News, Analysis, Trends, Management Innovations for
Clinical Laboratories and Pathology Groups

Hosted by Robert Michel

News, Analysis, Trends, Management Innovations for
Clinical Laboratories and Pathology Groups

Hosted by Robert Michel
Sign In

American Robotics Gets FAA Approval to Operate First Fully Automated Drone for Commercial Use ‘Beyond Visual Line of Sight’ Bringing Unmanned Delivery of Medical Supplies and Clinical Laboratory Specimens a Step Closer to Reality

Boston-based American Robotics is approved to operate its Scout unmanned aircraft in rural areas and below a certain altitude, achieving a milestone that may allow the industry to ‘truly take off’

Routine drone delivery of clinical laboratory specimens and medical supplies moved a step closer to reality with the Federal Aviation Administration’s (FAA) green light to American Robotics (AR) to operate its fully automated drones without on-site pilots or on-the-ground spotters.

The Massachusetts-based company becomes the first drone operator to receive an FAA Certificate of Waiver, allowing it to operate its unmanned aircraft “beyond the visual line of sight (BVLOS) of the remote pilot in command.”

According to a news release, “Prior waivers and certifications awarded by the FAA required visual observers (VOs) stationed along the flight path to keep eyes on the airspace at all times, or required other burdensome restrictions such as infrastructure masking. … With this approval, American Robotics’ Scout System is now the first drone technology allowed to continuously operate without this costly human requirement.”

The FAA is restricting American Robotics’ operations to specific rural areas and at altitudes below 400 feet, with a maximum takeoff weight of 20 pounds, The Hill reported. Nevertheless, should AR’s automated Scout System prove safe, pilotless drones may soon be delivering clinical laboratory specimens and supplies to remote areas as well as to more densely populated hospital systems.

The FAA’s Certificate of Waiver is effective until January 31, 2023.

A New Era of Drone Delivery for Hospitals and Clinical Laboratories

Even with the restrictions, the FAA’s decision moves the commercial drone industry ever closer to routine transport of medical laboratory specimens and medical supplies by unmanned aerial vehicles (UAV).

“With these approvals, American Robotics is ushering in a new era of widespread automated drone operations,” Reese Mozer, CEO and co-founder of American Robotics, said in the news release. “Decades’ worth of promise and projection are finally coming to fruition. We are proud to be the first company to meet the FAA’s comprehensive safety requirements, which had previously restricted the viability of drone use in the commercial sector.”

The Wall Street Journal (WSJ) reported that the FAA’s decision signals the agency’s “broader effort to authorize widespread flights by shifting away from case-by-case exemptions for specific vehicles performing specific tasks.” According to the WSJ, the FAA’s approval documents state that American Robotics’ proposed operations will provide the agency with “critical data for use in evaluating BVLOS [beyond the visual line of sight] operations from offsite locations.”

American Robotics Scout drone

Each American Robotics Scout drone (above) is stored within a weatherproof base station that enables autonomous charging, data processing, analysis, and data transmission. According to the news release, “Once installed in the field, all facets of Scout’s operation are automated, allowing this technology to gather and analyze ultra-high-resolution data multiple times per day for years without expensive human labor.” Clinical laboratory managers will want to watch for progress in using drones to deliver medical supplies. (Photo copyright: American Robotics.)

FAA Approval a ‘Game Changer’

In its quest to receive FAA approval, American Robotics completed a four-year testing program around its Scout line of UAV products. According to the company, Scout systems flew as many as 10 automated missions per day in 2020 for industrial and agricultural customers in multiple states capturing a variety of advanced data.

The Scout system addresses safety concerns by using acoustic detect-and-avoid technology to maintain a safe distance from other aircraft while also avoiding birds or other potential obstacles.

“The commercial drone industry is growing quickly and providing significant benefits to the American public, but enabling expanded operations beyond visual line of sight is critical for the industry to truly take off,” Lisa Ellman, JD, Partner at Hogan Lovells and Executive Director of the Commercial Drone Alliance, said in the news release.

“Automated beyond visual line of site operations are particularly important to opening the commercial sectors to the drone economy, including the agriculture and industrial verticals. Key to these operations is the use and FAA acceptance of new and innovative safety technologies, such as detect and avoid sensors and software-enabled automation.”

The agricultural and energy industries are seen as key beneficiaries of this latest FAA action. Lance Ruppert, Director of Agronomy Marketing and Technology at Growmark Inc., a leading US grower cooperative, calls the American Robotics’ approval a “game changer.”

“Our interest in American Robotics’ technology started with the desire to have a drone imagery solution that was reliable, scalable, and executed with minimal human resources,” Ruppert said in the news release. “This technology, along with the FAA approvals to operate it without humans on the ground, is key to making drones a widespread reality in our industry.”

Drone Delivery of Clinical Laboratory Specimens Worldwide

In, “UPS Expands Drone Delivery Service for Transporting Clinical Laboratory Specimens Across Healthcare Systems to Include Delivering Prescriptions from CVS Pharmacy to Customers’ Homes,” Dark Daily reported how the United Parcel Service (UPS) successfully delivered by air medical prescriptions from a CVS pharmacy to customers’ residences in Cary N.C. This was the next step in the package delivery company’s plan to become a major player in the use of drones in healthcare and it has major implications for clinical laboratories and pathology groups.

And past Dark Daily ebriefings reported on drone delivery of medical supplies being conducted in Virginia, North Carolina, Australia, Switzerland, and Rwanda. With potentially fully automated systems just around the corner, there’s no question the use of drones to transport critical medical supplies and biological specimens is poised for an amazing breakthrough.

While the FAA’s approval of the first fully automated commercial drone flights may not have an immediate impact on clinical laboratories, the increasing use of commercial drones brings drone transportation of lab specimens and other medical supplies one step closer to reality.

—Andrea Downing Peck

Related Information

American Robotics Becomes First Company Approved by FAA to Operate Automated Drones without Human Operators on Site

FAA Decision: Jan. 14, 2021

FAA Approves First Fully Automated Commercial Drone Flights

US Department of Transportation FAA Certificate of Waiver

The FAA Just Greenlit This Drone to Fly Autonomously without a Human Nearby

FAA Approves First Fully Automated Commercial Drone Flights

UPS Expands Drone Delivery Service for Transporting Clinical Laboratory Specimens Across Healthcare Systems to Include Delivering Prescriptions from CVS Pharmacy to Customers’ Homes

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 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 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?

University of East Anglia Researchers Develop Non-Invasive Prostate Cancer Urine Test

The researchers believe their test ‘could reduce the number of unnecessary prostate cancer biopsies by 32%,’ UEA reported

New diagnostic technologies may make it possible for men to provide a urine sample that can allow a clinical laboratory to not only accurately diagnose prostate cancer but also help determine whether it is an aggressive form of prostate cancer. Researchers in the United Kingdom (UK) recently described just such a test in an online, peer-reviewed journal.

Development of a non-invasive method of diagnosing prostate cancer would be significant for anatomic pathologists in the United States. In the US alone, approximately 248,000 men will be diagnosed with this type of cancer in 2021. Prostate biopsies represent a major proportion of case referrals to community pathology groups.

Moreover, were such a non-invasive test for prostate cancer also able to identify those individuals with fast-growing prostate cancers, that would help urologists make more informed treatment decisions.

A Disease Men More Commonly Die ‘With’ Rather than ‘From’

According to CDC statistics, most men over the age of 80 will have some form of slow-growing prostate cancer when they die. However, a percentage of men each year contract a rapidly growing aggressive form of the cancer, and until recently, diagnosing which cancer a patient was fighting often required multiple invasive prostate needle biopsies. But that may soon change.

Researchers at the University of East Anglia (UEA) Norwich Medical School in the United Kingdom (UK) have developed a non-invasive urine test for prostate cancer that they say also can determine the aggressiveness of the disease. Knowing this may help physicians better assess a patient’s risk prior to ordering invasive needle biopsies, a UEA article notes.

The UEA test may also allow for self-collection of the biological sample, and if it proves accurate, the test could bring additional revenue to clinical laboratories that would perform the urine testing.

The UEA researchers published their study in the peer-reviewed open-access journal Cancers, titled, “Integration of Urinary EN2 Protein and Cell-Free RNA Data in the Development of a Multivariable Risk Model for the Detection of Prostate Cancer Prior to Biopsy.”

“In this work we develop a test that predicts whether a patient has prostate cancer and how aggressive the disease is from a urine sample. This model combines the measurement of a protein-marker called EN2 and the levels of 10 genes measured in urine and proves that integration of information from multiple, non-invasive biomarker sources has the potential to greatly improve how patients with a clinical suspicion of prostate cancer are risk-assessed prior to an invasive biopsy,” they wrote.

“While prostate cancer is responsible for a large proportion of all male cancer deaths, it is more commonly a disease men die with rather than from,” said Daniel Brewer, PhD, one of the lead researchers on this study. “Therefore, there is a desperate need for improvements in diagnosing and predicting outcomes for prostate cancer patients to minimize over-diagnosis and overtreatment whilst appropriately treating men with aggressive disease, especially if this can be done without taking an invasive biopsy.

“Invasive biopsies come at considerable economic, psychological, and societal cost to patients and healthcare systems alike,” he added. Brewer is Senior Lecturer in Cancer Bioinformatics and a group leader within the Cancer Genetics Team at UEA’s Norwich Medical School.


“Our new urine test not only shows whether a patient has prostate cancer, but it importantly shows how aggressive the disease is. This allows patients and doctors to select the correct treatment,” said Daniel Brewer, PhD (above), Senior Lecturer and Lead Researcher, UEA Norwich Medical School, in the news release. (Photo copyright: Eastern Daily Press.)

Possibility of Reducing Needle Biopsies by 32%

Called “ExoGrail,” the UEA’s new test builds on their earlier development of the Prostate Urine Risk (PUR) and ExoMeth tests. The test works by integrating two biomarkers.

  • Measurements of EN2, a protein-marker, and
  • Levels of gene expression of 10 genes related to prostate cancer.

The researchers tested ExoGrail on urine samples from 207 patients at Norfolk and Norwich University Hospital (NNUH) who also had needle biopsy samples available.

According to the published study, the UEA ExoGrail urine test enabled:

  • Results comparable to the biopsy findings.
  • Identification of people with prostate cancer and people without it.
  • Risk scoring that noted aggressive prostate cancer and need for biopsy.
  • Potential to reduce unnecessary biopsies by 32%.

“ExoGrail resulted in accurate predictions even when serum PSA [protein-specific antigen] levels alone proved inaccurate; patients with a raised PSA but negative biopsy result possessed ExoGrail scores significantly different from both clinically benign patients and those with low-grade Gleason 6 disease, whilst still able to discriminate between more clinically significant Gleason ≥ 7 cancers,” the researchers stated in their published study.

“The adoption of ExoGrail into current clinical pathways for reducing unnecessary biopsies was considered, showing the potential for up to 32% of patients to safely forgo an invasive biopsy without incurring excessive risk,” they noted.

Prostate Cancer Patients May Soon Have Options

While more research is needed, the new UEA Norwich Medical School ExoGrail test introduces compelling non-invasive methods for diagnosing prostate cancer. Patients with findings of aggressive cancer can proceed to biopsies, while others determined to have non-aggressive forms of prostate cancer may be able to avoid more invasive tests and the associated costs and stress.

Additionally, men may soon be able to collect their own specimens without the need to visit the primary care doctor or a patient service center.

A follow-up study underway at the University of East Anglia and the NNUH involves sending 2,000 men in the UK, Europe, and Canada home testing “prostate screening boxes” to “to collect men’s urine samples at-home,” according to a UEA new release, which noted that “the Prostate Screening Box has been developed in collaboration with REAL Digital International Limited to create a kit that fits through a standard letterbox.”

“We have developed the PUR (Prostate Urine Risk) test, which looks at gene expression in urine samples and provides vital information about whether a cancer is aggressive or ‘low risk,’” said Jeremy Clark, PhD, Senior Research Associate at UEA’s Norwich Medical School.

“The Prostate Screening Box part sounds like quite a small innovation, but it means that in future the monitoring of cancer in men could be so much less stressful for them and reduce the number of expensive trips to the hospital,” he added.

Anatomic pathologists and clinical laboratory managers will want to follow the progress of these clinical studies. A non-invasive, urine-based test for prostate cancer could be a game-changer if it can detect prostate cancer with comparable accuracy to the tissue-based diagnostics that are the current standard of care in the diagnosis of prostate cancer.

—Donna Marie Pocius

Related Information:

Integration of Urinary EN2 Protein and Cell-Free RNA Data in the Development of a Multivariable Risk Model for the Detection of Prostate Cancer Prior to Biopsy

New Prostate Cancer Urine Test Shows How Aggressive Disease Is and Could Reduce Invasive Biopsies

Tests to Diagnose and Stage Prostate Cancer

Prostate Cancer Key Statistics

UEA Researchers Develop Prostate Cancer Test That Could Reduce Biopsies

Thousands of Men to Trial Prostate Cancer Home Testing Kit

Popular Science Review Finds Seven At-Home COVID-19 Antigen Tests ‘Easy to Use’ and ‘An Important Tool to Slow Spread of the Coronavirus’

Though clinical laboratory RT-PCR tests remain the ‘gold standard’ when diagnosing COVID-19, at-home antigen tests offer convenience and quick test results. But are they accurate?

Less than six months after the US Food and Drug Administration (FDA) issued the first ever emergency use authorization (EUA) for an over-the-counter SARS-CoV-2 diagnostic test to Ellume for its COVID-19 at-home antigen test, the number of do-it-yourself at-home tests available to consumers has grown large enough for Popular Science to publish a review of available consumer COVID-19 testing kits.

Clinical laboratory and pathologists generally acknowledge that RT-Polymerase Chain Reaction (RT-PCR) tests remain the preferred method for detecting COVID-19 disease. However, according to Popular Science, rapid at-home antigen tests that accurately identify people carrying larger loads of the virus are becoming important tools in the fight against spread of the coronavirus.

In “We Vetted Popular At-Home COVID-19 Tests. Here’s What We Learned: Everything you need to know about the growing number of at-home testing options for COVID,” Popular Science evaluated the ease-of-use and effectiveness of the following tests:

Many of the newest at-home tests not only have users collect their own swab or saliva samples, but some also provide results in less than an hour, which can be sent to the user’s smartphone. Conversely, home-based collection kits that are returned to clinical laboratories for testing can take 48 hours or longer for shipping and processing.

The FDA’s emergency use authorization announcement (EUA) for Ellume’s $38.99 COVID-19 At Home Test (above) states the test “is a rapid, lateral flow antigen test, a type of test that runs a liquid sample along a surface with reactive molecules. The test detects fragments of proteins of the SARS-CoV-2 virus from a nasal swab sample from any individual two years of age or older.” Ellume’s self-collection test was the first such test to receive an FDA EUA for use without a physician’s order. (Photo copyright: Ellume).

Are At-Home COVID-19 Tests a Good Idea?

“The more we can do simple, regular, at-home testing, the less we need it,” Mara Aspinall, Professor, College of Health Solutions at Arizona State University, told Popular Science. “It’ll become a habit, as easy as brushing your teeth,” she added.

But in “Pathologists Urge Caution on At-Home COVID Test Kits,” MedPage Today, reporting on the College of American Pathologists (CAP) March 11 virtual media briefing, pointed out downsides to at-home COVID-19 tests.

Among the issues cited were the potential for inadequate samples and improper handling to cause inaccurate results, as well as uncertainty whether at-home antigen tests will pick up on COVID-19 variants.

At-home tests also are less likely to be covered by insurance, MedPage Today reported.

During the CAP virtual media briefing, pathologist Kalisha Hill, MD (above), Chief Medical Officer and Chair, Department of Pathology and Medical Director, Laboratory Services, at AMITA Health St. Mary’s Kankakee (Ill.), said, “The gold standard is still a laboratory-performed real-time PCR test and that is the most sensitive and most accurate that we do that is very specific for COVID-19.” Hill called at-home tests a “good screening tool,” but she noted, “You’re testing that moment, that day, and as soon as you leave your home or come in contact with someone else, you could potentially be COVID positive. It’s also important to recognize that when you’re collecting a sample yourself, you may not be able to obtain enough sample for an accurate result … It’s very important how it is collected and also the sensitivity and specificity of the test,” she added. (Photo copyright: AMITA Health/LinkedIn.)

How Do the Tests’ Accuracy Compare?

The Quest Direct and LabCorp Pixel tests—both of which are sent to company labs for PCR testing—scored highest on the two main statistical measures of performance sensitivity (positive percent agreement) and specificity (negative percent agreement). According to Popular Science, each of these tests’ sensitivities and specificities are close to 100%.

According to the websites of the other tests reviewed by Popular Science:

  • DxTerity test, which uses a saliva sample—97.2% sensitivity and a 92.5% specificity.
  • BinaxNOW test—84.6% sensitivity and 98.5% specificity.
  • Cue COVID-19 test—98.7% sensitivity and 97.6% specificity.
  • Lucira Check Its test—98% accuracy.
  • Ellume test—95% sensitivity and 97% specificity.

Rapid Antigen Tests Accurate and Easy to Use, says Popular Science

Popular Science found the tests generally easy to use and concluded they are a beneficial—if imperfect—tool in the fight against COVID-19.

“If you’re unvaccinated and symptomatic, they’re a great way to confirm a COVID-19 infection without risking a trip out of the house,” Popular Science stated in its article. “If you’re unvaccinated and have no symptoms, and just want to know whether you can safely attend a family dinner or soccer game, an at-home test remains an imperfect way of self-screening. Remember: If the test comes back negative, there’s still the chance the result is false, and you could accidentally expose others by being within six feet of them without a mask on.”

As the popularity of at-home COVID-19 tests increases, clinical laboratories that perform RT-PCR tests may want to keep a watchful eye on the demand for at-home rapid antigen testing, especially now that some tests are available without prescription.

Andrea Downing Peck

Related Information:

We Vetted Popular At-Home COVID-19 Tests. Here’s What We Learned

Coronavirus (COVID-19) Update: FDA Authorizes Antigen Test as First Over-the-Counter Fully At-Home Diagnostic Test for COVID-19

Pathologists Urge Caution On At-Home COVID Test Kits

The Rapidly Changing COVID-19 Testing Landscape: Vaccines, Variants, and Health Disparities

Cue COVID-19 Test for Home and Over-the-Counter (OTC) Use

DxTerity SARS-CoV-2 RT-PCR Test EUA Summary

Ellume’s COVID-19 Home Test Shows 96% Accuracy in Multi-Site US Clinical Study

Wall Street Journal Investigation Finds Computer Code on Hospitals’ Websites That Prevents Prices from Being Shown by Internet Search Engines, Circumventing Federal Price Transparency Laws

In a letter, Congress urged the HHS Secretary to conduct “vigorous oversight and enforces full compliance with the final rule”

Analysis of more than 3,100 hospital websites by The Wall Street Journal (WSJ) has found “hundreds” containing embedded code that prevents search engines from displaying the hospitals’ prices. This is contrary to the Hospital Price Transparency Final Rule (84 FR 65524), passed in November 2019, which requires hospitals to “establish, update, and make public a list of their standard charges for the items and services that they provide,” including clinical laboratory test prices.

“Hundreds of hospitals embed code in their websites that prevented Alphabet Inc.’s Google and other search engines from displaying pages with the price lists,” the WSJ reported. “Among websites where [the WSJ] found the blocking code were those for some of the biggest US healthcare systems and some of the largest hospitals in cities including New York and Philadelphia.”

Additionally, the WSJ found hospitals were finding ways to “hide” the price lists they did display deep within their websites. The prices can be found, but the effort involves “clicking through multiple layers of pages,” on the providers’ websites, the WSJ added.

Lawmakers Put Pressure on CMS

The WSJ report drew the attention of federal lawmakers who weighed in on the current state of hospital price transparency and on the WSJ’s findings in a letter to Xavier Becerra, Secretary of the federal Department Health and Human Services (HHS).

In their letter, members of the Congressional Committee on Energy and Commerce called for HHS “to revisit its enforcement tools, including the amount of civil penalty, and to conduct regular audits of hospitals for compliance.”  

Committee members wrote, “The Hospital Price Transparency Final Rule requires hospitals to make public a machine-readable file containing a list of all standard charges for all items and services and to display charges for the hospital’s 300 most ‘shoppable’ services in a consumer-friendly format. We are concerned about troubling reports of some hospitals either acting slowly to comply with the requirements of the final rule or not taking any action to date to comply.”

The letter, which was signed by the committee’s Chairman Frank Pallone (D, New Jersey) and Committee Ranking Member Cathy McMorris Rodgers (R, Washington State), cited the WSJ investigation as well as other analyses of price transparency at US hospitals.

Cynthia Fisher founder of Patient Rights Advocate
Cynthia Fisher (above), founder of Patient Rights Advocate, told The Wall Street Journal, “In the past there was absolutely no power for the consumer. It was like highway robbery being committed every day by the healthcare system.” Now, Fisher added, “it’s the American consumer who is going to drive down the cost of care.” Clinical laboratories will note that consumer demand for, and federal regulation of, price transparency is not limited to hospitals. All healthcare providers need procedures in place that comply with federal guidelines for transparency. (Photo copyright: Morning Consult.)

Additional Studies Show Major Hospitals “Non-Compliant”

One such study cited by the Congressional committee in its letter to HHS was conducted by Health Affairs, which looked into transparency compliance at 100 hospitals. In a blog post, titled, “Low Compliance from Big Hospitals on CMS’s Hospital Price Transparency Rule,” the study authors wrote “our findings were not encouraging: Of the 100 hospitals in our sample, 65 were unambiguously noncompliant.

“Of these 65,” they added:

  • “12/65 (18%) did not post any files or provided links to searchable databases that were not downloadable.
  • “53/65 (82%) either did not include the payer-specific negotiated rates with the name of payer and plan clearly associated with the charges (n = 46) or were in some other way noncompliant (n = 7).

“We are troubled by the finding that 65 of the nation’s 100 largest hospitals are clearly noncompliant with this regulation. These hospitals are industry leaders and may be setting the industrywide standard for (non)compliance; moreover, our assessment strategy was purposefully conservative, and our estimate of 65% noncompliance is almost certainly an underestimate,” Health Affairs concluded.

A previous similar investigation by The Washington Post called compliance by hospitals with the pricing disclosure rules “spotty.”

In “The Health 202: Hospitals Drag Feet on New Regulations to Disclose Costs of Medical Services,” Ge Bai, PhD, Associate Professor of Practice, Johns Hopkins Carey Business School, an expert on healthcare pricing, wrote, “Hospitals are playing a hide-and-seek-game. Even with this regulation, most of them are not being fully transparent.”  

Are Hospitals Confused by the Final Rule?

So, why is complying with the federal price transparency rule so challenging for the nation’s largest hospitals? In its reporting on the Wall Street Journal analysis, Gizmodo wrote, “we’ve seen healthcare providers struggle to implement the new law due, in part, to how damn ambiguous it is. Past reports have pointed out that the vague requirements hoisted onto hospitals as part of these new rules often result in these pricing lists being difficult—if not downright—impossible to find, even if the lists are technically ‘machine-readable’ and ‘on the internet.’”

“Meanwhile,” Gizmodo continued, “as [the WSJ] points out, the order doesn’t specify exactly how much detail these hospitals are even supposed to offer on their pricing sheets—meaning that it’s up to the hospitals whether they want to include rates pertaining to specific health insurance plans, or whether they want to simply include different plan’s rates in aggregate.”

And in their letter to HHS, the Congressional committee wrote, “… some hospitals are providing consumers a price estimator tool instead of providing the full list of charges and payer-negotiated rates in one file, and some are making consumers fill out lengthy forms for estimates. Some hospitals also are providing the data in a non-useable format or failing to provide the codes for items and services.”

Clinical Laboratories Must Comply with Price Transparency Rules

Clearly, transparency in healthcare has a long way to go. Nevertheless, hospital medical laboratory leaders should expect reinforcing guidance from CMS on making price information on commonly used clinical laboratory tests fully accessible, understandable, and downloadable.  

As Dark Daily noted in previous coverage, consumer demand for price transparency is only expected to increase. Clinical laboratories need to have a strategy and process for helping consumers and patients see test prices in advance of service.

—Donna Marie Pocius

Related Information:

Hospitals Hide Pricing Data from Search Results

Coding to Hide Health Prices from Web Searches is Barred by Regulators

CMS Bands Coding Hospitals Use to Hide Prices from Web Searches

U.S. House of Representatives Committee on Energy and Commerce Letter to Xavier Becerra, HHS Secretary

Low Compliance from Big Hospitals on CMS’s Hospital Price Transparency Rule

The Health 202: Hospitals Drag Feet on New Regulation to Disclose Costs of Medical Services

Hospitals are Reportedly Hiding Federal Mandated Pricing Data from Search Engines

Hospitals Post Previously Secret Prices but Good Luck Trying to Find Them

Academic Institutions Still Rely Heavily on COVID-19 Symptom-Checking Technology Despite Questions About Its Usefulness

A New York Times report suggests that frequent testing is still the best approach to controlling spread of the SARS-CoV-2 coronavirus

Many colleges and universities go to great lengths to screen their students for signs of COVID-19 using technologies that include fever scanners, heart-rate monitors, and symptom-checking apps. But a recent report in The New York Times, titled, “Colleges That Require Virus-Screening Tech Struggle to Say Whether It Works,” suggests that academic institutions would be better off adopting frequent clinical laboratory testing for the SARS-CoV-2 coronavirus, even if it is more expensive than symptom screening.

This shouldn’t be a surprise to pathologists and other medical laboratory professionals who have followed news and research about the pandemic. Back in Sept. 2020, the federal Centers for Disease Control and Prevention (CDC) in a media statement noted that “symptom-based screening has limited effectiveness because people with COVID-19 may have no symptoms or fever at the time of screening, or only mild symptoms.”

That same month, Medscape reported that presidential advisor Anthony Fauci, MD, said, “It is now clear that about 40%-45% of infections are asymptomatic.”

But this hasn’t prevented educational institutions from investing in costly screening technologies. One cited by The New York Times (NYT) was the University of Idaho, where 9,000 students live on or near campus. The university has spent $90,000 on fever scanners resembling airport metal detectors, the paper reported, but as of early March, the units had identified fewer than 10 people with high skin temperatures.

“Even then, university administrators could not say whether the technology had been effective because they have not tracked students flagged with fevers to see if they went on to get tested for the virus,” the NYT reported, adding that many other institutions that adopted screening technologies have failed to systematically measure the effectiveness of these approaches.

“The moral of the story is you can’t just invest in this tech without having a validation process behind it,” infectious-disease epidemiologist Saskia Popescu PhD, MPH, of George Mason University told The New York Times.

Rising COVID-19 Infections on College Campuses

These efforts have come amid increasing COVID-19 infection rates on many US campuses. In “Cases Rise, Restrictions Begin,” Inside Higher Ed reported that large universities were doing better than they had in the fall 2020 semester, but that “other campuses—including those that kept cases low in the fall—are seeing numbers rise.” One such campus was Boston College, which cast blame on students who were not following safety protocols.

For its story, The New York Times surveyed more than 1,900 US colleges and universities as part of an effort to track outbreaks on campus. Respondents reported more than 120,000 campus-related COVID-19 cases between Jan. 1 and March 2, 2021, but because institutions measure outbreaks in different ways, the NYT reported that this is likely an undercount. Overall, institutions reported more than 535,000 cases since the pandemic began, according to the survey.

Clinical Laboratory Testing Still Ongoing on College Campuses

School administrators told The New York Times that despite questions about the usefulness of screening tools, this approach is still worthwhile as reminders for students to follow other protocols, such as mask wearing.

And universities have not abandoned testing for COVID-19. For example, The New York Times noted that students at the University of Idaho are tested at least twice each semester, and the school is also testing wastewater to identify outbreaks of SARS-CoV-2.

The Ohio State News, a publication of Ohio State University, reported in late February that it had tested 30,000 people in a single week, accounting for 12% of the COVID-19 tests conducted in Ohio. At the start of the fall semester, the university was sending test samples to a private company in New Jersey, but later it began processing samples at the on-campus Applied Microbiology Services Lab (AMSL).

“By the start of spring semester, the AMSL was processing about 85% of Ohio State’s COVID-19 tests,” the university reported, for a likely savings of $30 million to $40 million. Leaders of the testing program expect that they can realistically conduct 35,000 tests per week.

Chris Marsicano, PhD from interview screenshot
Chris Marsicano, PhD (above), a professor and researcher at Davidson College, told Inside Higher Ed that many institutions are relying on antigen testing, which is less costly but also less reliable than PCR (polymerase chain reaction) tests. “PCR tests are expensive,” he said. “Just because you’re testing multiple times a week doesn’t mean you’re catching all the cases.” Marsicano leads the institution’s College Crisis Initiative. Clinical laboratory leaders can attest to Marsicano’s statement. (Photo copyright: Twitter.)

Using Technology for COVID-19 Contact Tracing

In addition to symptom screening, some universities have adopted technologies that track student movement on campus for contact-tracing purposes. But again, the benefits are questionable. For example, Bridgewater State University in Bridgewater, Mass. asked students to scan QR codes at various locations, but only one-third were doing so, The New York Times reported. Another system at the university records entry to campus buildings when students swipe their IDs.

“We found what we need is tests and more tests,” clinical psychologist Christopher Frazer, Psy.D., Executive Director of the university’s wellness center, told The New York Times. He said that students on campus are tested once a week. When they have tested positive, contact tracers “often learned much more about infected students’ activities by calling them than by examining their location logs,” the NYT reported.

Colleges and universities are also banking on vaccination to reduce the spread of the virus, Inside Higher Ed reported. Some will require all students to be vaccinated for the fall semester, but such mandates are facing legal and political hurdles. For example, executive orders by Texas Governor Greg Abbott and Florida Governor Ron DeSantis may prohibit institutions in those states from imposing vaccination requirements.

As colleges and universities struggle to deal with the challenges of COVID-19, clinical laboratories have resources for staying up to date on current testing and tracking technologies in use on campuses. For example, the CDC is funding a program to facilitate sharing of best practices and other information. Inside Higher Ed reported that the Higher Education COVID-19 Community of Practice (CoP) will include a discussion board, webinars, and a searchable database of info uploaded by participating institutions.

—Stephen Beale

Related Information:

Colleges That Require Virus-Screening Tech Struggle to Say Whether It Works

New Effort Shares COVID-Fighting Practices

Behavioral Change Approaches to Promote COVID-19 Mitigation Behaviors Among Students

Vaccine Mandates: The Next Political Battlefront

Large Institutions Reporting Fewer COVID-19 Infections Now Than Fall

Cases Rise (Again) on College Campuses

Colleges Promise Return to In-Person Classes for Fall

Coronavirus Cases Around Colleges and Universities Are Colleges Superspreaders?