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Clinical Laboratories and Pathology Groups

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Clinical Laboratories and Pathology Groups

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Four Regulatory Developments Coming This Fall That Are Relevant for Clinical Laboratory Leaders and Pathology Group Managers

Regulators and lawmakers are considering proposed changes to CLIA and PAMA involving medical laboratory services

Clinical laboratories and pathology groups should monitor a series of federal regulatory developments underway this fall. The proposals and documents will potentially affect how lab managers and staff do their jobs and how much Medicare reimbursement medical laboratories receive for certain diagnostic tests next year.

Among the initiatives under consideration are the following:

Below are details about these laboratory-related federal bills and regulatory documents that observant laboratory managers will want to track in the coming months.

“Clinical laboratories need to make sure that they have proper requisitions and documentation for genetic testing that involves telemedicine.” Danielle Tangorre, JD (above), a partner at law firm Robinson and Cole LLP in Albany, NY, told Dark Daily. (Photo copyright: Robinson and Cole LLP.)

CLIA Fee Increases and Testing Personnel Changes

The federal Centers for Medicare and Medicaid Services (CMS) is examining fee and personnel changes for CLIA. Officials from CMS are reviewing public comments on the proposal ahead of publishing a final rule.

Among other changes, the proposal would:

  • Institute a 20% across-the-board increase on existing fees.
  • Establish a biennial increase of CLIA fees for follow-up surveys, substantiated complaint surveys, and revised certificates.
  • Add doctoral, master’s, and bachelor’s degrees in nursing to qualify testing personnel for high and moderate complexity testing.

As The Dark Report noted in “Clinical Laboratories Face 20% Increase in CLIA Fees,” opposition to the new nurse qualifications is coming from the American Hospital Association (AHA) and other groups. (If you are not a subscriber to The Dark Report, you can start a free trial by clicking here.)

Seven Characteristics of Potential Telemedicine Fraud That Affect Clinical Laboratories

In July, on the heels of federal prosecutors indicting 13 defendants for alleged genetic testing and telemedicine fraud, the US Department of Health and Human Services Office of Inspector General (OIG) issued a warning about telemedicine fraud.

The Special Fraud Alert, “OIG Alerts Practitioners to Exercise Caution When Entering into Arrangements with Purported Telemedicine Companies,” outlines seven “suspect characteristics” of telemedicine that might point to fraudulent Medicare billing.

The characteristics include:

  • “The Practitioner does not have sufficient contact with or information from the purported patient to meaningfully assess the medical necessity of the items or services ordered or prescribed.
  • “The Telemedicine Company compensates the Practitioner based on the volume of items or services ordered or prescribed, which may be characterized to the Practitioner as compensation based on the number of purported medical records that the Practitioner reviewed.
  • “The Telemedicine Company only furnishes items and services to Federal health care program beneficiaries and does not accept insurance from any other payor.
  • “The Telemedicine Company does not expect Practitioners (or another Practitioner) to follow up with purported patients nor does it provide Practitioners with the information required to follow up with purported patients (e.g., the Telemedicine Company does not require Practitioners to discuss genetic testing results with each purported patient).”
  • And more.

“In the telehealth space, the issue the OIG has flagged is that genetic tests are being ordered without patient interaction or with only brief telephonic conversations,” Danielle Tangorre, JD, a partner at law firm Robinson & Cole LLP in Albany, N.Y., told Dark Daily.

New Bill May Eliminate 2023 Medical Laboratory Payment Cuts Under PAMA

Medical labs and pathology groups face payment cuts of up to 15% for 800 lab tests on the Medicare Clinical Lab Fee Schedule (CLFS) on Jan. 1, 2023, as part of PAMA.

However, a bipartisan bill is before Congress that may change things. The Saving Access to Laboratory Services Act (SALSA) seeks to accomplish three things:

  • Eliminate the scheduled Jan. 1 price cuts.
  • Reduce future payment decreases to the Medicare CLFS under PAMA.
  • Reconfigure how CMS calculates lab test payments for the CLFS.

At last check, the bill was before the Senate Finance Committee. Proponents are hopeful a vote will come before PAMA’s Jan. 1 cuts occur.

The Dark Report explored the SALSA Act in detail in “PAMA Cuts Might Be Reduced to Zero for 2023.”

Changes to LDT Oversight in VALID Act Sidelined for Now

In “Proposed FDA Approval of Laboratory Developed Tests Will Reduce Innovation,” Dark Daily reported on the Verifying Accurate Leading-Edge IVCT Development Act (VALID Act) and why its opponents believe it stifles diagnostic innovation.

The bill proposes to move regulatory oversight of LDTs from CLIA to the federal Food and Drug Administration (FDA). Champions of the bill argue that FDA regulation is needed for in vitro clinical tests (IVCTs) because they are similar to medical devices and bring with them patient safety concerns.

The bill seemed ready for a Senate vote over the summer but stalled. On Sept. 30, Congress passed a short-term resolution to keep the federal government funded. During negotiation, the VALID Act was removed from the larger spending package, according to Boston law firm Ropes and Gray.

Expect discussion to renew in Congress about the VALID Act after the mid-term elections.

Clinical laboratory leaders and pathology group managers will want to closely monitor the progress of these four federal legislative and regulatory developments. Each of the possible actions described above would significantly change the status quo in the compliance requirements and reimbursement arrangements for both clinical laboratory testing and anatomic pathology services.

Scott Wallask

Related Information:

Clinical Laboratories Face 20% Increase in CLIA Fees

OIG Alerts Practitioners to Exercise Caution when Entering into Arrangements with Purported Telemedicine Companies

PAMA Cuts Might Be Reduced to Zero for 2023

Proposed FDA Approval of Laboratory Developed Tests Will Reduce Innovation

Congress Enacts Clean Reauthorization of FDA User Fees, Leaving Uncertain Future for Important Policy Reforms

Clinical Laboratory and Pathology Leaders in Canada Gather to Assess New Diagnostic Technologies and Respond to the Acute Shortage of Medical Technologists

There was cautious optimism about the ability of Canada’s medical laboratories to innovate in ways that advance patient care, while recognizing the ongoing challenge of adequate lab staffing and budget constraints

TORONTO, ONTARIO, CANADA—This week, more than 150 leaders representing clinical laboratories, anatomic pathology labs, in vitro diagnostics (IVD) companies, and provincial health officials gathered for the first “Canadian Diagnostic Executive Forum” (CDEF) since 2019. It would be apt to say that the speakers objectively addressed all the good, the bad, and the ugly of Canada’s healthcare system and its utilization of medical laboratory testing services.

Over the two days of the conference, speakers and attendees alike concurred that the two biggest issues confronting clinical laboratories in Canada were inadequate staffing and an unpredictable supply chain. There also was agreement that the steady increase in prices, fueled by inflation, is exacerbating continuing cost increases in both lab salaries and lab supplies.

Canada’s Health System Has Several Unique Attributes

Canada’s healthcare system has two unique attributes that differentiate it from those of other nations. First, healthcare is mandated by a federal law, but generally each of Canada’s 13 provinces and territories operates its own health plan. Thus, the health system in each province and territory may cover a different mix of clinical services, therapeutic drugs, and medical procedures. The federal government typically pays 40% of a province’s health costs and the province funds the balance.

Second, it is a fact that 90% of the Canadian population lives within 150 miles of the United States border. Yet there are provinces with large populations that have geography that ranges from the US border to north of the Arctic Circle. These provinces have a major challenge to ensure equal access to healthcare regardless of where their citizens live.

During day one of the conference, several presentations addressed innovations that supported those labs’ efforts to deliver value and timely insights during the COVID-19 pandemic. For example, a lab team in Alberta launched a research study involving SARS-CoV-2 virus surveillance from the earliest days of the outbreak. This study was presented by Mathew Diggle, PhD, FRCPath, Associate Professor and Program Lead for the Public Health Laboratory (ProvLab) Medical-Scientific Staff at Alberta Precision Laboratories in Edmonton, Alberta. 

Study Designed to Identify Coinfections with COVID-19

While performing tens of thousands of COVID-19 tests from the onset of the pandemic, and identifying the emergence of variants, the ProvLab team also tracked co-infection involving other respiratory viruses.

“This is one of the largest eCoV [endemic coronavirus] studies performed during the COVID-19 pandemic,” Diggle said. “This broad testing approach helped to address a pivotal diagnostic gap amidst the emergence of a novel pathogen: cross-reactivity with other human coronaviruses that can cause similar clinical presentations. This broad surveillance enabled an investigation of cross-reactivity of a novel pathogen with other respiratory pathogens that can cause similar clinical presentations.

“Fewer than 0.01% of specimens tested positive for both SARS-CoV-2 and an eCoV,” he explained. “This suggested no significant cross-reactivity between SARS-CoV-2 and eCoVs on either test and provided a SARS-CoV-2 negative predictive value over 99% from an eCoV-positive specimen … The data we collected was highly compelling and the conclusion was that there was no coinfection.”

Kevin D. Orr

Chairing the two days of presentations at this weeks’ Canadian Diagnostic Executive Forum was Kevin D. Orr (above), Senior Director of Hospital Business at In-Common Laboratories. He also served on the program for this national conference serving clinical laboratories, anatomic pathology labs, and in vitro diagnostics (IVD) companies throughout Canada. This was the first gathering of this conference since 2019. Attendees were enthusiastic about the future of medical laboratory services in Canada, despite lab staffing shortages and rising costs due to inflation. (Photo copyright The Dark Report.)

Clinical Laboratory Regionalization in Quebec

One of Canada’s largest projects to regionalize and harmonize clinical laboratory services is proceeding in Quebec. Leading this effort is Ralph Dadoun, PhD, Project Director for OPTILAB Montreal, which is part of the Ministry of Health and Social Services in Quebec. The ambitious goal for this project is to move the 123 clinical laboratories within the province into 12 clusters. Initial planning was begun in 2013, so this project is in its ninth year of implementation.

During his presentation, Dadoun explained that the work underway in the 12 clusters involves creating common factors in these categories:

  • Uniform test names.
  • Common test codes, labels, test reporting format.
  • Common abbreviations.
  • Uniform quality indicators (e.g., nonconformities, specimen acceptability, etc.).
  • Implementation consistent with and respecting ISO-15189 criteria.

Another notable achievement in Quebec is the progress made to implement a common laboratory information system (LIS) within all 12 clusters. The first three laboratory clusters are undergoing their LIS conversions to the same platform during the next 180 days. The expectation is that use of a common LIS across all clinical laboratory sites in Quebec will unlock benefits in a wide spectrum of lab activities and work processes.

The 2022 CDEF featured speakers from most of the provinces. The common themes in these presentations were the shortage of lab personnel across all technical positions, disruptions in lab supplies, and the need to support the usual spectrum of lab testing services even as lab budgets are getting squeezed.

At the same time, there was plenty of optimism. Presentations involving adoption of digital pathology, advances in early disease detection made possible by new diagnostic technologies, and the expansion of precision medicine showed that clinical laboratories in Canada are gaining tools that will allow them to contribute to better patient care while helping reduce the downstream costs of care.

The Canadian Diagnostics Executive Forum is organized by a team from In-Common Laboratories in North York, Toronto, Ontario. Founded in 1967, it is a private, not-for-profit company that works with public hospitals and laboratory medicine providers. Information about CDEF can be found at its website, where several of this year’s presentations will be available for viewing.

Robert L. Michel 

Related Information:

Canadian Diagnostic Executive Forum 2022

Broad Respiratory Testing to Identify SARS-Cov-2 Viral Co-Circulation and Inform Diagnostic Stewardship in the COVID-19 Pandemic

Canadian Diagnostics Executive Forum Will Provide Firsthand Insights into How Clinical Laboratories Can Leverage Technology and Innovation to ‘Do More with Less’

Researchers Create Artificial Intelligence Tool That Accurately Predicts Outcomes for 14 Types of Cancer

Proof-of-concept study ‘highlights that using AI to integrate different types of clinically informed data to predict disease outcomes is feasible’ researchers say

Artificial intelligence (AI) and machine learning are—in stepwise fashion—making progress in demonstrating value in the world of pathology diagnostics. But human anatomic pathologists are generally required for a prognosis. Now, in a proof-of-concept study, researchers at Brigham and Women’s Hospital in Boston have developed a method that uses AI models to integrate multiple types of data from disparate sources to accurately predict patient outcomes for 14 different types of cancer.

The process also uncovered “the predictive bases of features used to predict patient risk—a property that could be used to uncover new biomarkers,” according to Genetic Engineering and Biotechnology News (GEN).

Should these research findings become clinically viable, anatomic pathologists may gain powerful new AI tools specifically designed to help them predict what type of outcome a cancer patient can expect.

The Brigham scientists published their findings in the journal Cancer Cell, titled, “Pan-cancer Integrative Histology-genomic Analysis via Multimodal Deep Learning.”

Faisal Mahmood, PhD

“Experts analyze many pieces of evidence to predict how well a patient may do. These early examinations become the basis of making decisions about enrolling in a clinical trial or specific treatment regimens,” said Faisal Mahmood, PhD (above) in a Brigham press release. “But that means that this multimodal prediction happens at the level of the expert. We’re trying to address the problem computationally,” he added. Should they be proven clinically-viable through additional studies, these findings could lead to useful tools that help anatomic pathologists and clinical laboratory scientists more accurately predict what type of outcomes cancer patient may experience. (Photo copyright: Harvard.)

AI-based Prognostics in Pathology and Clinical Laboratory Medicine

The team at Brigham constructed their AI model using The Cancer Genome Atlas (TCGA), a publicly available resource which contains data on many types of cancer. They then created a deep learning-based algorithm that examines information from different data sources.

Pathologists traditionally depend on several distinct sources of data, such as pathology images, genomic sequencing, and patient history to diagnose various cancers and help develop prognoses.

For their research, Mahmood and his colleagues trained and validated their AI algorithm on 6,592 H/E (hematoxylin and eosin) whole slide images (WSIs) from 5,720 cancer patients. Molecular profile features, which included mutation status, copy-number variation, and RNA sequencing expression, were also inputted into the model to measure and explain relative risk of cancer death. 

The scientists “evaluated the model’s efficacy by feeding it data sets from 14 cancer types as well as patient histology and genomic data. Results demonstrated that the models yielded more accurate patient outcome predictions than those incorporating only single sources of information,” states a Brigham press release.

“This work sets the stage for larger healthcare AI studies that combine data from multiple sources,” said Faisal Mahmood, PhD, Associate Professor, Division of Computational Pathology, Brigham and Women’s Hospital; and Associate Member, Cancer Program, Broad Institute of MIT and Harvard, in the press release. “In a broader sense, our findings emphasize a need for building computational pathology prognostic models with much larger datasets and downstream clinical trials to establish utility.”

Future Prognostics Based on Multiple Data Sources

The Brigham researchers also generated a research tool they dubbed the Pathology-omics Research Platform for Integrative Survival Estimation (PORPOISE). This tool serves as an interactive platform that can yield prognostic markers detected by the algorithm for thousands of patients across various cancer types.  

The researchers believe their algorithm reveals another role for AI technology in medical care, but that more research is needed before their model can be implemented clinically. Larger data sets will have to be examined and the researchers plan to use more types of patient information, such as radiology scans, family histories, and electronic medical records in future tests of their AI technology.

“Future work will focus on developing more focused prognostic models by curating larger multimodal datasets for individual disease models, adapting models to large independent multimodal test cohorts, and using multimodal deep learning for predicting response and resistance to treatment,” the Cancer Cell paper states.

“As research advances in sequencing technologies, such as single-cell RNA-seq, mass cytometry, and spatial transcriptomics, these technologies continue to mature and gain clinical penetrance, in combination with whole-slide imaging, and our approach to understanding molecular biology will become increasingly spatially resolved and multimodal,” the researchers concluded.  

Anatomic pathologists may find the Brigham and Women’s Hospital research team’s findings intriguing. An AI tool that integrates data from disparate sources, analyzes that information, and provides useful insights, could one day help them provide more accurate cancer prognoses and improve the care of their patients.   

JP Schlingman

Related Information:

AI Integrates Multiple Data Types to Predict Cancer Outcomes

Pan-cancer Integrative Histology-genomic Analysis via Multimodal Deep Learning

New AI Technology Integrates Multiple Data Types to Predict Cancer Outcomes

Artificial Intelligence in Digital Pathology Developments Lean Toward Practical Tools

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

Artificial Intelligence and Computational Pathology

Patients Still Receive Surprise Medical Bills, Including for Medical Laboratory Testing, Despite Enactment of Federal No Surprises Act That Became Law on Jan. 1, 2022

Survey respondents specifically mentioned clinical laboratory charges as part of the balance billing they were receiving

Unexpected medical bills—which often include clinical laboratory test and pathology charges—are still arriving in patients’ mailboxes, even though the federal No Surprises Act (H.R.3630) was passed as part of the Consolidated Appropriations Act, 2021 specifically to prevent that from happening.

According to a survey conducted by Morning Consult, a global research firm with offices in New York, Washington, D.C., and San Francisco, 20% of patients said they or a family member received an unexpected medical bill in 2022.

Notably, survey respondents specifically mentioned charges for clinical laboratory testing as part of the unanticipated balance billing they received.

“Adults who received unexpected bills this year were most likely to get them for in-network lab work that was sent to an out-of-network lab for assessment, which is covered under the law, or for testing or procedures not covered by insurance, which isn’t,” a Morning Consult news release noted.

Morning Consult polled more than 2,000 adults between June 22 and June 24, 2022, according to the published results.

Matt Eyles

“The No Surprises Act ended the practice of surprise medical billing in most circumstances, providing relief for millions of patients who faced surprise medical bills they did not expect,” said Matt Eyles (above), President/CEO, America’s Health Insurance Plans, in an AHIP news release. “But more work needs to be done,” he added. Clinical laboratory managers should be aware of the federal law before balance billing their patients. (Photo copyright: Business Wire.)

When the Law Works, and When It Does Not

In “Judge Vacates Provision in No Surprises Act,” Dark Daily’s sister publication, The Dark Report, explained that the No Surprises Act aims to protect insured individuals from receiving unexpected medical bills for unanticipated emergency care or services—including clinical lab tests—that they unknowingly received from out-of-network providers.

However, certain provisions of the law can counteract its intention.

“[The No Surprises Act] doesn’t apply if a patient goes to his or her own primary care physician, or another doctor in the community, and that doctor sends that patient to an out-of-network laboratory,” healthcare attorney Charles Dunham IV, a shareholder at law firm Greenberg Traurig LLP in Houston, told The Dark Report. “In general, it applies to emergency services or a non-emergency service where the patient is in an inpatient or outpatient setting in a hospital that’s in network, and they utilize a lab that’s out of network.”

Bills for Lab Tests, Other Services Surprise Patients

Healthcare services cited by the most respondents to the Morning Consult survey that resulted in unexpected medical bills include:

  • Testing or procedures not covered by insurance, 34%.
  • Lab work at an in-network hospital or healthcare facility that was sent to an out-of-network lab for assessment, 32%.
  • Treatment by an out-of-network physician or specialist at an in-network hospital or healthcare facility, 21%.
  • Treatment at an out-of-network hospital or healthcare facility, 19%.
  • Transportation to an emergency department by an out-of-network ambulance, 18%.

Clinical laboratory testing was at the top of the unexpected charges, which were typically more than $1,000, according to 22% of those who received balance billing.

Could Billing Disputes Escalate?

Anatomic pathology practices, medical laboratories, and other providers who fail to comply with the No Surprises Act may be at risk. And, unfortunately, a Health Care Cost Institute study in 2020 found pathologists second only to emergency medicine physicians as specialists who most often bill for out-of-network hospital charges, according to a Dark Daily e-briefing.

“It’s possible providers continuing to send patients bills that violate the No Surprises Act may be targeted by the U.S. Department of Justice at some future time, even several years from now. So, there is risk,” said Robert Michel, Editor-in-Chief of Dark Daily and The Dark Report.

“Also, patients who realize that bills they received from healthcare providers were in violation of the No Surprises Act could potentially file class action lawsuits against those providers,” Michel added.

In fact, 63% of those surveyed by Morning Consult expressed confidence in their ability to address a surprise bill they deemed illegal. Thus, healthcare providers, clinical laboratory leaders, and pathology group managers are advised to brush up their understanding of the federal ban on certain types of balance billing.

“As the administration continues to work on implementing the law, it must continue to keep patients out of the middle of billing disputes and raise awareness about the law among both patients and providers,” said a spokesperson for Sen. Maggie Hassan (D-N.H), a cosponsor of the No Surprises Act (NSA), in the Morning Consult news release.

Only 16% of adults surveyed said they were aware of the No Surprises Act, down from 19% at the law’s launch in January, the study found.

Another Study Finds NSA Making Progress

America’s Health Insurance Plans (AHIP) and the Blue Cross and Blue Shield Association (BCBS) conducted a survey of commercial health plans. According to their findings, in its first two months, the No Surprises Act may have prevented two million surprise bills from reaching commercially insured patients, and it is possible 12 million surprise bills may be averted in 2022.

Though a much smaller survey, the 31 respondents to the AHIP-BCBS study represented 115 million commercial enrollees or 54% of the total commercial insurance market. The data they shared included:

  • Number of commercial claims incurred and paid during January and February.
  • Number of those claims that were No Surprises Act-eligible.

From those data, the study found 600,000 No Surprises Act-eligible claims in the market in January and February. Following calculations using 2020 Census data of commercial enrollees (213 million), the study authors estimated the No Surprises Act may stop 12 million unexpected healthcare bills in 2022.

Surprise medical bills may also be prevented by new hospital price transparency laws and state-led affordable medication initiatives, according to Insider Intelligence.

Follow-up Ideas for Clinical Laboratories

Clinical laboratory tests will likely be a focal point in more studies about the No Surprises Act’s effectiveness. Medical lab and anatomic pathology group leaders may want to check-in with reference laboratory and billing company partners to ensure compliance with the most recent federal laws concerning balance billing.    

Donna Marie Pocius

Related Information:

Morning Consult National Tracking Poll

Surprise Medical Bills Have Been Banned Since January. One in Five Americans Say They or Their Family Have Gotten an Unexpected Charge Anyway

More than Two Million Surprise Bills Avoided During January-February 2022

New Study Shows No Surprises Act Prevented Over Two Million Potential Surprise Bills for Insured Consumers

Unexpected Medical Bills Plague US Consumers-Here are Two Key Reasons Why This Could Improve Soon

Judge Vacates Provision in No Surprises Act

Pathologists Bill Out-of-Network More Frequently than Other Specialties, According to Health Care Cost Containment Study

News Report Shows How Elizabeth Holmes Tricked VP Joe Biden into Endorsing Theranos’ Fake Blood Testing Technology

Former Vice President received an exclusive tour of a completely fake medical testing laboratory within Theranos, which he found “most impressive”

One thing clinical laboratory leaders and pathologists may still be curious about concerning the whole Theranos affair is how the company founder Elizabeth Holmes could fool so many high-ranking individuals—including then Vice President Joe Biden—into endorsing a completely fraudulent medical laboratory test process.

In “The Wild Way Elizabeth Holmes and Theranos Tricked Joe Biden,” MSN attempts to explain how Holmes and her partner, Theranos president Ramesh “Sunny” Balwani, “managed to hoodwink some of the biggest names in the political and investment world, including former President Bill Clinton, News Corp owner Rupert Murdoch, Henry Kissinger, and four-star General James ‘Mad Dog’ Mattis.”

But it was the lengths to which Holmes and Balwani went to “trick” Joe Biden into endorsing Theranos—and subsequently receive the positive press that followed—that MSN found most intriguing.

According to MSN, in July of 2015 Holmes and Balwani procured Biden’s endorsement by giving the VP a tour of a “completely fake, staged lab.”

Joe Biden with Elizabeth Holmes

“What’s most impressive to me is you’re not only making these lab tests more accessible, you’re charging historically low prices, which is a small fraction of what is charged now, while maintaining the highest standards, and empowering people whether they live in the barrio or a mansion, putting them in a position to help take control of their own health,” stated then VP Joe Biden (above with Elizabeth Holmes) in a Theranos press release. Sadly, many clinical laboratory leaders who were skeptical and outspoken about Theranos’ claims were ignored by the press. (Photo copyright: ABC News.) 

Wall Street Journal Reporter Exposes Theranos Fraud

According to a 2018 article by John Carreyrou which was part of his expose´ of Theranos published in The Wall Street Journal, “Ms. Holmes and Mr. Balwani wanted to impress Vice President Biden with a vision of a cutting-edge, automated laboratory. Instead of showing him the actual lab with its commercial analyzers, they created a fake one, according to former employees who worked in Newark. They made the microbiology team vacate a room it occupied, had it repainted, and lined its walls with rows of [Theranos] miniLabs stacked up on metal shelves.”

And the ruse worked. A 2015 Theranos press release outlined the visit at the time and stated that Biden found the facility inspiring and was impressed by the work being done by the company.

“I just had a short tour and I’m glad because you can see first-hand what innovation is all about just walking through this facility. This is the laboratory of the future,” Biden said in the press release.  

Joe Biden and Elizabeth Holmes

In 2015, then Vice President Joe Biden toured the Theranos facility with Elizabeth Holmes, observed their supposedly innovative finger stick test system, and met with several Theranos employees. Later reports exposing the fraud stated that Holmes and Balwani were desperate to obtain Biden’s approval as it would provide positive press for Theranos, a good reputation within the industry, and lure potential investors. Theranos later tweeted a photo (above) of the visit showing Biden and Holmes walking amongst numbered blood-testing machines with a huge Theranos logo banner in the background. (Photo copyright: Connor Radnovich/The Chronicle.)

Biden’s visit occurred just a few months before Carreyrou’s Wall Street Journal report questioned the efficacy of Theranos’ blood testing technology and alleged the lab testing company tried to cover up its failures and mislead investors and patients.

Prior to that hard-hitting exposé, Holmes was heralded by the media as a star in the field of medicine. She was even prominently featured on magazine covers of influential business periodicals such as Fortune, Forbes, and Inc.

Others Who Were Bamboozled by Holmes and Balwani

Biden was not the only high-profile individual who was fooled by Holmes, Balwani and their billion-dollar con job. Other high-profile people included:

Theranos ceased operations in September of 2018 amidst the exposing of the fraud and inability to locate a buyer for the company. The shutdown rendered all investments in the company worthless.   

Holmes to Receive New Hearing in Federal Court

In January of this year, Holmes was found guilty of three counts of wire fraud and one count of conspiracy to commit wire fraud for lying to investors about Theranos products. She faces up to 20 years in prison and a fine of $250,000 plus restitution for each count.

However her sentencing, originally scheduled for October 17, was delayed due to her request for a new trial based on comments by former Theranos laboratory director Adam Rosendorff, MD, that he regretted his testimony in Holmes’ fraud trial. Dark Daily covered this in “Clinical Pathologist Once Again at the Center of a National News Story as Theranos Founder Elizabeth Holmes Seeks New Trial.”

Holmes was granted her request and will now undergo a new hearing in federal court, which we covered in “Judge Grants Delay in Ex-Theranos’ CEO Elizabeth Holmes’ Sentencing to Consider Alleged Prosecutor Misconduct.”

And so, clinical laboratory leaders and pathologists now have a better idea as to how Joe Biden was hoodwinked and endorsed a completely fake blood testing laboratory at Theranos. Can he be blamed for his ignorance of clinical laboratory test technology? Probably not. But it makes for interesting reading.

—JP Schlingman

Related Information:

The Wild Way Elizabeth Holmes and Theranos Tricked Joe Biden

Theranos Hosts Vice President Biden for Summit on a New Era of Preventive Health Care

Joe Biden Visited Theranos, Called Elizabeth Holmes ‘Inspiring’

Biden Played Big Role in Promoting Convicted Fraudster Elizabeth Holmes and Theranos

Hot Startup Theranos Has Struggled with Its Blood-Test Technology

Clinical Pathologist Once Again at the Center of a National News Story as Theranos Founder Elizabeth Holmes Seeks New Trial

Ex-Theranos CEO Elizabeth Holmes Testifies She Made Mistakes, Shifts Blame for Some of the Now Defunct Clinical Laboratory Testing Startup’s Failures

Ex-Theranos CEO Elizabeth Holmes Takes Witness Stand in Her Own Defense: Admits to Using Pharma Giants’ Logos on Reports to Investors, But Claims No Intent to Deceive

PwC Survey Finds 50% of Companies Plan Layoffs and 83% Intend to Move Forward with Streamlined Workforces

Amid cost pressures, healthcare providers also plan to cut staff though some jobs are plentiful; adequate staffing at medical laboratories continues to be a challenge

Thanks to the COVID-19 pandemic and subsequent “Great Resignation,” masses of people have left the workforce and companies large and small in all industries are struggling to retain employees. Clinical laboratories have been particularly hard hit with no relief in sight.

Now comes the results of a PricewaterhouseCoopers (PwC) survey which shows 50% of US companies in various industries—including major healthcare providers—plan to lay off employees. And 83% of organizations intend to move forward with a “streamlined workforce,” according to the latest PwC Pulse: Managing Business Risks in 2022 report.

How this will affect the workload on remaining hospital and medical laboratory staff is clear. And healthcare consumers may not take well to healthcare provides running leaner and with fewer staff than they currently do.

Nevertheless, the PwC survey results “illustrate the contradictory nature of today’s labor market, where skilled workers can still largely name their terms amid talent shortages even as companies look to let people go elsewhere,” Bloomberg wrote on the  CPA Practice Advisor website.

Bhushan Sethi

“Organizations are still walking a tightrope when it comes to talent as we begin to see the longer-term impacts of the ‘Great Resignation.’ Finding the proper balance between investing in specialized talent, managing headcount costs, and driving productivity and morale will remain a top focus,” said Bhushan Sethi (above), People and Organization Joint Global Leader at PwC and an adjunct professor at NYU Stern School of Business in a PwC news release. Clinical laboratories are finding it particularly challenging to fill staff positions across all areas of lab operations. (Photo copyright: PwC.)

Healthcare Has Biggest Challenges, says PwC

Clinical laboratory leaders and pathologist groups are well aware of the unique financial pressures on healthcare systems and medical labs, as well as shortages of pathologists, medical technologists, clinical laboratory scientists, information technology (IT) professionals, and other healthcare workers.

“Healthcare is seeing bigger talent challenges than other industries and is more focused on rehiring employees who have recently left,” the PwC report acknowledged. This is the second Pulse survey PwC conducted in 2022. The 722 respondents included leaders working in human capital and finance.  

Finding Right Talent, Focusing on Growth, Automation

Finding the right employees is so important to companies that PwC ranks “talent acquisition” as the second highest risk (38%) behind cyber-attacks (40%).

“Finding the right talent continues to be a challenge for business leaders,” PwC said. “After a frenzy of hiring and a tight labor market over the past few years, executives see the distinction between having people and having people with the right skills.”

Unlike the high-touch and personal nature of healthcare, industries such as consumer technology, media, and telecommunications can turn to automation to alleviate staffing struggles. And that is what nearly two-thirds, or 63%, of companies in those sectors, aim to do, PwC said.

Other survey talent findings:

  • 50% of companies plan layoffs.
  • 46% are dropping or eliminating sign-on bonuses.
  • 44% are rescinding job offers.

Conversely, the surveyed executives also told PwC they are “cautiously optimistic” and plan on growing and investing even as the economy gives mixed signals:

  • 83% of companies are focused on growth.
  • 70% plan an acquisition.
  • 53% aim to invest in digital transformation, 52% in IT, 49% in cybersecurity and privacy, and 48% in customer experience.

“After more than two years dealing with uncertainty related to the pandemic, business leaders recognize the urgent need to focus on growth in order to compete, and they’re zeroing in on what they can control,” PwC said.

New Remote Work Programs, Reduction in Real Estate Investing, Big Tech

Although companies report having more than enough physical office space, many (42%) have launched remote work programs:

  • 70% have expanded or plan to increase “permanent” remote work options as jobs permit.
  • 22% are reducing real estate investment (financial services and healthcare industries lead the way with 30% and 29%, respectively, saying real estate buys are cooling off).

“While companies continue to invest in many areas of the business, they’re scaling back the most in real estate and capex ex [capital expenditure]. After two years of remote work, many companies simply need less space, and they’re allocating capital accordingly,” the PwC report noted.

In a somewhat parallel release to PwC’s findings, news sources are reporting reductions in real estate and staff at high-profile Big Tech companies.

Meta Platforms, Inc. in Menlo Park, Calif. (formerly Facebook Inc.), is closing one of its New York offices and cutting back on plans to expand two other locations in the city, the Observer reported.

Business Insider reported, “More than 32,000 tech workers have been laid off in the US till July, including at Big Tech companies like Microsoft and Meta (formerly Facebook), and the worst has not been over yet for the tech sector that has seen massive stock sell-off.”

According to Forbes, “San Francisco-based electronic signature company DocuSign will lay off 9% of its more than 7,400 employees (roughly 670 employees), the company announced in a Securities and Exchange filing Wednesday, saying the cuts are ‘necessary to ensure we are capitalizing on our long-term opportunity and setting up the company for future success.’”

And Bloomberg recently reported that Intel is planning to layoff thousands of people “around the same time as its third-quarter earnings report on Oct. 27.”

Healthcare Providers Plan Layoffs, Seek IT Pros

Meanwhile, major healthcare provider networks also are planning staff cuts amid service closures, rising costs, and other issues, according to Becker’s Hospital Review:

“Our health system, like others around the nation, is facing significant financial pressures from historic inflation, rising pharmaceutical and labor costs, COVID-19, expiration of CARES Act funding, and reimbursement not proportional with expenses,” BHSH said in a statement shared with Becker’s.

Amidst these layoffs, however, IT jobs in healthcare seem to be growing. According to Becker’s Health IT, some healthcare providers have posted information technology openings:

So, though it appears IT positions continue to expand, clinical laboratory leaders and pathology practice managers may want to prepare now for dealing with customers’ response to leaner healthcare systems overall.

Donna Marie Pocius

Related Information:

PwC Pulse: Managing Business Risks in 2022

Layoffs are Being Planned at Half of US Companies, PwC Survey Shows

Business Executives Remain Bullish about Their Ability to Manage Turbulent Conditions, according to New PwC Survey

Meta Is Closing a Manhattan Office as It Consolidates Its New York City Presence

50% of Companies Planning Job Cuts Amid Economic Downturn: Report

Ascension to Close Hospital, Lay Off 133 Workers

Microsoft Reportedly Cuts Nearly 1,000 Employees—Here Are the Biggest US Layoffs This Year

Intel Is Planning Thousands of Job Cuts in Face of PC Slump

Hospitals Cut Jobs to Resuscitate Finances

IT Job Openings at Mayo, Northwell, CommonSpirit, and Providence

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