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Guidehouse Healthcare Experts Outline Six Ways COVID-19 Pandemic Is Accelerating Healthcare Transformation

Financial losses for hospitals and health systems due to cancelled procedures and coronavirus expenses will lead to changes in healthcare delivery, operations, and clinical laboratory test ordering

COVID-19 is reshaping how people work, shop, and go to school. Is healthcare the next target of the coronavirus-induced transformation? According to two experts, the COVID-19 pandemic is pushing hospitals and health systems toward a “fundamental and likely sustained transformation,” which means clinical laboratories must be prepared to adapt to new provider needs and customer demands.

In “Industry Voices—6 Ways the Pandemic Will Remake Health Systems,” published in Fierce Healthcare, authors David Burik, Partner, and Brian Fisher, Director, at Guidehouse (formerly Navigant Consulting and a “portfolio company of Veritas Capital”), stated that COVID-19 has wreaked havoc with the finances of America’s hospitals and healthcare systems.

Burik and Fisher called attention to the staggering $50 billion-per-month loss for hospitals and health systems that was first revealed in an American Hospital Association (AHA) report published in May. The AHA report estimated a $200 billion loss from March 1, 2020, to June 30, 2020, due to increased COVID-19 expenses and cancelled elective and non-elective surgeries.

Adding to the financial carnage is the expectation that patient volumes will be slow to return. In “Hospitals Forecast Declining Revenues and Elective Procedure Volumes, Telehealth Adoption Struggles Due to COVID-19,” Burik said, “Healthcare has largely been insulated from previous economic disruptions, with capital spending more acutely affected than operations. But this time may be different since the COVID-19 crisis started with a one-time significant impact on operations that is not fully covered by federal funding.

“Providers face a long-term decrease in commercial payment, coupled with a need to boost caregiver and consumer-facing digital engagement, all during the highest unemployment rate the US has seen since the Great Depression,” he continued. “For organizations in certain locations, it may seem like business as usual. For many others, these issues and greater competition will demand more significant, material change.”

A Guidehouse analysis of a Healthcare Financial Management Association (HFMA) survey, suggests one-in-three provider executives expect to end 2020 with revenues at 15% below pre-pandemic levels, while one-in-five of them anticipate a 30% or greater drop in revenues. Government aid, Guidehouse noted, is likely to cover COVID-19-related costs for only 11% of survey respondents.

“The figures illustrate how the virus has hurled American medicine into unparalleled volatility. No one knows how long patients will continue to avoid getting elective care or how state restrictions and climbing unemployment will affect their decision making once they have the option,” Burik and Fisher wrote. “All of which leaves one thing for certain: Healthcare’s delivery, operations, and competitive dynamics are poised to undergo a fundamental and likely sustained transformation.”

As a result, the two experts predict these pandemic-related changes to emerge:

  • Payer-Provider Complexity on the Rise; Patients Will Struggle. As the pandemic has shown, elective services are key revenues for hospitals and health systems. But the pandemic also will leave insured patients struggling with high deductibles, while the number of newly uninsured will grow. Furthermore, upholding of the hospital price transparency ruling will add an unwelcomed spotlight on healthcare pricing and provider margins.
  • Best-in-Class Technology Will Be a Necessity, Not a Luxury. COVID-19 has been a boon for telehealth and digital health usage, creating what is likely to be a permanent expansion of virtual healthcare delivery. But only one-third of executives surveyed say their organizations currently have the infrastructure to support such a shift, which means investments in speech recognition software, patient information pop-up screens, and other infrastructure to smooth workflows will be needed.
Chuck Peck, MD
“Through all the uncertainty COVID-19 has presented, one thing hospitals and health systems can be certain of is their business models will not return to what they were pre-pandemic,” Guidehouse Partner Chuck Peck, MD (above), a former health system CEO, said in a statement. “A comprehensive consumer-facing digital strategy built around telehealth will be a requirement for providers. Moreover, shifting hardware and physical assets to the cloud, and use of robotic process automation, has proven to be successful in improving back-office operations in other industries. Providers will need to follow suit.” Clinical laboratories and anatomic pathology groups should track these developments and respond appropriately to meet the changing needs of the hospitals and physicians they serve with diagnostic testing services. (Photo copyright: Athens Banner-Herald.)
  • The Tech Giants Are Coming. Both major retailers and technology stalwarts, such as Amazon, Walmart, and Walgreens, are entering the healthcare space. In January, Dark Daily reported on Amazon’s roll out of Amazon Care, a 24/7 virtual clinic, for its Seattle-based employees. Amazon (NASDAQ:AMZN) is adding to a healthcare portfolio that includes online pharmacy PillPack and joint-venture Haven Healthcare. Meanwhile, Walmart is offering $25 teeth cleaning and $30 checkups at its new Health Centers. Dark Daily covered this in an e-briefing in May, which also covered a new partnership between Walgreens and VillageMD to open up to 700 primary care clinics in 30 US cities in the next five years.
  • Work Location Changes Mean Construction Cost Reductions. According to Guidehouse’s analysis of the HFMA COVID-19 survey, one-in-five executives expect some jobs to remain virtual post-pandemic, leading to permanent changes in the amount of real estate needed for healthcare delivery. The need for a smaller real estate footprint could reduce capital expenditures and costs for hospitals and healthcare systems in the long term.
  • Consolidation is Coming. COVID-19-induced financial pressures will quickly reveal winners and losers and force further consolidation in the healthcare industry. “Resilient” healthcare systems are likely to be those with a 6% to 8% operating margins, providing the financial cushion necessary to innovate and reimagine healthcare post-pandemic.
  • Policy Will Get More Thoughtful and Data-Driven. COVID-19 reopening plans will force policymakers to craft thoughtful, data-driven approaches that will necessitate engagement with health system leaders. Such collaborations will be important not only during this current crisis, but also will provide a blueprint for policy coordination during any future pandemic.

As Burik and Fisher point out, hospitals and healthcare systems emerged from previous economic downturns mostly unscathed. However, the COVID-19 pandemic has proven the exception, leaving providers and health systems facing long-term decreases in commercial payments, while facing increased spending to bolster caregiver- and consumer-facing engagement.

“While situations may differ by market, it’s clear that the pre-pandemic status quo won’t work for most hospitals or health systems,” they wrote.

The message for clinical laboratory managers and surgical pathologists is clear. Patients may be permanently changing their decision-making process when considering elective surgery and selecting a provider, which will alter provider test ordering and lab revenues. Independent clinical laboratories, as well as medical labs operated by hospitals and health systems, must be prepared for the financial stresses that are likely coming.

—Andrea Downing Peck

Related Information:

Industry Voices–6 Ways the Pandemic Will Remake Health Systems

Amazon Care, the Company’s Virtual Medical Clinic, Is Now Live for Seattle Employees

Checkup for $30, Teeth Cleaning $25: Walmart Gets into Health Care

Walgreens and VillageMD to Open 500 to 700 Full-Service Doctor Offices within Next Five Years in a Major Industry First

New AHA Report Finds Financial Impact of COVID-19 on Hospitals and Health Systems to be Over $200 Billion through June

Hospitals Forecast Declining Revenues and Elective Procedure Volumes, Telehealth Adoption Struggles Die to COVID-19

Amazon Care Pilot Program Offers Virtual Primary Care to Seattle Employees; Features Both Telehealth and In-home Care Services That Include Clinical Laboratory Testing

Walmart Opens Second Health Center Offering Clinical Laboratory Tests and Primary Care Services

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.

Where Did all the Antibodies Go? Emory University’s Vaccine Center Studies Bone Marrow to Find Out Why Influenza Vaccines are Short-Lived

Pathologists and clinical laboratory scientists know that influenza vaccines typically produce short-lived protection and researchers have new clues as to why this is true

With so much interest in development of a COVID-19 vaccine, findings by researchers at Atlanta’s Emory Vaccine Center into why the vaccine for influenza (Flu) is so short-lived offer a new window on how the body’s immune system responds to invading viruses and what happens to the immunity over time.

Because the autumn influenza season is just weeks away, these insights into the body’s immune response to influenza will be of interest to clinical laboratories that provide testing for influenza, as well as SARS-CoV-2, the coronavirus that causes COVID-19.

Clinical laboratory managers recognize that an influenza vaccine is an annual imperative for people—especially the elderly and those with existing comorbidities—and medical laboratory tests are typically used to diagnose the illness and identify which strains of viruses are present. The flu vaccine is even more important amid the COVID-19 pandemic, infectious disease authorities say.

The scientists at the Emory Vaccine Center published their findings in the journal Science.  

How Does Influenza Differ from Other Viruses?

Vaccines for some viruses, such as Hepatitis A, Hepatitis B, and the human papillomavirus, may be taken only one time, but the immunity can last a lifetime.  

Not so with influenza vaccines. The immunity they impart generally only lasts for a single flu season and are “lost within one year,” the Emory study notes.

As Genetic Engineering and Biotechnology News (GEN) explains, the influenza genome has eight RNA segments which can change as the virus enters a cell. This antigenic shift creates new influenza strains that require updated vaccines, GEN noted.

However, the Emory researchers stated that “The fact that a small number did persist over one year raises prospects that the longevity of flu vaccines can be improved and provides key information for the development of universal vaccines against influenza.”

Bone Marrow Has Major Role in Producing New Flu Antibodies

The Emory study focused on the influenza vaccine’s role in how it affects the immune system and what needs to change to create a longer-lasting influenza vaccine. “Our results suggest that most bone marrow plasma cells (BMPC) generated by influenza vaccination in adults are short-lived. Designing strategies to enhance their persistence will be key,” the Emory researchers wrote in Science.

The scientists analyzed bone marrow from 53 healthy volunteers (age 20 to 45). An Emory news release states that bone marrow is the “home base for immune cells producing antibodies.”

Besides the bone marrow, the researchers also examined blood samples from the volunteers, all of which was collected between 2009 and 2018:

  • before influenza vaccination,
  • one month after influenza vaccination, and
  • one year post vaccination.

Through DNA sequencing the samples, the Emory researchers found the number of flu-specific cells increased from 0.8% to 1.9% after one month. They concluded that an annual vaccine does increase antibody-producing cells for influenza in bone marrow.

However, in follow-up visits one year after vaccination, they found that the number of cells present in the volunteers had fallen back to the starting point.

“Specific cells produced by the vaccine … produced unique antibodies that can be identified using sequencing techniques,” Carl Davis, PhD, postdoctoral fellow in the Rafi Ahmed Laboratory at Emory and first author of the paper, said in the news release, adding, “We could see that these new antibodies expanded in the bone marrow one month after vaccination and then contracted after one year.”

He continued, “On the other hand, antibodies against influenza that were in the bone marrow before the vaccine was given stayed at a constant level over one year.”

Vaccine Adjuvants Help Boost Immunity

A vaccine additive called an adjuvant could be the answer to extending the power of  influenza vaccines, the Emory scientists noted.

“Just getting to the bone marrow is not enough. A plasma cell has to find a niche within the bone marrow and establish itself there and undergo gene expression and metabolism changes that promote longevity,” Rafi Ahmed, PhD, Director of the Emory Vaccine Center, said in the news release.

Adjuvants could boost BMPC, because they act as “irritants” to beef up immune response, an article in Science titled, “Why Flu Vaccines Don’t Protect People for Long,” explained.

“It’s totally crazy (that the most commonly used influenza vaccines don’t include an adjuvant), Ahmed told Science. “I’m hoping that things will change in the influenza vaccine world, and 10 years from now, you will not be getting any nonadjuvanted vaccines.” 

Adjuvants used in vaccine studies for the SARS-CoV-1 coronavirus could be useful in developing vaccines for the SARS-CoV-2
Taken from the published study, “Potential Adjuvants for the Development of a SARS-CoV-2 Vaccine Based on Experimental Results from Similar Coronaviruses,” the graphic above shows adjuvants used in vaccine studies for the SARS-CoV-1 coronavirus could be useful in developing vaccines for the SARS-CoV-2 coronavirus as well. (Graphic copyright: Immunopharmacology/Elsevier.)

Are Adjuvants the Answer for COVID-19 Vaccines?

According to USA Today, about 20-million “essential” workers will likely be the first to receive the new COVID-19 vaccine and participate in check-in text messages with the Centers for Disease Control and Prevention (CDC) by the end of 2020.

In its COVID-19 vaccine testing, Novavax, a late-state biotechnology company, suggests that “an adjuvant is critical to its vaccine working well,” National Public Radio (NPR) reported in “The Special Sauce That Makes Some Vaccines Work.” However, vaccine developers may be reluctant to share their adjuvant research.

“Adjuvants end up being very proprietary. It’s kind of the secret sauce on how to make your protein vaccine work,” Barney Graham, MD, PhD, Deputy Director, Vaccine Research Center, National Institute of Allergy and Infectious Diseases, told NPR.

Still, a study published in Immunopharmacology revealed potential adjuvants for the COVID-19 vaccine based on vaccine studies of other coronaviruses. While there are many adjuvants available, not all have safety track records that can be leveraged to gain clearance from regulatory bodies, the researchers pointed out. But some do.

CpG 1018, MF59, and AS03 are already approved for human vaccine and their inclusion may expedite the vaccine development process. Further, Protollin has shown promising results in pre-clinical studies,” the authors wrote.

Clinical laboratories that provide influenza testing will want to follow these types of research studies. Findings on immunity will affect development of vaccines that medical labs provide—including for COVID-19.

—Donna Marie Pocius

Related Information:

Why Flu Vaccine Immunity is Short-Lived

Influenza Vaccine-induced Human Bone Marrow Plasma Cells Decline Within a Year After Vaccination

Seasonal Flu Vaccinations Don’t “Stick” Long-Term in Bone Marrow

Why Flu Vaccines Don’t Protect People for Long

First COVID-19 Vaccine Recipients Get Daily CDC Check Texts

Administration Announces $200 Million From CDC to Jurisdictions for COVID-19 Vaccine Preparedness

All You Wanted to Know About the Coronavirus Vaccine Science but Were Afraid to Ask

Potential Adjuvants for the Development of a SARS-CoV-2 Vaccine Based on Experimental Results from Similar Coronaviruses

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?

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