically useful sequencing information to diagnose epilepsy at the molecular level. This approach may avoid the excessive use of other neurological testing, including imaging studies of the brain.

 

The Evolving Role of HPV Testing in Cervical Cancer Screening

As the science involving HPV advances and as guidelines from professional organizations evolve, laboratorians need to keep abreast of cervical cancer testing developments and work with clinicians to ensure appropriate test utilization. Current HPV assays differ in methodology, target, and analytic cutoffs, but are all interpreted as positive or negative for HR-HPV and carry equivalent clinical implications for most practitioners. In general, the new guidelines extend the recommended screening intervals to every 3 years for women 21–29 years undergoing cytology alone, or every 5 years for those ages 30–65 who undergo both cytology and HPV testing. 

 

Reducing Blood Redraws When Testing Newborns for Direct Bilirubin

Researchers Propose Equation to Correct for Interference From Hemolysis
Hemolysis in newborn blood samples can lead to falsely decreased direct bilirubin test results, a common problem that many healthcare institutions deal with by rejecting hemolyzed neonatal samples outright and having them redrawn. Though necessary for the accurate diagnosis and management of neonatal liver conditions, these repeat blood collections are a serious stressor for infants. With the aim of reducing them, researchers recently developed an equation to predict the concentration of direct bilirubin in hemolyzed samples. Their findings are examined in this issue of Strategies.

 

Rapid HIV Tests Make for Swift Business Growth

It comes down to a prick to the finger and counting to 60. After giving a small blood sample, a patient can find out with nearly 100% accuracy whether he or she is HIV-positive. The INSTI test, which was developed at Richmond-based bioLytical Laboratories and approved by Health Canada in 2006, has been building momentum in the United States since being allowed to be used in non-lab settings, thanks to something called the Clinical Laboratory Improvement Amendments (CLIA) waiver.

 

How Often is Prostate Cancer Misdiagnosed?

The headline is worrying: "half of prostate cancer misdiagnosed". It came from a Cambridge University study which followed hundreds of men who were given a prostate cancer diagnosis. Half of the men who were told they had a less serious form of the disease, had in fact more serious cancer. Media reports suggested men with prostate cancer were being given 'false hope' by tests that underestimate the severity of the disease. But cancer specialists have said diagnostic techniques have 'moved on' considerably in recent years.

 

Gold Nanoparticles Help Target, Quantify Breast Cancer Gene Segments in a Living Cell

Purdue University researchers have developed a way to detect and measure cancer levels in a living cell by using tiny gold particles with tails of synthetic DNA. The technique also could increase our understanding of cell biology and paves the way for genetic profiling and diagnosis based on a single cell, Irudayaraj said. BRCA1 is a tumor suppressor gene that can transform a cell into a cancerous type under certain circumstances. Measuring the number of BRCA1 mRNA splice variants in a cell can indicate if the gene is being under-expressed, a possible sign of breast cancer. But current methods of detecting cancer rely on samples made up of hundreds or thousands of cells and cannot provide detailed information about how genes tied to cancer are being expressed in individual cells.

 

Biochip Mimics How the Body Produces Platelets so They Could Be Made in a Lab

When you hear about blood shortages, that doesn’t just mean there’s a shortage of donated red blood cells. It could also mean platelets, a blood component that Sven Karlsson described as Band-Aids of the bloodstream, because they’re necessary for blood clot formation to help stop bleeding. Platelets come from bone marrow cells called megakaryocytes, which collect along the endothelial cells that line blood vessels and extend ‘tendrils’ into blood vessels, Karlsson said. Eventually, those tendrils break off and become platelets. Platelet BioGenesis’ biochip has two chambers with a perforated barrier in between. One chamber mimics the bone marrow micro-environment, and the other mimics the blood vessel micro-environment. The company sources stem cells from partners who generate megakaryocytes, which are then inserted into the bone marrow chamber. The cells extend proplatelets into the blood vessel chamber that eventually break off, as they do in humans.

 

Eggbeater-like Device Could Bust Bladder Blood Clots

Rice university students create the “clot slayer,” an elegantly simple device that could help doctors go fishing for potentially life-threatening blood clots. Their device uses a hand-cranked spindle to turn an eggbeater-like head at the other end of a line. The line would be fed through a catheter into the bladder, where it would create a vortex that would suck clots toward the whipping wires and destroy them. According to the group of students, known as Team Evacuator, the process is superior to other methods currently used to dissolve bladder blood clots. These include surgery and/or a saline flushing process that Lung-Ying Yu, one of the students involved in the project, likens to "sucking Jell-O using a straw."

 

Uric Acid Linked to Fracture Risk

Older men with higher uric acid levels may be at increased risk for hip fracture, researchers reported. In a prospective cohort study, men ages 65 and up with uric acid levels above 7 mg/dL were 62% more likely than those with lower levels to fracture a hip, Tapan Mehta, MD, of the University of Colorado Denver, and colleagues reported at the National Kidney Foundation spring clinical meetings.
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High Phosphorus Ups Anemia Risk in the Non-CKD Population

Patients with higher serum phosphorus levels without obvious chronic kidney disease (CKD) are at an increased risk of anemia, according to a study reported at the National Kidney Foundation's 2014 Spring Clinical Meetings in Las Vegas. In a cross-sectional study, John J. Sim, MD, and collaborators at the Kaiser Permanente Los Angeles Medical Center examined 32,907 patients with documented serum phosphorus from January 1998 to December 2009 to determine the association between serum phosphorus and anemia in the non-CKD population.

 

Radon: The Silent Killer in Your Home

Tobacco smoke in a home is easy to detect as it drifts through the air or leaves its odor in clothes or furniture. Its health toll is equally as obvious as the leading cause of lung cancer in the U.S. Less obvious and almost as deadly is radon, an odorless gas that causes 21,000 lung cancer deaths a year. Radon is the second leading cause of lung cancer in the U.S. and the leading cause of lung cancer in non-smokers. It's a bigger concern during cold winters like the one we've just experienced when radon levels sky rocket in well-sealed homes. The odorless gas is caused by the natural breakdown of uranium in soil and water and seeps into homes through drains and cracks in the foundation. While radon is natural in the air, levels can be harmful when it is trapped inside a house. In the U.S. 1 in 15 homes have unsafe radon levels, according to the Environmental Protection Agency website.

Source: http://www.usatoday.com/External Web Site Icon

 

Potential Use of Google Glass in Surgical Settings

An article recently published in the International Journal of Surgery shows the potential applications for Google Glass in the surgical setting, particularly in relation to training. Personal portable information technology is advancing at a breathtaking speed. Google has recently introduced Glass, a device that is worn like conventional glasses, but that combines a computerized central processing unit, touchpad, display screen, high-definition camera, microphone, bone-conduction transducer, and wireless connectivity.

 

Scientists Explore Possibilities of Mind Reading

At Yale University, researchers recently used a brain scanner to identify which face someone was looking at — just from their brain activity. At the University of California-Berkeley, scientists are moving beyond "reading" simple thoughts to predicting what someone will think next. And at Carnegie Mellon, in Pittsburgh, cognitive neuroscientist Marcel Just has a vision that will make Google Glass seem very last century. Instead of using your eye to direct a cursor — finding a phone number for a car repair shop, for instance — he fantasizes about a device that will dial the shop by interpreting your thoughts about the car (minus the expletives). Mind reading technology isn't yet where the sci-fi thrillers predict it will go, but researchers like Just aren't ruling out such a future.

 

Reading Pain in a Human Face

In a new study, in Current Biology, by researchers at San Diego, the University of Toronto and the State University of New York at Buffalo, humans and a computer were shown videos of people in real pain or pretending. The computer differentiated suffering from faking with greater accuracy by tracking subtle muscle movement patterns in the subjects’ faces. “We have a fair amount of evidence to show that humans are paying attention to the wrong cues,” said Marian S. Bartlett, a research professor at the Institute for Neural Computation at San Diego and the lead author of the study.

 

Researchers See New Importance in Y Chromosome

There is new reason to respect the diminutive male Y chromosome. Besides its long-known role of reversing the default state of being female, the Y chromosome includes genes required for the general operation of the genome, according to two new surveys of its evolutionary history. These genes may represent a fundamental difference in how the cells in men’s and women’s bodies read off the information in their genomes. When researchers were first able to analyze the genetic content of the Y chromosome, they found it had shed hundreds of genes over time, explaining why it was so much shorter than its partner, the X chromosome. All cells in a man’s body have an X and a Y chromosome; women’s have two X chromosomes.

 

Pre-pregnancy Diet 'Permanently Influences Baby's DNA'

A mother's diet around the time of conception can permanently influence her baby's DNA, research suggests. Animal experiments show diet in pregnancy can switch genes on or off, but this is the first human evidence. The research followed women in rural Gambia, where seasonal climate leads to big differences in diet between rainy and dry periods. It emphasises the need for a well-balanced diet before conception and in pregnancy, says a UK/US team.

 

Scientists Identify Target for Treating Dengue

In a significant discovery, researchers have identified a target for dengue fever that can help develop vaccines for the deadly disease that has infected over 100 million people worldwide so far. In two recent papers, they explained how flaviviruses produce a unique RNA molecule that leads to disease. Flaviviruses are considered dangerous emerging pathogens. "The research shows that the virus causing dengue fever and other closely related viruses like West Nile and Japanese encephalitis use instructions encoded on a single strand of RNA to take over an infected cell and reproduce," explained Jeffrey S. Kieft, an associate professor of biochemistry and molecular genetics at University of Colorado's school of medicine. The viruses also exploit an enzyme that cells use to destroy RNA to instead produce short stretches of RNA that, among other things, may help the virus avoid the immune system of its host.

 

Human Skin Grown in Lab 'Can Replace Animal Testing'

Skin grown in the laboratory can replace animals in drug and cosmetics testing, UK scientists say. A team led by King's College London has grown a layer of human skin from stem cells - the master cells of the body. Stem cells have been turned into skin before, but the researchers say this is more like real skin as it has a permeable barrier. It offers a cost-effective alternative to testing drugs and cosmetics on animals, they say.

 

First Stem Cells Cloned From Diabetes Patient

The feat could lead to new cell-based treatments for the disease, but it relies on the willingness of women to donate their eggs. Is donating eggs to scientists for a research study any different from donating eggs to a couple hoping to have a baby using in vitro fertilization (IVF)? That’s a question that stem cell researchers — and policy makers — have been wrestling with ever since it became possible to “clone” cells with a technique involving eggs and skin cells. The debate is bound to heat up again thanks to a breaking study published in the journal Nature: for the first time, scientists have generated stem cells from a patient with a disease. And recently, researchers did the same with skin cells from two healthy men.
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Aspirin Benefits Some at Risk for Colon Cancer

Many studies have found that regular aspirin use reduces the risk for colon cancer. Now scientists have found that aspirin may benefit some people far more than others. Aspirin apparently exerts a protective effect only in people with high levels of an enzyme called 15-PGDH, which is found in the gut’s lining. Researchers tracked aspirin use among 127,865 participants in two large national health surveys, and found 270 cancer cases in which 15-PGDH levels were tracked. The study appears online in Science Translational Medicine.

 

CDC Reports Biggest Measles Outbreak Since 1996

Measles have infected 129 people in 13 states in 2014, the most in the first four months of any year since 1996, officials from the Centers for Disease Control and Prevention reported as they warned clinicians, parents and others to watch for the potentially deadly virus. Thirty-four of the cases were imported via travel to other countries, including 17 from the Philippines, where a huge outbreak has affected 20,000 people and caused 69 deaths, said Anne Schuchat, director of the National Center for Immunization and Respiratory Diseases.

 

Tracking Flu Levels With Wikipedia

Can monitoring Wikipedia hits show how many people have the flu? Researchers at Boston Children's Hospital, USA, have developed a method of estimating levels of influenza-like illness in the American population by analysing Internet traffic on specific flu-related Wikipedia articles. David McIver and John Brownstein's model, publishing in PLOS Computational Biology, estimates flu levels in the American population up to two weeks sooner than data from the Centers for Disease Control and Prevention becomes available, and accurately estimates the week of peak influenza activity 17% more often than Google Flu Trends data.

 

CDC: Vaccines Save Hundreds of Thousands of Lives

Vaccines given to infants and young children over the past two decades will prevent 322 million illnesses, 21 million hospitalizations and 732,000 deaths over the course of their lifetimes, according to a new report from the Centers for Disease Control and Prevention. Vaccines also will have saved $295 billion in direct costs, such as medical expenses, and a total of more than $1.3 trillion in societal costs over that time, because children who were spared from sometimes-devastating illnesses will be able to contribute to society, the report shows.

 

FDA Proposes First Regulations for Electronic Cigarettes

The federal government wants to ban sales of electronic cigarettes to minors and require approval for new products and health warning labels under regulations being proposed by the Food and Drug Administration.  Any further rules "will have to be grounded in our growing body of knowledge and understanding about the use of e-cigarettes and their potential health risks or public health benefits," Commissioner Dr. Margaret Hamburg said. Once finalized, the agency could propose more restrictions on e-cigarettes. Officials didn't provide a timetable for that action. Members of Congress and public health groups have raised concerns over e-cigarettes and questioned their marketing tactics.

 

New FDA Program Would Speed Up Access to Medical Devices

The US Food and Drug Administration (FDA) has proposed a new program designed to grant earlier access to high-risk medical devices intended to treat or diagnose patients with serious conditions whose needs are unmet by current technology, according to an FDA news release. The program is called the Expedited Access Premarket Approval Application for Unmet Medical Needs for Life Threatening or Irreversibly Debilitating Diseases or Conditions ("Expedited Access PMA" or "EAP").


CMS Official: HHS Will Make Release Plan for ICD-10 Delay Shortly

CMS is developing plans for dealing with the ICD-10 delay, and HHS will make an announcement regarding the plan soon, a CMS official told attendees at the American Health Information Management Association ICD-10 Summit, according to an ICD-10 Monitor report.

 

CMS Releases Interactive Tool for Searching Doctor Database

 Building on the recent release of information on Medicare payments to physicians, the Centers for Medicare and Medicaid Services (CMS) April 23 announced an interactive search tool for navigating the database. “Users can search for a provider by name, address, or National Provider Identifier (NPI),” Niall Brennan, CMS's acting director in the Offices of Enterprise Management, said in a CMS blog post. The available information includes the number of services provided to beneficiaries in the fee-for-service program, the number of beneficiaries treated, payment amounts, and submitted charges organized by Healthcare Common Procedure Coding System (HCPCS) codes.
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Early Evidence From Medicare’s Bundled Payment Pilots Show Improved Quality at Reduced Cost of Care in Findings With Consequences for Medical Laboratories

Early evidence indicates that Medicare’s bundled-payment pilot has helped participating providers improve the quality of care while better managing healthcare costs. Should more detailed findings confirm these outcomes, Medicare could decide to expand the range of clinical services it wants covered by a bundled-payment arrangement. As of the first of this year, in fact, Medicare officials expanded the bundled-payment program associated with the hospital Outpatient Prospective Payment System (OPPS) by requiring certain clinical laboratory, anatomic pathology, and other clinical services be reimbursed as part of the bundled payment initiative. This action was taken independent of the bundled-payment pilot program.

 

So Much Data

The Personal Genome Project has grown from having 10 participants in 2005 to now having more than 3,360 enrolled participants and more than 600 of them have had their data posted online, the New York Times writes. The PGP aims to find 100,000 people to volunteer as research subjects whose data — spanning genetic, microbiome, health record, and other data types — will be made publicly available. "We're prototyping a legal and technical infrastructure for sharing data," Jason Bobe, the executive director of the project, tells the Times.

 

FBI Warns Healthcare of Vulnerability to Cyberattacks

The FBI has issued two warnings this month that healthcare organization systems, including medical devices, could be vulnerable to cyberattacks. "The healthcare industry is not as resilient to cyber intrusions compared to the financial and retail sectors, therefore the possibility of increased cyber intrusions is likely," it said in a "private industry notice," or PIN, issued April 8.

 

Stolen Laptops Lead to Important HIPAA Settlements

Two entities have paid the U.S. Department of Health and Human Services Office for Civil Rights (OCR) $1,975,220 collectively to resolve potential violations of the Health Insurance Portability and Accountability Act (HIPAA) Privacy and Security Rules.  These major enforcement actions underscore the significant risk to the security of patient information posed by unencrypted laptop computers and other mobile devices. “Covered entities and business associates must understand that mobile device security is their obligation,” said Susan McAndrew, OCR’s deputy director of health information privacy. “Our message to these organizations is simple: encryption is your best defense against these incidents.”

 

Health IT Biggest Threat to Patient Safety, Report Says

Health information technology (IT)-related safety hazards topped the ECRI Institute's first annual list of the Top 10 Patient Safety Concerns for Healthcare Organizations. The list was based on more than 300,000 event reports, research requests, and root-cause analyses submitted to ECRI's patient-safety organization.
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Strong Data Infrastructure Needed to Improve Health Care for Americans

A new report funded by the Agency for Healthcare Research and Quality (AHRQ) describes interoperability challenges in the U.S. health information technology system and proposes a potential future state health IT architecture. “A Robust Health Data Infrastructure” includes recommendations for the Centers for Medicare and Medicaid Services and the Office of the National Coordinator for Health IT (ONC) as they continue to develop the national vision for an effective and efficient interoperable health ecosystem.

 

WHO Holds Emergency Meeting on Cross-Border Spread of Polio

The World Health Organisation (WHO) began an emergency meeting with experts on Monday on how to halt the spread of the crippling polio virus across international borders in Asia, Africa and the Middle East. Polio re-emerged in Syria in 2013 for the first time in 14 years, fanning fears of a wider international proliferation and prompting a vast regional emergency vaccination campaign.
Source: http://www.reuters.com/External Web Site Icon


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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