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.
“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.
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.
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.
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.”
“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.
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.
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.
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.
“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:
Ascension in St. Louis, Mo., plans to close an Indiana hospital and nine medical practices and lay off 133 employees.
“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:
Mayo Clinic in Rochester, Minn., has 43 IT job 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.
Encouraging patients—even children—to be more directly involved in their own medical care may reduce the burden on healthcare workers and might even help those clinical laboratories struggling to hire enough phlebotomists to collect specimens
Researchers at Emory University School of Medicine have concluded a study which found that school-aged children can successfully use a nasal swab to obtain their own SARS-CoV-2 test specimens. This may come as a surprise to hospital and clinical laboratory personnel who have performed nasal swabbing for COVID-19 tests. Some people, adults included, find the procedure so uncomfortable it brings tears.
And yet, after being shown a 90-second how-to video and given a handout with written instructions and pictures, 197 Atlanta children who had COVID-19 symptoms between July and August of 2021 performed their own self-swabbing. A healthcare worker then collected a second swabbed sample. All samples were submitted to a clinical laboratory for PCR analysis.
The Emory study provides another example of how the healthcare system is engaging patients to be directly involved in their own medical care. Results of the study could positively impact clinical laboratories facing a shortage of personnel, as well as schools where children have to take repeated COVID-19 tests with the assistance of trained professionals.
In a study with 197 school-age children, researchers at Emory University School of Medicine found that children could self-swab themselves for COVID-19 testing after watching a 90-second instructional video. Clinical laboratory leaders who are short on personnel may find these results intriguing. (Photo copyright: Emory University.)
How Did the Children Do?
The self-collected swabs and those collected by a healthcare worker agreed 97.8% of the time for a positive result and 98.1% of the time for a negative result. The analysis showed that both collection methods identified the 44% of symptomatic kids who were positive for COVID-19.
“Seeing how closely the results line up between the children and trained healthcare workers is a strong indicator that these age groups are fully capable of swabbing themselves if given proper instruction,” said Jesse Waggoner, MD, an Assistant Professor of Infectious Diseases with the Emory University School of Medicine and one of the lead authors on the study, in an Emory University press release.
A higher percentage of children age eight and under needed assistance, such as more instruction before correctly completing self-collection—21.8% compared to 6.1% for children older—but SARS-CoV-2 detection among the two age groups did not differ.
Does FDA Approve of Self-Swabbing?
The US Food and Drug Administration (FDA) has not authorized COVID-19 tests that include self-swabbing by children under age 14. However, data from the Emory study, published in JAMA, is now available to test manufacturers seeking authorization for pediatric self-collection.
“Pediatric self-swabbing will support expanded testing access and should make it even easier to test school age populations with fewer resources,” said Tim Stenzel, MD, PhD, Director of the Office of In Vitro Diagnostics at the FDA, in the Emory statement. “This study furthers our knowledge of test accuracy with these types of samples and provides test manufacturers with data to support their EUA (Emergency Use Authorization) requests to the FDA.”
Self-swabbing versus Clinical Laboratory Worker
While it has been longstanding medical practice to have healthcare workers collect samples for respiratory tract infection testing, the Emory researchers suggest that allowing children to collect their own COVID-19 samples could be one way to reduce the burden of a shortage of healthcare workers.
The researchers also believe pediatric self-swabbing would expand access to diagnostic tests and make it easier to test school-age populations.
“Every minute of a healthcare worker’s time is at a premium,” said senior study author Wilbur Lam, MD, Professor of Pediatrics and Biomedical Engineering, Emory University and Georgia Tech, in a National Institutes of Health (NIH) press release. “Why not allow a kid to self-swab? It’s a win-win! They would rather do it themselves and it frees up the healthcare worker to do other things,” he added.
In 2020, a Stanford University School of Medicine study published in JAMA showed test samples collected by adults who swabbed their own nasal passages were as accurate as those collected by healthcare workers. This study involved 30 participants who had previously tested positive for COVID-19.
Though the Emory University and Stamford University studies were small, they agreed in their findings which is significant. Clinical laboratory executives and pathologists should expect this trend toward direct-to-consumer and other forms of self-testing to continue, even among young patients.
These findings may be useful to clinical laboratory professionals when physicians want guidance in effective treatments for COVID-19 patients, particularly when there are concerns about a rebound of the infection
Drug interactions are a major concern for physicians and clinical laboratories. That is especially true given the push for nearly universal COVID-19 vaccinations and boosters. Now, a study conducted in Denmark may show that the use of Paxlovid as an antiviral drug to treat early SARS-CoV-2 infection could trigger drug-drug interactions (DDI) in some patients.
For clinical laboratory managers, insights into the issues associated with Paxlovid may be useful in helping client physicians diagnose their patients and anticipate possible negative drug reactions where other anti-viral drugs are involved.
Also of interest to medical laboratory leaders is the fact that the federal Centers for Disease Control and Prevention (CDC) in May released a Health Alert Network (HAN) Health Advisory about the potential for COVID-19 rebound after Paxlovid treatment.
COVID-19 Rebound, according to the CDC, “has been reported to occur between two and eight days after initial recovery and is characterized by a recurrence of COVID-19 symptoms or a new positive viral test after having tested negative.”
In an article she penned for STAT, Joan Susan Bregstein, MD (above), a pediatric emergency medicine physician and professor of pediatrics at Columbia University Irving Medical Center in New York, wrote, “Is Paxlovid worth it? The CDC advisory states in black, bold, and no uncertain terms that, despite the risk of rebound COVID, ‘Paxlovid continues to be recommended for early-stage treatment of mild to moderate COVID-19 among persons at high risk for progression to severe disease.’ But the definition of ‘high risk’ in this situation has been a moving target since the first days of COVID-19.” Clinical laboratory leaders can attest to the accuracy of that statement. (Photo copyright: Columbia University.)
Do Anti-Viral Drugs Interact with Other Medications?
Paxlovid is the retail name for a combination of two anti-viral drugs: nirmatrelvir and ritonavir. The medication for COVID-19 was developed by American pharmaceutical company Pfizer (NYSE:PFE) and received Emergency Use Authorization from the US Food and Drug Administration in August of this year.
The drug is taken orally for five days by people who test positive for the SARS-CoV-2 coronavirus to head off disease progression as well as serious illness, according to the CDC advisory.
But a “sizeable proportion” of elderly people are on medications that could interact with Paxlovid, Reuters reported.
“Two oral antiviral drugs—nirmatrelvir/ritonavir (NMV/r) and molnupiravir—have been approved for early outpatient treatment of COVID-19 to prevent severe disease. Ritonavir, contained in NMV/r is known to have significant DDI with several drugs frequently used by the elderly. This communication puts the problem with DDI with oral antiviral COVID-19 treatment into perspective,” the study authors wrote.
Their analysis of prescription data from Denmark residents found “extensive use of drugs likely to interact with NMV/r” as follows:
Anticoagulants (blood thinners): used by 20% of people over age 65 and by 30% of people over 80.
Statins (cholesterol-lowering medications): taken by 15% to 18% of people over 65.
Analgesics (for pain), calcium channel blockers (used to decrease blood pressure in patients with hypertension), or digoxin (used to treat heart conditions): taken by 20% of those studied.
In their paper, the researchers offered guidance to physicians. “Before prescribing NMV/r, the patient’s full medical history, including herbals and over-the-counter and recreational drugs, must be known and co-treatment carefully managed by the treating physician or by a specialist to avoid detrimental effects.”
However, one infectious disease specialist told Scientific American it may just take the elderly who were taking Paxlovid more time to completely get over COVID-19.
“Being of an elderly age and then having other risk factors—like diabetes, heart disease, kidney disease, or some sort of cancer—does put you at higher risk of rebound,” Aditya Shah, MBBS, Mayo Clinic Infectious Disease Physician and Researcher, told Scientific American.
That study’s researchers retrospectively reviewed 92 million electronic health records (EHR) from US patients. They found most people (11,270) had been treated with Paxlovid. However, 2,374 patients took molnupiravir, which also was granted EUA status by the FDA and is marketed as Lagevrio.
That COVID-19-rebound study found:
After nirmatrelvir/ritonavir (Paxlovid) treatment: 3.53% had rebound infections, 2.3% with rebound symptoms, and .44% were hospitalized.
After molnupiravir (Lagevrio) treatment: 5.86% had rebound infections, 3.75% with rebound symptoms, and .84% were hospitalized.
“Patients who took molnupiravir were significantly older and had more comorbidities than those who took Paxlovid,” the researchers wrote. “Results further suggest that rebound was not unique to Paxlovid and may be associated with persistent viral infection in some patients treated with either of these two antivirals. There has been more attention to COVID-19 rebound following Paxlovid treatment than molnupiravir, which may be attributable to more people being treated with Paxlovid,” they concluded.
Clinical Laboratories Can Guide Doctors
In an article she penned for STAT, titled, “Paxlovid Rebound Happens, Though Why and to Whom Are Still a Mystery,” Joan Susan Bregstein, MD, a pediatric emergency medicine physician and professor of pediatrics at Columbia University Irving Medical Center in New York, wrote of COVID-19 rebound, “My emergency medicine physician colleagues are seeing tons of it. Although people tend to think of medical care as something that is certain, it is actually a real-time experiment. Paxlovid, like a lot of COVID-19 care, is a reminder of this.”
Similarly, Mayo Clinic’s Shah acknowledged difficulty in identifying a COVID-19 rebound case. “You need real documentation of three tests—a positive, a negative, a positive—and clear documentation of symptoms—all symptoms gone, symptoms come back,” Shah told Scientific American.
Thus, clinical laboratories play a vital role in diagnosing and treating COVID-19 rebound patients, because that is what clinical labs do: test, document, and report. And as the study of the Danish population pointed out, doctors need guidance as they prescribe oral antivirals to COVID-19 patients who are on other drugs and at possible risk of drug-drug interactions.
Issues arose after a pathologist who once was the clinical laboratory director at Theranos suggested his testimony during the trial was misconstrued by federal prosecutors
Just when clinical laboratory directors and pathology group managers thought they could look forward to a world without an ongoing Theranos fraud trial, company founder and ex-CEO Elizabeth Holmes requested a new trial. Her request was based on comments by pathologist and former Theranos lab director Adam Rosendorff, MD, that he was remorseful about his testimony in Holmes’ fraud trial.
Now, it appears the court will hear Holmes’ argument. On October 4, a federal judge agreed to delay Holmes’ sentencing to consider new evidence that was submitted to the court in a September filing and further evaluate her request for a new trial.
In that filing, Holmes claimed that Rosendorff visited her home on August 8 to express regret over his testimony. According to Holmes, Rosendorff alleged that his statements had been misconstrued by prosecutors at her trial. He stated that “he tried to answer the questions honestly, but that the prosecutors tried to make everyone look bad” and he now feels like “he had done something wrong,” The Guardian reported.
Theranos founder and ex-CEO Elizabeth Holmes (left) as she was seen entering the federal courthouse in San Jose, Calif., on Sept. 1 to argue that her trail verdict should be overturned due to new comments from pathologist and former lab director Adam Rosendorff, PhD, who expressed remorse over his original testimony. Clinical laboratory managers may want to track these new developments in the unfolding saga of Theranos and Elizabeth Holmes. (Photo copyright: AP/Daily Mail.)
Pathologist Rosendorff’s Testimony about Holmes
Rosendorff, the pathologist who served as the CLIA laboratory director at Theranos for several years, was a major witness for the prosecution in the Holmes trial which lasted nearly four months. During his four-day testimony, he contended that Holmes was cognizant of accuracy issues with Theranos’ blood-testing device and that she intentionally misled both investors and patients.
In January, a jury found Holmes guilty of three counts of wire fraud and one count of conspiracy to commit wire fraud for lying to investors about Theranos products. The jury of eight men and four women deliberated for more than 50 hours over seven days to arrive at the verdict. She faces up to 20 years in prison and a fine of $250,000 plus restitution for each count.
In September, US District Judge Edward Davila, who presided over Holmes’ original fraud trial, declined to overturn the guilty verdict.
The new hearing regarding the issues with Rosendorff’s testimony will occur on October 17, the original date of Holmes’ sentencing. Davila stated that he has scheduled an entire day for hearing, but that he expects it to take less than the full allotted day.
Judge Wants to Know If Former Theranos Lab Director Told the Truth
If her request for a new trial is denied, Holmes will be sentenced sometime between November and January. She is currently free on bail while awaiting her sentencing.
Regarding the latest development, Davila stated that it was unusual for a witness to appear at a convicted defendant’s home. “I will say I haven’t seen a case where this happened before,” Davila told CNN.
“What the court wants to know is, Dr. Rosendorff, do you feel the government manipulated you in the preparation or in any way in regards to your testimony?” Davila said about what will be covered in the October 17 hearing. “What I want to know is, did you tell the truth?”
After Holmes used Rosendorff’s appearance at her home to request a new trial, the former Theranos lab director filed a sworn declaration with the court on September 21 that he stands by his testimony “in every respect.”
“Nevertheless, I feel compassion for Ms. Holmes and Mr. Balwani, and even more so for the members of their families who were not responsible for their conduct but will be affected by the punishment they may receive,” he wrote.
And so, the saga of Elizabeth Holmes continues. Clinical laboratories will once again get a view into how a lab director’s responsibilities can alter testing outcomes—and fraud trials.
