Payers are unwilling to reimburse for autopsies despite the fact that autopsies are a proven way to learn more about new diseases and how they attack the human body
Each year, less money is spent by Medicare and private health insurers on autopsies. However, autopsies regularly provide pathologists with relevant, clinically useful information about exact causes of death and other elements of disease in the deceased. Some diseases cannot be identified any other way but by autopsy. And data from autopsies have helped developers bring critical new medical laboratory tests, therapeutic drugs, and vaccines to market.
Thus, the healthcare system is losing valuable research that would bring a better understanding of diseases and processes in the body that contribute to poor health and death. This is true with COVID-19. Autopsy results have already provided revelations into how the SARS-CoV-2 coronavirus affects the body, and yielded clues that are helping pathologists combat the illness.
“Many lives have been saved by looking closely at someone’s death,” he added.
Autopsies performed on deceased patients could help clarify why there is such a wide array of symptoms for those affected by COVID-19 and provide details that cannot be detected in living patients.
For example, autopsies completed early in the pandemic confirmed that the SARS-CoV-2 coronavirus causes respiratory disease, and that extended use of ventilators could cause considerable damage to the lungs, the AP article noted. This discovery led physicians to re-evaluate how ventilators should be used on COVID-19 patients.
The AP story also stated that pathologists learned the SARS-CoV-2 coronavirus may spread the illness to other organs such as the heart, brain, liver, kidneys, and colon.
Through autopsies, COVID-19 patients also were discovered to have dramatic blood clotting issues in almost every organ of the body and micro-clotting in the lungs.
“The clotting was not only in the large vessels but also in the smaller vessels,” said Amy Rapkiewicz, MD, an anatomic and forensic pathologist, Chair of the Department of Pathology at NYU Langone Medical Center and Associate Professor, Department of Pathology at NYU Long Island School of Medicine, in an Advisory Board Daily Briefing. “And this was dramatic, because though we might have expected it in the lungs, we found it in almost every organ that we looked at in our autopsy study.”
Doctors are now exploring whether blood thinners should be utilized to prevent blood clots from forming in COVID-19 patients.
“When you’re able to see what’s happening at the level of the cells, you just have a broader picture of the potential mechanism by which the disease is happening,” Amy Rapkiewicz, MD (above), Chair of the Department of Pathology at NYU Langone Medical Center and Associate Professor, Department of Pathology at NYU Long Island School of Medicine, told Undark. (Photo copyright: Associated Press.)
Autopsies Identify Secondary Causes of Death
Autopsies also have shown that some COVID-19 patients are dying from secondary bacterial infections that appear alongside the disease. This discovery may help doctors understand lingering symptoms that plague some coronavirus patients.
“What you see at autopsy represents an effective catalogue of the injury that occurs in patients who have COVID,” pathologist Stephen Hewitt, MD, PhD, associate research physician, Laboratory of Pathology, and head of the Experimental Pathology Laboratory at the National Cancer Institute Center for Cancer Research, told Undark. “And it gives you an understanding and a basis to try and forecast forward what we’re going to see in post-COVID syndrome.”
Shortage in Funding and Forensic Pathologists
With advances in technology, clinical laboratory testing, and imaging scans, autopsies are performed much less than they were in the past. In the 1950s, autopsies were performed on about half of the patients who passed away in hospital situations, but now that number is somewhere between only five and 11%, ABC News reported.
At this time, hospitals are not required to provide autopsy services and the costs to perform autopsies are often not covered by private or government insurance.
“As medicine has become closer to the bottom line, community hospitals don’t want to perform the autopsies because they’re not getting any functional reimbursement for them,” Hewitt told Undark.
Hospitals usually have to cover costs associated with autopsies themselves or pass those expenditures along to the deceased patient’s family. Autopsies typically cost anywhere from $1,000 to $5,000 per patient, Undark reported.
“When you consider there’s no reimbursement for this, it’s almost an altruistic practice,” Billie Fyfe-Kirschner, MD, a pathologist with Rutgers University, told the Associated Press. “It’s vitally important, but we don’t have to fund it.”
According to the AP, the US faces a critical shortage of forensic pathologists who are trained to perform autopsies. It is estimated, AP reported, that “the US has only a few hundred forensic pathologists but could use several thousand—and less than one in 100 graduating medical school students enters the profession each year.”
Clearly, pathologists have much to offer in the field of autopsies. Autopsying patients who died from COVID-19 may provide data that could greatly affect treatment for those diagnosed with the disease and improve patient outcomes overall.
In the absence of a “gold standard,” researchers are finding a high frequency of false negatives among SARS-CoV-2 RT-PCR tests
Serology tests designed to detect antibodies to the SARS-CoV-2 coronavirus that causes the COVID-19 illness have been dogged by well-publicized questions about accuracy. However, researchers also are raising concerns about the accuracy of molecular diagnostics which claim to detect the actual presence of the coronavirus itself.
“Diagnostic tests, typically involving a nasopharyngeal swab, can be inaccurate in two ways,” said Steven Woloshin, MD, MS, in a news release announcing a new report that “examines challenges and implications of false-negative COVID-19 tests.” Woloshin is an internist, a professor at Dartmouth Institute, and co-director of the Geisel School of Medicine at Dartmouth.
“A false-positive result mistakenly labels a person infected, with consequences including unnecessary quarantine and contact tracing,” he stated in the news release. “False-negative results are far more consequential, because infected persons who might be asymptomatic may not be isolated and can infect others.”
Woloshin led a team of Dartmouth researchers who analyzed two studies from Wuhan, China, and a literature review by researchers in Europe and South America that indicated diagnostic tests for COVID-19 are frequently generating false negatives. The team published their results in the June 5 New England Journal of Medicine (NEJM).
For example, one research team in Wuhan collected samples from 213 hospitalized COVID-19 patients and found that an approved RT-PCR test produced false negatives in 11% of sputum samples, 27% of nasal samples, and 40% of throat samples. Their research was published on the medRxiv preprint server and has not been peer-reviewed.
The literature review Woloshin’s team studied was also published on medRxiv, titled, “False-Negative Results of Initial Rt-PCR Assays for COVID-19: A Systematic Review.” It indicated that the rate of false negatives could be as high as 29%. The authors of the review looked at five studies that had enrolled a total of 957 patients. “The collected evidence has several limitations, including risk of bias issues, high heterogeneity, and concerns about its applicability,” they wrote. “Nonetheless, our findings reinforce the need for repeated testing in patients with suspicion of SARS-Cov-2 infection.”
Another literature review, published in the Annals of Internal Medicine, titled, “Variation in False-Negative Rate of Reverse Transcriptase Polymerase Chain Reaction–Based SARS-CoV-2 Tests by Time Since Exposure,” estimated the probability of false negatives in RT-PCR tests at varying intervals from the time of exposure and symptom onset. For example, the authors found that the median false-negative rate was 38% if a test was performed on the day of symptom onset, versus 20% three days after onset. Their analysis was based on seven studies, five of which were peer-reviewed, with a total of 1330 test samples.
Doctors also are seeing anecdotal evidence of false negatives. For example, clinicians at UC San Diego Health medical center treated a patient with obvious symptoms of COVID-19, but two tests performed on throat samples were negative. However, a third test, using a sample from a bronchial wash, identified the virus, reported Medscape.
Sensitivity and Specificity of COVID-19 Clinical Laboratory Tests
The key measures of test accuracy are sensitivity, which refers to the ability to detect the presence of the virus, and specificity, the ability to determine that the targeted pathogen is not present. “So, a sensitive test is less likely to provide a false-negative result and a specific test is less likely to provide a false-positive result,” wrote Kirsten Meek, PhD, medical writer and editor, in an article for ARUP Laboratories.
“Analytic” sensitivity and specificity “represent the accuracy of a test under ideal conditions in which specimens have been collected from patients with either high viral loads or a complete absence of exposure,” she wrote. However, “sensitivity and specificity under real-world conditions, in which patients are more variable and specimen collection may not be ideal, can often be lower than reported numbers.”
In a statement defending its ID Now molecular point-of-care test, which came under scrutiny during a study of COVID-19 molecular tests by NYU Langone Health, Northwell Health, and Cleveland Clinic, according to MedTech Dive, Abbott Laboratories blamed improper sample collection and handling for highly-publicized false negatives produced by its rapid test. An FDA issued alert about the test on May 14 noted that Abbott had agreed to conduct post-market studies to identify the cause of the false negatives and suggest remedial actions.
Issues with Emergency Use Authorizations
In their NEJM analysis, Woloshin et al point to issues with the FDA’s process for issuing Emergency Use Authorizations (EUAs). For example, they noted variations in how manufacturers are conducting clinical evaluations to determine test performance. “The FDA prefers the use of ‘natural clinical specimens’ but has permitted the use of ‘contrived specimens’ produced by adding viral RNA or inactivated virus to leftover clinical material,” they wrote.
When evaluating clinical performance, manufacturers ordinarily conduct an index test of patients and compare the results with reference-standard test, according to the Dartmouth researchers. For people showing symptoms, the reference standard should be a clinical diagnosis performed by an independent adjudication panel. However, they wrote, “it is unclear whether the sensitivity of any FDA-authorized commercial test has been assessed in this way.” Additionally, a reference standard for determining sensitivity in asymptomatic people “is an unsolved problem that needs urgent attention to increase confidence in test results for contact-tracing or screening purposes.”
“To truly determine false negatives, you need a gold standard test, which is essentially as close to perfect as we can get,” Stephen Rawlings, MD, PhD, (above), a resident physician of internal medicine and infectious diseases fellow at UC San Diego’s Center for AIDS Research (CFAR), who has been working on SARS-CoV-2 test validation since March. “But there just isn’t one yet for coronavirus,” he told Medscape. (Photo copyright: University of California, San Diego.)
Continued adherence to current measures, such as physical distancing and surface disinfection.
Development of highly sensitive and specific tests or combinations of tests to minimize the risk of false-negative results and ongoing transmission based on a false sense of security.
Improved RT-PCR tests and serological assays.
Development and communication of clear risk-stratified protocols for management of negative COVID-19 test results.
“These protocols must evolve as diagnostic test, transmission, and outcome statistics become more available,” they wrote.
Meanwhile, clinical laboratories remain somewhat on their own at selecting which COVID-19 molecular and serology tests they want to purchase and run in their labs. Complicating such decisions is the fact that many of the nation’s most reputable in vitro diagnostics manufacturers cannot produce enough of their COVID-19 tests to meet demand.
Consequently, when looking to purchase tests for SARS-CoV-2, smaller medical laboratory organizations find themselves evaluating COVID-19 kits developed by little-known or even brand-new companies.
Genetic testing, gene sequencing done by clinical laboratories and anatomic pathology groups underpin how first-mover hospitals, health networks are improving patient outcomes
In just a few weeks, an unprecedented gathering will bring together the nation’s most prominent first-mover health networks, hospitals, and companies operating programs that deliver precision medicine daily to patients in clinical care settings.
On Sept. 12-13, 2018, “Breakthroughs with Genetic and Precision Medicine: What All Health Network CEOs Need to Know,” will take place at the Hutton Hotel in Nashville, Tenn. “What differentiates these sessions is the emphasis on each organization’s strategy, how it launched its precision medicine programs, what is improving in patient outcomes, and how payers are reimbursing for these services,” stated Robert L. Michel, Executive Director of the Precision Medicine Institute in Austin, Texas. “This is not about the science of precision medicine. Rather, it is about the practical elements required for any hospital, health system, or physician group to actually set up and deliver a precision medicine service to patients on a daily basis.”
Precision Medicine’s First-Mover Hospitals and Providers to Speak
Health systems and hospitals headlining this special conference are:
Exhibitors include the above, plus: Thermo Fisher, Philips, Sunquest, and MyGenetx.
“This meeting will give you the insider’s understanding about delivering precision medicine in real patient care settings that cannot be accessed at other venues,” noted Michel. “The goal is to have first-mover providers share their experiences, thus providing a road map that other hospitals, physician practices, and other providers at this conference can take back and follow with confidence.”
Michel said that sessions will be dedicated to precision medicine strategies, how it is being used in oncology, primary care, the role of pharmacogenomics, and use of healthcare big data. Speakers will describe the clever ways innovative health networks and hospitals are using healthcare big data to inform physicians in ways that improve outcomes, lower the cost of care and, in two real-world case studies, are generating seven-figure reimbursement from shared savings programs with certain health plans.
This year’s keynote address is by Jeffrey R. Balser, MD, PhD (above), President and CEO, Vanderbilt University Medical Center and Dean of the Vanderbilt University School of Medicine, one of the most progressive and innovative health systems in the country. (Photo copyright: Vanderbilt University.)
Using Healthcare Big Data to Achieve Precision Medicine Success, Shared Savings
“Shared savings successes will be one of the breakthrough achievements reported at the Nashville event,” he explained. “We’ve invited two prominent provider organizations to share how they are using healthcare big data to support physicians in achieving improved patient outcomes while at the same time impressively reducing the overall cost of care. To my knowledge, this is the first time these precision medicine case studies have been presented at a national meeting.”
One such presentation will be delivered by Philip Chen, MD, PhD, Chief Healthcare Informatics Officer at Sonic Healthcare USA Austin, Texas. Their precision medicine goal was to use healthcare big data to help physicians better manage diabetes and other chronic conditions in their practices. This program involved a large primary care practice and a major health insurer. Now in its fourth year, Sonic Healthcare USA is earning six- and seven-figure payments as part of a shared savings arrangement with the insurer.
“Shared savings is definitely a Holy Grail for all large health networks and physician groups as payers drop fee-for-service and switch providers to value-based payments,” said Michel. “The experience of Sonic Healthcare in this innovative three-way collaboration with an insurer and a very large physician group demonstrates that a strong data analytics capability and engagement with physicians can simultaneously bend the cost-of-care-curve downward while improving patient outcomes, as measured year-by-year. This is a presentation every C-Suite executive should attend.
Strategic, Business, Operational, and Financial Aspects of Precision Medicine
“This conference—centered upon the strategic, business, operational, and financial aspects of a precision medicine program—came to be because it is the unmet need of every health network CEO and C-Suite administrator,” observed Michel. “Every healthcare leader tasked with developing an effective clinical and financial strategy for his or her institution knows that the real challenge in launching a precision medicine program for patient care is not the science.
“Rather, the true challenges come from how to support clinical needs with the availability of capital, recruiting experienced clinicians, and putting the right informatics capabilities in place,” he stated. “Most hospital and health network administrators recognize the risk of launching a precision medicine program too early. They know such programs can suck up huge amounts of resources without producing significant improvements in patient care. What adds to the risk is that payers may be slow to reimburse for precision medicine.”
Register by September 1 and save $300 on tuition! Plus, take advantage of our special Team Discount Program, so you and your key team members can get the most out of the conference by attending together.
“Breakthroughs with Genetic and Precision Medicine: What All Health Network CEOs Need to Know” is the gold-standard summit for everyone active or interested in succeeding with precision medicine programs. Don’t miss out—register today!
Pathologists and clinical laboratories should be watching for the arrival of community paramedicine programs in their communities
Studies reveal that a sizeable proportion of 911 medical emergency calls result in an ambulance ride and emergency room visit for a medical condition that is relatively simple and not truly urgent. Recognizing this fact, some innovative health systems are creating a mobile “emergency room” service that can go to the patient’s home, provide appropriate care, and save the time and costs of the ambulance transport and emergency room (ER) visit.
This care model is being called “community paramedicine.” Pathologists and clinical laboratory managers should see this as a new example of how the traditional provision of healthcare services is being rethought. The goal is to combine modern workflow redesign techniques with new information technologies (IT) and medical laboratory tests to improve patient care while eliminating unnecessary cost.
The concept of bringing the ER to the patient’s home is consistent with the US medical industry’s shift toward offsite healthcare, which can include telehealth, to accommodate the growing population of geriatric, house-bound, and remote location patients. That is why programs are being created that allow patients to receive ER care in the comfort of their own homes. (more…)
Because of ongoing advances in gene sequencing and the data analytics needed to interpret that information, new approaches to clinical care are becoming available to physicians and pathologists
COLD SPRING HARBOR, NEW YORK—Internationally-recognized as a leader in bringing together the brightest minds in genetics, the Banbury Center at the Cold Spring Harbor Laboratory (CSHL) produced a three-day conference here last week to explore the future state of anatomic pathology and identify opportunities in genetic medicine and image sciences that play to the strengths of the nation’s pathology laboratories.
The Cold Spring Harbor Laboratory has a long history and an enviable reputation. It was founded in 1890 to train teachers in biology. However, by 1904, the laboratory’s mission had been expanded to include research in genetics. In 1924, the research mission was further enlarged to include quantitative biology—in particular, physiology and biophysics.
It was in 1968 that Nobel laureate James Watson, then a professor at Harvard University, accepted the directorship of the Cold Spring Harbor Laboratory while also keeping his professorship at Harvard University. Watson served at some level of leadership until 2008, when he became Chancellor Emeritus. Currently CSHL laboratory houses about 200 research-related personnel. (more…)
