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Attention All Surgical Pathologists: Algorithms for Automated Primary Diagnosis of Digital Pathology Images Likely to Gain Regulatory Clearance in Near Future

Hello primary diagnosis of digital pathology images via artificial intelligence! Goodbye light microscopes!

Digital pathology is poised to take a great leap forward. Within as few as 12 months, image analysis algorithms may gain regulatory clearance in the United States for use in primary diagnosis of whole-slide images (WSIs) for certain types of cancer. Such a development will be a true revolution in surgical pathology and would signal the beginning of the end of the light microscope era.

A harbinger of this new age of digital pathology and automated image analysis is a press release issued last week by Ibex Medical Analytics of Tel Aviv, Israel. The company announced that its Galen artificial intelligence (AI)-powered platform for use in the primary diagnosis of specific cancers will undergo an accelerated review by the Food and Drug Administration (FDA).

FDA’s ‘Breakthrough Device Designation’ for Pathology AI Platform

Ibex stated that “The FDA’s Breakthrough Device Designation is granted to technologies that have the potential to provide more effective treatment or diagnosis of life-threatening diseases, such as cancer. The designation enables close collaboration with, and expedited review by, the FDA, and provides formal acknowledgement of the Galen platform’s utility and potential benefit as well as the robustness of Ibex’s clinical program.”

“All surgical pathologists should recognize that, once the FDA begins to review and clear algorithms capable of using digital pathology images to make an accurate primary diagnosis of cancer, their daily work routines will be forever changed,” stated Robert L. Michel, Editor-in-Chief of Dark Daily and its sister publication The Dark Report. “Essentially, as FDA clearance is for use in clinical care, pathology image analysis algorithms powered by AI will put anatomic pathology on the road to total automation.

“Clinical laboratories have seen the same dynamic, with CBCs (complete blood counts) being a prime example. Through the 1970s, clinical laboratories employed substantial numbers of hematechnologists [hematechs],” he continued. “Hematechs used a light microscope to look at a smear of whole blood that was on a glass slide with a grid. The hematechs would manually count and record the number of red and white blood cells.

“That changed when in vitro diagnostics (IVD) manufacturers used the Coulter Principle and the Coulter Counter to automate counting the red and white blood cells in a sample, along with automatically calculating the differentials,” Michel explained. “Today, only clinical lab old-timers remember hematechs. Yet, the automation of CBCs eventually created more employment for medical technologists (MTs). That’s because the automated instruments needed to be operated by someone trained to understand the science and medicine involved in performing the assay.”

Primary Diagnosis of Cancer with an AI-Powered Algorithm

Surgical pathology is poised to go down a similar path. Use of a light microscope to conduct a manual review of glass slides will be supplanted by use of digital pathology images and the coming next generation of image analysis algorithms. Whether these algorithms are called machine learning, computational pathology, or artificial intelligence, the outcome is the same—eventually these algorithms will make an accurate primary diagnosis from a digital image, with comparable quality to a trained anatomic pathologist.

How much of a threat is automated analysis of digital pathology images? Computer scientist/engineer Ajit Singh, PhD, a partner at Artiman Ventures and an authority on digital pathology, believes that artificial intelligence is at the stage where it can be used for primary diagnosis for two types of common cancer: One is prostate cancer, and the other is dermatology.

Ajit Singh, PhD speaking at the Executive War College

On June 17, Ajit Singh, PhD (above), Partner at Artiman Ventures, will lead a special webinar and roundtable discussion for all surgical pathologists and their practice administrators on the coming arrival of artificial intelligence-powered algorithms to aid in the primary diagnosis of certain cancers. Regulatory approval for such solutions may happen by the end of this year. Such a development would accelerate the transition from light microscopes to a fully digital pathology workflow. Singh is shown above addressing the 2018 Executive War College. (Photo copyright: The Dark Report.)

“This is particularly true of prostate cancer, which has far fewer variables compared to breast cancer,” stated Singh in an interview published by The Dark Report in April. (See TDR, “Is Artificial Intelligence Ready for First Use in Anatomic Pathology?” April 12, 2021.)

“It is now possible to do a secondary read, and even a first read, in prostate cancer with an AI system alone. In cases where there may be uncertainty, a pathologist can review the images. Now, this is specifically for prostate cancer, and I think this is a tremendous positive development for diagnostic pathways,” he added.

Use of Digital Pathology with AI-Algorithms Changes Diagnostics

Pathologists who are wedded to their light microscopes will want to pay attention to the impending arrival of a fully digital pathology system, where glass slides are converted to whole-slide images and then digitized. From that point, the surgical pathologist becomes the coach and quarterback of an individual patient’s case. The pathologist guides the AI-powered image analysis algorithms. Based on the results, the pathologist then orders supplementary tests appropriate to developing a robust diagnosis and guiding therapeutic decisions for that patient’s cancer.

In his interview with The Dark Report, Singh explained that the first effective AI-powered algorithms in digital pathology will be developed for prostate cancer and skin cancer. Both types of cancer are much less complex than, say, breast cancer. Moreover, the AI developers have decades of prostate cancer and melanoma cases where the biopsies, diagnoses, and downstream patient outcomes create a rich data base from which the algorithms can be trained and tuned.

To help surgical pathologists, pathologist-business leaders, and pathology group practice administrators understand the rapid developments in AI-powered digital pathology analysis, Dark Daily is conducting “Clinical-Grade Artificial Intelligence (AI) for Your Pathology Lab: What’s Ready Now, What’s Coming Soon, and How Pathologists Can Profit from Its Use,” on Thursday, June 17, 2021, from 1:00 PM to 2:30 PM EDT.

This webinar is organized as a roundtable discussion so participants can interact with the expert panelists. The Chair and Moderator is Ajit Singh, PhD, Adjunct Professor at the Stanford School of Medicine and Partner at Artiman Ventures.

Panelists for June 17 webinar, Clinical-Grade Artificial Intelligence (AI) for Your Pathology Lab: What’s Ready Now, What’s Coming Soon, and How Pathologists Can Profit from Its Use

The panelists (above) represent academic pathology, community hospital pathology, and the commercial sector. They are:

Because the arrival of automated analysis of digital pathology images will transform the daily routine of every surgical pathologist, it would be beneficial for all pathology groups to have one or more of their pathologists register and participate in this critical webinar.

The roundtable discussion will help them understand how quickly AI-powered image analysis is expected be cleared for use by the FDA in such diseases as prostate cancer and melanomas. Both types of cancers generate high volumes of case referrals to the nation’s pathologists, so potential for disruption to long-standing client relationships, and the possible loss of revenue for pathology groups that delay their adoption of digital pathology, can be significant.

On the flip side, community pathology groups that jump on the digital pathology bandwagon early and with the right preparation will be positioned to build stronger client relationships, increase subspecialty case referrals, and generate additional streams of revenue that boost partner compensation within their group.

Act now to guarantee your place at this important webinar. Click HERE to register, or copy and paste the URL https://www.darkdaily.com/webinar/clinical-grade-artificial-intelligence-for-your-pathology-lab/ into your browser.

Also, because so many pathologists are working remotely, Dark Daily has arranged special group rates for pathology practices that would like their surgical pathologists to participate in this important webinar and roundtable discussion on AI-powered primary diagnosis of pathology images. Inquire at info@darkreport.com or call 512-264-7103.

—Michael McBride

Related Information:

Ibex Granted FDA Breakthrough Device Designation: Ibex’s Galen AI-powered platform is recognized by the FDA as breakthrough technology with the potential to more effectively diagnose cancer

Is Artificial Intelligence Ready for First Use in Anatomic Pathology?

Medscape Report on Physician Salaries in 2020 Shows Pathologists at Middle in Pay, but Near Top in Job Satisfaction

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 Medscape news 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.

“COVID took a terrible emotional toll on physicians and healthcare workers, and many are still struggling financially, but our findings showed that physicians will innovate and change quickly to meet the needs of patients through extremely difficult times,” said Leslie Kane (above), Senior Director, Medscape’s Business of Medicine, in the news release. Pathologists who were at the center of the nation’s COVID-19 pandemic response would likely echo her sentiments. (Photo copyright: Medscape.)

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):

Specialist Salary Increases and Decreases

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:

  • Infectious diseases: 24%
  • Public health/preventive medicine: 20.7%
  • Nephrology: 19.8%
  • Internal medicine: 19.7%
  • Pathology: 19%

If They Could Do It Again, Most Would

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.

—Donna Marie Pocius

Related Information:

Medscape Physician Compensation Report: The Recovery Begins 2021

Medscape Physician Compensation Report Shows Salaries Held Steady Despite Pandemic

A Pandemic of Dysmorphia: “Zooming” into the Perception of Our Appearance

AAFPRS Announces annual Survey Results, A Look at How COVID-19 Disrupted Facial Plastic Surgery

New Test Under Development That Detects Breast Cancer within One Hour with 100% Accuracy Has Potential to Help Pathologists Deliver More Value

Such a test, if proved safe and accurate for clinical use, could be a useful diagnostic tool for anatomic pathologists

What would it mean to anatomic pathology if breast cancer could be diagnosed in an hour from a fine needle aspiration (FNA) rather than a core biopsy? A new test created by researchers affiliated with Massachusetts General Hospital in Boston may be just such a game changer. Especially in remote locations where clinical laboratory resources are in short supply.

Regardless of how the next round of research and clinical studies turn out, one reason this development is significant is that it demonstrates how newer technologies and analytical software are being combined to create a faster diagnostic test for different types of cancer.

Another benefit to this research is that it may utilize simpler, less expensive instruments. In fact, the researchers said this test can be performed for about $5. For these reasons, pathologists may want to follow the progress of these researchers as they work to improve this test so it can be used in clinical care.

Affordable Image Cytometry of FNA Specimens

Though still in development, the new image cytometry system, dubbed CytoPAN, has demonstrated the ability to diagnose breast cancer within a one-hour time frame, and, according to the study published in Science Translational Medicine, “is devoid of moving parts for stable operations, harnesses optimized antibody kits for multiplexed analysis, and offers a user-friendly interface with automated analysis for rapid diagnoses.”

The international researcher team included scientists from:

“Here, we report the development and validation of an affordable image cytometry system that allows automated and same-day molecular analyses of fine needle aspiration (FNA) specimens. Termed CytoPAN, for portable fluorescence-based image cytometry analyzer, the system performs multichannel imaging for cancer diagnosis and subtyping,” the researchers wrote.

The CytoPAN technique is minimally invasive, they note, and only requires a few cellular specimens to determine if breast cancer cells are present, with results available in one hour.

CytoPAN rapid diagnostic tool for cancer diagnosis.
The researchers are hopeful the CytoPAN diagnostic tool (above) can be a valuable resource in developing countries and remote areas where patients face long wait times before receiving a cancer diagnosis. In these areas, diagnoses typically come after advanced symptoms, such as palpable mass lesions and malaise, become present, which can have a negative impact on patient outcomes. And anatomic pathologists worldwide would benefit greatly from such an advance in cancer diagnostics. (Photo copyright: Jouha Min, Lip Ket Chin Center for Systems Biology, Massachusetts General Hospital.)

“Unfortunately, in many low- and middle-income countries, [breast cancer] diagnosis often takes an extraordinarily long time—up to a few months—due to a lack of specialists and limited laboratory infrastructure,” Hyungsoon Im, PhD, Assistant Professor at Harvard Medical School and one of the researchers involved in the project, told United Press International (UPI).

“From a public health aspect, it is critically important to develop new diagnostic methods that overcome these barriers,” he added.

Because FNA testing is less invasive than surgical biopsy collection, it has fewer complications and is generally considered safe. Thus, it is “feasible to be performed even in resource-limiting settings at much lower costs,” Im told UPI. “This could lead to earlier treatment and accelerate new drug testing in clinical trials.”

CytoPAN Testing and Additional Trials

The researchers tested CytoPAN on 68 breast cancer patients in South Korea.

“To determine the clinical utility of the approach,” they wrote in the published study, “we next conducted a prospective clinical study in which the FNA could be directly compared to conventional pathology results. We enrolled treatment-native patients at the Kyungpook National University Chilgok Hospital (Daegu, South Korea) and who were referred for primary surgery. All patients consented to have a preoperative breast FNA before clinically indicated surgery. The breast masses were visualized by ultrasound or computed tomography, and a coaxial needle was introduced through which FNA samples (CytoPAN) and core biopsies were obtained. Surgical specimens and/or core biopsies were processed by routine pathology and served as the gold standard.”

The CytoPAN platform detected the presence of breast cancer cells with a 100% accuracy, using as few as 50 harvested cells per collected specimen.

The test also successfully identified two key breast cancer biomarkers:

 “We are also preparing additional trials in the US and other countries,” Im told UPI. “The success in those trials will (hopefully) accelerate … widespread adoption of the technology.”

The researchers are currently testing CytoPAN on a larger number of patients in Botswana, with funding from the US federal National Institutes of Health (NIH).

According to the American Cancer Society (ACS), approximately 300,000 individuals are diagnosed with breast cancer annually in the US. The Union for International Cancer Control (UICC) states on their website that, globally, there are more than two million new cases of breast cancer diagnosed each year. And more than 600,000 people died from breast cancer worldwide in 2018. A disproportionate number of those deaths occurred in developing countries that have limited resources to diagnose and treat the disease.

Additional Research for Other Applications in Cancer Testing and Pathology

The new CytoPAN technology requires minimal training, according to the researchers, and only costs about $5 per test kit. This is substantially less expensive than the price associated with other tests available on the market, UPI noted.

Though additional research and clinical trials are needed before CytoPAN will be available for widespread clinical use, a cost-effective, relatively non-invasive test that can accurately diagnose cancer within an hour would be transformational for anatomic pathology and, potentially, could save many lives.

—JP Schlingman

Related Information:

CytoPAN—Portable Cellular Analyses for Rapid Point-of-care Cancer Diagnosis

System Provides ‘Faster, Less Invasive’ Method for Breast Cancer Detection

Cheap, Fast Breast Cancer Test 100% Accurate, Study Finds

Autopsies Clearly Help Pathologists Understand COVID-19 and How It Affects the Body, So Why Are More Not Being Performed?

Payers are unwilling to reimburse for autopsies despite the fact that autopsies are a proven way to learn more about new diseases and how they attack the human body

Each year, less money is spent by Medicare and private health insurers on autopsies. However, autopsies regularly provide pathologists with relevant, clinically useful information about exact causes of death and other elements of disease in the deceased. Some diseases cannot be identified any other way but by autopsy. And data from autopsies have helped developers bring critical new medical laboratory tests, therapeutic drugs, and vaccines to market.

Thus, the healthcare system is losing valuable research that would bring a better understanding of diseases and processes in the body that contribute to poor health and death. This is true with COVID-19. Autopsy results have already provided revelations into how the SARS-CoV-2 coronavirus affects the body, and yielded clues that are helping pathologists combat the illness.

Looking Closely at Death from COVID-19

“You can’t treat what you don’t know about,” Alex Williamson, MD, an anatomic/clinical/pediatric/forensic pathologist at Northwell Health in New York and Associate Professor of Pathology at Zucker School of Medicine at Hofstra/Northwell, told the Associated Press (AP), ABC News reported in “The Autopsy, a Fading Practice, Revealed Secrets of COVID-19.”

“Many lives have been saved by looking closely at someone’s death,” he added.

Autopsies performed on deceased patients could help clarify why there is such a wide array of symptoms for those affected by COVID-19 and provide details that cannot be detected in living patients.

For example, autopsies completed early in the pandemic confirmed that the SARS-CoV-2 coronavirus causes respiratory disease, and that extended use of ventilators could cause considerable damage to the lungs, the AP article noted. This discovery led physicians to re-evaluate how ventilators should be used on COVID-19 patients.

The AP story also stated that pathologists learned the SARS-CoV-2 coronavirus may spread the illness to other organs such as the heart, brain, liver, kidneys, and colon.

Through autopsies, COVID-19 patients also were discovered to have dramatic blood clotting issues in almost every organ of the body and micro-clotting in the lungs.

“The clotting was not only in the large vessels but also in the smaller vessels,” said Amy Rapkiewicz, MD, an anatomic and forensic pathologist, Chair of the Department of Pathology at NYU Langone Medical Center and Associate Professor, Department of Pathology at NYU Long Island School of Medicine, in an Advisory Board Daily Briefing. “And this was dramatic, because though we might have expected it in the lungs, we found it in almost every organ that we looked at in our autopsy study.”

Doctors are now exploring whether blood thinners should be utilized to prevent blood clots from forming in COVID-19 patients.

Lab samples and Amy Rapkiewicz, MD, Chair of the Department of Pathology at NYU Langone Medical Center and Associate Professor, Department of Pathology at NYU Long Island School of Medicine
“When you’re able to see what’s happening at the level of the cells, you just have a broader picture of the potential mechanism by which the disease is happening,” Amy Rapkiewicz, MD (above), Chair of the Department of Pathology at NYU Langone Medical Center and Associate Professor, Department of Pathology at NYU Long Island School of Medicine, told Undark. (Photo copyright: Associated Press.)

Autopsies Identify Secondary Causes of Death

Autopsies also have shown that some COVID-19 patients are dying from secondary bacterial infections that appear alongside the disease. This discovery may help doctors understand lingering symptoms that plague some coronavirus patients.

“What you see at autopsy represents an effective catalogue of the injury that occurs in patients who have COVID,” pathologist Stephen Hewitt, MD, PhD, associate research physician, Laboratory of Pathology, and head of the Experimental Pathology Laboratory at the National Cancer Institute Center for Cancer Research, told Undark. “And it gives you an understanding and a basis to try and forecast forward what we’re going to see in post-COVID syndrome.”

Shortage in Funding and Forensic Pathologists

With advances in technology, clinical laboratory testing, and imaging scans, autopsies are performed much less than they were in the past. In the 1950s, autopsies were performed on about half of the patients who passed away in hospital situations, but now that number is somewhere between only five and 11%, ABC News reported.

At this time, hospitals are not required to provide autopsy services and the costs to perform autopsies are often not covered by private or government insurance.

“As medicine has become closer to the bottom line, community hospitals don’t want to perform the autopsies because they’re not getting any functional reimbursement for them,” Hewitt told Undark.

Hospitals usually have to cover costs associated with autopsies themselves or pass those expenditures along to the deceased patient’s family. Autopsies typically cost anywhere from $1,000 to $5,000 per patient, Undark reported.

“When you consider there’s no reimbursement for this, it’s almost an altruistic practice,” Billie Fyfe-Kirschner, MD, a pathologist with Rutgers University, told the Associated Press. “It’s vitally important, but we don’t have to fund it.”

According to the AP, the US faces a critical shortage of forensic pathologists who are trained to perform autopsies. It is estimated, AP reported, that “the US has only a few hundred forensic pathologists but could use several thousand—and less than one in 100 graduating medical school students enters the profession each year.”

Clearly, pathologists have much to offer in the field of autopsies. Autopsying patients who died from COVID-19 may provide data that could greatly affect treatment for those diagnosed with the disease and improve patient outcomes overall.

—JP Schlingman

Related Information:

The Autopsy, a Fading Practice, Revealed Secrets of COVID-19

Collection and Submission of Postmortem Specimens from Deceased Persons with Confirmed or Suspected COVID-19

Autopsy Rates Were Falling for Years. Then COVID-19 Came Along

What Dozens of COVID-19 Patient Autopsies Have Revealed About the Disease

Autopsies in Maryland Show Much Higher Rate of COVID-19 than Expected

Dirty, Smelly, Raw: The Future of Forensic Pathology

McKinsey and Company Says the COVID-19 Pandemic is Accelerating Six Critical Trends in Healthcare, at Least One Which Would Benefit Anatomic Pathologists

Clinical laboratory and pathology groups that support ambulatory and virtual care, and urgent care and retail clinics may experience growth

Global management consulting company McKinsey and Company’s report, “The Great Acceleration In Healthcare: Six Trends to Heed,” identifies six trends in healthcare that are accelerating due to the global COVID-19 pandemic.

Clinical laboratory managers and pathology practice administrators should consider how these trends may affect their business and patients when planning for the future.

The McKinsey graphic six trends that are likely to shape post-COVID-19 healthcare
The McKinsey graphic above illustrates the “six trends that are likely to shape post-COVID-19 healthcare.” Clinical laboratories that support health networks struggling with any of these challenges should take steps to prepare for anticipated changes to healthcare delivery. (Graphic copyright: McKinsey and Company.)

1: Healthcare Reform

McKinsey identified three areas where the coronavirus pandemic may impact healthcare reform:

  • “COVID-19-era waivers that could become permanent.
  • “Actions that may be taken to strengthen the healthcare system to deal with pandemics.
  • “Reforms to address the COVID-19-induced crisis.”

McKinsey reports that “the Centers for Medicare and Medicaid Services has introduced more than 190 waivers since the beginning of March 2020.” These waivers can affect all aspects of healthcare, from clinical practice to reimbursement. Some of them, according to McKinsey, are “only relevant during the crisis (for example, the waiver of intensive care unit death reporting). A retrospective assessment of others (for example, expansion of telehealth access) could reveal beneficial innovation worth preserving.”

Several areas that McKinsey says are clearly ripe for reform include improving the resiliency of the healthcare system and the way the system is funded.

Public sector budgets are generally kept strictly separate, each with its own rules and policies that dictate operations. But in his article, “After COVID-19—Thinking Differently About Running the Health Care System,” published in JAMA Health Network, Stuart M. Butler, PhD, Senior Fellow in Economic Studies at the Brookings Institution, wrote, “The intensity of the COVID-19 pandemic … is forcing jurisdictions all across the country to find ways to be nimble so that multiple agencies can work together.”

Thus, McKinsey recommends, “Given the substantial shifts in relative market positioning among industry players that prior reforms have created, leaders would do well to plan ahead now.”

2: Better Access to Healthcare Services

Some people who develop COVID-19 are at far greater risk of hospitalization and death than others, including those who have:

  • Chronic health conditions, including obesity.
  • Mental and behavioral health challenges, such as substance abuse.
  • Unmet social needs, such as food or housing insecurity.
  • Poor access to healthcare.

McKinsey wrote that these “intersecting health and social conditions,” combined with certain races that have higher risk for severe complications, including Black, Indian, and Hispanic/Latino Americans, “correlated with poorer health outcomes.”

Value-based healthcare, telehealth, and greater attention to the social determinants of health may help address some of these issues, McKinsey notes, but the pandemic has shined a spotlight on how lack of care increases risk for certain populations during a public health crisis.

3: Era of Exponential Improvement Unleashed

Some of the trends that appear to be accelerating as a result of the pandemic are good news. McKinsey cites several benefits, including:

  • Improved understanding of patients.
  • Delivery of more convenient and individualized care.
  • $350-$410 billion in annual revenue by 2025.

Through telehealth and other types of virtual care enabled by digital technology, “intuitive healthcare ecosystems” may arise and offer a more integrated experience for patients and their caregivers, McKinsey notes.

“While the pace of change in healthcare has lagged other industries in the past, potential for rapid improvement may accelerate due to COVID-19. An example is the exponential uptake of digitally enabled, virtual care,” McKinsey wrote. “Our analysis … showed that health systems, primary care, and behavioral health practices are reporting increases of more than 50–175 times in telehealth visits, and the potential market size for virtual care could reach around $250 billion.”

McKinsey and Co. report digital enabled virtual care graph
The graphic above is taken from the McKinsey and Co. report, which noted, “Proliferation of digitally enabled, virtual care could further contribute to the rise of personalized and intuitive healthcare ecosystems [that] have the potential to deliver an integrated experience to consumers, enhance productivity of providers, engage both formal and informal caregivers, and improve outcomes while lowering cost.” (Graphic copyright: McKinsey and Company.)

4: The Big Squeeze

The pandemic has caused an enormous outflow of cash from the healthcare system, and some experts don’t expect an injection of funding until 2022. “This outflow is expected to be primarily driven by coverage shifts out of employer-sponsored insurance and possible coverage reductions by employers as well as Medicaid rate pressures from states,” McKinsey states.

“We estimate that COVID-19 could depress healthcare industry earnings by between $35 billion and $75 billion compared with baseline expectations,” McKinsey predicted, adding, “Select high-growth segments will remain attractive (for example, virtual care, home health, software and platforms, specialty pharmacy) and will disproportionally drive growth. These high-growth areas are expected to increase more than 10% over the next five years, while other segments may stagnate or decline altogether.”

5: Fragmented, Integrated, Consolidated Care Delivery

McKinsey says, “The shift of care out of hospitals is not new but has been accelerated by COVID-19.” Rather than the hospital being the center of care delivery, patients are increasingly choosing to receive care at a range of sites across many healthcare ecosystems that are connected digitally and through analytics.

Early in the course of the pandemic, visits to ambulatory care facilities dropped nearly 60% by early April. But by mid-May, those visits were beginning to rebound.

In, “The Impact of the COVID-19 Pandemic on Outpatient Visits: A Rebound Emerges,” the Commonwealth Fund reported that “the relative decline in visits remains largest among surgical and procedural specialties and pediatrics” but is “smaller in other specialties, such as adult primary care and behavioral health.”

virtual care and outpatient options show more potential revenue growth through 2022 graph
The McKinsey graphic above shows how “virtual care and outpatient options show more potential revenue growth through 2022.” Clinical laboratories that support those healthcare settings, especially ambulatory surgery, behavioral health, and retail clinics, should experience similar growth. (Graphic copyright: McKinsey and Company.)

6: Adoption of Next-Generation Managed Care Is Accelerating

How will COVID-19 affect the managed care industry? McKinsey says the “next generation” of managed care might use Medicare Advantage as a model.

“Payers pursuing the next generation of managed care model (through deep integration with care delivery) demonstrate better financial performance, capturing an additional 50 basis points of earnings before interest, taxes, depreciation, and amortization above expectation,” McKinsey noted, adding, “Employers and payers could consider fundamentally rethinking how employer-sponsored health coverage is structured. Learning from Medicare Advantage could provide inspiration for such a reimagination.”

What Should Clinical Laboratory Managers Do?

The McKinsey article concludes by stating, “While the challenges are numerous, leaders who seize the mindset that “disruptive change provides an opportunity to separate yourself from the pack” will build organizations meaningfully stronger than the ones they ran going into the crisis.”

The McKinsey article authors recommend that healthcare organizations take several proactive steps, including:

  • Launch a plan-ahead team.
  • Question your role and your future business model.
  • Prepare to transform your business.
  • Reimagine your organization to make faster decisions.
  • Take action to drive health equity.

Though the McKinsey and Company article covered healthcare in general, many of the authors’ observations and recommendations can apply to clinical laboratories and pathology groups as well and may be valuable in future planning.

—Dava Stewart

Related Information:

The Great Acceleration in Healthcare: 6 Trends to Heed:

After COVID-19—Thinking Differently About Running the Health Care System:

The Next Wave of Healthcare Innovation: The Evolution of Ecosystems

The Impact of the COVID-19 Pandemic on Outpatient Visits: A Rebound Emerges

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

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