Good behavior in federal prison by the disgraced founder of the now-defunct clinical laboratory company earned her the reduction in her original sentence of 11 years
Elizabeth Holmes, founder of failed clinical laboratory blood analysis company Theranos, continues to serve a lengthy term in prison after being convicted of multiple counts of fraud in 2022. However, now comes news that good behavior at her federal prison has shortened her sentence by nearly two years, according to NBC News.
The latest reduction took Holmes’ release from December 2032 to August 2032 in her “11-plus-year (135 month) prison sentence for wire fraud and conspiracy,” NBC reported, adding that Holmes, though Theranos, “defrauded investors out of hundreds of millions of dollars.”
Holmes entered FPC Bryan, a federal prison camp in Bryan, Texas, to begin serving her term in May 2023.
“Holmes had her sentence computation done within the first 30 days of arriving at Bryan,” Forbes reported. Given Good Conduct Time (GCT), Holmes was given 608 days off calculated from the start of her sentence. “If she were to incur a disciplinary infraction, some of those days can be taken away. Most all prisoners receive 54 days per year of GCT based on the sentence imposed,” Forbes added.
The Federal Bureau of Prisons (BOP) can additionally shave off up to a year through its Residential Drug Abuse Program (RDAP). “To qualify, the prisoner must not have a disqualifying offense, such as terrorism or gun charge, and voluntarily provided information that they had a drug or alcohol problem prior to their arrest. This disclosure has to be done prior to sentencing during the pre-sentence interview and must be also documented in the Presentence Report, a detailed report used by the BOP to determine things like classification and programming for the prisoner,” Forbes noted.
Additionally, the federal First Step Act, which President Trump signed into law in 2018, enables Holmes to “earn up to 365 days off any imposed sentence by participating in prison programming such as a self-improvement classes, a job, or religious activities,” Forbes reported.
Given the opportunities to shave time off her sentence, Holmes may ultimately serve just 66 months of her original 135 month sentence in federal prison.
Elizabeth Holmes (above) taken backstage at TechCrunch Disrupt San Francisco 2014 when Holmes was at the height of her fame and popularity. At this point, Theranos’ Edison blood testing device had not yet been shown to be a fake. But evidence was mounting as clinical laboratory scientists and anatomic pathologists became aware of the technology’s shortcomings. (Photo copyright: Max Morse/Wikimedia Commons.)
Fall of a Silicon Valley Darling
Theranos boasted breakthrough technology and became an almost overnight sensation in Silicon Valley when it burst onto the scene in 2003. Holmes, a then 19-year-old Stanford University dropout, claimed Theranos would “revolutionize the world of blood testing by reducing sample sizes to a single pin prick,” Quartz reported.
The height of the company saw Theranos valued at $9 billion, which came crashing down when the Wall Street Journal reported in 2015 that questionable accuracy and procedures were being followed by the company, CNN reported.
“From the moment Holmes concluded her presentation and stepped off the podium on Monday afternoon, she, her company, and her comments became the number one subject discussed by attendees in the halls between sessions and in the AACC exhibit hall,” Michel wrote, adding, “The executive team and the investors at Theranos have burned through their credibility with the media, the medical laboratory profession, and the public. In the future, the company’s claims will only be accepted if presented with scientific data developed according to accepted standards and reviewed by credible third parties. Much of this data also needs to be published in peer-reviewed medical journals held in highest esteem.”
Ultimately, investors who had jumped in early with financial support for Theranos were defrauded of hundreds of millions of dollars and Holmes was sentenced to 11 years/three months behind bars.
“Theranos had only ever performed roughly a dozen of the hundreds of tests it offered using its proprietary technology, and with questionable accuracy. It also came to light that Theranos was relying on third-party manufactured devices from traditional blood testing companies rather than its own technology,” CNN added.
The company shut down in 2018.
And so, the Elizabeth Holmes saga continues with reductions in her prison sentence for “good behavior.” The irony will likely not be lost on the anatomic pathologists, clinical laboratory scientists, and lab managers who followed the federal trials.
Doctors report difficulty differentiating COVID-19 from other viral infections, impacting clinical laboratory test orders
Because the SARS-CoV-2 coronavirus is in the same family of viruses that cause the common cold and influenza, virologists expected this virus—which caused the global COVID-19 pandemic—would evolve and mutate into a milder form of infection. Early evidence from this influenza season seems consistent with these expectations in ways that will influence how clinical laboratories offer tests for different respiratory viruses.
While new variants of the SARS-CoV-2 virus continue to appear, indications are that early in this flu season individuals infected with the more recent variants are experiencing milder symptoms when compared to the last few years. Doctors report they find it increasingly difficult to distinguish COVID-19 infections from allergies or the common cold because patients’ symptoms are less severe, according to NBC News.
This, of course, makes it challenging for doctors to know the most appropriate clinical laboratory tests to order to help them make accurate diagnoses.
“It isn’t the same typical symptoms that we were seeing before. It’s a lot of congestion, sometimes sneezing, usually a mild sore throat,” Erick Eiting, MD, Vice Chair of Operations for Emergency Medicine at Mount Sinai Hospital in New York City, told NBC News. “Just about everyone who I’ve seen has had really mild symptoms. The only way that we knew that it was COVID was because we happened to be testing them.” Knowing which tests for respiratory viruses that clinical laboratories need to perform may soon be the challenge for doctors. (Photo copyright: Mt. Sinai.)
Milder COVID-19 Symptoms Follow a Pattern
Previous hallmarks of a COVID-19 infection included:
Loss of taste,
loss of smell,
dry cough,
fever,
sore throat,
diarrhea,
body aches,
headaches.
However, physicians now observe milder symptoms of the infection that follow a distinct pattern and which are mostly concentrated in the upper respiratory tract.
Grace McComsey, MD, Vice President of Research and Associate Chief Scientific Officer at University Hospitals Health System (UH) in Cleveland, Ohio, told NBC News that some patients have described their throat pain as “a burning sensation like they never had, even with Strep in the past.”
“Then, as soon as the congestion happens, it seems like the throat gets better,” she added.
In addition to the congestion, some patients are experiencing:
headache,
fever,
chills,
fatigue,
muscle aches,
post-nasal drip.
McComsey noted that fatigue and muscle aches usually only last a couple of days, but that the congestion can sometimes last a few weeks. She also estimated that only around 10-20% of her newest COVID patients are losing their sense of smell or taste, whereas early in the pandemic that number was closer to 60-70% of her patients.
Doctors also noted that fewer patients are requiring hospitalization and that many recover without the use of antivirals or other treatments.
“Especially since July, when this recent mini-surge started, younger people that have upper respiratory symptoms—cough, runny nose, sore throat, fever and chills—99% of the time they go home with supportive care,” said Michael Daignault, MD, an emergency physician at Providence Saint Joseph Medical Center in Burbank, California.
Milder SARS-CoV-2 Variants Should Still be Taken Seriously
Doctors have varying opinions regarding why the current COVID-19 variants are milder. Some believe the recent variants simply aren’t as good at infecting the lungs as previous variants.
“Overall, the severity of COVID-19 is much lower than it was a year ago and two years ago,” Dan Barouch, MD, PhD, Director of the Center for Virology and Vaccine Research at Beth Israel Deaconess Medical Center, told NBC News. “That’s not because the variants are less robust. It’s because the immune responses are higher.”
McComsey added that she doesn’t think mild cases should be ignored as she is still seeing new cases of long COVID with rapid heart rate and exercise intolerance being among the most common lingering symptoms. Re-infections also add to the risks associated with long COVID.
“What we’re seeing in long COVID clinics is not just the older strains that continue to be symptomatic and not getting better—we’re adding to that number with the new strain as well,” McComsey said. “That’s why I’m not taking this new wave any less seriously.”
Clinical Laboratory COVID-19 Testing May Decrease
According to Andrew Read, PhD, Interim Senior Vice President for Research and Evan Pugh University Professor of Biology and Entomology at Pennsylvania State University, there is nothing unexpected or startling about the coronavirus acquiring new mutations.
“When a mutation confers an interesting new trick that’s got an advantage, it’s going to be popping up in many different places,” Read told the New York Times. “Everything we see is just consistent with how you imagine virus evolution proceeding in a situation where a new virus has jumped into a novel host population.”
Data from the Centers for Disease Control and Prevention’s COVID-19 Data Tracker—which reports weekly hospitalizations, deaths, emergency department (ED) visits, and COVID-19 test positivity results—shows infection trends fluctuating, but overall, they are decreasing.
For the week of October 21, 2023, there were 16,186 hospitalizations due to COVID-19 compared to the highest week recorded (January 15, 2022) with 150,674 hospitalizations nationwide.
The highest number of deaths reported in a single week were 25,974 for the week of January 8, 2021, while 637 patients perished from COVID-19 during the week of October 21, 2023.
In January of 2021, COVID accounted for 13.8% of all ED visits and in October 2023, COVID-19 was responsible for 1.3% of ED visits.
“What I think we’re seeing is the virus continuing to evolve, and then leading to waves of infection, hopefully mostly mild in severity,” Barouch told The New York Times.
As severity of COVID-19 infections continues to fall, so, presumably, will demand for COVID-19 testing which has been a source of revenue for clinical laboratories for several years.
CDC asks physicians and clinical laboratories to be on the lookout and report symptoms of hepatitis to state health departments
Growing incidences of hepatitis in children are perplexing medical professionals and researchers in several countries around the world. The mysterious outbreak is occurring in otherwise healthy children and, to date, is of unknown origin, though an adenovirus may be involved.
Microbiologists and clinical laboratory scientists who perform virology testing may want to prepare for increased numbers of children presenting with hepatitis symptoms in the US.
On April 21, the Centers for Disease Control and Prevention (CDC) issued a nationwide health alert to notify the public about a cluster of children in Alabama who presented with hepatitis and adenovirus infections. The CDC asked physicians to watch for symptoms in children and to inform local and state health departments of any new suspected cases.
Also in April, the World Health Organization (WHO) issued its own alert to an outbreak of acute hepatitis of unknown etiology among young children in several countries. In addition to the United States, cases were reported in the United Kingdom, Spain, Israel, Denmark, Ireland, the Netherlands, Italy, Norway, France, Romania, and Belgium.
All the cases reported to the WHO involved children between one month and 16 years of age with the majority of cases occurring in children under five.
According to NBC News, as of May 19, the worldwide number of cases “under investigation” had reached 600 in more than 25 countries. In the US, more than 90% of the patients required hospitalization and 14% of those patients needed a liver transplant. The CDC is investigating five pediatric deaths that may be attributed to the mysterious hepatitis outbreak.
Adenovirus/SARS-CoV-2 May Be Linked to Hepatitis Outbreak
The cause of the hepatitis outbreak is as yet undetermined, but the pre-eminent theory among disease experts points to the presence of an adenovirus, which often causes cold and flu-like symptoms in addition to stomach issues.
NBC News reported that more than half of the US patients, 72% of the UK patients, and 60% of the affected patients across Europe tested positive for human adenovirus type 41. This virus, however, is generally not associated with hepatitis in healthy children, and rarely impacts the liver so severely.
Medical experts are also considering the possibility that COVID-19 infections could somehow be an underlying cause since the hepatitis outbreak occurred during the pandemic. The WHO is investigating whether exposure to the SARS-CoV-2 coronavirus might have prompted the immune systems in the infected children to react abnormally to adenoviruses that are typically non-life threatening.
“The big focus over the next week is really looking at the serological testing for previous exposure and infections with COVID,” Phillipa Easterbrook, MD, a senior scientist at the WHO headquarters in Geneva, told NBC News.
Hepatitis, or inflammation of the liver, is typically caused by heavy alcohol use, exposure to toxins, certain medical conditions and medications, or a virus.
The most recent children diagnosed with hepatitis presented with some or most of these symptoms, particularly stomach issues and fatigue. However, one symptom was present in all the children.
“The big symptom that made all of these kids different was that they all showed signs of jaundice, which is the yellowish coloration of the skin and eyes,” Markus Buchfellner, MD, a pediatric infectious disease fellow at the University of Alabama, told NBC News.
Buchfellner was the first person in the US to notice an unusual pattern of hepatitis among children. He reported his findings to the CDC last fall in 2021.
“We were able to uncover the possible association with the adenovirus 41 strain because it is our standard practice to screen patients diagnosed with hepatitis for adenovirus,” he said. “For us to dig deeper into this medical mystery and see if this strain is the cause of these severe hepatitis cases, we first need more data on how widespread the outbreak is.”
Adenovirus 41 is usually spread through fecal matter, which makes hand washing critical, especially after visits to the bathroom or diaper changes. This type of adenovirus typically presents as diarrhea, vomiting, and fever, and is often accompanied by respiratory issues.
Clinical Labs Performing Gene Sequencing Can Help
Medical scientists around the world are responding to this threat to the youngest and most vulnerable among us. Research is underway into identifying additional cases, determining what is causing the hepatitis globally among children, and establishing preventative measures.
Pathologists and clinical laboratory managers in the US will want to be on the alert for positive hepatitis tests in children whose specimens were tested at their facilities. With advances in gene sequencing that make testing economical and expeditious, more labs have the ability to not only detect hepatitis, but also to identify any genetic variants that may be associated with the increased number of pediatric hepatitis cases appearing around the world.
To help patients pay their clinical laboratory test bills, Sonora Quest Laboratories partners with CarePayment to provide patients with no-interest loans
With tens of millions of Americans now covered by a high-deductible health plan (HDHP), hospitals, physicians, and clinical laboratories now share a common problem: how to collect the full amount due for a patient who may have an annual deductible of $5,000 (individual) or $10,000 (family).
Thus, many pathologists and clinical laboratory managers will be interested in a new solution that the largest commercial laboratory company in Arizona is using to help cope with the need to collect larger amounts of money from patients with a high-deductible health plan. Recently, Senora Quest Laboratories announced an innovative collaboration with healthcare finance company CarePayment to ensure cost is not a barrier to clinical laboratory and pathology patients needing medical tests.
Sonora Quest Laboratories, which performs more than 60-million diagnostic tests per year in Arizona, has established a new partnership with CarePayment of Nashville to provide no-interest loans to any Sonora Quest patient whose testing bill exceeds $100.
David Dexter, Chief Executive Officer at Sonora Quest Laboratories, believes patients have a right to “affordable access to much-needed laboratory testing.” In a statement, Dexter notes, “Across Arizona, rising out-of-pocket medical costs are impacting families’ budgets, and ultimately, their health. No one should delay having clinical testing done because they are worried about costs.
“Sonora Quest Laboratories understands the importance of making healthcare services affordable to consumers,” he added. “We are working with CarePayment to do our part to provide affordable access to much needed laboratory testing. We believe this will help improve testing compliance and lead to better outcomes for patients managing chronic disease or monitoring their overall wellness.”
Annual Deductibles Rise 153% for Workers
The annual deductible that patients must cover is climbing, not just in Arizona, but nationally. According to the Kaiser Family Foundation 2016 Employer Health Benefits Survey, the average worker’s annual deductible has gone up 153% from 2009 to 2016. In addition, after meeting their annual deductibles, most workers face additional cost sharing for hospital admission or outpatient surgery.
To address the problem of collecting these larger deductibles from patients and to avoid racking up patient bad debt, Healthcare Finance News (HFN) points out that hospitals and healthcare providers are looking for financial solutions that “benefit both sides of the patient-provider relationship.”
As the graph above illustrates, more workers each year find themselves enrolled in high-deductible health plans (HDHPs) they can barely afford. That’s why hospitals, medical laboratory companies, and financial services organizations are partnering to develop programs patients can use to make affordable payments on their healthcare bills. (Image copyright: Kaiser Family Foundation/Obeo Health.)
To fill this need, a new type of company is popping up: third-party finance companies. CarePayment is one example. These new companies want to partner with hospitals and other healthcare organizations to identify patients who need assistance with out-of-pocket expenses. After a patient’s insurance company pays its portion of a bill, patients are referred to the healthcare finance company, which charges the hospital or provider a “discount factor” on the accounts it establishes.
Helping Clinical Laboratories, Pathology Groups Collect from Patients
According to CarePayment, enrollment in its programs is voluntary, requires no application, and has no impact on a patient’s credit score. CarePayment states that providers “double net collections on average” when patients use its financing solutions.
Craig Hodges, CEO of CarePayment, maintains innovative payment solutions are necessary because of the increased consumer responsibility for healthcare costs. “There’s evidence out there that asking a consumer to pay interest on top of their out-of-pocket expense is impractical,” Hodges stated in the HFN article. “Consumer responsibility for the [the total] bill has grown from sub 5% to 25%. There’s a lot of sticker shock out there.”
Third-party healthcare finance companies are not the only alternative financing option open to healthcare providers. Healthcare Finance News points out that Docpay offers automated clearinghouse payment plans, which require the patient to preauthorize a payment schedule from their bank account or credit card, guaranteeing payments are made each month. A service fee is charged to the patient that covers credit card processing fees as well as payment plan fees. According to the company’s website, a healthcare practice receives a higher net collection percentage than if they used a third-party financing company or processed credit card payments in-house.
Banks Get into the Act to Help Physicians, Hospitals, Medical Laboratories
NBC News adds that some hospitals are partnering with banks to offer patients no-interest or low-interest loans as well, with the goal of offering patients more affordable payment options while increasing payment rates.
David and Nicole Rayman of Chatham, Ill., told NBC News a zero-interest hospital loan saved them from high-interest financing after they were hit with an unexpected $2,800 bill to remove a benign growth from David’s neck. Under terms of the loan, they paid $80 a month for 36 months.
“That’s going out to dinner one time a month, so that’s definitely something we could cut out,” Nicole Rayman stated in the NBC News article.
Failure to Collect Bills Directly from Patients
While Hodges predicts that healthcare financing could potentially be a $70-billion industry, he also notes that growth has been fueled by providers’ difficulty communicating costs with consumers and collecting bills directly from them.
“As those high-deductible health plans grew over time, providers realized they didn’t have the infrastructure to deal with that,” Hodges noted in the HFN article. “The portion of the bill the patient was responsible for used to be small. As that grew, providers didn’t have the experience, in-house, to interact with the consumer in a consumer-like environment.”
While medical laboratories and other providers have been slow to embrace price transparency, Hodges believes simplified and transparent financial responsibility will fuel healthcare consumerism and improve the provider-patient relationship.
“My theory is that we have to evolve to total transparency,” he told Healthcare Finance News. “Here’s what the service is going to cost you from an out-of-pocket perspective—that’s the first step.”
This development is another sign HDHPs are creating financial challenges for clinical laboratories and pathology groups as more patients are unable to pay out-of-pocket cost for testing services. In this environment, medical laboratory managers and pathology practice administrators will need a strategy for collecting payments from patients at the time of service.
Unorthodox approach could one day provide clinical laboratories with new market opportunities to offer patients diagnostic services
Patients turning to the Internet to learn about medical ailments, chronic disease, medical laboratory tests, or pathology treatments is nothing remarkable these days. The Internet has become ubiquitous to patients who are engaged in their own healthcare. However, crowdsourcing medical problems to find probable diagnoses for rare medical conditions is a novel approach that is gaining in popularity.
Crowdsourcing is a relatively new type of project outsourcing. It involves acquiring specialized advice, services, and other contributions from a large group of qualified individuals who provide their work through the Internet from locations all over the globe.
The general idea is that more brains are better than few or one when it comes to completing tricky projects. It was only a matter of time before crowdsourcing discovered healthcare and companies sprang up to provide it as a service to patients with difficult-to-diagnose conditions, and to the physicians who are treating them. (more…)