DLPSS|HEALTHCARE NEWS|November 13, 2014
A Weekly Compilation of Clinical Laboratory and Related Information
from The Division Of Laboratory Programs, Standards And Services
November 13, 2014
Leading News
Millions of US Women are not Getting Screened for Cervical Cancer
Treating Those Treating Ebola in Liberia
The FDA’s Expected Next Steps on LDTs: Agency First Announced its Plans to Regulate LDTs in 2010
Laboratory Testing / Diagnostics
AABB Releases New Guidelines on the Appropriate Use of Platelet Transfusion in Adult Patients
Do Patients With Diabetes Need to Fast for Lipid Tests?
Need for Decreasing Use of Biopsies as Diagnostic Tool for Lung Cancer Indicated by Medicare Costs Analysis
Research and Development
Plant Protein Could be Used for Blood, say Scientists
UK Research Shows MRSA Transfers From Livestock to Humans
Public Health and Patient Safety
Sounding the Alarm on the Rapid Spread of Drug-Resistant Tuberculosis
‘Kissing bug’ Disease: Should You be Worried?
Health IT and Other
Health Plan Identifier Rule put on Hold
Making the Case for Personal Health Data Sharing
View Previous Issues - Healthcare News Archive
Leading News
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Millions of US Women are not Getting Screened for Cervical Cancer
Despite evidence that cervical cancer screening saves lives, about eight million women ages 21 to 65 years have not been screened for cervical cancer in the past five years, according to a new
Vital Signs( www.cdc.gov/vitalsigns) report from the Centers for Disease Control and Prevention. More than half of new cervical cancer cases occur among women who have never or rarely been screened. “Every visit to a provider can be an opportunity to prevent cervical cancer by making sure women are referred for screening appropriately,” said CDC Principal Deputy Director Ileana Arias, Ph.D. “We must increase our efforts to make sure that all women understand the importance of getting screened for cervical cancer. No woman should die from cervical cancer.” Researchers reviewed data from the 2012 Behavioral Risk Factor Surveillance System to determine women who had not been screened for cervical cancer in the past five years. They analyzed the number of cervical cancer cases that occurred during 2007 to 2011 from CDC’s National Program of Cancer Registries and the National Cancer Institute’s Surveillance, Epidemiology and End Results Program. Cervical cancer deaths were based on death certificates submitted to the National Vital Statistics System. Key findings:
In 2012, 11.4 percent of women reported they had not been screened for cervical cancer in the past five years; the percentage was larger for women without health insurance (23.1 percent) and for those without a regular health care provider (25.5 percent).
The percentage of women not screened as recommended (www.cdc.gov/cancer/cervical/basic_info/screening.htm) was higher among older women (12.6 percent), Asians/Pacific Islanders (19.7 percent), and American Indians/Alaska Natives (16.5 percent).
From 2007 to 2011, the cervical cancer incidence rate decreased by 1.9 percent per year while the death rate remained stable.
The Southern region had the highest rate of cervical cancer (8.5 per 100,000), the highest death rate (2.7 per 100,000), and the largest percentage of women who had not been screened in the past five years (12.3 percent).
Source:
http://www.cdc.gov/media/releases/2014/p1105-vs-cervical-cancer.html
Treating Those Treating Ebola in Liberia
As the number of people sickened with Ebola soared this summer, American and Liberian officials faced a new challenge: How could they encourage international medical workers, understandably frightened about the risks, to come help fight the disease? The officials knew they would have to provide some assurances to the workers that they would be cared for if they fell ill. Their answer, a dedicated Ebola field hospital for health workers, is scheduled to open soon outside Monrovia, the capital. The facility was originally a modular trauma hospital installed by the United States military over more than a month at a cost of $10.4 million. It has been modified to house up to 25 infectious patients near the international airport here, about 35 miles east of Monrovia. It will be staffed by 69 members of the United States Public Health Service, who will treat health care workers from abroad as well as from Liberia. More than 150 Liberian medical workers have died from Ebola. “All of us here are trying to convey to the world that you can come here as a health care worker and provide care that’s greatly needed, and if something were to happen to you, we’ll give you the best care,” said Cmdr. Jamal K. Gwathney, a family-medicine doctor and the team’s chief of operations.
Source: http://www.nytimes.com/
U.S. Will Test Multiple Ebola Drugs in Clinical Trials
U.S. health officials are planning a clinical trial that would involve multiple experimental Ebola drugs in an effort to speed approval of the medicines. The National Institute of Allergy and Infectious Diseases and the Food and Drug Administration are working to complete a protocol and prioritize which treatments will be studied, said Edward Cox, director of the FDA’s Office of Antimicrobial Products. The trial will require some patients to forgo experimental drugs so researchers can see if the treatments are better than the standard of care, Cox said.
Source: http://www.bloomberg.com/
The FDA’s Expected Next Steps on LDTs: Agency First Announced its Plans to Regulate LDTs in 2010
The Food and Drug Administration (FDA) in October formally launched its plan to regulate laboratory- developed tests (LDTs), but it will take years for the increased oversight to take effect, according to an article in the November issue of CLN. FDA Director of In Vitro Diagnostics Alberto Gutierrez, PhD, laid out a 9-year timeframe to implement LDT regulation—but the clock on the timeframe won’t start ticking until after the FDA issues final guidance on the topic, and that could take years, reports Bill Malone. And “based on FDA’s history with LDTs, the one thing that is certain is that the initial plan will not look exactly like the final plan—and it will probably take even longer to implement than the agency would like,” Malone writes. FDA first announced in 2010 that it intended to regulate LDTs, and lab advocacy groups, biotech companies, and Congress pushed back. In July 2014, FDA notified Congress that it planned to proceed with regulating LDTs, and on October 3 published draft guidance. A 120-day comment period on the draft guidance is now in effect, which means that the agency will gather feedback through January 2015. A public meeting is in the works for early 2015, and it is expected to draw a large group of participants, Malone reports.
Source: https://www.aacc.org/
Safety of Lab Equipment
When physicians at the Nebraska Medical Center got their first Ebola case in September, they knew they'd rely heavily on sophisticated blood-test machines to monitor the man's condition. They didn't expect the virus might leave the machines incapacitated for longer than the patient. Several leading manufacturers of high-tech diagnostic devices have alerted hospital laboratories that they will restrict service, support and warranties for equipment used to test blood and organ functions for Ebola patients. Fearing infections, some decline to have their technicians perform tuning and maintenance the expensive devices often require. Others advise labs to quarantine the equipment after use on Ebola patients or even destroy it -- a policy that one company's own CEO calls "the dumbest" approach imaginable. Hospital officials, including some involved in treating the few U.S. patients who have gotten Ebola, see many of the restrictions as irrational. They cite guidance from the Centers for Disease Control and Prevention, which advises that devices used to test biological samples from Ebola patients can be disinfected and reused safely. They note that the same equipment has been used for years to test blood from patients with other infectious diseases, such as HIV and hepatitis, and reused without problems.
Source: http://usatoday30.usatoday.com/
Pathologists at Pinnacle of Move to Curb Unnecessary Testing
An estimated 20% to 30% of laboratory tests performed in the United States are inappropriate, warned speakers presenting at the American Society for Clinical Pathology (ASCP) 2014. "The fee-for-service environment has encouraged a volume-driven approach to healthcare," said Stephen Kroft, MD, from the Medical College of Wisconsin in Milwaukee, who is outgoing president of the ASCP. "The more you do, the more you get paid, without really needing to focus on whether you're seeing value for those healthcare dollars," he told Medscape Medical News. This isn't happening just to pathologists, of course, he added. In fact, as several presenters pointed out, the United States spends far more than any other developed nation on healthcare without achieving proportionately better outcomes. "Many of the laboratory tests done in this country are unnecessary, meaning the testing doesn't add any value to patient care," Dr Kroft said. "We just don't need to be doing as much testing as we do." The approach is typically driven by physician request — "the doctor wants it, the doctor gets it," he explained. The speakers here agreed that this model of healthcare financing is unsustainable.
Source: http://www.medscape.com/
Laboratory Testing / Diagnostics
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AABB Releases New Guidelines on the Appropriate Use of Platelet Transfusion in Adult Patients
New guidelines from the AABB (formerly, the American Association of Blood Banks) specify clinical situations in which platelet transfusion is recommended in adult patients. The guidelines are being published in Annals of Internal Medicine. Platelet transfusions are administered to prevent or treat bleeding in patients with quantitative or qualitative platelet disorders. To inform its recommendations, researchers for the AABB conducted a systematic review of randomized, clinical trials and observational studies that reported clinical outcomes in patients receiving prophylactic or therapeutic platelet transfusions.
Source: http://www.medicalnewstoday.com/
Do Patients With Diabetes Need to Fast for Lipid Tests?
Should patients with diabetes be required to fast for lipid tests? No, say the authors of a review article published in the November issue of Postgraduate Medicine. Others disagree, however, and debate on the topic is heating up. "We would like doctors who treat patients with diabetes to ask, 'Do I really need to fast my patient for this test?' There is now strong and compelling evidence that in the case of the lipid-profile [test] perhaps we don't need to fast our patients," lead author of the new paper, Dr Saleh Aldasouqi (Michigan State University College of Human Medicine, East Lansing) told Medscape Medical News. Dr Aldasouqi and coauthor Dr George Grunberger (Grunberger Diabetes Institute, Bloomfield Hills, MI), who is incoming president of the American Association of Clinical Endocrinologists, present a number of arguments in their article as to why they think fasting is no longer necessary. They point to recent evidence suggesting there is little difference in LDL-cholesterol levels between tests done in fasted vs nonfasted states and say that the two testing modes equally predict mortality. In addition, capturing postprandial triglyceride spikes may actually better predict cardiovascular risk, they add. Moreover, they say, fasting is inconvenient and can even be dangerous, because of the risk for hypoglycemia in patients with type 1 diabetes and in those with type 2 diabetes who use insulin or sulfonylureas (Diabetes Care. 2011;34:e52).
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Need for Decreasing Use of Biopsies as Diagnostic Tool for Lung Cancer Indicated by Medicare Costs Analysis
Biopsies were found to be the most costly tool prescribed in lung cancer diagnosis, according to research presented at the 2014 Chicago Multidisciplinary Symposium in Thoracic Oncology. The Symposium is sponsored by the American Society of Clinical Oncology (ASCO), the American Society for Radiation Oncology (ASTRO), the International Association for the Study of Lung Cancer (IASLC) and The University of Chicago Medicine. Diagnostic tests used until a patient was diagnosed with lung cancer included chest CT scans, chest X-rays, lung biopsies and positron emission tomography (PET) scans. For patients diagnosed with lung cancer, the average total cost of the diagnostic workup was $7,567 (standard deviation (SD) = $11,062). In patients not diagnosed with lung cancer, the average total cost of the diagnostic workup was $3,558 (SD = $23,089). The median cost of each biopsy procedure was $3,784, with a mean cost of $14,634 (SD = $32,271). The average cost of a lung biopsy with complications (adverse events) was approximately four times higher than a complication- free biopsy ($37,745 vs. $8,869). Adverse events were reported in 19.3 percent (336) of patients who underwent a lung biopsy. From this analysis, it was found that the National Comprehensive Cancer Network (NCCN) lung cancer screening guidelines were not followed, which resulted in many patients who ultimately had a negative lung cancer diagnosis undergoing unnecessary biopsies. The NCCN guidelines call for low-dose computed tomography of the chest followed by a PET scan to identify patients for biopsy.
Source:
HbA1c Levels, Not Fasting Plasma Glucose, Predict LV Dysfunction After STEMI
HbA1c levels are predictive of left ventricular diastolic dysfunction and impaired filling pressures following ST-segment-elevation MI (STEMI), whereas fasting plasma glucose levels had poor prognostic value, according to the results of a new report. The study also showed that HbA1c levels identified previously undiagnosed diabetic patients and that the concordance between HbA1c and fasting plasma glucose levels was poor. Researchers say the reason for the poor concordance between HbA1c and fasting plasma glucose as criteria for diagnosing diabetes in the study is likely the result of "stress hyperglycemia" that can develop in the setting of acute illnesses. "Diagnostic tests that utilize blood glucose readings are inaccurate in acutely unwell patients due to the epiphenomenon of stress hyperglycemia, whereby fasting plasma glucose becomes elevated in the absence of underlying diabetes," write Dr Josh Tsai (University of Queensland, Brisbane, Australia) and colleagues in the Canadian Journal of Cardiology. "Therefore, if fasting plasma glucose were used as a diagnostic criterion, the overall incidence of diabetes in this study would have been significantly overestimated, at 45.0%."
Source:
University of Washington Scientists and Engineers Create Credit-Card-Sized, Microfluidic Device Capable of Diagnosing Pancreatic Cancer in Minutes
The device automates the process used by pathology labs to process biopsy specimens and could be applied to automate other scientific processes Hoping to speed up the processing of human biopsies to reduce the time required to diagnose cancers, two undergraduate engineering students at the University of Washington (UW) have developed a cheap, miniaturized device that could one day be used in anatomic pathology laboratories. The protype is a low-cost, credit-card-sized device that automates the processing of human tissue biopsies using fluid transport. The device could help pathologists diagnose pancreatic cancer earlier and faster, to hopefully treat patients before it progresses to a deadly stage, according to a UW press release.
Source: http://www.darkdaily.com/
ThyroSeq Hits Target Negative Predictive Value (NPV)
A new next-generation sequencing (NGS) test for indeterminate thyroid nodules, with the ability to scan for more genes and gene expression patterns than any other test on the market, showed good results in an early trial, researchers reported. The ThyroSeq version 2.0 test hit a negative predictive value (NPV) of 96%, high marks for what has traditionally been seen as a rule-in test, Yuri Nikiforov, MD, PhD, of the University of Pittsburgh Medical Center, and colleagues reported during an oral session at the American Thyroid Association meeting.
Source: http://www.medpagetoday.com/
Lung Cancer Diagnosed Before it is Detected by Imaging
Circulating cancer cells are extremely rare in the bloodstream, are very heterogeneous and fragile, and are difficult to isolate without bias or loss. The team of researchers led by Paul Hofman used a blood test developed during French research, which isolates all types of tumour cells from the bloodstream, without any loss, leaving them intact. The team studied a group of 245 people without cancer, including 168 patients at risk of later developing lung cancer because they had Chronic Obstructive Pulmonary Disease (COPD). Participants systematically underwent the blood test and standard diagnostic imaging tests. Using the blood test, circulating cancer cells were identified in 5 patients (3%), whereas imaging did not show any nodules in the lungs. In these 5 patients, a nodule became detectable 1-4 years after detection of circulating cancer cells by the blood test. They immediately underwent surgery, and analysis of the nodule confirmed the diagnosis of lung cancer.
Source: http://www.sciencedaily.com/
Chembio Earns CLIA Waiver for HIV 1/2 Assay, Opening Door to Expansion
Chembio Diagnostics, Medford, NY, has received a CLIA waiver from FDA for its DPP HIV 1/2 assay after previously receiving FDA clearance for the diagnostic. The DPP HIV 1/2 assay is one of two FDA-approved, CLIA- waived oral-fluid HIV 1/2 rapid tests currently available in the United States. The assay detects HIV antibodies in oral fluid or blood using Chembio’s patented dual path platform (DPP). A SampleTainer specimen collection bottle also provides a secure, closed system for collecting potentially infectious samples.
Source: http://www.clpmag.com/
Accelerate Dx, CDC Collaborate on Early Detection of Antibiotic-Resistant Pathogens
Accelerate Diagnostics announced that it has partnered with the US Centers for Disease Control and Prevention's Rapid Antimicrobial Susceptibility Testing Laboratory to develop faster methods of analyzing biological threats such as anthrax and plague. Accelerate Dx will develop assays for rapid identification of infectious pathogens, their virulence markers, and their antibiotic susceptibility and resistance profiles. The CDC will provide its expertise on the molecular biology of the biothreat agents, and it will evaluate and optimize the performance of the platform using its collection of harmful biological agents.
Source: http://www.genomeweb.com/
PositiveID Collaborates With U.S. Military to Further Develop Handheld Real-time PCR Device
PositiveID announced an agreement with the US Special Operations Command Research, Development, and Acquisition Center to further develop military applications for the company's real-time PCR pathogen detection system, Firefly Dx. Firefly Dx is a handheld system that can deliver molecular diagnostic results at the point of need using Thermo Fisher Scientific Life Technologies' TaqMan PCR chemistry. It can derive results from a sample in less than 20 minutes, as opposed to two to four hours for a laboratory-based device, the company said in a statement.
Source: http://www.genomeweb.com/
Research and Development
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Plant Protein Could be Used for Blood, say Scientists
A protein found in sugar beet could be used as a blood substitute to help tackle the shortage of blood, researchers in Sweden suggest. Haemoglobin is the protein that carries oxygen in blood and the team says plant and human versions are very similar. They are looking at whether they can repackage the plant protein in a way that can be accepted by human tissue. Scientists said this could be in three years. One UK expert said the study was "exciting" but a "long-term prospect." Blood transfusions can help many people in emergency situations who have lost a lot of blood and also those needing long-term treatments, such as for cancer and blood diseases. Work by scientists at Lund University built upon an earlier study published in the journal Plant & Cell Physiology that found haemoglobin had an important role in plant development.
Source: http://www.bbc.com/
UK Research Shows MRSA Transfers From Livestock to Humans
New research from the U.K. supports the theory that antibiotic-resistant bacteria in livestock can be transmitted to humans. Scientists at the University of Edinburgh studied the evolutionary history of methicillin-resistant Staphylococcus aureus (MRSA) clonal complex 398 (CC398), mapping the full genetic code of the strains from the U.K. and comparing them with published genetic data on CC398 bacteria from humans and livestock around the world.
Source: http://www.foodsafetynews.com/
Scientists Find Mechanism for Spontaneous HIV Cure
French scientists unveiled the genetic mechanism by which they believe two men were spontaneously cured of HIV, and said the discovery may offer a new strategy in the fight against AIDS. In both asymptomatic men, the AIDS-causing virus was inactivated due to an altered HIV gene coding integrated into human cells, they wrote in the journal Clinical Microbiology and Infection. This, in turn, was likely due to stimulation of an enzyme that may in future be targeted for drug treatment to induce the same response, they said. "This finding represents an avenue for a cure," study co-author Didier Raoult of the French Institute of Health and Medical Research (Inserm) told AFP.
Source: http://www.msn.com/
Diversity Outbred Mice Better Predict Potential Human Responses to Chemical Exposures
A genetically diverse mouse model is able to predict the range of response to chemical exposures that might be observed in human populations, researchers from the National Institutes of Health have found. Like humans, each Diversity Outbred mouse is genetically unique, and the extent of genetic variability among these mice is similar to the genetic variation seen among humans. Using these mice, researchers from the National Toxicology Program (NTP), an interagency program headquartered at the National Institute of Environmental Health Sciences (NIEHS), were able to identify specific genes or chromosomal regions that make some mice more susceptible, and others more resistant, to the toxic effects of benzene. Benzene is a common air pollutant and human carcinogen found in crude oil, gasoline, and cigarette smoke, and naturally produced by wildfires and volcanoes.
Source: http://www.nih.gov/
Aspirin Protects Against Colon Cancer, Pitt Study Shows
Doctors have known for years that taking aspirin might reduce the risk of colon cancer by as much as 50 percent — they just didn't know how the science works. A study based at the University of Pittsburgh Cancer Institute has spotted a biological mechanism that could unravel the mystery, a discovery that might lead to better treatments with fewer side effects, researchers announced. The disease ranks as the second-leading cause of cancer-related fatalities nationwide and is projected to kill 50,000 people in 2014.
Source: http://triblive.com/
Japanese Mushroom Extract Could Help Treat HPV Infections
A Japanese mushroom extract, active hexose correlated compound (AHCC), appears to be effective in eradicating persistent human papillomavirus (HPV) infection, according to results of a small pilot study. Ten women with persistent HPV infection received a once-daily oral dose (3 g) of AHCC for up to 6 months, and half of the participants achieved a negative result for HPV infection. Three of these women with a confirmed eradication have stopped using AHCC, and the remaining two responders are continuing on the study. The results were presented at the 11th International Conference of the Society for Integrative Oncology.
Phase 2 in the Works
AHCC is an extract prepared from co-cultured mycelia of several species of Basidiomycete mushrooms. Preclinical studies have shown it to have anticancer properties, and both in vitro and in vivo studies have confirmed that it can eradicate HPV. Its ability to eradicate oncogenic HPV types 16/18 is attributed to modulation of the expression and signaling of interferon-α, β, and γ. "We've been evaluating the efficacy of AHCC with chemotherapy for over a decade," said Dr Smith. "It is a nutritional supplement with no known side effects, and it modulated the immune system to fight off infections and inhibit tumor growth."
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Public Health and Patient Safety
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Sounding the Alarm on the Rapid Spread of Drug-Resistant Tuberculosis
Widespread improper prescription and usage of antibiotics has given rise to drug-resistant strains of tuberculosis, badly straining the health-care systems of developing countries. A report from Médecins Sans Frontières (MSF) examines the rates of tuberculosis diagnosis and treatment in eight countries with high disease burdens—Brazil, India, Kenya, Myanmar, Russia, South Africa, Uzbekistan, and Zimbabwe—and found minimal compliance with World Health Organization guidelines for containing further spread of the disease.
Source: http://www.businessweek.com/
‘Kissing Bug’ Disease: Should You be Worried?
Researchers at the annual gathering of tropical medicine experts warned of a deadly disease from abroad that is threatening the health of more and more Americans. They weren't talking about Ebola, but Chagas, the "kissing bug" disease. Called a silent killer because it's often hard to diagnose in the early stages, Chagas is a parasitic infection that can lead to serious cardiac and intestinal complications and even death. It typically spreads through blood-sucking "kissing" bugs that bite on people's faces during the night and is estimated to affect 7 to 8 million people worldwide. The disease can also be spread from blood transfusions, organ transplants and congenital transfer from mother to child, according to the CDC. Until recently it was considered a problem only in Mexico, Central America and South America. Over the past few years, the Centers for Disease Control and Prevention has seen cases across half the United States, but in most cases the victims were believed to have been infected abroad. As recently as 2012, scientists expressed worry about the "globalization" of Chagas.
Source: http://www.washingtonpost.com/
Study Points to Overdiagnosis of Thyroid Cancer
To the shock of many cancer experts, the most common cancer in South Korea is not lung or breast or colon or prostate. It is now thyroid cancer, whose incidence has increased fifteen fold in the past two decades. “A tsunami of thyroid cancer,” as one researcher puts it. Similar upward trends for thyroid cancer are found in the United States and Europe, although not to the same degree. The thyroid cancer rate in the United States has more than doubled since 1994. Cancer experts agree that the reason for the situation in South Korea and elsewhere is not a real increase in the disease. Instead, it is down to screening, which is finding tiny and harmless tumors that are better left undisturbed, but that are being treated aggressively.
Source: http://www.nytimes.com/
When Cervical Cancer is Common, HPV Vaccination Usually isn't, Study Finds
Rates of cervical cancer vary substantially from state to state, and health experts hoped that the HPV vaccine would help even them out. But new research shows that hasn’t happened – at least not so far. As of 2012, some of the states with the highest incidence of cervical cancer also did the worst job of vaccinating girls against human papillomavirus, the virus that can lead to cervical cancer, according to a study presented at a health disparities conference organized by the American Assn. for Cancer Research.
Source: http://www.latimes.com/
What Our Sewage Can Teach Us
Beneath Visionaire, a breathtaking high-rise overlooking the southern tip of Manhattan, sewage gushes through a network of pipes and then drools into a stone tank, which is draped in quivering cockroaches. They scatter as Dennis Keefe, a contractor for Natural Systems Utilities, dips a metal ladle into the putrid stew and gently stirs. Jane M. Carlton, a geneticist and director of New York University’s Center for Genomics and Systems Biology, hovers near as her graduate students snap on latex gloves and draw samples from Mr. Keefe’s grimy ladle. Each vial of sewage that they collect is teeming with microscopic life and saturated with dangerous viruses and essential bacteria — exactly what Dr. Carlton is looking for. By analyzing wastewater samples from each of the five boroughs, Dr. Carlton hopes to uncover trends in infectious disease — to detect flu viruses before the next outbreak, for instance, and keep tabs on antibiotic-resistant bacteria. But her ultimate goal is far more ambitious: Dr. Carlton wants to sequence the microbiome of New York City.
Source: http://well.blogs.nytimes.com/
CDC Increasing Supply of Ebola-specific Personal Protective Equipment for U.S. Hospitals
The Centers for Disease Control and Prevention (CDC) has ordered $2.7 million in personal protective equipment (PPE) to increase Strategic National Stockpile (SNS) supplies to assist U.S. hospitals caring for Ebola patients. Products are being configured into 50 kits that can be rapidly delivered to hospitals. Each kit can provide the PPE needed by clinical teams to manage the care of one Ebola patient for up to five days. Purchases are based on PPE guidance for caring for Ebola patients that was issued by CDC on October 20. As product is delivered to SNS facilities, it is assembled into kits by SNS personnel. The kits can be rapidly delivered from the SNS as requested to those hospitals that receive suspected or confirmed Ebola cases but may need additional PPE supplies that otherwise are not immediately available. Although the number of kits is limited, they will help address short-term PPE needs. Purchases include impermeable gowns, coveralls, and aprons; boot covers; gloves; face shields and hoods; N95 respirators; powered-air purifying respirator systems and ancillaries; and disinfecting wipes.
Source: http://www.cdc.gov/
Health IT
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Health Plan Identifier Rule put on Hold
The Department of Health and Human Services (HHS) has put on indefinite hold its requirement for use of a Health Plan Identifier (HPID) in HIPAA transactions. It announced a delay "until further notice, in enforcement of 45 CFR 162, Subpart E," the rule published in September 2012 that required health plans to obtain HPIDs by Nov. 5, 2014. It added language to its identifier webpage, saying the delay covers all HIPAA covered entities, including healthcare providers, health plans and healthcare clearinghouses.
The National Committee on Vital and Health Statistics (NCVHS) in a Sept. 23 letter to HHS Secretary Sylvia Mathews Burwell urged holding off on implementing the rule, with two recommendations:
HHS should rectify in rulemaking that all covered entities will not use HPID in administrative transaction, and that the current payer ID will not be replaced with HPID
HHS should further clarify when and how the HPID would be used in health plan compliance certification and if there will be a connection with the federally-facilitated marketplace
HHS plans to consider these recommendations, according to the webpage.
Source: http://www.fiercehealthit.com/
Report: Health IT Market Moves to More Powerful Care Delivery Method
As venture capitalists pump more money into healthcare tech and innovation, and companies make more valuable contributions to the field, the industry is entering Health Market 2.0, according to a report by global consulting firm Oliver Wyman. "The tech entrepreneur developing a new app may not realize it, but he is helping to create the infrastructure of a new, more powerful way of delivering healthcare," write the authors of the report, Tom Main and Adrian Slywotzky, both partners at Oliver Wyman.
Source: http://www.fiercehealthit.com/
Making the Case for Personal Health Data Sharing
Despite the security risks, we all have a responsibility to help advance medicine by sharing our health data, Beth Seidenberg, M.D., writes at Wired. She doesn't downplay the seriousness of proliferating breaches in healthcare, including the one at Tennessee-based Community Health Systems, in which the information for 4.5 million patients was accessed, but appeals to the greater good that is achieved by sharing data.
Source: http://www.fiercehealthit.com/
Other News
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Should Life Insurance Firms Have Access to Your Genetic Test Results?
So, you're thinking you might like to check out one of those inexpensive new tests that would give you some insight into, say, the health implications of your ethnic heritage. It may, incidentally, turn up findings you may or may not want -- say, on your Alzheimer's disease risk, or your risk of developing lung, breast or skin cancer. And let's say in the next year or two that when you apply for life insurance (or long-term care or disability insurance), the insurance company demands to know whether you've had any genetic testing done, and if so, wants to see it. Or requires some genetic testing done as a condition of providing coverage. The insurance companies have -- and, fortunately for us, so has a group of bioethicists from Columbia University, who in a commentary in this week's Journal of the American Medical Assn. pondered the not-at-all distant future in which insurers will seek access to applicants' genetic test findings before making their underwriting decisions. Now that it can cost as little as $1,000 to have a full-genome scan -- and that more than 700,000 Americans have done it -- the future is now. Although the Genetic Information Nondiscrimination Act of 2008 bars the use of genetic information for health insurance coverage decisions, it does not do so when it comes to life insurance, disability insurance or long-term care insurance. A few U.S. states have adopted some protections against such use by insurance companies, but most have none. Only Vermont outright bars its use by insurers. And some insurance companies have already started asking.
Source: http://www.latimes.com/
CMS Finalizes OPPS Rule Packaging Pathology Services Ordered for Hospital Outpatients
As part of the Outpatient Prospective Payment System (OPPS) Rule issued last week, the Centers for Medicare & Medicaid Services (CMS) finalized its proposal to conditionally package certain ancillary services assigned to APCs with a “geographic mean cost” of $100 or less. This change, which will take effect on January 1, 2015, will apply to the technical component of most anatomic pathology services. Because the hospital’s payment for the primary procedure will cover these services, the hospital may no longer bill for them separately. But physicians can continue to seek reimbursement under the Medicare Physician Fee Schedule for the professional component of the service.
Source: http://www.natlawreview.com/
Disclaimer- The information provided in this news digest is intended only to be general summary information. It does not represent the official position of the Centers for Disease Control and Prevention and is not intended to take the place of applicable laws or regulations.
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