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Whistleblower Lawsuit Alleges Massive Fraud in Cigna Medicare Advantage Plans

A former officer of a Cigna contractor claims the insurer hatched a scheme to submit invalid diagnostic codes and filed the now-unsealed qui tam action in 2017

In a case that could provide a cautionary tale for clinical laboratories, a federal whistleblower lawsuit alleges that Cigna, through its HealthSpring subsidiary, “received billions in overpayments from the federal government” in a scheme involving the insurer’s Medicare Advantage plans. The Qui tam (whistleblower) lawsuit was filed by Robert A. Cutler, a former officer of Cigna contractor Texas Health Management LLC (THM), under the federal False Claims Act.

Cutler alleged that “Cigna-HealthSpring has knowingly defrauded the United States through an intentional and systematic pattern and practice of submitting to CMS invalid diagnosis codes derived from in-home health assessments.” He claimed this took place “from at least 2012 until at least 2017,” and likely thereafter.

Cigna has denied the allegations. “We are proud of our industry-leading Medicare Advantage program and the manner in which we conduct our business,” the insurer stated in an email to HealthPayerIntelligence. “We will vigorously defend Cigna against all unjustified allegations,” Cigna stated.

As the lawsuit explains, Medicare Advantage (MA) plans are administered by private insurers under Medicare Part C. “Rather than pay providers directly based on the medical services provided, Medicare Part C pays MA Organizations a monthly capitated rate for each covered beneficiary, and tasks the MA Plan with paying providers for services rendered to plan members,” the lawsuit states. “MA insurers are generally paid more for providing benefits to beneficiaries with higher-risk scores—generally older and sicker people—and less for beneficiaries with lower-risk scores, who tend to be younger and healthier.”

The lawsuit notes that CMS relies on information—specifically ICD codes—from the insurers to calculate the risk scores.

Cigna’s 360 Program as Described in Lawsuit

Cutler alleged that Cigna defrauded CMS through its “360 Program,” in which primary care providers (PCPs) were encouraged to perform enhanced annual wellness visits that included routine physical exams. He claimed that “Cigna-HealthSpring designed the program so that, in practice, the 360 assessment was a mere data-gathering exercise used to improperly record lucrative diagnoses to fraudulently raise risk scores and increase payments from CMS.”

Cigna-HealthSpring, he alleged in the court documents, offered PCPs financial bonuses to perform the 360 program exams, especially on patients deemed most likely to yield high-risk scores. However, many clinicians declined, so the insurer recruited third-party contract providers, including THM, to send nurse practitioners (NPs) or registered nurses (RNs) to the homes of MA plan members.

For each visit, the NPs and RNs were given health reports listing the beneficiary’s previous diagnoses. “Cigna-HealthSpring intended the document to serve as a ‘cheat-sheet’ list of conditions and diagnoses it expected 360 contractors to capture during the in-home visit,” Cutler alleges. “The list of diagnoses did not indicate the date they were reported or any other information concerning their status.”

During each visit, which typically lasted 30-60 minutes, “NPs and RNs relied primarily on the patient’s self-assessment, i.e., subjectively reported information, as well as current medications to the extent available and, during certain time periods and for certain plan members, limited [clinical] laboratory findings,” Cutler alleged.

NPs were expected to record 20 or more diagnoses per visit, he wrote, including diagnoses based on “weak links” involving medications. “For example, Cigna-HealthSpring encouraged contractors to record atrial fibrillation, deep vein thrombosis, and pulmonary embolus based on the presence of certain classes of anti-coagulation medications on members’ medication lists or in their homes,” he stated.

He also alleged that “Cigna-HealthSpring, in purposeful violation of CMS rules, designed its 360 form to force NPs to capture diagnoses that were uncertain, probable, or merely suspected.”

These diagnoses were subsequently submitted as risk-adjustment data to CMS, he alleged, adding up to “hundreds of thousands of false claims from its six contractors during the relevant period. Although the exact amount will be proven at trial, the United States has paid billions of dollars in improper, inflated payments to Defendants under the MA Plan as a result of this scheme.”

Medicare Under Assault from Fraudsters graphic
The graphic above is taken from an AARP article, titled, “Medicare Under Assault from Fraudsters,” which states, “The amount of tax dollars that are lost each year to Medicare fraud and waste is greater than the entire annual budget of some of the federal government’s most important programs and departments.” Clinical laboratories also are in danger of being drawn into the federal government’s fraud investigations which can be disruptive to business and revenues. (Graphic copyright: AARP.)

The False Claims Act Explained

Cutler, an attorney who is representing himself, originally filed the lawsuit under seal in 2017, in the US District Court for the Southern District of New York. An amended version was unsealed on August 4, 2020.

The Federal False Claims Act “allows a private citizen to step into the shoes of and pursue a claim on behalf of the government,” explained the Boyers Law Group of Coral Gables, Fla., in an article for HG.org, which states, the lawsuit “may proceed with or without the assistance of the government.”

If the government chooses to intervene, the whistleblower, known formally as the “relator,” can receive 15% to 25% of the proceeds recovered in the action, the law firm explained in another article for HG.org, adding that, in most cases, the government does not intervene, which increases the potential award to 30%.

In the Cigna case, the US Attorney’s office notified the court on Feb. 25, 2020, that the government had decided not to intervene “at this time.”

Significance for Clinical Laboratories

Regardless of how this case proceeds, medical laboratory managers should remember that they are subject to legal action if internal whistleblowers identify policies or procedures that violate federal fraud and abuse laws. And because it involves coding, it is also a reminder of the importance of documenting diagnoses and clinical laboratory test orders as protection against fraud allegations.

Another benefit of carefully documenting each lab test order is that labs can make the information available when auditors from government or private payers show up and want documentation on the medical necessity of each lab test claim.

—Stephen Beale

Related Information:

DOJ Sues Cigna, Alleging $1.4B in Medicare Advantage Fraud

Cigna Bilked Medicare Advantage For $1.4B, FCA Suit Says

Cigna Faces Whistleblower Lawsuit Over $1.4 Billion in Fraudulent Medicare Advantage Billings

Suit against Cigna is Latest Attempt by DOJ to Crack Down on Medicare Advantage Fraud

Cigna Embroiled in Lawsuit Over Wellness Program Risk Adjustment

Tex. Health Management V. HealthSpring Ins. Co.

Teladoc Health’s Agreement to Acquire Livongo Is a Blockbuster Deal in the Telehealth Sector, But Is it Positive or Negative for Clinical Laboratories?

Physician acceptance of virtual visits with their patients is being accelerated by the pandemic and the pending merger would combine the nation’s two biggest telehealth companies

Telehealth visits with virtual healthcare providers are increasing as the COVID-19 pandemic continues. This is forcing the entire healthcare industry—clinical laboratories in particular—to adapt to new methods of patient data exchange and communications. What is not clear is how independent clinical laboratories and hospital labs should expect to interact with telehealth providers, receive lab test orders from virtual doctors, and return test results.

But perhaps more important, patients’ acceptance of virtual care—i.e., reduced face-to-face access to their doctors—may be motivating telehealth companies to expand their offerings while also using mergers and acquisitions as a way to expand market share.

The recent announcement of Teladoc Health’s (NYSE:TDOC) agreement to acquire Livongo (NASDAQ:LVGO) is such an example. Some experts believe it could reset the competitive playing field, noted Robert Michel, Editor-in-Chief of Dark Daily.

The Teladoc-Livongo deal, if completed, will combine a virtual care company with a digital chronic disease management company, thus creating one of the largest telehealth companies to ever exist, noted Fierce Healthcare, which reported, “The combination of two of the largest publicly-traded virtual care companies announced Wednesday will create a health technology giant just as the demand for virtual care soars. The combined worth of the two companies is said to be worth about $37 billion, according to Piper Sandler.” Piper Sandler (NYSE:PIPR) is an American multinational “investment bank and institutional securities firm,” according to the company’s website.

During a call announcing the acquisition, Jason Gorevic, CEO of Teladoc, told business analysts that Teladoc will pay $18.5 billion in cash and stock to acquire Livongo, which went public in July at $28/share, and at the time of the acquisition, was worth $159/share, Fierce Healthcare reported.

Details of the Teledoc-Livongo Deal

COVID-19 has accelerated the trend toward expanded use of telehealth, and as a result, both Teladoc and Livongo have seen exponential growth in the last few months. Fierce Healthcare reported that Teladoc has experienced year-over-year growth of 85%, that revenue growth of 30-40% is expected in the next two to three years, and that Livongo has reported 125% revenue growth in the second quarter of 2020. The combined company is expected to reach $1.3 billion in revenue, Fierce Healthcare predicted.

Jennifer Schneider, MD
“What Teladoc brings is an incredible access to 70 million people with loads of data and the ability to deliver a one-to-one service at scale. What Livongo brings is a digital-first footprint, a strong data science engine, and the ability to deliver a one-to-many at scale, so it really is the combination of the two organizations that is delivering on that shared common vision of this consumer-center virtual care,” Livongo President and Chief Medical Officer Jennifer Schneider, MD (above), told MobiHealthNews.” What was not discuss is how clinical laboratories fit into the virtual care paradigm. (Photo copyright: Kimberly White/Getty Images for Tech Crunch.)

Analysts who have commented on the deal tend to agree with the leadership of the two companies. “I’d expect this to become a single point of access for virtual care in the next five years with one app to control them all,” Stephanie Davis, Senior Equity Research Analyst at SVB Leerink, an investment bank that specializes in healthcare, told FierceHealthcare.

Along with providing a “single point solution” to consumers, the combined company may be able to improve management of chronic conditions and access to high-quality care. “This combination creates an opportunity to empower patients to manage serious health conditions through a single, integrated delivery platform with robust capabilities,” Daniel Stewart, Managing Director, RBC Capital Markets (NYSE:RY), told FierceHealthcare.

Impact on Clinical Laboratories

Although the Teladoc-Livongo deal may not have immediate or direct repercussions for those who work in clinical laboratories, it represents an accelerating trend toward virtual health. Since there is no widely accepted way to collect lab specimens when a physician sees a patient remotely and orders tests, medical laboratory managers will want to remain flexible so as to develop effective ways to collect and test specimens after a patient’s virtual visit with a physician.

Dark Daily discussed this in “As Primary Care Providers and Health Insurers Embrace Telehealth, How Will Clinical Laboratories Provide Medical Lab Testing Services?” To stay ahead of the curve, labs must be proactive in their approach to responding to virtual care. Robust strategies that include communication with health plans, hospitals, and networks must be implemented sooner rather than later, because the push toward telehealth has gained momentum far sooner than most experts originally predicted. 

“My advice in these times of change is to do something,” Ted Schwab, Healthcare Strategist and Entrepreneur told attendees at the 24th Annual Executive War College, in New Orleans. “What we know today is that providers—including clinical laboratories and pathology groups—who do nothing will get trampled. However, those providers that do something proactively will most likely be the winners as healthcare continues to transform.”

As ever-larger numbers of physicians and patients grow comfortable with the use of telehealth because of the COVID-19 pandemic, clinical laboratories will benefit from adapting their specimen collection and transport arrangements to meet the needs of patients who do not physically visit their physicians’ offices and do not go to a laboratory patient service center.

Patients who visit providers in person can leave the office with a doctor’s order for lab tests and go directly to a lab’s patient service, often in the same building. But what will the process be when they have just completed a virtual office visit with their providers?

—Dava Stewart

Related Information:

How Teladoc’s Blockbuster Deal Could Impact the Entire Virtual Care Landscape

Livongo’s President Dr. Jennifer Schneider Talks Potential in Livongo and Teladoc Merger

As Primary Care Providers and Health Insurers Embrace Telehealth, How Will Clinical Laboratories Provide Medical Lab Testing Services?

Strategist Explains Key Trends in Healthcare’s Transformation

New Artificial Intelligence Algorithm Uses Routine Clinical Laboratory Tests to Identify Patients Likely Infected with COVID-19

At hospitals where results of molecular COVID-19 testing can take up to several days to return, this new method for identifying potentially infected patients could improve triage

Frustrated by shortages of essential COVID-19 tests and supplies—as well by lengthy coronavirus test turn-around times—researchers at Weill Cornell Medicine have created an Artificial Intelligence (AI) algorithm that can use routine clinical laboratory test data to determine if a patient is infected with SARS-CoV-2, the coronavirus that causes the COVID-19 disease.

This is an important development because the turn-around-time (TAT) for common lab tests is generally much shorter than COVID-19 molecular diagnostics—such as real-time reverse transcription polymerase chain reaction (RT-PCR), currently the most popular coronavirus test—and certainly serological (antibody) diagnostics, which require an infection incubation time of as much as 10-14 days before testing.

Some RT-PCR diagnostic tests for COVID-19, which detect viral RNA on nasopharyngeal swab specimens, can take up to several days to return depending on the test and on the lab’s location. But routine medical laboratory tests generally return much sooner, often within minutes or hours, making this a potential game-changer for triaging infected patients.

Machine Learning Brings AI to COVID-19 Diagnostics

Advances in the use of AI in healthcare have led to the development of machine-learning algorithms that are being utilized as diagnostic tools for anatomic pathology, radiology, and for specific complex diseases, such as cancer. The Weill Cornell scientists wanted to see if alternative lab test results could be used by an algorithmic model to identify people infected with the SARS-CoV-2 coronavirus.

Sarina Yang, MD, PhD
“When patients come to the [emergency department] and the doctor orders several panels of routine lab [tests] and also the [SARS-CoV-2] RT-PCR test, generally the routine test results come back in a couple of hours,” Sarina Yang, MD, PhD (above), one of the authors of the study, told Modern Healthcare. “So, we thought it could be useful to use the routine labs to predict whether the RT-PCR results would be positive or negative to improve the triage process.” Yang is an assistant professor in the Department of Pathology and Laboratory Medicine, and Assistant Director of the central laboratory and Director of the toxicology laboratory at Weill Cornell Medicine. (Photo copyright: Weill Cornell Medicine.)

To perform the research, the team incorporated patients’ age, sex, and race, into a machine learning model that was based on results from 27 routine lab tests chosen from a total of 685 different tests ordered for the patients. The study included 3,356 patients who were tested for SARS-CoV-2 at New York-Presbyterian Hospital/Weill Cornell Medical Center between March 11 and April 29 of this year. The patients ranged in ages from 18 to 101 with the mean age being 56.4 years. Of those patients, 1,402 were RT-PCR positive and the remaining 1,954 were RT-PCR negative.  

Using a machine-learning technique known as a gradient-boosting decision tree, the algorithm identified SARS-CoV-2 infections with 76% sensitivity and 81% specificity. When looking at only emergency department (ED) patients, the model performed even better with 80% sensitivity and 83% specificity. ED patients comprised just over half (54%) of the patients used for the study. 

Weill Cornell Medicine Algorithm Could Lower False Negative Test Results

The algorithm also correctly identified patients who originally tested negative for COVID-19, but who tested positive for the coronavirus upon retesting within two days. According to the researchers, these results indicated their model could potentially decrease the amount of incorrect test results.

“We are thinking that those potentially false negative patients may demonstrate a different routine lab test profile that might be more similar to those that test positive,” Fei Wang, PhD, Assistant Professor of Healthcare Policy and Research at Weill Cornell Medicine and the study’s senior author, told Modern Healthcare. “So, it offers us a chance to capture those patients who are false negatives.”

The researchers validated their model by comparing the results with patients seen at New York Presbyterian Hospital/Lower Manhattan Hospital during the same time period. Among those patients, 496 were RT-PCR positive and 968 were negative and the algorithmic model performed with 74% specificity and 76% sensitivity. 

In their study, published in the Oxford Academic journal Clinical Chemistry, titled, “Routine Laboratory Blood Tests Predict SARS-CoV-2 Infection Using Machine Learning,” the Weill Cornell Medicine scientists concluded that their research illustrated the algorithm could:

  • preliminarily identify high-risk SARS-CoV-2 infected patients before RT-PCR results are available,
  • risk stratify patients in the ED,
  • select patients who need relatively urgent retesting if initial RT-PCR results are negative,
  • help isolate infected patients earlier, and
  • assist in the identification of SARS-CoV-2 infected patients in areas where RT-PCR testing is unavailable due to financial or supply constraints.

Early Results of Study Promising, But More Research is Needed

Wang noted that more research is needed on the algorithm and that he and his colleagues are currently working on ways to improve the model. They are hoping to test it with different conditions and geographies.

“Our model in the paper was built on data from when New York was at its COVID peak,” he told Modern Healthcare. “At that time, we were not doing wide PCR testing, and the patients who were getting tested were pretty sick.”

At the time of the study, the positivity rate for COVID-19 at New York-Presbyterian Hospital was in the 40% to 50% range. That was substantially higher than the current positivity rate, which is in the 2% to 3% range, Modern Healthcare reported.

“This model we built in a population in New York in a certain time period, so we can’t guarantee that it will work well universally,” Wang told Modern Healthcare.

It’s exciting to think that advances in software algorithms may one day make it possible to combine routine clinical laboratory testing and create diagnostics that identify diseases in ways the individual tests were not originally designed to do.

This study is an example that researchers in AI and informatics are working to bring new tools and diagnostic capabilities to clinical laboratories. Also, this is a demonstration of how a patient’s results from multiple other types of lab tests can by analyzed using AI and similar analytical algorithms to diagnose a health condition unrelated to the original reasons for performing those tests.

If this can be demonstrated with other diseases and health conditions, it would open up one more way that pathologists and clinical laboratory scientists can contribute to more accurate diagnoses and improved selection of the most appropriate therapies for individual patients.

—JP Schlingman

Related Information:

Routine Lab Tests Could Help Identify COVID-19 Patients

Routine Laboratory Blood Tests Predict SARS-CoV-2 Infection Using Machine Learning

Mobile Device Software Companies Are Developing Smartphone Apps That Use Artificial Intelligence to Test for COVID-19, Potentially Bypassing the Clinical Laboratory Altogether

Florida Hospital Utilizes Machine Learning Artificial Intelligence Platform to Reduce Clinical Variation in Its Healthcare, with Implications for Medical Laboratories

Apple Updates Its Mobile Health Apps, While Microsoft Shifts Its Focus to Artificial Intelligence. Both Will Transform Healthcare, But Which Will Impact Clinical Laboratories the Most?

February COVID-19 Superspreader Event in Boston Confirmed by Use of Genetic Sequencing as Next-Gen Sequencing Is Put to Novel Uses, including in Clinical Laboratories

Gene sequencing is enabling disease tracking in new ways that include retesting laboratory specimens from before the SARS-CoV-2 outbreak to determine when it arrived in the US

On February 26 of this year, nearly 200 executives and employees of neuroscience-biotechnology company Biogen gathered at the Boston Marriott Long Wharf hotel for their annual leadership conference. Unbeknownst to the attendees, by the end of the following day, dozens of them had been exposed to and become infected by SARS-CoV-2, the coronavirus that causes the COVID-19 illness.

Researchers now have hard evidence that attendees at this meeting returned to their communities and spread the infection. The findings of this study will be relevant to pathologists and clinical laboratory managers who are cooperating with health authorities in their communities to identify infected individuals and track the spread of the novel coronavirus.

This “superspreader” event has been closely investigated and has led to intriguing conclusions concerning the use of genetic sequencing to revealed vital information about the COVID-19 pandemic. Recent improvements in gene sequencing technology is giving scientists new ways to trace the spread of COVID-19 and other diseases, as well as a method for monitoring mutations and speeding research into various treatments and vaccines. 

Genetic Sequencing Traces an Outbreak

“With genetic data, a record of our poor decisions is being captured in a whole new way,” Bronwyn MacInnis, PhD, Director of Pathogen Genomic Surveillance at the Broad Institute of MIT and Harvard, told The Washington Post (WaPo) during its analysis of the COVID-19 superspreading event. MacInnis is one of many Broad Institute, Harvard, MIT, and state of Massachusetts scientists who co-authored a study that detailed the coronavirus’ spread across Boston, including from the Biogen conference.

Titled, “Phylogenetic Analysis of SARS-CoV-2 in the Boston Area Highlights the Role of Recurrent Importation and Superspreading Events,” the paper explains how the researchers “sequenced and analyzed 772 complete SARS-CoV-2 genomes from the region” in order to investigate how the virus was introduced and spread through the area. They traced a specific mutation in the virus—“a simple switch of two letters in the virus’ 30,000-character genetic code,” WaPo reported.

What they discovered is both surprising and enlightening. According to WaPo’s report, at least 35 new cases of the virus were linked directly to the Biogen conference, and the same strain was discovered in outbreaks in two homeless shelters in Boston, where 122 people were infected. The variant tracked by the Boston researchers was found in roughly 30% of the cases that have been sequenced in the state, as well as in Alaska, Senegal, and Luxembourg.

“The data reveal over 80 introductions into the Boston area, predominantly from elsewhere in the United States and Europe. We studied two superspreading events covered by the data, events that led to very different outcomes because of the timing and populations involved. One produced rapid spread in a vulnerable population but little onward transmission, while the other was a major contributor to sustained community transmission,” the researchers noted in their study abstract.

“The same two events differed significantly in the number of new mutations seen, raising the possibility that SARS-CoV-2 superspreading might encompass disparate transmission dynamics. Our results highlight the failure of measures to prevent importation into [Massachusetts] early in the outbreak, underscore the role of superspreading in amplifying an outbreak in a major urban area, and lay a foundation for contact tracing informed by genetic data,” they concluded.

Anthony Fauci, MD
Some experts think humankind may be entering a period of increased pandemics. In their report published in Cell, titled, “Emerging Pandemic Diseases: How We Got to COVID-19,” Anthony Fauci, MD (above) Director of the National Institute of Allergy and Infectious Diseases (NIAID), and David Morens, MD, a senior associate professor at Johns Hopkins School of Public Health and Senior Advisor to Fauci, wrote, “One can conclude from this recent experience that we have entered a pandemic era. The causes of this new and dangerous situation are multifaceted, complex, and deserving of serious examination.” (Photo copyright: NIAID.)

Genetic Sequencing and Mutation Tracking

The use of genetic sequencing to trace the virus could inform measures to control the spread in new ways, but currently, only about 0.33% of cases in the United States are being sequenced, MacInnis told WaPo, and that not sequencing samples is “throwing away the crown jewels of what you really want to know.”

Another role that genetic sequencing is playing in this pandemic is in tracking viral mutations. One of the ways that pandemics worsen is when viruses mutate to become deadlier or more easily spread. Scientists are using genetic sequencing to monitor SARS-CoV-2 for such mutations.

A group of scientists at Texas A&M University led by Yue Xing, PhD, published a paper titled, “MicroGMT: A Mutation Tracker for SARS-CoV-2 and Other Microbial Genome Sequences,” which explains that “Although most mutations are expected to be selectively neural, it is important to monitor if SARS-CoV-2 will eventually evolve to be a stronger or weaker infectious agent as time goes on. Therefore, it is vital to track mutations from newly sequenced SARS-CoV-2 genome.”

Another group of researchers have identified such a mutation. “A SARS-CoV-2 variant carrying the Spike protein amino acid change D614G has become the most prevalent form in the global pandemic. Dynamic tracking of variant frequencies revealed a recurrent pattern of G614 increase at multiple geographic levels: national, regional, and municipal,” Bette Korber, PhD and her colleagues wrote in “Tracking Changes in SARS-CoV-2 Spike: Evidence That D614G Increases Infectivity of the COVID-19 Virus,” published in Cell. Korber is a Laboratory Fellow at Los Alamos National Laboratory and visiting faculty at Santa Fe Institute.

Korber’s findings are important because the mutation the scientists identified appears to have a fitness advantage. “Our data show that, over the course of one month, the variant carrying the D614G Spike mutation became the globally dominant form of SARS-CoV-2,” they wrote. Additionally, the study noted, people infected with the mutated variant appear to have a higher viral load in their upper respiratory tracts.

Genetic Sequencing, the Race for Treatments, Vaccines, and Managing Future Pandemics

A vaccine is the best hope for stopping a pandemic, but short of a vaccine, an effective clinical laboratory treatment is the next best thing. And as Dark Daily reported in “Advances in Gene Sequencing Technology Enable Scientists to Respond to the Novel Coronavirus Outbreak in Record Time with Medical Lab Tests, Therapies,” genetic sequencing is quickly becoming a critical tool to develop both.

If, as Fauci and Morens predict, future pandemics are likely, improvements in gene sequencing and analysis will become even more important for tracing, monitoring, and suppressing outbreaks. Clinical laboratory managers will want to watch this closely, as medical labs that process genetic sequencing will, no doubt, be part of that operation.

—Dava Stewart

Related Information:

Genetic Data Show How a Single Superspreading Event Sent Coronavirus Across Massachusetts and the Nation

How the Biogen Leadership Conference in Boston Spread the Coronavirus

How a Premier U.S. Drug Company Became a Virus ‘Super Spreader’

This Cambridge Drug Company Inadvertently Spread the Coronavirus. Now, It’s Creating A ‘Biobank’ To Hopefully Treat the Disease

Phylogenetic Analysis of SARS-CoV-2 in the Boston Area Highlights the Role of Recurrent Importation and Superspreading Events

MicroGMT: A Mutation Tracker for SARS-CoV-2 and Other Microbial Genome Sequences

Tracking Changes in SARS-CoV-2 Spike: Evidence That D614G Increases Infectivity of the COVID-19 Virus

The D614G Mutation in the SARS-CoV-2 Spike Protein Reduces S1 Shedding and Increases Infectivity

Emerging Pandemic Diseases: How We Got to COVID-19 Advances in Gene Sequencing Technology Enable Scientists to Respond to the Novel Coronavirus Outbreak in Record Time with Medical Lab Tests, Therapies

Canada’s Early Response to COVID-19 Garnered Praise, But Critical Shortages of Clinical Lab Tests and Delays in Test Results Brought Criticism of the Government’s Actions. Sound Familiar?

Though coronavirus infections were detected nearly simultaneously in both Canada and the US, total cases and total deaths vary dramatically leading experts to question how differences in healthcare systems might have contributed

Can clinical laboratories in the United States learn from Canada’s response to the COVID-19 pandemic? While our northern neighbor won praise for its early response to the coronavirus, since then Canada has faced criticism over a lack of access to SARS-CoV-2 testing and long wait times for test results—criticism levied at the United States’ response to the outbreak as well.

In “Canada Shows How Easy Virus Testing Can Be,” Foreign Policy reported that Canada was more prepared to mount a successful response to COVID-19 because it systematically improved its pandemic-response preparedness and testing capacity after the 2003 SARS coronavirus (SARS-CoV-1) outbreak.

“Provincial laboratories put the infrastructure in place that would allow them to run their own testing and validation without help from the federal government,” Foreign Policy wrote. “At the same time, the federally run National Microbiology Laboratory in Winnipeg expanded its own capacity to support those efforts.”

However, Canada’s pandemic response has not been criticism free. In “Health Minister Says Test Result Wait Times ‘Not Acceptable’ As Ontario Confirms 25 New COVID-19 Cases,” CBC News reported in late March about COVID-19 testing shortages and four-day wait times for test results that were “not acceptable,” particularly in Ontario, where people with mild symptoms were being refused testing and sent home unless they worked in high-risk settings.

In “Why It’s So Difficult to Get Tested for COVID-19 in Canada,” CBC News suggested that Canada’s test rationing was due to a laboratory-supply shortage, a problem which The New York Timesreports still has not been overcome in the US more than six months into the pandemic.

Government Bureaucracy’s Effect on Response to COVID-19

In “Canada’s Coronavirus Response Has Not Been Perfect. But It’s Done Far Better than the US,” The Washington Post reported that the initial exposure to the virus by the US and Canada was similar. Both the US and Canada have extensive ties to Europe and China, resulting in the two countries identifying their first cases of COVID-19 within a week of one another in January. Since then, however, the progression of the disease diverged dramatically in the two nations.

To date, the US has experienced 7,361,611 total cases with 209,808 total deaths, placing it in the number one spot globally on Worldometers’ COVID-19 tracking site. By contrast, Canada is in 26th place, with 155,301 total cases and 9,278 total deaths. However, to date the US has conducted 105,401,706 total clinical laboratory tests, as opposed to Canada’s 7,220,108 total tests. This might account for the disparity in total cases, but what accounts for the huge difference in total US deaths due to COVID-19 compared to Canada?

A Fraser Institute blog post authored by Steven Globerman, PhD, Resident Scholar and Addington Chair in Measurement at the Institute and Professor Emeritus at Western Washington University, titled, “US COVID Experience Highlights Risks of Centralized Management of Healthcare,” blamed the US’ “top-down, centralized approach to testing” for the “testing fiasco” that marked the US’ initial slow response to the pandemic. Globerman maintained the Centers for Disease Control and Prevention’s insistence on producing its own COVID-19 diagnostic test, rather than using a proven German-produced test, was the first of several missteps by the US.

Steven Globerman, PhD
“While there has been much criticism of the decentralized private insurance industry in the US, the major shortcomings in testing that characterize the US experience during the current pandemic seem to be the result of the government healthcare bureaucracy,” wrote Steven Globerman, PhD, (above), Resident Scholar and Addington Chair in Measurement at the Fraser Institute and Professor Emeritus at Western Washington University. (Photo copyright: Fraser Institute.)

Globerman also noted the problems were compounded by the US government’s low initial Medicare payments to private laboratories for COVID-19 tests. “Medicare is reputed to have paid about half the price it pays for a flu test, even though the coronavirus test is substantially more expensive to produce. The price forced labs to take losses on the test, blocking many labs from scaling up production to expand the nation’s testing capacity.

“Only after major lab organizations made public pleas for increased Medicare reimbursement, and long backlogs emerged for testing and reporting test results, did Medicare agree to double its payments for coronavirus tests,” Globerman wrote.

Could National Differences in Healthcare Systems Be to Blame for Disparate COVID-19 Outcomes?

In “Canada Succeeded on Coronavirus Where America Failed. Why?” Canadian public health experts told Vox differences in the two countries’ political leadership, public health funding, and healthcare systems are to blame for the US experiencing a worse coronavirus outbreak than Canada.

Is that true? Sally C. Pipes, CEO, and Thomas W. Smith Fellow in Health Care Policy at the Pacific Research Institute, a former resident of Canada and an ardent critic of single-payer healthcare, argued that Canada’s healthcare system is plagued by long waits for elective procedures, equipment shortages, and limited access to cutting-edge drugs and therapies.

In “The Canadian Health-Care Scare,” Pipes wrote, “Our northern neighbors wait months for routine care and lack access to the latest life-saving medications and technology. Importing this system would lead to widespread misery,” adding, “Is a six-month wait for a knee replacement—the median in Canada last year—reasonable, when it keeps someone in pain and unable to work? One study puts the total cost of waiting for joint-replacement surgery after taking into account lost wages and additional tests and scans at almost $20,000. It’s no wonder that more than 323,000 Canadians left the country to seek care abroad in 2017.”

A Fraser Institute study of wait times in Canada for medically-necessary treatments underscores Pipes’ claims. According to the study, the median wait time—from general practitioner referral to treatment—across 12 medical specialties was 20.9 weeks in 2019, the second highest recorded by the Institute. If this is the case, how did Canada earn praise for its early COVID-19 response?

It’s unclear what lessons American clinical laboratories can glean from Canada’s response to COVID-19. Nevertheless, lab managers should closely watch their counterparts in other nations around the world. The coronavirus does not respect borders or care about disparities in healthcare systems.

—Andrea Downing Peck

Related Information:

The Canadian Health-Care Scare

Waiting Your Turn: Waiting Times for Healthcare in Canada, 2019 Report

Worldometers COVID-19 Coronavirus Pandemic Tracking

Canada Succeeded on Coronavirus Where America Failed. Why?

Coronavirus Test Results Are Still Delayed

U.S. Doctor in Canada: Medicare for All would Have Made America’s COVID Response Much Better

Canada’s Coronavirus Response Has Not Been Perfect. But It’s Done Far Better than the U.S.

Why It’s so Difficult to Get Tested for COVID-19 in Canada

Health Minister Says Test Result Wait Times ‘Not Acceptable’ as Ontario Confirms 25 New COVID-19 Cases

Canada Shows How Easy Virus Testing Can Be

Clinical Laboratories in Hospitals Continue to Experience Reductions in Test Orders as Emergency Department Visits for Common Conditions Slowly Climb Back to Pre-Pandemic Levels

Multiple recent studies reveal a substantial number of patients continue to delay needed healthcare in the months since the onset of the SARS-CoV-2 outbreak

Based on an analysis of hospital emergency department (ED) usage, federal researchers concluded that patients continue to be cautious when visiting healthcare providers, including clinical laboratories, and that people are altering how they seek and utilize emergency care due to the COVID-19 pandemic. This not only reduces the number of typical test orders from the ER to the hospital lab, but also reduces the source of inpatient admissions.

The study, titled, “Impact of the COVID-19 Pandemic on Emergency Department Visits—United States, January 1, 2019–May 30, 2020,” found that ED visits declined 42% during the early stages of the COVID-19 pandemic. It was conducted by the federal Center for Disease Control and Prevention’s National Syndromic Surveillance Program (NSSP) and published in the CDC’s Morbidity and Mortality Weekly Report (MMWR).

Between March 29 and April 25 of this year, facilities the CDC examined recorded 1.2 million visits to EDs, compared to 2.1 million visits between March 31 and April 27 of last year. The steepest decrease in patient demographics was for individuals under the age of 14, women, and people living in the Northeast region.

The CDC’s data showed that 12% of ED visits were for children in pre-pandemic 2019, which dropped to 6% during the 2020 pandemic period. The CDC included ED visits from hospitals in 47 states (excluding Hawaii, South Dakota, and Wyoming) and captured information from approximately 73% of ED visits in the US.

Delaying Healthcare Visits Worsens Medical Conditions, Reduces Revenues

ED visits are an important referral source for inpatient admissions. Fewer patients in EDs means lost revenue for hospitals. However, one positive aspect of the waning number of ED visits is that it may be keeping patients with non-emergency situations away from emergency departments, thus reducing the overuse of costly ED visits. But healthcare professionals are concerned that individuals also may be avoiding or delaying care when needed, which could worsen medical situations and outcomes. 

“We saw people, with COVID-19 and without, coming into the ED who were very ill,” Vik Reddy, MD, Chief Medical Officer at Wellstar Kennestone Hospital and Wellstar Windy Hill Hospital in the Atlanta area, told Modern Healthcare. He noted that some patients delayed care for critical non-COVID-19 illnesses. “The good news is that we’re seeing that trend reverse this time around. It was scary in March when we knew that people weren’t coming into the ED for heart attacks.”

The NSSP’s analysis concluded that the report’s findings were subject to at least four limitations:

  • The number of hospitals reporting to NSSP changes over time as facilities are added or closed. For example, 3,173 hospitals reported data in April of 2019, while 3,467 reported data in April 2020.
  • Diagnostic categories rely on the use of specific codes, which were missing in 20% of the ED visits reported.
  • NSSP coverage is not uniform across or within all the participating states.
  • The analysis is limited only to ED visits and does not take into account patients who did not go to an ED, but instead received treatment in other healthcare environments, such as urgent care clinics. 
Map analysis of smartphone location data of hospital traffic in 2020
The graphics above are taken from a Washington Post article which reported that the newspaper’s analysis of smartphone location data of hospital traffic in 2020 showed the “drop” in hospital usage had turned into “a crash,” compared to the same two months last year, and that, “As in many other industries, those lost visits represented a widespread financial crisis for hospitals and other healthcare providers, even in places the novel coronavirus hardly touched.” (Graphics copyright: The Washington Post.)

Additional Studies Show Patients Avoiding Hospital EDs, Delaying Care

Other sources also are reporting similar findings regarding consumer attitudes towards seeking medical care during the COVID-19 pandemic. A PricewaterhouseCoopers survey released in May found that about 45% of 2,500 consumers surveyed plan to forgo their annual physical in 2020, due to the pandemic, Modern Healthcare reported.

In addition, an Optum Consumer Pulse Survey released in May found that nearly 20% of 700 surveyed individuals stated they were likely to avoid hospital EDs even if they were showing signs of a heart attack or appendicitis. Another 40% stated they were likely to avoid the ED if they had a cut that required stitches.

In “Americans Are Delaying Medical Care, and It’s Devastating Health-Care Providers,” The Washington Post analyzed hospital use during the pandemic based on smartphone tracking data. WaPo’s report found a significant drop in patients seeking in-person healthcare with many areas across the country reporting a 50% reduction in patients when compared to last year.

The article also states that almost 94 million people have delayed medical care due to the COVID-19 pandemic, and that 66 million of those individuals needed medical care unrelated to the virus but did not receive it.

These studies and others are showing a pattern. The COVID-19 pandemic has changed when and where patients access healthcare, and if the trend continues, it could have a long-term impact on clinical laboratories. Since fewer people are seeking medical care, fewer laboratory tests are being ordered and performed, which means less work and revenue for the nations’ hospital and independent clinical labs.

—JP Schlingman

Related Information:

Emergency Department Visits Continue to Lag

Impact of the COVID-19 Pandemic on Emergency Department Visits—United States, January 1, 2019-May 30, 2020

COVID-19 Caused Hospital ED Visits to Dive More than 40%

Learning from the Decrease in US Emergency Department Visits in Response to the Coronavirus Disease 2019 Pandemic

With Emergency Visits Down 42%, US Hospitals Reeling from COVID-19

Trends in Emergency Department Visits and Hospital Admissions in Health Care Systems in 5 States in the First Months of the COVID-19 Pandemic in the US

How Patients Feel About Returning to Care

Americans are Delaying Medical Care, and It’s Devastating Healthcare Providers

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