Following a nearly two-year disruption due to the SARS-CoV-2 pandemic, pathologists and clinical laboratory professionals once again have an opportunity to gather and learn from each other
It is good news that the daily number of new cases of COVID-19 continue declining here in the United States. That fact, and the growing number of vaccinations, have encouraged state and federal officials to lift many restrictions on business and social activities.
Clinical laboratories are watching a big drop in the daily number of COVID-19 tests they perform, even as routine test volumes climb and more patients show up in doctors’ offices for the typical mix of ailments and health conditions.
It’s true that many familiar routines are back. But it is also true that things are not exactly the way they were pre-pandemic. And that’s the rub. Going forward, what should medical laboratory managers and pathologists expect to be the “post-pandemic normal” in how patients access care and how providers deliver clinical services? How will healthcare in this country be different from what it was pre-pandemic?
Preparing Clinical Lab Leaders for What Comes Next
These questions and more will be front and center when the Executive War College on Lab and Pathology Management returns on Nov. 2-3, 2021, at the Hyatt Riverwalk Hotel in San Antonio. The theme of this first live gathering since the spring of 2019 will be “Preparing Your Clinical Laboratory and Pathology Group for Post-Pandemic Success.”
“Today, lab managers have the interesting challenge of understanding the new opportunities they can use to advance their labs, both clinically and financially,” stated Robert L. Michel, Editor-in-Chief of Dark Daily and its sister publication The Dark Report, and founder of the Executive War College. “It isn’t that the pandemic changed healthcare in fundamental ways. Rather, it is that the pandemic accelerated changes that were underway before the outbreak began.
“That’s true of telehealth as well, for example,” he continued. “Once the nation was locked down, utilization of virtual physician visits and telehealth services skyrocketed. Today, national surveys confirm that as many as 50% of all patients and physicians have used a telehealth service, are comfortable with this type of appointment, and are ready to continue to use virtual office visits.
“Another trend accelerated by the pandemic is patient self-testing at home,” Michel added. “Government health officials saw the benefit of clearing for clinical use different specimen collection systems and COVID-19 test methods designed for use by consumers in the comfort of their home. Today, consumers can choose from multiple specimen collection products and SARS-CoV-2 tests designed for in-home use. Clinical laboratory managers should consider this development to be a consumer home-test baseline. Federal officials have created a regulatory pathway that will make it easier and faster for federal regulators to clear other types of diagnostic tests for consumer home use.”
What if the FDA Approves More Consumer At-Home Tests?
There are implications to each of the two trends described above. In the case of telehealth, if patients see their doctors virtually and the doctors order medical tests, how do clinical laboratories access these patients to collect the specimens needed to do this testing?
Similarly, if, in coming years, the federal Food and Drug Administration (FDA) increases the number of diagnostic test specimen-collection kits that consumers can use from home, how should local clinical laboratories position themselves to receive those kits and perform those tests?
These are two examples of important questions to be answered at sessions scheduled for the Executive War College in San Antonio on Nov. 2-3. Case studies by innovative lab leaders will address topics ranging from high-level strategy to daily management, operations, marketing, and managed care contracting.
Attendance Limited at This Fall’s Executive War College
At the first live edition of the Executive War College since May 2019, attendees will notice one significant difference from earlier years. By design, and for the safety and well-being of attendees, the number of attendees will be limited to 300. The hotel follows the Centers for Disease Control and Prevention (CDC) guidelines and is prepared to adjust those numbers as CDC guidance evolves. Thus, those interested in attending this year’s conference are advised to register early to guarantee their place and avoid being disappointed.
Suggestions for session topics and speakers are welcome and can be sent to info@darkreport.com. Conference details, session topics, and speakers will be updated regularly at www.executivewarcollege.com.
So, register today because seating is limited at the 2021 Executive War College Presents “Preparing Your Clinical Laboratory and Pathology Group for Post-Pandemic Success.” To ensure your place at this valuable conference, click HERE or place this URL (https://dark.regfox.com/2021-ewc-presents) into your browser.
Though pathology salaries rank 16th among 29 medical specialties, it is in the top 10 among specialties that attract women and respondents say that comes with a lot of paperwork
Despite “hardships” brought on by the COVID-19 pandemic, 18,000 physicians in more than 29 medical specialties who participated in Medscape’s 2021 Physician Compensation Report said that, overall, their 2020 income was similar to prior years. Pathologists reported earnings in 2020 of $316,000, $28,000 below the average specialist’s salary of $344,000.
The average pathologist’s salary ranked 16th among medical specialty salaries.
Compared to 2019, medical specialists on average made $2,000 less in 2020. The average salary for primary care doctors was $242,000 in 2020, down $1,000 from 2019, according to a Medscapenews release.
“Physicians experienced a challenging year on numerous fronts, including weathering the volatile financial impact of lockdowns,” said Leslie Kane, Senior Director, Medscape Business of Medicine, in the news release. “Our report shows that many were able to pivot to use telemedicine and focus on tactics that would protect their practices.”
Medscape, a health information provider that is part of the WebMD network, said that in addition to telehealth, doctors turned to MACRA (Medicare Access and CHIP Reauthorization Act of 2015) value-based payment reward programs and other strategies to minimize the effects of office closures last year.
Pathology Salary Unchanged
To complete its study, Medscape asked physicians to take a 10-minute online survey. The reported findings included responses from 17,903 physicians (61% male, 36% female) practicing in more than 29 specialties between October 2020 and February 2021.
Pathologists who participated in the survey reported no change in their annual salary since 2019. Other specialties that reported no salary change include:
Family medicine,
Infectious diseases,
Ophthalmology, and
Orthopedics/orthopedic surgery.
Top 10 Medical Specialty Salaries
Medscape’s report listed these top-10 medical specialties as earning the highest salaries (see the graphic below for the full list of medical specialties surveyed):
Contrary to what many specialists reported, plastic surgeons did not experience slowdowns in appointments during the COVID-19 pandemic. In fact, not only did plastic surgeons earn the most, at 10% they are the medical specialists who got the biggest increase in pay of previous years as well.
According to the American Academy of Facial Plastic and Reconstructive Surgery (AAFPRS), which conducted its own salary survey of its member surgeons, “70% of AAFPRS surgeons report an increase in bookings and treatments over the course of the COVID-19 pandemic, with nine in 10 facial plastic surgeons indicating an increase of more than 10%. Surgical procedures are the most common procedures as part of this upsurge, perhaps cancelling out any decreases that might have resulted from the economic crisis and lockdowns.”
Other specialist salaries which Medscape found increased in 2020 include:
Oncology: up 7%
Rheumatology and cardiology: up 5%
Diabetes/endocrinology: up 4%
Neurology, critical care, psychiatry: up 3%
General surgery, urology, public health/preventive medicine: up 2%
Medical specialties that reported reductions in salary included:
Otolaryngology and allergy/immunology: down 9%
Pediatrics and anesthesiology: down 5%
Dermatology: down 4%
Pulmonary medicine, physical medicine, gastroenterology, and radiology: down 3%
Emergency medicine and internal medicine: down 1%
About 92% of physicians surveyed indicated that the COVID-19 pandemic caused their income to decline. Also, 22% of doctors noted they experienced loss of work hours.
Pathologists Received Low Average Bonuses
Reporting on receipt of incentive bonuses, Medscape ranked pathology in the bottom half of its list with $42,000 as an average bonus. The top incentive bonuses went to those practicing:
Orthopedics/orthopedics surgery: $116,000
Ophthalmology: $87,000
Otolaryngology: $72,000
About 59% of primary care physicians and 55% of specialists surveyed reported receiving an incentive bonus.
Pathologists Rank High in Job Satisfaction
In responding to a question about compensation, pathologists ranked near the top (seventh position) with 64% saying they are content with their pay. Others expressing salary satisfaction included:
Oncology: 79%
Psychiatry: 69%
Plastic surgery: 68%
Dermatology: 67%
Public health/preventive medicine: 66%
Radiology: 65%
Pathology: 64%
Pathology Popular Among Women MDs
Medscape found that women MDs chose certain medical specialties more often than others, including pathology, which ranked eighth. The top eight specialties employing female physicians are:
Pediatrics: 61%
Obstetrics/gynecology: 59%
Diabetes/endocrinology: 50%
Family medicine: 47%
Dermatology: 46%
Infectious diseases: 46%
Internal medicine: 44%
Pathology: 43%
Specialties with the fewest female physicians are:
Plastic and general surgery: 20%
Cardiology: 14%
Urology: 11%
Orthopedics/orthopedics surgery: 9%
Pathology a Leader in Paperwork
Medscape also surveyed physicians as to the estimated hours they spend per week on paperwork and administration. Here, pathology ranked the fifth highest with 19%, while radiologists and hospital-based physicians were third from the bottom with 11.6%.
Specialists that reported the highest hours spent on paperwork include:
Amid a trying year, the Medscape survey respondents made an encouraging point: 78% of them said they would choose medicine as a career again. And 85% of pathologists said they would choose the same specialty.
Medscape’s report may be helpful to hospital-based clinical laboratory leaders preparing salary budgets and to pathologists in salary negotiations and determining professional responsibilities.
COVID-19 pandemic has elevated virtual care into the mainstream, creating opportunities to increase access to care, including clinical laboratory testing, and drive down healthcare costs
As the COVID-19 pandemic fuels demand for virtual healthcare, Cigna is acquiring telehealth provider MDLIVE in a move that may indicate the insurance giant anticipates virtual visits playing a major role in healthcare delivery going forward. And, with each acquisition within the telehealth space, the need for clinical laboratories and pathology groups to have a strategy to respond to this trend increases.
The acquisition of MDLIVE by Cigna’s health services subsidiary Evernorth is expected to be completed in the second quarter of 2021, pending regulatory approval, according to an Evernorth press release.
Evernorth, noted Becker’s Hospital Review, is a division of Cigna that “includes pharmacy benefit manager Express Scripts, specialty pharmacy Accredo, and the rest of Cigna’s health service product lines.” And that Evernorth focuses on, “… benefit management, behavioral and clinical care, pharmacy, and intelligence.”
Tim Wentworth, Evernorth’s CEO, anticipates consumers’ desire for telehealth options will not disappear as SARS-CoV-2 infections decrease and the country returns to a new normal.
“Customers expect more convenient care interactions and COVID-19 has rapidly accelerated this need. We see an immediate opportunity to build a new model of care delivery, one that delivers a connected experience with greater affordability, predictability, and simplicity,” Wentworth said in the press release.
The MDLIVE website states the telehealth company’s provider network includes physicians who are board certified in:
Internal medicine,
Family practice,
Emergency medicine, and
Pediatrics.
The company also provides counseling and behavioral health services by licensed mental health professionals.
Virtual Care Expanded Rapidly Due to COVID-19 Pandemic
Cigna was an early investor in MDLIVE. According to the company’s investors page, other investors include:
Health Care Service Corporation (HCSC), a Chicago-based mutual legal reserve company and independent licensee of the Blue Cross and Blue Shield Association.
Sentara Healthcare, a not-for-profit that operates more than 100 sites of care across Virginia and North Carolina.
Sutter Health, a not-for-profit integrated health delivery system headquartered in Sacramento, Calif., that operates 24 acute care hospitals and more than 200 clinics in Northern California.
And various venture capital and private equity firms.
Cigna began investing in virtual care years before the COVID-19 pandemic arrived in America. In 2018, members of Cigna’s employee-sponsored health plans were given access to virtual urgent care services. In 2019, the partnership was expanded to include online appointments with psychiatrists and behavior health counselors, while some primary care services were added last year.
Then, according to Cigna’s Virtual Investment Day Excerpt Video, virtual care expanded rapidly during the COVID-19 pandemic, with the use of telehealth jumping 46% in 2020 compared to an 11% increase in 2019.
That trend was highlighted last month in a report published in the American Journal of Preventive Medicine (AJPM), titled, “Who Is (and Is Not) Receiving Telemedicine Care During the COVID-19 Pandemic.” The study’s authors found a twentyfold increase in telehealth visits starting in March 2020 among six million people with employer-based health insurance, while office-based encounters fell by almost 50%.
Telehealth Drives New Model of Virtual Healthcare
In the Cigna video, Cigna President and CEO David Cordani says telehealth will be an important driver behind a new model of healthcare delivery.
“The emergence of virtual care is an important example of this,” he states. “We have seen consistent growth in virtual care over the past decade and it has rapidly accelerated further during the COVID pandemic. At Cigna, we see this trend continuing and accelerating further, moving well beyond urgent care to primary, coordinated chronic and behavioral care.”
Cordani added that the MDLIVE acquisition will not only increase patient access to care, but also help Cigna drive down healthcare costs to “below CPI (Consumer Price Index) and ultimately to zero or less.”
Evernorth, however, does not appear to be signaling that its expanded network of virtual providers will serve as gatekeepers for patients scheduling in-office visits with their providers. The Evernorth press release states MDLIVE’s 24/7 virtual care platform will “complement—not replace—the way customers and patients interact with their existing providers.” The goal, Evernorth says, is to achieve:
Earlier identification and diagnosis of critical care needs;
Faster and more seamless referrals to high-performing providers, including specialists and behavioral health; and
More convenient access to appropriate, affordable sites of service, and pharmaceutical fulfillment.
“From cost to complexity to quality, there is tremendous potential for progress in healthcare,” Evernorth President and Chief Operating Officer Eric Palmer said in the company press release. “As one, Evernorth and MDLIVE can accelerate meaningful change. MDLIVE will be part of the new, differentiated, and future-state care solutions that improve the patient experience, close the patient-provider accessibility gap, and bring providers opportunities to augment the services they currently offer. We’ll also have the opportunity to expand the reach of MDLIVE’s capabilities to Evernorth’s clients, as well as Cigna’s US Medical customers and clients.”
Opportunities for Clinical Laboratories That Can Support Virtual Care
Evernorth’s acquisition of MDLIVE expands Cigna’s health services portfolio of healthcare services and may provide opportunities for clinical laboratories that are prepared to support telehealth providers.
As virtual healthcare networks become a signature part of employee-sponsored health plans, clinical laboratories and pathology groups will need to keep pace with a changing healthcare landscape that puts a premium on remote and virtual visits. Outreach to health plans may be necessary to ensure clinical laboratories are included in an ever-growing virtual network.
It’s the latest example of how the ongoing SARS-CoV-2 pandemic is making it possible for new competitors to enter the clinical laboratory marketplace
In response to increasing demand for COVID-19 testing, warehouse retailer Costco (NASDAQ:COST) is seizing the opportunity to sell at-home saliva self-collection test kits to its customers. It makes Costco the latest company to enter the market for SARS-CoV-2 testing and compete against clinical laboratories.
And these non-invasive tests—which are as simple as spitting saliva into a container and mailing it to a medical laboratory—may be more effective at detecting the SARS-CoV-2 coronavirus than uncomfortable nasal swabs.
Costco is selling its COVID-19 Saliva PCR Test Kit for $129.99 ($139.99 with video observation). Included in the price is a self-collection device, a biohazard bag, a sticker for personal data, and a box for shipping the saliva to a medical laboratory.
The test is actually P23 Labs’ TaqPath SARS-CoV-2 assay and will be administered by Azova, a digital health services provider. P23 says their test has a 98% sensitivity and 99% specificity, according to Business Insider.
Saliva-Collection Kits Gain Popularity and FDA Emergency Use Authorizations
P23 Labs’ assay is one of 12 COVID-19 home tests that have received US Food and Drug Administration (FDA) Emergency Use Authorization (EUA). Three of which use saliva specimens.
The FDA’s EUA authorization summary for the P23 assay states it is “for use with saliva specimens that are self-collected at home or in a healthcare setting with or without the supervision and/or assistance of [a healthcare provider (HCP)], by individuals using the P23 At-Home COVID-19 Test Collection Kit, when determined to be appropriate by an HCP based on the results of a COVID-19 medical questionnaire. This test is also for use with nasal swab specimens that are self-collected at home or in a healthcare setting with or without the supervision and/or assistance of an HCP by individuals.”
In a news release announcing the first diagnostic test using saliva specimens, oncologist and FDA Commissioner Stephen Hahn, MD, said that “Authorizing additional diagnostic tests with the option of at-home sample collection will continue to increase patient access to testing for COVID-19. This (saliva sample collection) provides an additional option for the easy, safe, and convenient collection of samples required for testing without traveling to a doctor’s office, hospital, or testing site.” That test was manufactured by Clinical Genomics laboratory of Rutgers New Jersey Medical School.
Below is a list from Business Insider for at-home self-collection SARS-CoV-2 coronavirus tests that have received an FDA EUA. Most can be ordered online, and prices range from $109 to $149, which may be covered by insurance depending on the health plan.
Binx Health Home Nasal Swab COVID-19 sample collection kit
Yale Study Indicates Saliva Tests Have Greater Detection Sensitivity over Swab
Should consumers choose COVID-19 saliva tests over nasal cavity swab tests? Maybe.
A study led by the Yale School of Public Health found and “conducted at Yale New Haven Hospital with 44 inpatients and 98 health care workers—found that saliva samples taken from just inside the mouth provided greater detection sensitivity and consistency throughout the course of an infection than the broadly recommended nasopharyngeal (NP) approach. The study also concluded that there was less variability in results with the self-sample collection of saliva,” states a Yale University news release.
Yale received FDA EUA for SalivaDirect, a real-time quantitative polymerase chain reaction (RT-qPCR) for detection of SARS-CoV-2. However, SalivaDirect is not an “at-home” test. It requires saliva samples to be self-collected into a sterile container in the presence of a healthcare professional, and is being provided by Yale to clinical laboratories as an “open source” protocol, the FDA said in a news release.
“We are trying to work with smaller local labs that want to get up and running to support schools, community groups, universities, and colleges,” Wyllie told Time.
In “Saliva or Nasopharyngeal Swab Specimens for Detection of SARS-CoV-2,” published in the New England Journal of Medicine (NEJM), Wyllie and others suggest saliva can be just as effective in detecting the coronavirus that causes COVID-19. In their study, COVID-19 patients who were tested by healthcare workers using nasopharyngeal swabs were then asked to collect their own saliva samples.
The researchers found that “Collection of saliva samples by patients themselves negates the need for direct interaction between healthcare workers and patients. This interaction is a source of major testing bottlenecks and presents a risk of nosocomial infection. Collection of saliva samples by patients themselves also alleviates demands for supplies of swabs and personal protective equipment. Given the growing need for testing, our findings provide support for the potential of saliva specimens in the diagnosis of SARS-CoV-2 infection.”
The Yale scientists used primer sequences identified by the Centers for Disease Control and Prevention to detect the coronavirus. They found more SARS-CoV-2 RNA in saliva specimens than in the nasopharyngeal swab specimens. Also, 81% of saliva samples were positive one to five days after diagnosis, as compared to 71% of the nasopharyngeal swab specimens.
“The findings suggest saliva specimens and nasopharyngeal swab specimens have at least similar sensitivity in the detection of SARS-CoV-2 during the course of hospitalization,” the researchers wrote in their NEJM paper.
The increasing popularity of at-home COVID-19 testing—along with studies showing that results improve when specimens are self-collected—suggest that medical laboratory managers should closely monitor the rise of COVID-19 home tests, as well as progress being made in saliva for diagnosing the SARS-CoV-2 coronavirus.
Further, it might be a smart strategy for clinical laboratories with the capability to perform this testing to approach retailers in their region and establish relationships where retailers sell the collection kits, and the lab performs the test and reports the results.
Since patients pay cash for the SARS-CoV-2 tests at the time they purchase the kits, clinical labs are guaranteed payment for the tests without the need to submit claims to consumers’ insurance companies. That’s another benefit to these types of arrangements.
United Airlines creates pilot program for on-site rapid PCR tests, as other airlines facilitate at-home specimen collection for rapid coronavirus testing
Four US airlines attempting to recover lost business due to the COVID-19 pandemic are partnering with developers of rapid RT-PCR (reverse transcription polymerase chain reaction) tests to facilitate testing of passengers either at airports before they board their flights, at drive-through testing sites, or at-home in advance of scheduled travel.
This would be a great opportunity for clinical laboratories to gain business, but few details are known about how these airlines are selecting providers for the COVID-19 tests that will be part of their programs.
The deals come amid calls from the International Air Transport Association (IATA) “for the development and deployment of rapid, accurate, affordable, easy-to-operate, scalable and systematic COVID-19 testing for all passengers before departure as an alternative to quarantine measures” in many countries, states an IATA press release.
“The key to restoring the freedom of mobility across borders is systematic COVID-19 testing of all travelers before departure,” said Alexandre de Juniac, IATA Director General and CEO, in the IATA press release. “This will give governments the confidence to open their borders without complicated risk models that see constant changes in the rules imposed on travel.”
From a clinical laboratory testing perspective, the requirement for passengers to be tested prior to travel may contribute to two changes in the lab testing marketplace:
Consumers may become accustomed to buying home collection kits for COVID-19 and sending specimens to clinical laboratories. This could have the added benefit of helping consumers become comfortable doing this for other diagnostic tests as well.
Pursuit of profit from manufacturing COVID-19 tests that utilize consumer-collected specimens may increase competition in this market and would likely increase the number of at-home specimen collection products that are easier and more convenient to use.
US carriers offering the COVID-19 tests include United Airlines, American Airlines, Hawaiian Airlines, and JetBlue.
United Airlines
United is providing on-site testing through pilot programs at San Francisco International Airport (SFO) and Newark Liberty International Airport (EWR). At SFO, passengers are tested before taking flights to Hawaii. At EWR, they are tested prior to boarding a thrice-weekly flight to London Heathrow.
“We believe the ability to provide fast, same-day COVID-19 testing will play a vital role in safely reopening travel around the world and navigating quarantines and travel restrictions, particularly to key international destinations like London,” said Toby Enqvist, United’s Chief Customer Officer, in a press release.
United began offering testing at SFO on Oct. 15. According to “COVID-19 Testing for United Travelers,” the San Francisco to Hawaii passengers have two options:
A $105 drive-through test administered two or three days prior to flights by Color, a San Francisco Bay area health technology company.
The airline says a negative test ensures that travelers can bypass Hawaii’s mandatory quarantine requirements in Lihue, Maui, and Honolulu. For the Newark-to-London flights, United plans to run a pilot rapid testing program from Nov. 16 to Dec. 11. for passengers boarding Flight 14, departing at 7:15 p.m. Mondays, Wednesdays, and Fridays. Premise Health will administer the testing, which will be free to passengers. Those who choose not to be tested will be placed on other flights.
American Airlines
American is offering COVID-19 testing for passengers scheduled on flights to Hawaii, Latin America, and the Caribbean, according to a press release. For the most part, these are at-home specimen collection RT-PCR tests provided by healthcare testing services company PrivaPath Diagnostics, Inc. (d.b.a., LetsGetChecked). Customers receive their results within 24 to 72 hours after the lab receives the samples.
As with the United flights to Hawaii, the testing program allows passengers to bypass quarantine requirements at their destinations. Customers pay $119 for the LetsGetChecked at-home specimen-collection kit and subsequent RT-PCR testing.
“Our initial preflight testing has performed remarkably well, including terrific customer feedback about the ease and availability of testing options,” American Airlines President Robert Isom said in the press release.
Hawaiian Airlines and JetBlue
In separate press releases, Hawaiian Airlines and JetBlue announced partnerships with Vault Health to offer at-home saliva tests to passengers. After receiving the at-home specimen collection kit, customers can connect through Zoom video conferencing with a Vault Health supervisor who ensures the sample is collected properly.
Hawaiian Airlines also offers drive-through testing at SFO and Los Angeles International Airport through a partnership with Worksite Labs. Passengers pay $90 to receive test results within 36 hours or $150 for express service on the day of travel. Worksite uses a Droplet Digital PCR shallow nasal swab test. The airline says it plans to expand this to other airports.
The Vault Health and Worksite Labs tests meet the state’s guidelines for exemption from the 14-day quarantine requirement, the airlines say.
Impact on Medical Laboratories
Airlines offering COVID-19 testing to their passengers may trigger both an opportunity and a change in the clinical laboratory testing marketplace. First, there is a business opportunity for labs to provide rapid molecular SARS-COV-2 tests to airlines.
Second, if consumers begin using at-home specimen collection kits in greater numbers as part of their air travel requirements, might this make them more comfortable doing self-collection for other types of clinical laboratory tests? A shift in consumer willingness to collect their own medical laboratory specimens—accompanied by ongoing innovations in diagnostic technologies, may eventually reduce the need for medical labs to operate extensive networks of patient service centers.
Of course, such a scenario is years away. But airline COVID-19 testing programs are just one of the progressive steps that can help make that possibility into a reality.