Sep 15, 2017 | Compliance, Legal, and Malpractice, Instruments & Equipment, Laboratory Instruments & Laboratory Equipment, Laboratory Management and Operations, Laboratory Operations, Laboratory Pathology, Management & Operations
Horseshoe crabs have been utilized by the biomedical industry to save millions of lives around the globe for years. But now researchers fear the practice of bleeding them may be threatening their survival
Many medical laboratory scientists are aware that horseshoe crabs are harvested to get their blue blood and the limulus amebocyte lysate, or LAL (pronounce “el-ay-el”), because it can detect bacterial endotoxins. The popular wisdom has been that the collection procedure does not harm the crabs. However, there are growing concerns that indicate the biomedical industry is having a negative impact on the horseshoe crab population.
More than 600,000 horseshoe crabs are harvested annually for their blood in the United States (US). It is estimated that the blood is worth $60,000 per gallon and the global industry of processing the blue blood is valued at over $50-million per year, according to a CNN article.
The blood of the horseshoe crab is bright blue in color because it is rich in copper. Horseshoe crabs are bled in laboratories for a protein contained in their blood that scientists use to make LAL. This protein can detect bacterial endotoxins in clinical laboratory tests by solidifying when it comes in contact with certain bacteria.
LAL is prized by the biomedical industry because it can detect dangerous bacteria in injectable drugs, implantable medical devices, and on instruments and equipment. Federal law mandates that any medical device that is inserted or injected into a human body must pass the LAL test for contamination.
Capture, Bleeding, Leading to Depopulation of the Species
After the crabs are dredged from the ocean floor, or captured as they come ashore for breeding, they are transported to one of a handful of facilities authorized to perform the bleeding process. Once there, the horseshoe crabs are cleaned and sterilized, suspended upside down and inserted with a needle which extracts approximately one third of their blood. The helmet-shaped creatures are then returned to the sea.
Like all animals, horseshoe crabs have an immune system to protect them from infection due to an injury or presence of bacteria. The immune system of a horseshoe crab uses endotoxin as the major chemical signal that the crab is being infected. Even miniscule amounts of endotoxin will spark a clotting reaction. Types of cells in the blood called amebocytes are separated from all the harvested blood and broken open, or lysated, to release the coagulation properties. (Photo copyright: Popular Mechanics.)
An LAL solution is then concocted to test for endotoxins in medications and on medical supplies. After this solution is combined with a sample from a batch of medication or placed on a piece of equipment, the presence or absence of the clotting reaction signifies whether endotoxin is present or not. There are currently no other tests that can analyze the purity of medications with the same accuracy as the LAL test.
Fisherman Regulated but Not Biomedical Laboratories
The Atlantic States Marine Fisheries Commission (ASMFC) regulates how many horseshoe crabs fishermen can collect for use as bait. However, the biomedical industry is not bound to restrictions because the crabs are returned to the water after the blood is extracted. The number of crabs harvested by the US biomedical industry jumped 86% between 2003 and 2014, according to an article in Scientific American.
In “Changing Global Perspectives on Horseshoe Crab Biology, Conservation and Management”, Thomas Novitsky, PhD, Chief Executive Officer of Cape Cod Biosystems of East Falmouth, Mass., wrote, “Evidence is accumulating that mortality of bled horseshoe crabs is higher than originally thought [29% versus 15%]; that females may have an impaired ability to spawn following bleeding and release; and that bled crabs become disoriented and debilitated for various lengths of time following capture, handling, bleeding, and release.”
In 2012, a horseshoe crab subcommittee was created by the International Union for Conservation of Nature (IUCN), an organization that establishes global standards for species extinction. That subcommittee later determined the Atlantic horseshoe crab is “vulnerable to extinction,” which is just one level from its Red List of Threatened Species. Their report also stated that horseshoe crab populations could decrease by 30% over the next 40 years, the Scientific American article noted.
“I wouldn’t be surprised if they weren’t on the Red List very soon. The [Asian] populations are significantly declining,” stated John Dubczak, Director of Operations at LAL facility Charles River Laboratories in Charleston, S.C. “Between pollution, loss of habitat, and the animals being eaten in Asia, their populations are under a tremendous amount of stress.”
The facilities that perform the bleeding assert they are not harming the horseshoe crabs. Dubczak states his company has procedures in place to ensure the creatures will not be harmed during the bleeding process. They also provide economic incentives to their suppliers to help guarantee the crabs are being handled appropriately outside their facility.
“It reduces the injury, it reduces the stress, it’s better for [sustaining] the population, and it’s better for us,” Dubczak said in the Scientific American article, noting that the mortality rate for crabs used in his operation is just 4%. “One of my suppliers built a water slide to put the crabs back into the water. They love it!”
Christopher Chabot, PhD, Professor of Neurobiology, Physiology and Behavior at Plymouth State University in Plymouth, N.H. questions how the overall health of the crabs is affected by the 24- to 72-hours they spend out of the water during the bleeding process.
“As you might imagine, being an aquatic organism, that probably has an impact on their viability, their health, their mortality, perhaps, as well as their ability to bounce back after this bleeding,” said Chabot. It takes about a month for the horseshoe crabs to replenish the blood that was extracted and they are not very active after they are bled.
Horseshoe Crabs Critical to Marine Ecosystems
The biomedical industry isn’t the only threat to the survival of the horseshoe crab. Fishermen use them for bait to catch eel and conch. Many shorebirds, migratory birds, fish, and turtles dine on horseshoe crab eggs. In addition, developments along the shorelines are destroying their natural habitat and breeding grounds.
Since horseshoe crabs have a vital role in the preservation of marine ecosystems, it is crucial that alternatives to the current bleeding procedure are developed. Practical and cost-effective substitutes for the LAL test that do not require horseshoe crab blood are under development. A synthetic version of the clotting factor called recombinant factor C is made from cloned Deoxyribonucleic acid (DNA). A test called the monocyte activation test (MAT) uses human blood and may have the ability to detect endotoxin bacteria that horseshoe crab blood is unable to expose. At this time, however, the LAL test is the only one approved by the Food and Drug Administration.
These news reports about the shrinking population of horseshoe crabs along the Atlantic coast demonstrate how interconnected environmental issues are with society’s use of natural resources. Clinical laboratory managers and pathologists should take note of the fact that researchers determined that the number of horseshoe crabs harvested nearly doubled between 2003 and 2014. That raises the stakes for researchers to find a substitute for the limulus amebocyte lysate that is produced from the blood of horseshoe crabs and has some many essential uses in medicine and healthcare.
—JP Schlingman
Related Information:
Medical Labs May Be Killing Horseshoe Crabs
The Blood of the Crab
Crab Bleeders
As Horseshoe Crab Populations Steadily Decrease, their Indispensable Medical Use is Threatened
Could the Multi-Million Dollar Industry that Bleeds 500,000 Horseshoe Crabs a Year for Medical Research Drive Them to Extinction?
Jul 26, 2017 | Compliance, Legal, and Malpractice, Laboratory Management and Operations, Laboratory News, Laboratory Operations, Laboratory Pathology
Decline in hospital-acquired conditions (HACs) overall since 2010 attributed to increased attention to safety protocols and practices by hospital staff in cooperation with clinical laboratory services
It’s now been almost nine years since the Medicare Program stopped paying hospitals and other providers for certain hospital-acquired conditions (HACs). Included in this list are hospital-acquired infections (HAIs). The goal is to substantially reduce the number of HACs and HAIs, thus improving patient outcomes, while substantially reducing the healthcare costs associated with these conditions.
So, almost nine years into these programs, has there been progress on these goals? This is a question of key interest to Medical laboratories and pathology groups because they have a front-line role in working with clinicians to diagnose and treat HAIs, while also looking to identify the transmission of HAIs within the hospital.
A recent report by the Agency for Healthcare Research and Quality (AHRQ), a division of the US Department of Health and Human Service (HHS), indicates that there has been progress in the goal of reducing HACs. The AHRQ report noted a 21% decline in HACs between 2010 and 2015. Data collected during that time indicates a reduction of more than 3.1 million HACs and nearly 125,000 patient deaths due to HACs.
In 2015 alone, nearly one million fewer HAC incidents occurred. The reduction saved “approximately $28 billion in healthcare costs,” an outcome which, the AHRQ report notes, is the result of increased attention to safety protocols in hospitals and a “period of concerted effort by hospitals throughout the country to reduce adverse events.”
Clinical Pathologists/Laboratories Play Key Role in HAI Prevention
Though many reported incidents are associated with adverse drug events, HAIs have been significantly reduced in recent years due to focused efforts on infection prevention. The report notes that clinical pathologists have become vital players in infection prevention programs, and that increased coordination between hospital medical laboratories and clinicians played a crucial role in the reduction.
Eileen O’Rourke is an Infection Preventionist at the Lankenau Medical Center in Philadelphia. And she has served as a leader and consultant for hospital-based infection prevention programs in Pennsylvania since 1984. In an article on the Wolters Kluwer Pharmacy OneSource blog, O’Rourke noted that successful infection prevention and control requires development of “a highly visible and administratively supported infection prevention and control program with qualified and trained personnel.” Clinical pathologists are part of that support team, providing surveillance, testing, and interpretation of data essential for identifying epidemiological origins of infection and pathogen distribution. And the vital services that clinical laboratories provide to reduce HAIs center on surveillance, prevention, and control.
The chart above was calculated on US Dollars in 2012. Since then, thanks to contributions by medical laboratories and pathologists in collaboration with hospitals, those costs have decreased significantly. (Image copyright: MLive.com.)
In an article for Lab Testing Matters, John Daly MD, Chief Medical Officer at the Commission on Office Laboratory Accreditation, and former Director of Clinical Laboratories for the Duke University Health System, highlights the importance of surveillance. He states that it is “an essential element of an infection control program” providing “data to identify infected patients and determine the site of infection” as well as “factors that contributed to the infection.” Medical laboratories must, Daly stresses, provide “easy access to high-quality and timely data and give guidance and support on how to use its resources for epidemiologic purposes.”
Daly argues that medical laboratories function as liaisons to clinical services, working to “improve the quality of specimens sent to the laboratory and promoting appropriate use of cultures and other laboratory tests.” The laboratory should, according to Daly, be involved in all aspects of the infection control programs. This ensures:
- Proper specimen collection;
- Accurate and rapid testing; and
- Accurate reporting of laboratory data.
Laboratory Data Provide ‘Early Warning’ for HAI Surveillance Systems
Robert A. Weinstein, MD, wrote in his 1978 article, “The Role of the Microbiology Laboratory in Surveillance and Control of Nosocomial Infections,” that medical laboratories and pathologists are central to prevention and control of HAIs. Laboratory records, Weinstein remarked, serve as important data sources that can identify early spread of infection, thus becoming an “early warning system” for a potential outbreak of infections. The sampling that laboratories perform identifies not only the strain of infection, but the method by which infection is spread, and the best treatment options. Nearly 40 years later his statements ring truer than ever, as anatomic pathology laboratory data continues to reveal patterns of infection faster and more precisely than ever before.
Sarah Mahoney, PhD, is a research scientist at Navitor Pharmaceuticals in Cambridge, Mass. In an article published in the American Journal of Clinical Pathology, she states that in surveilling patterns of infection, pathologists also decipher the source of infection. Mahoney wrote that it is “necessary to identify the causative organism” for surveillance and management control of HAIs. She also noted that pathologists must strive to discriminate between “hospital- and community-acquired infection” in order to provide clinicians with guidance for treatment, and to map “infection transmission within a clinical setting.”
Hospitals Rely on Medical Laboratories and Pathologists to Help Reduce HAIs
The concerted effort to reduce HACs and HAIs was inspired by incentives put forth by the US government. In 2008-2009, the Centers for Medicare and Medicaid Services (CMS) ceased paying for hospital-acquired conditions, including HAIs. Since that time, hospitals have worked to prevent and better manage HAIs. In the years since those incentives went into effect, hospitals have increasingly relied on medical laboratories and pathologists to provide necessary testing to prevent HAIs.
The CDC’s Antimicrobial Stewardship Programs create a further need for lab professionals to be involved in the identification, prevention, and treatment of HAIs. The core elements of the program state that the role of diagnostic laboratory testing—especially rapid diagnostic tests—is imperative in providing the necessary data needed to combat HAIs. The pressure is on for hospitals to reduce HAIs further to save lives and reduce costs. Thus, there is increased pressure on medical laboratories as well.
In an article in the College of American Pathologists’ online journal Cap Today,
Larry Massie, MD, Professor of Pathology at the University of New Mexico, and Chair of Pathology and Laboratory Medicine for the New Mexico VA Health Care System in Albuquerque, states that turn-around time is crucial for HAIs, but that laboratories often have difficulty keeping up with large volumes of samples. Massie suggests the use of new technologies could speed up turnaround time, particular for large healthcare providers.
The fight to reduce HAIs and HACs is showing significant progress, and clinical laboratories, working in tandem with clinicians and prevention programs, are a fundamental part of the success of HAI reduction. Clinical pathologists and laboratories often are the front line in prevention and management of HAIs, and the work they do in identifying infections is essential in the assessment and control of those infections.
— Amanda Warren
Related Information:
National Scorecard on Rates of Hospital-Acquired Conditions 2010 to 2015: Interim Data from National Efforts to Make Health Care Safer
How Hospitals Can Reduce Hospital-Acquired Infections
HAI Data and Statistics
Hospital Acquired Infection: Molecular Study and Infection Control Guidelines
Rapid Sequencing and Characterization of Pathogens in Hospital-Acquired Infections
The Role of the Microbiology Laboratory in Surveillance and Control of Nosocomial Infections
Core Elements of Hospital Antibiotic Stewardship Program
Pressure’s on to Halt Nosocomial Infections
Hospital Acquired Infections
Surveillance of Hospital-acquired Infections: A Model for Settings with Resource Constraints
The Laboratory and Infection Control
Role of the Microbiologist in Infection Control and Hospital Epidemiology
Study Finds Occupying Hospital Bed Previously Used by Patient Receiving Antibiotics Increases Odds of Developing C.diff Infection
Jul 17, 2017 | Compliance, Legal, and Malpractice, Laboratory Management and Operations, Laboratory News, Laboratory Operations, Laboratory Pathology, Uncategorized
Another big question is whether the lobbying of medical laboratory and pathology societies can educate and convince members of Congress to delay and reform the PAMA Final Rule that uses the market price study of what private payers pay for lab tests
Coming in just five months are the deepest, most painful clinical laboratory test price cuts ever implemented by Medicare officials. During calendar 2018 alone, both the Centers for Medicare and Medicaid Services (CMS) and the Office of Inspector General US Department of Health and Human Services (OIG) expect the price cuts to the Medicare Part B Clinical Laboratory Fee Schedule (CLFS) to lower spending on lab tests by $400 million!
The bad news doesn’t stop there. Lab industry observers say that significant numbers of hospital laboratories and independent lab companies are unprepared for the drop in revenue they will experience once the Medicare price cuts take effect. And, with only 157 days remaining before Jan. 1, 2018, medical laboratory executives and pathologists have precious little time to prepare their labs to operate on significantly less Medicare revenue.
PAMA Market Study of What Private Payers Pay for Clinical Laboratory Tests
Blame it on the Protecting Access to Medicare Act (PAMA) of 2014! PAMA directed CMS to conduct a market study of the lab test prices paid by private health insurers, and then use this data to set the prices of the CLFS. As many lab professionals know, CMS spent the last 24 months publishing a final price reporting rule that defined which medical laboratories must report the prices they are paid by private payers, and then collecting that data.
The data reporting period ended on May 31. In coming months, CMS will publish the new CLFS test prices and allow time for public comment.
Recognizing the need to help lab executives and pathologists understand the scale and scope of the Medicare lab test price cuts coming their way, Dark Daily and its sister publication, The Dark Report, have asked two experts with unique knowledge about this issue to give interested lab managers an up-to-the-minute intelligence briefing during an important webinar. It’s titled, “Deep Medicare Fee Cuts Are Coming to Your Clinical Laboratory in 157 Days: What You Must Do Now, Why Congress Might Intervene, and Action Steps to Protect Your Lab’s Financial Integrity,” and it happens later this week on Thursday, July 20, at 1 PM Eastern.
First Opportunity to See What Private Payers Pay for Medical Laboratory Tests
The first expert to speak is Lâle White, Executive Chairman and CEO of XIFIN, Inc., a health information technology (HIT) company headquartered in San Diego. Annually, White and her colleagues handle as many as 300 million lab test claims for hundreds of their clinical laboratory clients. Also, XIFIN is electronically interfaced with every health insurance plan in the US. These two facts mean that White has essentially the same data their lab clients reported to CMS.
During her presentation, White will show you how her company analyzed the real information from hundreds of millions of medical lab test claims that were reimbursed by thousands of private payers. You are in for a big surprise!
Learn Why Medicare Lab Test Fee Cuts Will Be Deep and Painful
XIFIN’s conclusions are based on real-world data. They demonstrate how the CMS final rule was written to direct the way federal officials calculate and set the 2018 Part B clinical laboratory test prices, and reveal why the fee cuts will be deep and painful for the lab industry’s highest-volume tests. You’ll hear facts about XIFIN’s analysis and learn to use that knowledge to model and predict precisely how deep Medicare’s revenue cuts to your lab will be when the new price schedule becomes effective on Jan. 1.
Lâle White (above left), CEO of XIFIN, Inc., spoke at the Executive War College on Laboratory and Pathology Management last May, where she shared insights about the coming price cuts to the Medicare Part B Clinical Laboratory Fee Schedule (CLFS). Julie Scott Allen (above right) is Senior Vice President of the District Policy Group, Drinker Biddle, and represents the National Independent Laboratory Association (NILA) in Washington, DC. White and Allen will be speaking at a special Dark Daily webinar later this week on the current status of the Medicare fee cuts and how lab executives should respond to protect the financial integrity of their labs. (White photo copyright: The Dark Report. White photo by Linda Reineke. Allen photo copyright: Drinker Biddle.)
Because it is generally agreed that CMS officials will target the top 20 lab tests by volume for the deepest price cuts, the actual revenue drop will depend on your mix of tests and the volume of Medicare patients associated with each test. CMS says it will use the weighted median of the private payer lab test price data to determine its new Part B fees.
However, that is a flawed approach and the source of much criticism.
White will show why the weighted median generates a lower price than the use of a weighted average calculation. You’ll see the direct impact that CMS’ use of the weighted median will have on your lab’s Medicare revenue, beginning on Jan. 1.
Understanding Current Developments at CMS and Within Congress
Julie Scott Allen will be the second speaker on the July 20 webinar. She is Senior Vice President, District Policy Group, Drinker Biddle, and represents the National Independent Laboratory Association (NILA) in Washington, DC. In this role, Allen works with officials at CMS, the Department of Health and Human Services (HHS), and with members of Congress on issues relevant to the clinical laboratory members of NILA. She regularly participates as part of the Clinical Laboratory Coalition on these matters.
Allen will give you an up-to-the minute perspective on efforts by the clinical laboratory industry to educate officials within Congress, HHS, and CMS about the consequences of allowing the PAMA final rule price cuts to become effective on January 1, 2018. This is important information you can use to craft strategies to protect your lab’s financial stability. You’ll also recognize opportunities to contact your elected officials in Congress at the time when your input can make an important difference.
The message of many in the Clinical Laboratory Coalition to members of Congress is that, if the PAMA Medicare fee cuts happen as planned, many hospital lab outreach programs and community lab companies in the states and districts of the various Senators and Representatives will probably end up going out of business, filing bankruptcy, or selling to a national lab company.
Behind the Scenes on PAMA Fee Cuts, ACA Repeal-and-Replace
Allen will take you behind the scenes of the inside-the-beltway developments that relate to the coming Medicare Part B clinical laboratory fee cuts. Different players from the clinical laboratory community are in discussions with CMS officials about the need to delay and reform the implementation of these price cuts.
Meanwhile, there are several developments unfolding within Congress that affect clinical laboratories. Yes, one of them is the PAMA final rule on lab price cuts. However, congressional efforts to repeal and replace the Affordable Care Act (ACA) are creating opportunities for different medical specialties—including the profession of laboratory medicine—to advocate for needed reforms in their areas of clinical services.
When clinical laboratory and anatomic pathology leaders are informed, they are more effective in two roles:
- Protecting the clinical excellence and financial sustainability of their respective laboratories;
- Advocating with government officials and lawmakers on the issues that are important to keeping the nation’s laboratories financially viable and key contributors to improving the quality of patient care.
Full details about this important webinar are at this link. Or copy and paste this URL into your browser: https://ddaily.wpengine.com/webinar/deep-medicare-fee-cuts-are-coming-to-your-clinical-laboratory-in-157-days-what-you-must-do-now-why-congress-might-intervene-and-action-steps-to-protect-your-labs-financial-integrity to register.
—Michael McBride
Related Information:
NILA and Other Stakeholders Ask HHS to Delay the Medicare Laboratory Payment Reform Rule
Nation’s Most Vulnerable Clinical Laboratories Fear Financial Failure If Medicare Officials Cut Part B Lab Fees Using PAMA Market Price Data Final Rule
Overview of CMS-1621-F Medicare Clinical Diagnostic Laboratory Test Payment System Final Rule
Dark Report Cracks the Mystery on PAMA Pricing; Genetic Coverage Still Tough Going
XIFIN Analysis of Its Real Price Data Shows Hospital Lab Price Effect: Study Based on Hundreds of Millions of Lab Test Claims
10% PAMA Fee Cut Would Lower Medicare Pay to Laboratories by $400 Million: New OIG Report Provides Clues as to How Cuts to CLFS Prices Will Reduce Payments to Clinical Labs
CMS Issues PAMA Final Rule That Aims to Cut Medicare’s Clinical Laboratory Test Price Schedule Sharply Beginning in 2018
Deep Medicare Fee Cuts Are Coming to Your Clinical Laboratory in 157 Days: What You Must Do Now, Why Congress Might Intervene, and Action Steps to Protect Your Lab’s Financial Integrity
Jul 14, 2017 | Compliance, Legal, and Malpractice, Laboratory Management and Operations, Laboratory Pathology, Laboratory Testing
Experts concerned people will be unable to judge a true emergency from a minor health concern; patients could be left with a big ER bill if they are wrong
Here’s a groundbreaking way payers are keeping healthcare costs down: Anthem Blue Cross and Blue Shield (BCBS) of Georgia sent letters to its members in May informing them that they will no longer be reimbursed by the insurer for “non-emergency” related services obtained in emergency rooms (ERs).
Pathology groups and medical laboratory leaders, will want to monitor and potentially respond to this important emergency coverage development. Hospital-based medical laboratories receive high volumes of test orders from the ER. Any decline in ER visits from a payer policy like this will have staffing and budget implications for hospital labs.
Medical Groups Warn of Dire Consequences
The new policy garnered national media coverage in addition to local exposure in Georgia, where it went into effect on July 1. BCBS affiliates in New York, Missouri, and Kentucky are considering similar policies as well, noted an article in The Fiscal Times.
“Anthem believes that primary care doctors are in the best position to have a comprehensive view of their patient’s health status and should be the first medical professionals patients see with any non-emergency medical concerns,” Anthem stated in the Fiscal Times article.
In its letter, BCBS of Georgia defines an emergency as a “medical or behavioral health condition of recent onset” that a “prudent layperson” deems health-threatening. However, many symptoms, such as chest pain, can lead to sudden death. How is the average person to know if what they are experiencing will turn out to be angina, a painful but often non-fatal condition, and not a life-threatening embolism?
“The prudent layperson standard requires that insurance coverage is based on a patient’s symptoms, not their final diagnosis,” the American College of Emergency Physicians (ACEP) in Georgia explained in its own statement.
“Anyone who seeks emergency care suffering from symptoms that appear to be an emergency, such as chest pain, should not be denied coverage if the final diagnosis does not turn out to be an emergency,” the ACEP concluded.
Are Patients Able to Judge Where They Should Go?
Some experts warn that many people might be unable to judge the true nature of their conditions when under stress.
The ACEP and its Missouri Chapter said in a statement that Anthem BCBS lists almost 2,000 diagnoses it considers to be “non-urgent” and not covered in the ER. The professional organization contends, however, that some of the diagnoses on the insurer’s list have the propensity to be medical emergency symptoms as well.
Two examples ACEP noted are:
However, cold symptoms, sore throat, physical exams, and minor injuries are among the complaints best addressed by walk-in clinics or urgent care centers, BCBS explained in a blog article.
Nevertheless, Debbie Diamond, Public Relations Director for BCBS of Georgia, told The Fiscal Times that a person who mistakes indigestion for chest pain is likely to be covered for ER care (in keeping with prudent layperson guidance).
Distinguishing Between Necessary and Unnecessary ER Visits
It’s not always simple to recognize an emergency from a non-emergency. Even emergency medicine professionals often have difficulty doing so.
In a Los Angeles Times article, Renee Hsia, MD, Professor and Director of Health Policy Studies, Department of Emergency Medicine at the University of California San Francisco School of Medicine, noted that, “People don’t come with a sticker on their forehead saying what the diagnosis is. We as physicians can’t always distinguish necessary from unnecessary visits.”
Renee Hsia, MD (above), is Professor and Director of Health Policy Studies, Department of Emergency Medicine at the University of California School of Medicine, San Francisco (UCSF). She told the Los Angeles Times that the Blue Cross Blue Shield of Georgia emergency coverage policy is a “well-intentioned policy with dangerous consequences.” (Photo copyright: Angie’s List/Adm Golub.)
According to the Centers for Disease Control and Prevention, there are 130.4 million emergency department visits each year in the US. A study published in the Journal of the American Medical Association (JAMA) Journal of Internal Medicine found that six of the 10 top symptoms that send people to non-emergency care settings match those driving decisions to head to emergency departments as well. They include:
- Back symptoms;
- Abdominal pain;
- Sore throat;
- Headache;
- Chest pain; and
- Low back pain.
“Our findings indicate that either patients or healthcare professionals do entertain a degree of uncertainty that requires further evaluation before diagnosis,” the authors wrote in JAMA.
Where Next? Who’s Next?
Despite the discord over the reduction in non-emergency coverage, more BCBS affiliates may soon adopt the same policy. And what of other large insurers? Might they be watching and considering whether to alter their emergency coverage, as well, to save money?
Thus, clinical laboratories in Georgia hospitals will want to closely monitor their institution’s ER test volume. It could take a while for Blue Cross patients in Georgia to realize that some ER visits (and the clinical laboratory tests associated with them) might not be covered by their insurance. This will happen in instances where their insurer denies claims for services that, in Anthem’s opinion, were better suited for primary care doctors and urgent care centers rather than ERs.
—Donna Marie Pocius
Related Information:
Got Chess Pain? This Insurer May Not Cover Your Emergency Room Visit
Blue Cross in Georgia to Limit Emergency Room Coverage
Choosing Between ER and Urgent Care
Blue Cross Blue Shield of Georgia Launch Emergency Room Policy
Emergency Physicians: Anthem Blue Cross Blue Shield Policy Violates Federal Law
Emergency Physicians: Georgia Blue Cross Blue Shield Policy Violates Federal Law
A Big Health Insurer is Planning to Punish Patients for Unnecessary ER Visits
Urgent Care Needs Among Non-Urgent Visits to the Emergency Department
Jun 21, 2017 | Compliance, Legal, and Malpractice, Laboratory News, Laboratory Operations, Laboratory Pathology, Laboratory Testing, Management & Operations
Despite blinding data and following protocols, a recent investigation in Bloomberg Businessweek shows that clinical laboratories can be at risk in deals with pharmaceutical and big data companies
While big data is transforming how healthcare is both researched and applied, it also offers opportunities for clinical laboratories to create additional revenue from the endless streams of data generated by diagnostic tests and genetic assays. However, these opportunities come at a cost.
Data mining and pharmaceutical companies are turning to medical laboratories for blinded data (patients’ names are removed) to aid in their research and marketing efforts. Although the data is blinded to adhere to consumer privacy protocols, a story on the biopharmaceutical company Alexion (NASDAQ:ALXN) in Bloomberg Businessweek shows how clinical laboratories may be at risk for civil and legal ramifications, as well as public relation concerns.
When Blinded Patient Data Is Not Blind
Despite requirements to anonymize medical data, the increased computing and data collection abilities of data mining companies make it possible to bridge gaps in information by collating multiple data sources. Companies then can make assumptions about the data with relative accuracy.
With Alexion’s drug Soliris, the blinded data was enough to locate healthcare professionals treating patients with paroxysmal nocturnal hemoglobinuria (PNH), a rare disease of the blood, and atypical hemolytic uremic syndrome (aHUS) a rare disease of the immune system.
Cover of the Bloomberg Businessweek issue containing the article on Pharmaceutical companies’ use of blinded patient data for marketing high-cost “orphan drugs” that were developed to treat just one specific rare disease. (Photo copyright: Bloomberg Businessweek.)
On the surface, this seems like an ideal example of how making clinical laboratory and pathology data available to companies can be beneficial to patients and a victory for healthcare.
However, the Bloomberg Businessweek article highlights a darker side of the issue, noting, “Alexion set out to persuade doctors to test more frequently for PNH and aHUS—and to find a way to glimpse these test results, which traditionally have been shared only among the patient, the doctor ordering the test, and the lab.”
Liability and Risk in Age of Big Data
By reaching out to doctors and encouraging them to route lab tests to preferred medical laboratories with which they allegedly had partnered, Alexion could collect information and compare it to their database to pinpoint opportunities to sell their orphan drug Soliris. An orphan drug contains a unique pharmaceutical agent that was developed to treat a specific rare disease.
Five clinical laboratory companies are named in the story. While these laboratories might have followed regulations and the partnerships might be legal, news stories such as these could result in public relations crises and damaged reputations.
According to the Bloomberg Businessweek article, Alexion is resolving legal or regulatory concerns in at least seven countries. Though there is no precedent for medical laboratories assuming liability or being implicated in the crimes of a company to which they sold blinded data, the possibility exists.
Increased Scrutiny as Privacy Becomes a Public Concern
Healthcare big data continues to unlock new opportunities and create new approaches in treating disease and improving health around the world. However, as the public gains awareness of how healthcare big data is collected, shared, and used, greater scrutiny of how the data is handled, and the parties involved, will likely follow.
Dark Daily reported on the balancing act faced by laboratories in a 2016 e-briefing titled, “Trading in Medical Data: Is this a Headache or an Opportunity for Pathologists and Clinical Laboratories?”
That e-briefing cites a Scientific American article in which author Adam Tanner, a fellow at Harvard University’s Institute for Quantitative Social Science, states, “At present, the system is so opaque that many doctors, nurses, and patients are unaware that the information they record or divulge in an electronic health record, or the results from lab tests they request or consent to, may be anonymized and sold.”
In a similar story, Ancestry recently experienced how fast opinions can shift when certain online publications questioned the terms and conditions of the company’s AncestryDNA service. In a matter of days, the service went from an interesting example of consumer genomics to a trending topic on social media.
In the Slate article “Who Owns Your Genetic Data After a Home DNA Test?,” author Jacob Brogan notes, “Even if Ancestry maintains its current commitment to protecting its customers’ data, its willingness to profit from that information may raise red flags for the future of consumer genetic testing.”
While Ancestry might resolve its immediate troubles with an update to its terms of service governing how and when it sells the genetic information of its customers, the hit to the company’s reputation could continue to impact its business. This is something the five clinical lab companies affiliated with Alexion and named in the Bloomberg Businessweek story may be experiencing as well.
As competition increases and clinical laboratories work to cultivate and improve revenue streams and reduce costs, it remains important to stay ahead of trends—and public opinion—by choosing partnerships carefully and remaining transparent about how patient data is collected, shared or sold, and used.
—Jon Stone
Related Information:
When the Patient Is a Gold Mine: The Trouble With Rare-disease Drugs
Your Medical Data Is for Sale, and There’s Nothing You Can Do About It
How Data Brokers Make Money Off Your Medical Records
Who Owns Your Genetic Data After a Home DNA Test?
Jun 9, 2017 | Compliance, Legal, and Malpractice, Laboratory Management and Operations, Laboratory News, Laboratory Operations, Laboratory Pathology, Uncategorized
New studies show number of Americans who are unwilling to reveal private health information is growing, hindering medical technology developers
Healthcare consumers appear not only to be raising their expectations of the quality of care they receive, but also in the privacy and security of their protected health information (PHI) as well. This is an important development for clinical laboratories and pathology groups, since they hold large quantities of patient test data.
News reports indicate that, due to the increase in patient distrust about privacy and security, developers of health information technology (HIT) products that collect and transmit patient data are struggling to insert their products into the broader healthcare market.
However, there is a positive side to this trend for medical laboratory professionals. Patients’ interest in tighter security and privacy protections provides pathology groups and clinical laboratory leaders with an invaluable opportunity to inform patients on their lab’s use of cybersecurity measures and to reiterate their commitment to protecting their patients’ data.
Clinical Laboratories Can Ease Patient Fears
It’s not enough that medical laboratories promote their services and efficiencies. They also must tout the capability of their laboratory information management systems (LIMS) to protect a patient’s PHI. That’s critical because recent studies indicate high proportions of healthcare consumers are becoming increasingly wary of how their healthcare data are protected.
The graphic above taken from a 2017 Accenture survey may indicate why healthcare consumer trust in an organization’s ability to secure protected health data (PHI) has eroded so deeply. (Graphic copyright: Accenture.)
Numerous reports of data hacking and security breaches have eroded healthcare consumers’ trust. Patients are more skeptical than ever about the benefits of HIT, such as:
That’s according to a national poll conducted by Black Book Market Research of more than 12,000 consumers in the fourth quarter of 2016.
The poll aimed at exploring consumers’ adoption and acceptance of HIT. It found:
- 87% of consumers are unwilling to divulge all their medical information (up from 66% in 2013);
- 70% of Americans distrust health technology (a significant increase from 10% in 2014);
- And 57% of people who underwent actual encounters with providers’ technology (including ancillary providers, such as clinical laboratories) remain skeptical of HIT.
Even with all the bells and whistles, HIT cannot penetrate the healthcare system if people don’t adopt it, a Black Book news release pointed out.
89% of Patients Withhold Information During Office Visits
Respondents to Black Book’s poll reported being especially alarmed by their data being shared (without their acknowledgement or consent) beyond their hospital and physician. This includes:
- Pharmacy prescriptions (90%);
- Mental health notes (99%); and
- Chronic conditions (81%).
Other key findings from the Black Book poll include the fact that:
- 89% of consumers withheld health information during their 2016 provider visits;
- 93% are concerned about security of their personal financial information;
- 69% say their primary care doctor does not have the technological expertise necessary for them to feel safe divulging extensive personal information.
Missing Data Compromises Care, Analytics
An article in Healthcare IT News reported that fear of breaches is translating to consumers’ reticence to share information. And, the Black Book survey states that data analytics and population health efforts by healthcare providers could be compromised due to consumer distrust, according to a FierceHealthcare article.
“Incomplete medical histories and undisclosed conditions, treatment, or medications raises obvious concerns on the reliability and usefulness of patient health data in application of risk-based analytics, care plans, modeling, payment reforms, and population health programming,” stated Doug Brown, President, Black Book, in the news release.
“This revelation should force cybersecurity solutions to the top of the technology priorities in 2017 to achieve tangible trust in big data dependability,” he concluded.
Patients/Doctors at Odds Over Use of Patient Data
According to the Black Book poll, 91% of people surveyed who use wearable medical tracking devices believe their physician’s EHR should be able to store any health-related data they wish. However, physicians responding to the provider section of the survey stated they have all the information they need. In fact, 94% of the doctors stated patient-generated data (generated by wearables) are “overwhelming, redundant, and unlikely to make a clinical difference.”
The disconnect has led to miscommunication and frustration in the doctor/patient relationship, noted a HealthITSecurity article.
Low Health Literacy Linked to Distrust of HIT
A study published in the Journal of Medical Internet Research by the University of Texas at Austin (UT) linked skepticism of HIT with low health literacy.
People who struggle to find and understand medical information tend to also be wary of health technologies, such as wearables, patient portals, and mobile apps, noted a UT news release.
Conversely, Americans with a high degree of health literacy are more likely to use fitness trackers and online portals and view them as useful and trustworthy, UT researchers stated.
This study of nearly 5,000 Americans also explored patients’ perceptions of privacy and trust in institutions. Researchers found lower health literacy was associated with more distrust and less adoption of HIT tools.
“There is a pressing need to further the understanding of how health literacy is related to HIT app adoption and usage. This will ensure that all users receive the full health benefits from these technologies in a manner that protects health information privacy, and that users engage with organizations and providers they trust,” the researchers wrote.
Cybersecurity a Priority for Labs
Cybersecurity and wearable technologies were identified as among the three primary trends (along with Social Media) facing clinical laboratories and in vitro diagnostics (IVD) manufacturers in 2017, according to insights shared by the Diagnostics Marketing Association in a recent Dark Daily e-briefing.
Another Dark Daily e-briefing summarized accounts of ransomware and cyberattacks on hospitals and medical labs in 2016. Clinical laboratory leaders are reminded to work with provider teams and appropriate experts to determine the lab’s ability to prevent and withstand cyberattacks.
Labs may glean some ideas from these cybersecurity “2017 must-haves” shared (along with others) in a Healthcare IT News article:
- Invest in a risk assessment that makes clear exactly what needs to be protected;
- Recognize that beyond medical and billing information, high tech equipment (such as lab analyzers) need to be addressed in planning.
Medical laboratory leaders should not be shy about communicating their lab’s cybersecurity priority, investment, and actions taken to keep their patient’s PHI private and secure. That message could be just what skeptical consumers need to hear and could be well received by the lab’s patients.
—Donna Marie Pocius
Related Information:
Healthcare’s Digital Divide Widens, Black Book Consumer Survey
Healthcare Digital Divide Getting Bigger and Other Bad News from Black Book
Patients Don’t Trust Health Information Technology Effects of Patient Distrust on health Data Exchange Security
Effects of Patient Distrust on health Data Exchange Security
One in Four US Consumers Have Had Their Healthcare Data Breached, Accenture Survey Reveals
New Health Literacy Digital Divide: Low Health Literacy Connected to Distrust of Health Technologies
Health Literacy and Health Technology Adoption: The Potential for a New Digital Divide
Top 10 Cybersecurity Must-Haves in 2017
Diagnostic Marketing Association’s Global Marketing Summit Will Convene in New Orleans Just Prior to the Executive War College to Discuss Primary Trends Facing IVD
MedStar Health Latest Victim in String of Ransomware Attacks on Hospitals and Medical Laboratories that Reveal the Vulnerability of Healthcare IT
