Theranos founder and former CEO continues down the path she began by defrauding her investors and lying to clinical laboratory leaders about her technologyâs capabilities
As a result of the ban, Holmes is âbarred from receiving payments from federal health programs for services or products, which significantly restricts her ability to work in the healthcare sector,â ARS Technica reported.
So, Holmes, who is 39-years old, is basically banned for life. This is in addition to her 11-year prison sentence which was paired with $452,047,200 in restitution.
âThe exclusion was announced by Inspector General Christi Grimm of the Department of Health and Human Servicesâ Office of Inspector General,â ARS Technica noted, adding that HHS-OIG also âexcluded former Theranos President Ramesh âSunnyâ Balwani from federal health programs for 90 years.â This is on top of the almost 13-year-long prison sentence he is serving for fraud.
âThe Health and Human Services Department can exclude anyone convicted of certain felonies from Medicare, Medicaid, and Pentagon health programs,â STAT reported. Â
âAccurate and dependable diagnostic testing technology is imperative to our public health infrastructure,â said Inspector General Christi Grimm (above) in an HHS-OIG statement. âAs technology evolves, so do our efforts to safeguard the health and safety of patients, and HHS-OIG will continue to use its exclusion authority to protect the public from bad actors.â Observant clinical laboratory leaders will recognize this as yet another episode in the Elizabeth Holmes/Theranos fraud saga theyâve been following for years. (Photo copyright: HHS-OIG.)
Why the Ban?
âThe Office of Inspector General (OIG) for the Department of Health and Human Services (HHS) cited Holmesâ 2022 conviction for fraud and conspiracy to commit wire fraud as the reason for her ban,â The Hill reported.
âFalse statements related to the reliability of these medical products can endanger the health of patients and sow distrust in our healthcare system,â Grimm stated in the HHS-OIG statement, which noted, âThe statutory minimum for an exclusion based on convictions like Holmesâ is five years.
âWhen certain aggravating factors are present, a longer period of exclusion is justified,â the statement continued. âThe length of Holmesâ exclusion is based on the application of several aggravating factors, including the length of time the acts were committed, incarceration, and the amount of restitution ordered to be paid.â
Rise and Fall of Elizabeth Holmes
Readers of Dark Dailyâs e-briefs covering the Holmes/Theranos fraud saga will recall details on Holmesâ journey from mega success to her current state of incarceration for defrauding her investors.
In November 2022, she was handed an 11-year prison sentence for not disclosing that Theranosâ innovative blood testing technology, Edison, was producing flawed and false results. Theranos had âraised hundreds of millions of dollars, named prominent former US officials to its board, and explored a partnership with the US military to use its tests on the battlefield,â STAT reported.
To get Holmes physically into prison was a journey unto itself. At one point, evidence showed her as a potential flight risk. âIn the same court filings, prosecutors said Holmes and her partner, William Evans, bought one-way tickets to Mexico in December 2021, a fact confirmed by her lawyers,â Dark Dailyâs sister publication The Dark Report revealed in âElizabeth Holmesâ Appeal Questions Competence of CLIA Lab Director.â
Drama around her move into prison continued. âThe former CEOâs attorneys are making last-minute legal moves to delay her prison sentence while she appeals her guilty verdict,â Dark Daily reported.
At the same time, Holmes appeared to be on a mission to revamp her public image.
In the Times piece, Holmes talked about her plans to continue to pursue a life in healthcare. âIn the story, Holmes contended that she still thinks about contributing to the clinical laboratory field. Holmes told The Times that she still works on healthcare-related inventions and will continue to do so if she reports to prison,â The Dark Report covered in âElizabeth Holmes Still Wants âTo Contributeâ in Healthcare.â
In the meantime, her legal fees continued to mount beyond her ability to pay. âHolmesâ prior cadre of lawyers quit after she could not compensate them, The Times reported,â The Dark Report noted. âOne pre-sentencing report by the government put her legal fees at more than $30 million,â according to The New York Times.
Apparently, this closes the latest chapter in the never-ending saga of Elizabeth Holmesâ fall from grace and ultimate conviction for defrauding her investors and lying to healthcare executives, pathologists, and clinical laboratory leaders.
Several young companies hope to expand the direct-to-consumer test market by introducing new diagnostic tests to serve the womenâs health market
Providing women with at-home lab test kits is the goal of a growing class of start-up companies that are bringing to market consumer test kits for a range of health conditions common to women. These companies believe they can shift a substantial volume of such testing away from the nationâs medical laboratories.
Moreover, diagnostic startups that develop at-home direct-to-consumer (DTC) clinical laboratory genetic tests have been hot commodities among venture capitalists and other healthcare investors willing to put tens of millions of dollars into these new firms. The New York Times observed that, until recently, womenâs healthcare needs have rarely been the focus of new diagnostic testing companies, but that the situation may be changing.
âFemtechâ (short for female technology) products and services that address the health and wellness needs of women is the new buzz word in healthcare. It describes female-focused diagnostic startups aiming at vaginal health and other medical issues that go beyond reproductive health concerns.
This, however, is a dual-edged sword for clinical laboratory leaders. Growth in this segment could lead to new diagnostics tests that boost a medical labâs bottom line or, conversely, it could reduce revenue as patients self-diagnose urinary tract infections (UTIs), yeast infections, and other conditions through at-home DTC testing.
âThe market potential is huge,â Michelle Tempest, MD (above), a partner at the London-based healthcare consulting firm Candesic, told The New York Times. âThereâs definitely an increasing appetite for anything in the world which is technology and a realization that female consumer power has arrivedâand that itâs arrived in healthcare.â Tempest maintains the womenâs health marketplace is ripe for growth, which could mean a boon for clinical laboratory testing and diagnostics designed specifically for women. (Photo copyright: Candesic.)
Vaginal Microbiome At-home Clinical Laboratory Tests in High Demand
One area in particular drawing the attention of several female-led startups is vaginal health. According to an article in Vogue, test developers Juno Bio and Evvy are leading the way with at-home vaginal microbiome tests that let users âknow whatâs up down there.â
New York City-based Evvy ($129 for a single test or $99 each for four tests per year) uses metagenomic sequencing to identify the bacteria and fungi present in the vaginal microbiome. This information helps customers to understand their levels of protective and disruptive bacteria, which can be associated with everything from reoccurring infections and transmission of sexually transmitted diseases to infertility.
London-based Juno Bio ($149 per test) does not disclose its testing method. It does, however, provide users with a âfull vaginal microbiome profile.â The profile is accessed online within a âfew daysâ of returning the vaginal swab sample to the companyâs clinical laboratory.
Both companies note that their tests are intended to be used for wellness purposes and are not meant to diagnose or treat disease or substitute for a physicianâs consultation.
Gynecologist Oluwatosin Goje, MD, MSCR, FACOG, a reproductive infectious disease specialist at Cleveland Clinic, believes the availability of at-home vaginal microbiome testing will provide valuable information to both women and their doctors.
âItâs a powerful tool because it enables us to look at the entire microbial community through metagenomics and decipher how the overall composition might be affecting symptoms and infections, as well as determine the best treatment pathway,â Goje, an Evvy Medical Advisor, told Vogue. âUnderstanding the complete vaginal microbiome allows us to be good antibiotic stewards and only administer antibiotics when needed. Patients can also retest remotely to understand how antibiotics and other treatments impacted their vaginal microbiome.â
Evvy, which offers women an at-home vaginal microbiome test (above) that can provide insights into chronic vaginal infections and proclivity to contract sexually transmitted diseases and other womenâs health issues, is one of several women-led diagnostic start-ups focused on womenâs health. (Photo copyright: Evvy.)
Removing the Discomfort of Shopping for Womenâs Health Products
Jamie Norwood and Cynthia Plotch, co-founders of Stix, a supplier of womenâs health products and education, launched their company with a product line of at-home pregnancy and ovulation tests. They have since expanded their offerings to include urinary tract infection (UTI) and yeast infection testing and treatments.
âYou can test, relieve, treat, and help prevent future infectionsâall from the comfort of your own home,â Norwood, told Vogue. She emphasized that this is the kind of experience healthcare consumers are demanding in todayâs ever-growing direct-to-consumer clinical laboratory testing landscape. âAgonizing over confusing over-the-counter products in the drugstore aisles, or bending over backwards to pick up a prescription at the pharmacy, just isnât cutting it for Millennial and Gen Z consumers.â
According to WebMD, yeast infections are a chronic problem for many women. While 75% of women will get at least one yeast infection in their lifetime, up to 8% get more than four a year. In addition, the federal Centers for Disease Control and Prevention (CDC) points out that bacterial vaginosis is the most common vaginal condition in females ages 15-44.
Lola Priego, is CEO and founder of blood test company Base, which sells at-home saliva and finger-prick blood tests to monitor hormone levels, vitamin levels, neurotransmitters, and blood cell markers to improve everything from sleep and diet to sex drive. She predicts direct-to-consumer testing will become as common as fitness watches.
âEventually, at-home lab testing will be another readily-used tool, similar to your health-tracking wearables, that helps us optimize for a well-rounded healthy lifestyle in a more individualized way,â Priego told Vogue.
Femtech a âSignificantly Underdevelopedâ Market
In its latest Analyst Note, financial data firm PitchBook maintained that the market for female health products is poised for growth. TechCrunch, which reviewed PitchBookâs analysis of female-focused health products, reported that Femtech remains a âsignificantly underdevelopedâ slice of health-tech spending.
While women spend an estimated $500 billion annually on medical expenses, only 4% of research and development money is targeted at womenâs health, PitchBook noted. In its analysis, Pitchbook predicted the global market for female-focused health products will reach $3 billion by the end of 2030. By comparison, that segment of the healthcare market totaled $820.6 million last year.
âWhile we still view Femtech as a niche industry, we believe secular drivers could help propel new growth opportunities in the space,â PitchBook analysts wrote. âThese include the increasing representation of women in the venture-backed technology community, rising awareness and acceptance of womenâs health issues, and the growing prevalence of infectious diseases among women in some countries in Africa and Asia.
âFurthermore, while the majority of Femtech products have traditionally focused on reproductive health, we believe new approaches to womenâs health research will help open the door to new products and services,â they noted.
Clinical laboratory leaders will be wise to carefully watch the growth of at-home DTC tests and products targeted at female healthcare consumers since fewer trips to physiciansâ offices may mean fewer test orders for local labs.
At the same time, the opportunity exists for innovative pathologists and lab managers to develop digital services that allow consumers who are self-testing to store their home-test results in the labâs app. They can then receive relevant insights from clinical pathologists to help them fully understand the implications of the test results.
Accelerating pace of hospital consolidation brings new pressure to pathologists and clinical laboratory directors to maximize the value of pathology services
Large and financially-stable multi-hospital health systems are racing to form regional mega-systems. Itâs a strategy to get ahead of the Affordable Care Actâs (ACA) mandate to improve quality and increase efficiency through coordinated care across the entire care continuum.
This growing national trend means further consolidation of clinical laboratory testing services within the merging organizations. For pathology groups, the new super-systems may encourage the different pathology groups within the system to consolidate into a single practice entity. This would help improve how pathology services are more deeply integrated into the care continuum. It would also facilitate contract negotiations between the pathologists and the parent health system. (more…)
Pathology groups and medical laboratories may benefit if federal and state legislators legislate broadening of provider networks
Insurers are increasingly using narrow networks as a business strategy to control costs. As a consequence, more consumers are complaining even as some excluded providers are suing health insurers. For pathologists and clinical laboratory managers, this accelerating trend of excluding providers means increasingly restricted access to patients.
Health Insurers Walk a Fine Line between Cost and Access
Many health plans currently sold on the new state insurance exchanges offer substantially smaller networks of providers than was typical in recent years, according to a story published in Modern Healthcare. The payers say narrower networks are necessary for two reasons.
First, narrow networks can keep premiums affordable. Second, health insurers say narrow networks help them address the requirements of the Patient Protection and Affordable Care Act (ACA). (more…)
Savvy pathologists and clinical laboratory professionals will look for ways to generate increased value to clinicians by becoming partners and consultants in clinical decisions
Beckerâs Hospital Review has identified seven trends in hospital-based physician pay that have emerged over the past several years. These trends reflect fundamental changes in the private practice of medicine and will be of interest to those pathologists and clinical laboratory managers who provide medical laboratory tests to office-based physicians.
As defined by Beckerâs in a story published last year, the seven trends indicate shifts in income, along with increasing numbers of physicians migrating out of private practice to salaried hospital positions. Pathologists will want to keep these trends in mind as they plan their personal careers, taking special note of emerging opportunities to generate value in new ways. (more…)
