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

Hosted by Robert Michel

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

Hosted by Robert Michel
Sign In

Patient Rights Group Says Too Many Hospitals Are Not Complying with CMS Price Transparency Rules

Only about a third of the hospitals surveyed are in full compliance with giving public access to prices, the watchdog group contends, but the AHA disputes its methodology

It’s been almost four years since the Centers for Medicare and Medicaid Services (CMS) enacted its Hospital Price Transparency rule which requires hospitals—including their medical laboratories—to make their prices available and easily accessible to the public. But according to a 2024 report from PatientRightsAdvocate.org (PRA), just 34.5% of reviewed hospitals are fully compliant with the transparency rule. That’s a slight decrease from the 36% compliance rate the PRA listed in its 2023 report, the watchdog group stated in a blog post.

Released on Feb. 29, this was the group’s sixth semi-annual hospital price transparency report since the CMS rule took effect in 2021.

The rule “requires hospitals to post all prices online, easily accessible and searchable, in the form of (i) a single machine-readable standard charges file for all items, services, and drugs by all payers and all plans, the de-identified minimum and maximum negotiated rates, and all discounted cash prices, as well as (ii) prices for the 300 most common shoppable services either as a consumer-friendly standard charges display listing actual prices or, alternatively, as a price estimator tool,” the report states.

The required viewable prices are to be for, among others, medical imaging, clinical laboratory testing, and outpatient procedures such as a colonoscopies, etc.

“With full transparency, consumers can benefit from competition to make informed decisions, protect from overcharges, billing errors, and fraud, and lower their costs,” the report states. “Employer and union plans can use pricing and claims data to improve their plan designs and direct members to lower cost, high-quality facilities. However, continued noncompliance impedes this ability.”

At any time, the US Department of Justice (DOJ) could decide to file charges against a hospital or a clinical laboratory for not posting their prices on their websites in compliance with the federal rule. Such an action by DOJ officials would be to specifically put the entire industry on notice that there will be consequences for non-compliance.

The PRA’s report provides hospitals and clinical laboratories with a reminder that consumer watchdogs are also monitoring compliance.

“Our comprehensive study of 2,000 hospitals indicates nearly two-thirds (65.5%) of hospitals reviewed continue failing to fully comply with the rule, yet the Centers for Medicare and Medicaid Services (CMS) has only fined fourteen hospitals for noncompliance out of the thousands found to not be meeting all of the rule’s requirements. When hospitals don’t post their prices, they can charge whatever they want,” wrote PRA Founder and Chairman Cynthia Fisher (above) in a letter to President Biden. Hospital medical laboratories are also required to post their prices for tests. (Photo copyright: PatientRightsAdvocate.org.)

Increasing Penalties for Non-compliance

In a March 18 Health Affairs blog post on price transparency, two healthcare policy experts—David Muhlestein, PhD, JD, Chief Research Officer at Leavitt Partners, Washington, DC, and Adjunct Assistant Professor of The Dartmouth Institute (TDI) at the Geisel School of Medicine at Dartmouth College; and Yuvraj Pathak, PhD, Associate Director at West Health—argued that CMS should increase penalties for non-compliance, so the dollar amounts are greater than the cost of compliance.

To compile their report, PRA analysts examined the websites of 2,000 US hospitals between September 3, 2023, and January 13, 2023, and found that 1,311, or 65.5%, were not in full compliance, mostly due to “missing or significantly incomplete pricing data,” the report states.

More than 6,000 licensed hospitals operate in the US, the report notes. The group said it focused on hospitals owned by the largest US health systems.

Among the notable findings:

  • The 2023 report found that 98% of Kaiser Permanente’s 42 hospitals were in full compliance with the rule, but in the 2024 study, none were compliant because the hospitals began posting multiple files instead of a single file.
  • In total, 103 hospitals rated as noncompliant in the previous report were found to be compliant in the new analysis. Conversely, 135 hospitals previously rated as compliant were listed as noncompliant in the 2024 report.

The report lauded three hospitals for posting “exemplary files” that were “easily accessible, downloadable, machine-readable, and including all negotiated rates by payer and plan.” Those were Cape Cod Hospital in Hyannis, Mass.; Christus Santa Rosa Medical Center in San Antonio; and UW Health University Hospital in Madison, Wis.

In its discussion of the findings, PRA called on CMS to step up enforcement of the pricing transparency rule. The group also wants the government to close what it describes as the “estimator tool loophole,” which allows hospitals to list non-binding price estimates and price ranges instead of concrete prices.

“Price estimator tools do not achieve the goals of price transparency policy and fundamentally undermine the intent of the regulations,” the PRA’s report contends.

AHA Pushes Back on PRA Assessment

The American Hospital Association (AHA) took issue with PRA’s methodology, as Dark Daily reported in “CMS Proposes New Amendments to Federal Hospital Price Transparency Rule That May Affect Clinical Laboratories and Pathology Groups.”

In response to the 2023 PRA report, AHA Group Vice President for Public Policy Molly Smith issued the following statement, “Once again, Patient Rights Advocate has put out a report that blatantly misconstrues, ignores, and mischaracterizes hospitals’ compliance with federal price transparency regulations. The AHA has repeatedly debunked point-by-point Patient Rights Advocate’s intentionally misleading ‘reports’ on price transparency.”

Citing CMS data, Smith said that as of 2022, 70% of US hospitals had complied with two key federal rules:

  • One requiring hospitals to post machine-readable files with pricing information.
  • The other mandating a list of prices for at least 300 “shoppable” services.

More than 80% of hospitals had complied with at least one of the rules, she contended in an AHA press release.

Speaking to the New Orleans Times-Picayune, PRA Founder and Chairman Cynthia Fisher said her group performs a more in-depth study of pricing data compared with CMS.

“They did not do a comprehensive review,” she told the publication. “We do a deep dive for full compliance.”

The PRA study came on the heels of a January report from Turquoise Health that offered a rosier assessment of hospital compliance, albeit with different criteria. According to the Turquoise report, as of Dec. 15, 2023:

  • 90.7% of 6,357 US hospitals had posted machine-readable files,
  • 83.1% posted information about negotiated rates, and
  • 77.3% posted cash rates.

The Turquoise Health end-to-end price transparency platform uses a 5-point system to rate the quality of hospitals’ machine-readable files and said that more than 50% scored five stars. Clinical laboratory managers and pathologists may find it timely to review their lab organization’s compliance with this federal price transparency rule.

—Stephen Beale

Related Information:

Just 34.5% of Reviewed Hospitals Fully Compliant with Federally-Mandated Price Transparency Rule

Sixth Semi-Annual Hospital Price Transparency Compliance Report

Improving Hospital Compliance with Price Transparency Rules

Only Half of LA Hospitals Publish Prices as Required by Law, Hindering Patient Choice

34.5% of Hospitals Complying with Price Transparency Rule, Report Says

Little Progress Made with Hospital Price Transparency Compliance

CMS Releases Tool to Validate Price Transparency File Compliance

Hospital Price Transparency Compliance Dips: Report

Hospitals Backslide on Price Transparency Test

Moving into 2024: State of Price Transparency

Hospitals Finally Reached Widespread Price Transparency Compliance in 2023

More Hospitals, Payers Compliant with Price Transparency Laws

Clinical Trial Shows New Laboratory Developed Blood Test 83% Effective at Detecting Colorectal Cancer

Accurate blood-based clinical laboratory testing for cancer promises to encourage more people to undergo early screening for deadly diseases

One holy grail in diagnostics is to develop less-invasive specimen types when screening or testing for different cancers. This is the motivation behind the creation of a new assay for colorectal (colon) cancer that uses a blood sample and that could be offered by clinical laboratories. The data on this assay and its performance was featured in a recent issue of the New England Journal of Medicine(NEJM).

The company developing this new test recognized that more than 50,000 people will die in 2024 from colon cancer, according to the American Cancer Society. That’s primarily because people do not like colonoscopies even though the procedure can detect cancer in its early stages. Similarly, patients tend to find collecting their own fecal samples for colon cancer screening tests to be unpleasant.

But the clinical laboratory blood test for cancer screening developed by Guardant Health may make diagnosing the deadly disease less invasive and save lives. The test “detects 83% of people with colorectal cancer with specificity of 90%,” a company press release noted.

“Early detection could prevent more than 90% of colorectal cancer-related deaths, yet more than one third of the screening-eligible population is not up to date with screening despite multiple available tests. A blood-based test has the potential to improve screening adherence, detect colorectal cancer earlier, and reduce colorectal cancer-related mortality,” the study authors wrote in the NEJM.

As noted above, this is the latest example of test developers working to develop clinical laboratory tests that are less invasive for patients, while equaling or exceeding the sensitivity and specificity of existing diagnostic assays for certain health conditions.

“I do think having a blood draw versus undergoing an invasive test will reach more people, My hope is that with more tools we can reach more people,” Barbara H. Jung, MD (above), President of the American Gastroenterological Association, told NPR. Clinical laboratory blood tests for cancer may encourage people who do not like colonoscopies to get regular screening. (Photo copyright: American Gastroenterology Association.)

Developing the Shield Blood Test

Colorectal cancer is the “third most common cancer among men and women in the US,” according to the American Gastrological Association (AGA). And yet, millions of people do not get regular screening for the disease.

To prove their Shield blood test, Guardant Health, a precision oncology company based in Redwood City, Calif., enrolled more than 20,000 patients between the ages of 45-84 from across the US in a prospective, multi-site registrational study called ECLIPSE (Evaluation of ctDNA LUNAR Assay In an Average Patient Screening Episode).

“We assessed the performance characteristics of a cell-free DNA (cfDNA) blood-based test in a population eligible for colorectal cancer screening. The coprimary outcomes were sensitivity for colorectal cancer and specificity for advanced neoplasia (colorectal cancer or advanced precancerous lesions) relative to screening colonoscopy. The secondary outcome was sensitivity to detect advanced precancerous lesions,” the study authors wrote in the NEJM.

In March, Guardant completed clinical trials of its Shield blood test for detecting colorectal cancer (CRC) in men and women. According to the company press release, the test demonstrated:

  • 83% sensitivity in detecting individuals with CRC.
  • 88% sensitivity in detecting pathology-confirmed Stages I-III.

Additionally, the Shield test showed sensitivity by stage of:

  • 65% for pathology-confirmed Stage I,
  • 55% for clinical Stage I,
  • 100% for Stage II, and
  • 100% for Stage III.

“The results of the study are a promising step toward developing more convenient tools to detect colorectal cancer early while it is more easily treated,” said molecular biologist and gastroenterologist William M. Grady, MD, Medical Director, Gastrointestinal Cancer Prevention Program at Fred Hutchinson Cancer Center and corresponding author of the ECLIPSE study in the press release. “The test, which has an accuracy rate for colon cancer detection similar to stool tests used for early detection of cancer, could offer an alternative for patients who may otherwise decline current screening options.”

Are Colonoscopies Still Needed?

“More than three out of four Americans who die from colorectal cancer are not up to date with their recommended screening, highlighting the need for a more convenient and less invasive screening method that can overcome barriers associated with traditional options,” Daniel Chung, MD, gastroenterologist at Massachusetts General Hospital and Professor of Medicine at Harvard Medical School, said in the Guardant press release.

Barbara H. Jung, MD, President of the American Gastroenterological Association, says that even if Guardant’s Shield test makes it to the public the “dreaded colonoscopy” will still be needed because the procedure is used to locate and test polyps. “And when you find those you can also remove them, which in turn prevents the cancer from forming,” she told NPR.

There is hope that less invasive clinical laboratory testing will encourage more individuals to get screened for cancer earlier and regularly, and that the shift will result in a reduction in cancer rates.

“Colorectal cancer is highly treatable if caught in the early stages,” said Chris Evans, President of the Colon Cancer Coalition, in the Guardant press release.

Guardant Health’s ECLIPSE study is a prime example of the push clinical laboratory test developers are making to create user-friendly test options that make it easier for patients to follow through with regular screening for early detection of diseases. It echoes a larger effort in the medical community to think outside the box and come up with creative solutions to reach wider audiences in the name of prevention.

—Kristin Althea O’Connor

Related Information:

Guardant Health ECLIPSE Study Data Demonstrating Efficacy of Shield Blood-based Test for Colorectal Cancer Screening to be Published in The New England Journal of Medicine

A Cell-free DNA Blood-Based Test for Colorectal Cancer Screening

Guardant Health Announces Positive Results from Pivotal ECLIPSE Study Evaluating a Blood Test for the Detection of Colorectal Cancer

A Simple Blood Test Can Detect Colorectal Cancer Early, Study Finds

Key Statistics for Colorectal Cancer

Colorectal Cancer Facts and Statistics

Cancer Stat Facts: Colorectal Cancer

New Zealand Blood Service Workers and Junior Doctors Hit the Picket Line Once Again to Fight against Pay Disparities and Poor Working Conditions

As before, the ongoing strikes continue to cause delays in critical clinical laboratory blood testing and surgical procedures

After seven months of failed negotiations, New Zealand’s blood workers, clinical laboratory technicians, and medical scientists, are once again back on strike. According to Star News, hundreds of lab workers walked off the job on May 31, 2024, with another longer walkout planned for June to protest pay disparities.

New Zealand Blood Service (NZBS) workers, who are represented by the Public Service Association or PSA (Māori: Te Pūkenga Here Tikanga Mahi), collect and process blood and tissue samples from donors to ensure they are safe for transfer.

“Our colleagues at Te Whatu Ora [Health New Zealand] are being paid up to 35% more than us and we want to be paid too. We want fair pay,” Esperanza Stuart, a New Zealand Blood Service scientist, told Star News.

“The stall in negotiations is largely attributed to a lack of movement from NZBS on the principal issue of parity with Te Whatu Ora laboratory workers rates of pay. There is currently a 21-28% pay differential between NZBS and Te Whatu Ora laboratory workers, despite both groups of workers performing essentially the same work,” NZ Doctor noted.

Health New Zealand is the country’s government-run healthcare system.

The first strike took place on May 31 from 1-5 pm. A second 24-hour strike is planned for June 4. The strikers outlined the rest of their strike schedule as follows:

  • No work outside paid hours (5/29-6/6)
  • Refusal to conduct duties associated with processing AHF [antihemophilic factor] plasma (5/29-6/6)
  • No overtime or extra shifts (6/6-6/19)

The PSA union claims that the pay disparity workers are experiencing is pushing veteran workers out and complicating recruitment of new workers.

New Zealand Blood Service workers and junior doctors are once again back on the picket line to protest wage cuts and pay disparities. “I think it should be a signal that things are not right in our health system when there are multiple groups of workers going on strike simultaneously,” said PSA union organizer Alexandra Ward. Clinical laboratory workers in the US are closely monitoring the goings on in New Zealand as pressure over staff shortages and working conditions continue to mount in this country as well. (Photo copyright: RNZ.)

Clinical Laboratory Worker Strikes Ongoing in New Zealand

This is far from the first time New Zealand lab workers have hit the picket line.

In “Medical Laboratory Workers Again on Strike at Large Clinical Laboratory Company Locations around New Zealand,” Dark Daily reported on a medical laboratory workers strike that took place in 2023 in New Zealand’s South Island and Wellington regions. The workers walked off the job after a negotiated agreement was not reached between APEX, a “specialist union representing over 4,000 allied, scientific, and technical health professionals,” according to the union’s website, and Awanui Labs, one of the country’s largest hospital and clinical laboratory services providers.

And in “Four Thousand New Zealand Medical Laboratory Scientists and Technicians Threatened to Strike over Low Pay and Poor Working Conditions,” we covered a series of walkouts in 2022 sparked by an unprecedented surge in PCR COVID-19 testing that pushed the country’s 10,000 healthcare workers—including 4,000 medical laboratory scientists and technicians—to the breaking point.

This latest strike is likely to cause delays in vital surgeries and risk the nation’s critical blood supply. All of these strikes were spurred on by low pay, negative working conditions and worker burnout. Similar issues have caused labor actions in the United Kingdom’s National Health Service in recent years.  

Junior Doctors Join Blood Service Workers on Picket Line

Blood service workers aren’t the only healthcare employees in New Zealand’s medical community taking action. In May about half of the nation’s junior doctors walked off the job for 25 hours to protest proposed pay cuts, NZ Herald reported.

In a letter to the nation’s public hospitals, Sarah Morley, PhD, NZBS’s Chief Medical Officer, “warned [that] even high priority planned surgeries should be deferred because they did not meet the definition of a ‘life-preserving service,’” and that “only surgeries where there is less than a 5% risk that patients may need a transfusion should be carried out,” RNZ reported.

According to an internal memo at Mercy Ascot, NZBS “did not consider cancers and cardiac operations in private hospitals to be a life-preserving service,” RNZ noted.

The situation may be more dangerous than officials are letting on, NZ Herald noted. A senior doctor at Waikato Hospital told reporters, “There are plenty of elective services cancelled today—clinics, surgery, day stay procedures etc. … And although I can only speak for my department, we are really tight for cover from SMO [senior medical officers] staff for acute services and pretty much all elective work has been cancelled. So, it’s actually pretty dire, and if next week’s planned strike goes ahead it’s going to be worse. I’d go as far as to say that it’s bordering on unsafe.”

The strike did take place, and the junior doctors went back on strike at the end of May as well, according to RNZ.

Support from Patients

Eden Hawkins, a junior doctor on strike at Wellington Hospital told RNZ that patient wellbeing is a top concern of striking workers and that patients have shown support for the doctors.

“When patients have brought it up with me on the wards or in other contexts there seems to be a bolstering sense of support around us, which is really reassuring and heartening because there’s obviously a conflict within ourselves when we strike, we don’t want to be doing that,” she said. Hawkins also makes the argument that striking workers can improve patient wellbeing in the long run. Improvement of pay and conditions could lessen staff turnover and overall improve the standard of care.

New Zealand healthcare workers haven’t been shy when it comes to fighting for the improved working conditions and fair pay. And their problems are far from unique. American healthcare workers have been struggling with worker burnout, pay disparities, high turnover as well. Clinical laboratory and other healthcare professionals in the US would be wise to keep an eye on their Kiwi counterparts.

—Ashley Croce

Related Information:

Fed-Up Blood Service Workers Go on Strike

NZ Blood Workers Plan 24-Hour Strike for Pay Parity

New Zealand Blood Service Laboratory Workers to Strike after 7 Months of Stalled Pay Negotiations

Significant Risk to Blood Supply as Blood Service Lab Workers Strike

Junior Doctors to Strike for 25 Hours, May Postpone Treatments

‘Pretty Dire’ Situation for Patients as Junior Doctors Strike Over Pay Cuts

Junior Doctors Go on Strike Again, More Surgeries Deferred

Medical Laboratory Workers Again on Strike at Large Clinical Laboratory Company Locations around New Zealand

Four Thousand New Zealand Medical Laboratory Scientists and Technicians Threatened to Strike over Low Pay and Poor Working Conditions

UK’s National Health Service Tests AI Tool That Can Spot Cancer in Mammograms Missed by Doctors

This AI platform has the potential to also reduce workload of radiologists, but also of anatomic pathologists and oncologists allowing them to be more productive

When the UK’s National Health Service (NHS) recently tested an artificial intelligence (AI) platform’s ability to analyze mammograms, the AI found early signs of breast cancer that “human doctors” had previously missed, the BBC reported. This level of ability by AI might soon be adapted to aid overworked anatomic pathologists and cancer doctors in the United Kingdom.

The pilot program, which was conducted at NHS Grampian Aberdeen in Scotland, tested the Mammography Intelligent Assessment (MIA) AI platform for breast screening developed by Kheiron Medical Technologies and Imperial College London

Out of 10,000 mammograms MIA analyzed, the AI platform found “tiny signs of breast cancer in 11 women” which had not been spotted during earlier examinations, the BBC noted, adding that the cancers “were practically invisible to the human eye.”

This is a significant development in AI’s role in healthcare. Anatomic pathologists and clinical laboratory leaders will note that ongoing advancements in AI are enabling technology developers to apply their solutions to assessing radiology images, as well as in whole slide imaging used in digital pathology. In the UK, use of AI, the BBC noted, may also help ease doctor’s workloads.

“This is just the beginning of our work with Kheiron,” said Ben Glocker, PhD (above), Professor in Machine Learning for Imaging at Imperial College London and Head of ML Research at Kheiron Medical, in a news release. “We are actively working on new methodologies for the safe deployment and continuous monitoring of MIA to support a US and UK rollout. We are working hard to make sure that as many women as possible will benefit from the use of this new technology within the next year.” AI tools such as MIA may soon take much of the load from anatomic pathologists and radiologists. (Photo copyright: Imperial College London.)

MIA Cloud-based AI Platform

Kheiron was founded in 2016 and MIA was named one of the seven biggest medical breakthroughs in 2023 by ABC News. A study conducted by Imperial College London in 2023 found that MIA “could significantly increase the early detection of breast cancers in a European healthcare setting by up to 13%,” according to an Imperial news release.

“The study was conducted over three phases (two pilot phases and a live roll-out). Overall across the three phases, the AI reader found 24 more cancers than the standard human reading—a 7% relative increase—and resulted in 70 more women recalled (0.28% relative increase),” the news release reported. “Of the additional recalls, six (initial pilot), 13 (extended pilot), and 11 (live use) additional cancers were found, increasing relative cancer detection rate by 13%, 10%, and 5% respectively. [The researchers] found that 83% of the additional cancers detected using MIA in real clinical practice were invasive, showing that MIA can detect cancers where early detection is particularly vital.”

Supported by Microsoft’s Azure Cloud, MIA came together over six years based on training encompassing millions of mammograms worldwide, Healthcare Digital reported.

“AI tools are generally pretty good at spotting symptoms of a specific disease if they are trained on enough data to enable them to be identified. This means feeding the program with as many different anonymized images of those symptoms as possible, from as diverse a range of people as possible,” Sarah Kerruish, Chief Strategy Officer, Kheiron, told Healthcare Digital.

MIA has been trained to “recognize subtle patterns and anomalies” that can point to “cancerous cells even in their earliest stages of development,” Dataconomy reported.

MIA Finds Early Cancer Signs

In the pilot study, MIA examined mammograms from 10,889 women. Each image had previously been reviewed by two radiologists, the BBC reported.

Findings include the following according to Healthcare Digital:

  • MIA “flagged” all people the physicians previously identified with symptoms.
  • The AI platform discovered 11 people with cancer the doctors did not identify.
  • The cancer MIA discovered—and the doctors did not—suggested cancer in early stages.

So, how did the doctors miss the cancer that MIA spotted? Gerald Lip, MD, Clinical Director for Breast Screening in North East Scotland who led the pilot study for the NHS, told Healthcare Digital, “part of the power of AI is it’s not prone to exhaustion or distraction.

“There is an element of fatigue,” he said. “You get disruptions, someone’s coming in, someone’s chatting in the background. There are lots of things that can probably throw you off your regular routine as well. And in those days when you have been distracted, you go, ‘how on earth did I miss that?’ It does happen.”

Lip is also the Chief Investigator in the Mammography Artificial Intelligence Project in the Industrial Center for Artificial Intelligence and Digital Diagnostics in Scotland.  

“I see MIA as a friend and an augmentation to my practice,” he told Healthcare Digital. “MIA isn’t perfect. It had no access to patient history so [it] would flag cysts that had already been identified by previous scans and designated harmless.”

AI as a Safety Net

In the 2023 study, researchers from Imperial College London deployed MIA as an extra reader for mammograms of 25,065 women who visited screening sites in Hungary between April 2021 and January 2023, according to a news release.

“Our prospective real-world usage data in Hungary provides evidence for a significant, measurable increase of early breast cancer detection when MIA is used in clinical practice,” said Peter Kecskemethy, PhD, CEO and co-founder of Kheiron Medical, in the news release.

“Our study shows that AI can act as an effective safety net—a tool to prevent subtler signs of cancer from falling through the cracks,” said Ben Glocker, PhD, Professor in Machine Learning for Imaging at Imperial College London and Head of ML Research at Kheiron Medical, in the news release.

More studies are needed before MIA can be used in clinical settings. Nevertheless, use of AI in radiology—specifically mammograms—where the AI tool can identify very small cancers typically undetectable by radiologists, would be a boon to cancer doctors and the patients they treat.

So far, the research suggests that the AI-powered MIA has benefits to deployment in breast cancer screening. Eventually, it may also make impressive contributions to medical diagnosis and patient care, particularly if MIA eventually proves to be effective at analyzing the whole slide images used by anatomic pathologists. 

—Donna Marie Pocius

Related Information:

NHS AI Test Spots Tiny Cancers Missed by Doctors

Seven Biggest Medical Breakthroughs of 2023

AI Tool Picks up Early-Stage Breast Cancers Doctors Missed

AI Tool MIA Accurately Detects Subtle Breast Cancers

Meet MIA/Introducing Kheiron Medical Technologies

New AI Tool Detects up to 13% More Breast Cancers than Human Clinicians Can

Prospective Implementation of AI-assisted Screen Reading to Improve Early Detection of Breast Cancer

Ex-Theranos Founder and CEO Elizabeth Holmes Reduced Her Prison Sentence by Nearly Two Years

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.

In “After AACC Presentation, Elizabeth Holmes and Theranos Failed to Convince Clinical Laboratory Scientists and the News Media about Quality of Its Technology,” Dark Daily’s Editor-in-Chief Robert Michel reported on Holmes’ presentation at the American Association of Clinical Chemistry (AACC) annual meeting in 2016, after which the clinical laboratory scientists in attendance were highly skeptical of Holmes’ claims.

“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.”

A follow-up Dark Daily ebriefing concerning Theranos covered a fraud settlement with the Securities and Exchange Commission (SEC), sanctions from the Centers for Medicare and Medicaid Services (CMS), investor lawsuits, consumer lawsuits, and a settlement with Walgreens over claims about Theranos’ Edison portable blood analyzer. Theranos’ web of lies was unraveling.

Theranos Saga Continues

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.

—Kristin Althea O’Connor

Related Information:

Elizabeth Holmes Sees More Months Trimmed from Prison Release Date

Theranos Founder Elizabeth Holmes’ Prison Sentence Keeps Getting Shorter

Hot Startup Theranos Has Struggled with Its Blood-Test Technology

Elizabeth Holmes Shaves More Time Off Her Sentence

The Infatuation with Elizabeth Holmes’ Prison Term

After AACC Presentation, Elizabeth Holmes and Theranos Failed to Convince Clinical Laboratory Scientists and the News Media about Quality of Its Technology

Previously High-Flying Theranos Provides Clinical Laboratories and Pathology Groups with Valuable Lesson on How Quickly Consumer Trust Can Be Lost

University of Warwick Researchers Identity Blood Protein Biomarkers That Can Predict Dementia Onset Years in Advance

With further study, this research may provide clinical laboratories with a new proteomic biomarker for dementia screenings that identifies risk more than 10 years before symptoms appear

Researchers at the University of Warwick in the UK and Fudan University in Shanghai, China, identified four protein biomarkers in blood that they say can predict dementia up to 15 years before diagnosis. They say these biomarkers may lead to clinical laboratory blood tests that offer alternatives to costly brain scans and lumbar punctures for diagnosis of dementia.

The scientists “used the largest cohort of blood proteomics and dementia to date,” according to a University of Warwick news release. This included taking blood from 52,645 “healthy” people without dementia who participated in the UK Biobank—a population-based study cohort, the new release noted.

“The proteomic biomarkers are [easy] to access and non-invasive, and they can substantially facilitate the application of large-scale population screening,” said neurovegetative disease specialist Jin-tai Yu, MD, PhD, a professor at Fudan University and co-author of the study, in the news release.

The scientists published their findings in the journal Nature Aging titled, “Plasma Proteomic Profiles Predict Future Dementia in Healthy Adults.”

“The advent of proteomics offers an unprecedented opportunity to predict dementia onset,” the researchers wrote.

“This is a well-conducted study that adds to what we know about changes in blood that occur very early in diseases that cause dementia, which will be important for early diagnosis in the future,” said Tara Spires-Jones, PhD, in a post from the Science Media Center in the UK. “However,” she added, “it is important to note that these are still scientific research studies and that there are currently no blood tests available for routine use that can diagnose dementia with certainty.

Jones, who was not involved in the study, is President of the British Neuroscience Association (BNA) and group leader of the UK Dementia Research Institute at the University of Edinburgh.

“Based on this study, it does seem likely that blood tests will be developed that can predict risk for developing dementia over the next 10 years, although individuals at higher risk often have difficulty knowing how to respond,” Suzanne Schindler, MD, PhD (above), told Reuters. Schindler, an Associate Professor of Neurology at Washington University in St. Louis, was not involved in the research. Clinical laboratories may soon have a new blood test for dementia. (Photo copyright: VJDementia.)

Predicting Onset of Dementia with 90% Accuracy

The researchers analyzed 52,645 blood samples from the UK Biobank (UKBB). The samples were collected between 2006 and 2010 from healthy individuals who at that time were without dementia.

By March 2023, 1,417 of the study participants had developed Alzheimer’s disease or some other form of dementia. The researchers looked at 1,463 proteins and identified four that were present in high levels among those people:

“Individuals with higher GFAP levels were 2.32 times more likely to develop dementia,” the researchers wrote in Nature Aging. “Notably, GFAP and LTBP2 were highly specific for dementia prediction. GFAP and NEFL began to change at least 10 years before dementia diagnosis.”

When adding known risk factors such as age, sex, and genetics, the researchers said they could predict onset of dementia with 90% accuracy, according to the University of Warwick news release.

“Our findings strongly highlight GFAP as an optimal biomarker for dementia prediction, even more than 10 years before the diagnosis, with implications for screening people at high risk for dementia and for early intervention,” the researchers wrote.

The news release also noted that smaller studies had already identified some of the proteins as potential biomarkers, “but this new research was much larger and conducted over several years.”

Further Validation Needed

Amanda Heslegrave, PhD, of the UK Dementia Research Institute, University College London described the UKBB as “an excellent resource” in the Science Media Center (SMC) post. However, she noted, it’s “a highly curated biobank and may not capture all populations that we need to know the risk for. The new biomarkers identified will need further validation before being used as screening tools.”

Another expert raised additional questions about the University of Warwick/Fudan University study in the SMC post.

“These results may help researchers understand the biological systems involved in the development of dementia,” said David Curtis, MD, PhD, of the UCL Genetics Institute at University College London. “However in my view the strengths of the reported associations are not really strong enough to say that these would form a useful test for predicting who will get dementia in the future.”

Conversely, Curtis pointed to other studies suggesting that phosphorylated tau (p-tau) proteins are better candidates for developing a simple blood test.

P-tau “provides a very good indicator of whether the pathological processes leading to Alzheimer’s disease are present in the brain,” he said. “When effective treatments for Alzheimer’s disease are developed it will be very helpful indeed to have simple blood tests—such as measuring phosphorylated tau—available in order to identify who could benefit.”

At least two blood tests based on the p-tau217 variant—from ALZpath and C2N—are currently available to US clinicians as laboratory developed tests (LDT).

In “University of Gothenburg Study Findings Affirm Accuracy of Clinical Laboratory Blood Test to Diagnose Alzheimer’s Disease,” Dark Daily reported on a study from the University of Gothenburg in Sweden which found that the ALZpath test was as good or better than lumbar punctures and brain scans as a diagnostic tool for Alzheimer’s.

UK Biobank

The UK Biobank continues to be used by researchers both in the UK and abroad because of the full sets of data on large numbers of patients over many years. There are few other sources of such data elsewhere in the world. The UK Biobank is a large-scale biomedical database and research resource. It contains de-identified genetic, lifestyle and health information, and biological samples from 500,000 UK participants.

On its website, the UK Biobank states, “It is the most comprehensive and widely-used dataset of its kind and is globally accessible to approved researchers who are undertaking health-related research that is in the public interest, whether they are from academic, commercial, government or charitable settings.”

Thus, clinical laboratory managers and pathologists can expect a continuing stream of published studies that identify biomarkers associated with different health conditions and to see where the data used in these analyses came from the UK’s biobank.

—Stephen Beale

Related Information:

Protein Biomarkers Predict Dementia 15 Years Before Diagnosis, According to New Study

Plasma Proteomic Profiles Predict Future Dementia in Healthy Adults

Proteins May Predict Who Will Get Dementia 10 Years Later, Study Finds

Expert Reaction to Study of Potential Protein Biomarkers for Dementia Risk

Two New p-Tau217 Blood Tests Join a Crowded Field

Plasma p-Tau-217 Assays Work Well, But No Home Run for Diagnosis

Dementia Can Be Predicted More than a Decade Before Diagnosis with These Blood Proteins

Dementia Predicted 10 Years Before Diagnosis

Early Blood Test to Predict Dementia Is Step Closer as Biological Markers Identified

Validating Blood Tests as A Possible Routine Diagnostic Assay of Alzheimer’s Disease

;