Additional research may lead to precision medicine FMT treatments for patients with specific cancers
Research continues to show that the human gut microbiome plays a significant role in a person’s health and longevity. One recent example is a clinical trial study conducted by scientists at MD Anderson Cancer Center in Houston which demonstrated that fecal microbiota transplants (FMTs) can help in the eradication of some cancers.
If approved for clinical treatment of cancer, the use of FMT may increase the demand for diagnostic tests to verify that the approach worked in a patient.
Our guts are home to trillions of microorganisms (aka, microbiota), known as the gut microbiome, which serve many important functions in the body. The microbiome is a delicate ecosystem that can be pushed out of balance when unfavorable microbes outnumber advantageous ones.
An FMT is an uncomplicated and powerful method of repopulating the microbiome with beneficial microbes. The researchers at MD Anderson administered FMTs from donors with advanced cancers that had been completely cured by immunotherapy into the guts of patients whose cancers were not improving.
“[Early reports] demonstrate that gut microbiota is contributing to immunotherapy resistance in at least some patients and provide hope that by changing the microbiome, some will respond,” Jonathan Jacobs, MD, PhD, a gastroenterologist at the Fielding School of Public Health at the University of California, Los Angeles (UCLA), told NBC News. Jacobs was not involved in the MD Anderson research.
“These early reports of patients who were previously immunotherapy-resistant but experienced clinical response after receiving FMT [fecal transplants] and immunotherapy retreatment are very exciting,” said Jonathan Jacobs, MD, PhD (above), a gastroenterologist at the Fielding School of Public Health at the University of California, Los Angeles, in an interview with NBC News. (Photo copyright: UCLA.)
‘Miraculous’ Treatment for Cancer
Fecal microbiota transplant is a procedure where stool from a healthy donor is transplanted into the microbiome of a patient plagued by a certain medical condition. The procedure has been used as a standard treatment for recurrent Clostridioides difficile for years and is currently being studied as a potential cure for illnesses such as Parkinson’s disease, autism, obesity, and inflammatory bowel disease.
The premise of the MD Anderson clinical trial study was that gut bacteria from the now cancer-free individuals may assist the immune systems of the current patients to recognize and fight their cancers. The scientists focused their efforts on PD-1 immune checkpoint inhibitors that help keep white blood cell lymphocytes (T cells) from attacking other cells in the body.
PD-1 inhibitors are especially effective in treating tumors known as microsatellite instability-high cancer tumors. This type of tumor has an unusually large numbers of DNA mutations. PD-1 inhibitors help pinpoint these mutations and attack the cancerous tumors.
“They’re miraculous drugs,” Timothy Yeatman, MD, PhD, associate director of translational research at the Tampa General Hospital Cancer Institute, told NBC News. “They’ve been able to cure people with no chemotherapy, no radiotherapy, or no surgery.”
Yeatman also said that some patients “experience improvements that are barely believable: people with mere months to live who are then cured of their disease. In medical parlance, this is referred to as a complete response.”
FMT Treatment Brings Fast Results
Yinghong Wang, MD, PhD, a gastroenterology specialist and professor in the department of gastroenterology, hepatology and nutrition at MD Anderson, said in a news release that positive results for cancer patients undergoing the FMT treatment can appear expeditiously.
“The quickest response can be seen within 24 hours. Patients have reported having much better energy and appetite the next day. Some say they feel like a new person,” she said. “Usually, though, I’d recommend giving it at least a week. If two weeks pass by without any discernable benefit, it probably wasn’t effective.”
According to Wang, FMTs can be delivered by several methods that fall into two categories:
Lower GI tract: The colonoscopy method is used very frequently since it allows more thorough coverage of the colon’s interior walls and reduces the chance of leakage after the procedure. However, liquid donor stool can also be delivered via enema.
Upper GI tract: These include frozen or freeze-dried capsules that can be swallowed, as well as liquids that can be placed directly in the GI tract via a feeding tube or upper endoscopy procedure.
This ongoing pilot study at MD Anderson could aid in the advancement of using the gut microbiome to help the immune system fight all sorts of diseases.
Future Developments of FMT Research
MD Anderson has partnered with biotechnology startup Kanvas Biosciences, which developed a technology known as HiPR-FISH (high-phylogenetic-resolution microbiome mapping by fluorescence in situ hybridization) to examine the relationships between gut bacteria and the immune system. This tool enables scientists to identify key microbial strains and place those strains in a pill that MD Anderson will use in further research to determine if PD-1 inhibitors can help the immune system on a larger scale.
“We have essentially made a synthetic version of the superdonor stool and then optimized and immortalized it so that it can be reproduced and used in the treatment of cancer patients worldwide,” Matthew Cheng, MD, a trained medical microbiologist and co-founder and CEO of Kanvas, told NBC News.
More research and clinical trials are needed before fecal microbiota transplants can be used on a mainstream basis in the treatment of cancer. However, the MD Anderson research is promising in foreseeing the possibility that cancer patients who do not respond well to immunotherapy may have better luck through a personalized medicine approach geared to specific patients.
As such, the research is of interest to pathologists who want to learn more about the potential role of the human microbiome in precision medicine and clinical laboratory testing.
“It’s possible that even better outcomes could be obtained with a more precise understanding of the recipient’s microbiome, genetics, type of cancer, and antitumor immune responses, to select the optimal combinations,” said Jacobs in the NBC News interview.
This follows class action lawsuits in multiple states against insurance companies that deny millions of healthcare claims each year
Artificial intelligence (AI) has become ubiquitous in many aspects of healthcare. But perhaps its most controversial use is in the payer denial-of-claims process. Multiple states are pursuing legislation that would limit or outright ban AI’s use without physician involvement.
Clinical laboratories experience payment denials at both the prior authorization stage when a doctor orders a lab test as well as when the claim is submitted for reimbursement. And many labs perform tests for which they know they will not be paid just to maintain the client account relationships with doctors.
Now, several states are taking measures to protect patients from what some say is a dangerous trend to use AI algorithms only to review and deny medical claims for critical healthcare and clinical laboratory testing. This will be of interest to lab managers and those in charge of their lab’s revenue.
“Physicians and patients already face daunting challenges in navigating medical insurers’ bureaucratic administrative processes,” said Arizona Medical Association (ArMA) President Nadeem Kazi, MD, in a news release. “Taking physicians’ clinical experience out of these processes entirely is a misguided step,” he added.
However, on March 13, the Arizona Senate’s Finance Committee altered the language in its version of the bill. In it, AI is not specifically mentioned.
Instead, the bill’s language now “requires a medical director or healthcare provider, before a healthcare insurer may deny a claim or issue a direct denial of a prior authorization, to individually review any denial that involves medical necessity or experimental status or that requires the use of medical judgment and prohibits the director or provider from relying solely on recommendations derived from any other source during the prior authorization denial or claim denial review.”
Presumably, “any other source” includes AI-driven software platforms used by payers for prior authorization denials and claims processing.
“While AI promises innovation for several areas of healthcare, the review and denial of medical insurance claims—some of which represent life-changing treatments and procedures—should be left to physicians who can make nuanced clinical judgments,” said Shelby Job, ArMA communications director, in a statement following that state’s passage of the House bill in February.
The bill is now being debated in the Arizona Senate. If the Senate passes its version, the two sides will need to reconcile their bills.
“Patients deserve healthcare delivered by humans with compassionate medical expertise, not pattern-based computer algorithms designed by insurance companies,” said ArMA President Nadeem Kazi, MD (above), in a news release. (Photo copyright: Arizona Medical Association.)
Multiple States Move to Limit Use of AI in Claims Denials
In an Arizona House of Representatives Committee on Commerce meeting, state Republican representative Julie Willoughby, who is also an ER nurse, said that “she hopes the bill will protect Arizonians from losing healthcare access due to AI interference,” NBC News reported following passage of the House bill.
“What we’re asking for in this is that any claims that are denied have a provider look them over for completeness to ensure that there isn’t anything that the AI algorithm may not have accounted for,” she said.
If signed into law, the bill will require a medical director at the insurance carrier in question to “individually review each claim or prior authorization before a healthcare insurer is able to deny a claim for that patient,” NBC News noted.
California passed similar legislation in September that would “ensure that a licensed physician supervises the use of AI decision-making tools when they are used to inform decisions to approve, modify, or deny requests by providers,” NBC News reported.
The author of the California bill, Democratic senator Josh Becker, JD, argued upon the bill’s passing that AI “should never replace the expertise and judgment of physicians,” adding, “An algorithm cannot fully understand a patient’s unique medical history or needs, and its misuse can lead to devastating consequences.”
And in Texas, a bill introduced by Republican senator Charles Schwertner, MD, states that AI “should not be used as the ‘sole basis of a decision to wholly or partly deny, delay, or modify healthcare services,’” NBC News reported.
In a statement, the Texas Coalition of Patients said the bill is “crucial in ensuring that life-altering healthcare decisions remain in the hands of medical professionals rather than Big Insurance’s automated systems.”
In all, 11 states have introduced legislation to “to push back on artificial intelligence use in reviewing medical claims,” according to NBC News.
In May 2023, The Dark Report explored payer claims denials, and it was acknowledged back then that automated systems were already reviewing claims.
And then there are the lawsuits. According to The Guardian, Cigna, Humana, and UnitedHealth all face class-action lawsuits concerning the use of AI to “deny lifesaving care.”
Can AI Coexist with Human-based Care?
Although at this time AI may not understand the nuanced complexities of healthcare claims, there seem to be plenty of uses for it in healthcare decision-making. It can analyze large sets of data for diagnosis, transcribe medical documents using automatic speech recognition, and streamline administrative tasks––all of which can help a workforce plagued by staff burnout and shortages, Los Angeles Pacific University noted.
And though its use in payer claims reviews and denials is being resisted, AI will likely continue to help doctors diagnose disease and make better treatment decisions. Nevertheless, clinical laboratory and pathology workers should be aware of how the tool is being used and keep an eye out for suspicious claims denials.
New EHR installations may require new laboratory information system upgrades and interfaces
Electronic health record (EHR) systems continue to be one of the costliest investments healthcare providers can make. And the company that holds the largest portion of the EHR market is Epic, with anywhere from 36% to 44%, according to various published reports and research briefs.
Healthcare executives remorseful about the cost of their hospital’s EHR may take solace in Becker’s Health IT’s recent list of the “most expensive” Epic EHR installations. It is common for the largest projects to cross the $1 billion mark.
Clinical laboratory leaders tasked with interfacing their hospital’s laboratory information system (LIS) with their healthcare system’s EHR may find the following information useful. The investment in time begins months before the actual EHR implementation.
One example is Lake Charles Memorial Health System (LCMHS) Lake Charles, La. In a blog post, the health system reported that it took 18 months for its physicians, clinicians, and staff to prepare for the installation of their new Epic MyChart EHR.
“There are lots of things we wish our customers would do to make sure their system runs well. Making sure every user is trained, for example. Putting in upgrades quickly. Making sure that the hardware runs fast enough,” wrote Judy Faulkner, Epic founder and CEO, in an Epic blog post.
“The LCMHS staff and physicians have championed this project from the beginning, and I have them to thank for the success of this EMR transition and look forward to seeing the positive impacts as we settle into the operational changes and new experiences Epic brings Lake Charles Memorial Health System and those we serve,” said Devon Hyde (above), President and CEO of Lake Charles Memorial Health System, about the provider’s transition to a new Epic MyChart EHR. (Photo copyright: Lake Charles Memorial Health System.)
Top 10 Most Expensive Epic EHR Installs of 2024
While Becker’s noted that the following compilation is “not an exhaustive list,” here’s its list of the top 10 most expensive Epic EHR projects based on publicly available sources.
KLAS reported that among the healthcare leaders KLAS interviewed:
27% had “an above-average EHR post-implementation” likely due to “providing technological foundation needed” at go-live, while,
40% said implementation of the EHR “had significant misses” and,
22% reported “average satisfaction with room for improvement.”
Providing staff with adequate training may smooth the way for new EHRs, according to the KLAS report. “Often, leaders wish they had invested in more training time and workflow-specific training in the context of patient care,” the authors wrote.
New EHR May Mean New LIS
Pathologists and clinical laboratory leaders may need to transition the laboratory information system (LIS) when the healthcare organization moves to a new EHR. At the very least, new interfaces will be required.
While a new EHR and LIS requires significant investments, they also provide opportunities for needed upgrades, competitive advantage, and security.
New owner plans to take the pharmacy company private as it continues to shutter retail locations
Last year, Walgreens announced plans to close a large number of its stores “due to financial difficulties and ongoing environmental pressures,” according to Becker’s Hospital Review. Dark Daily has covered the struggles facing all of the major pharmacy companies in many ebriefs over the past few years.
Now, in another sign of the financial woes facing retail pharmacy chains, Walgreens Boots Alliance (WBA) announced in March that it had agreed to be acquired by private equity firm Sycamore Partners. As part of the $10 billion deal, Sycamore will take WBA private, according to a company press release.
The sale is valued at up to $23.7 billion when debt is included. The company’s brands include Walgreens and Duane Reade in the US, and Boots in the UK.
The deal follows WBA’s plans to close approximately 1,200 US retail locations over the next 30 months. The pharmacy company announced the plan last October as it reported an $8.6 billion net loss for the 2024 fiscal year.
“You have a business that is shrinking, and then you layer on losses and cash burn, all of that was the perfect recipe for what we are seeing today,” Jefferies research analyst Brian Tanquilut told Reuters following the March announcement.
WBA said the deal is expected to close in Q4 of calendar year 2025, pending approval by regulators and its shareholders. The agreement includes a “go-shop” provision that allows the company to consider other proposals.
“Given the size and number of moving parts involved—a potential split of the US business, Boots, and Health—we don’t expect a competing bid to come over the top,” Leerink Partners analyst Michael Cherny told Reuters.
“Sycamore will provide us with the expertise and experience of a partner with a strong track record of successful retail turnarounds,” said Walgreens Boots Alliance CEO Tim Wentworth (above) in a press release. “We believe this agreement provides shareholders premium cash value, with the ability to benefit from additional value creation going forward from monetization of the VillageMD businesses.” (Photo copyright: Walgreens Boot Alliance.)
Long Way Down for Walgreens Boots Alliance
The purchase price of this sale demonstrates how far WBA has fallen since its formation in 2014, when Walgreen Co. completed a merger with Alliance Boots GmbH, a large retail group headquartered in Switzerland.
At its peak in April 2015, WBA had a market valuation of more than $100 billion, according to financial reports.
Analysts have pointed to industrywide challenges that have also affected rivals CVS and Rite Aid, according to reports in The New York Times and the Associated Press (AP). These include rising operating costs, declining reimbursement for prescription drugs, and stiff competition from discount retailers such as Amazon and Walmart.
“We are at a point where the current pharmacy model is not sustainable, and the challenges in our operating environment require we approach the market differently,” said WBA CEO Tim Wentworth during a June 2024 call with analysts, the AP reported.
News Outlets Report Questionable Moves Over the Years
Reuters, however, pointed to questionable moves by Stefano Pessina, the former executive chairman of Alliance Boots who became CEO of WBA following completion of the merger in 2014. Pessina is also WBA’s largest shareholder, Reuters noted.
In October 2015, WBA offered $9.5 billion to acquire US pharmacy chain Rite Aid. But the company eventually backed away from the deal as regulators raised antitrust concerns, CNBC reported. Instead, in 2017, WBA paid $4.375 billion to acquire nearly 2,000 of Rite Aid’s 4,600 US retail locations.
“But that store footprint proved too big and soon after the acquisition, Walgreens started to close locations,” Reuters reported.
Billions Spent on Retail Clinic Plans
In July 2020, WBA announced a $1 billion deal with VillageMD to open as many as 700 primary care clinics at Walgreens locations. That deal gave WBA a 30% ownership stake in the provider.
Nine months later, Pessina stepped down as CEO to become executive chairman of the board. Taking his place was former Starbucks chief operating officer Roz Brewer. Under her watch, WBA spent an additional $5.2 billion to take a majority stake in VillageMD, which provides primary care services.
That deal has become a “cash drain,” on WBA, Reuters reported. CNBC noted that other retailers have also faced headwinds in their efforts to provide primary care services. Walmart said it would close its in-store health clinics, and CVS also shuttered dozens of clinics in New England and Southern California.
In March 2024, Wentworth revealed a turnaround plan that included $1 billion in cost cuts and closure of 160 VillageMD clinics, according to Fierce Healthcare. At the time, the company had already closed hundreds of stores in the US and UK, AP reported.
Wentworth followed that plan with October’s announcement to shutter an additional 1,200 retail locations.
Mizuho Bank analyst Ann Hynes told Reuters that, as a private company, WBA will be better positioned to deal with its challenges because it won’t have to answer to shareholders.
One likely move is a divestment of the company’s stake in VillageMD, Reuters reported. And the Boots portion of WBA’s business is a likely spinoff candidate, analysts told the news outlet.
Lab professionals will learn more at the upcoming 30th annual edition of the event
Big changes and challenges are coming for the clinical laboratory anatomic pathology industry, and with them a slew of opportunities for lab and pathology practice leaders. At the upcoming 30th Annual Executive War College on Diagnostics, Pathology, and Clinical Laboratory Management, expert speakers and panelists will focus on the three most disruptive forces.
There will be more than 169 presenters at this year’s Executive War College. Those speakers include:
David Dexter, MD, clinical and laboratory pathology at M Health Fairview, and Sam Terese, president and CEO at Alverno Laboratories, who will present a strategic case study about the support labs can provide to parent hospitals when navigating new waters.
Paul Wilder, executive director of CommonWell Health Alliance, who will speak on the effort to improve the transferability and portability of patient and healthcare data in ways that improve the quality of care.
“Since the inception of The Dark Report in 1995 there has been continual change both within the US healthcare system and within the profession of laboratory medicine,” noted Robert L. Michel, Dark Daily’s editor-in-chief and creator of the Executive War College. “Now, three decades later, the following three items are imperatives for all labs: controlling costs; having adequate lab staff across all positions; and having enough capital to acquire and deploy new diagnostic technologies, along with the latest information technologies.”
“Most clinical laboratory managers would agree that many of the same operational pain points faced by labs in the 1990s exist today,” said Robert L. Michel (above), founder of the Executive War College. In an interview with Dark Daily, Michel broke down the nuances of this triad of forces and what participants in the Executive War College can expect. (Photo copyright: LabX.)
Forces at Work in Clinical Labs and Pathology Groups
Here’s a more detailed look at each of the forces that Michel noted.
Force 1: An acute shortage of experienced lab scientists
“When you look at the supply-demand for laboratory personnel in the United States today, it is recognized that demand exceeds supply, and that gap continues to widen,” Michel noted. “For example, in the case of anatomic pathologists, the increased number of case referrals grows faster than medical schools can train new pathologists. Currently, the ability of pathology laboratories large and small to hire and retain an adequate number of pathologists is a challenge.”
Executive War College attendees can expect panelists and speakers to highlight creative problem solving techniques to circumvent the challenges labor shortages cause.
Force 2: New applications of artificial intelligence
“Today every instrument vendor, every automation supplier, every software supplier, every service supplier is telling labs that they have artificial intelligence (AI) baked inside,” Michel observed. “It is important for lab managers to understand that a variety of technologies are used by different AI solutions.”
Clinical laboratory managers and pathologists interested in acquiring a deeper understanding of where to start with AI in their lab will find numerous sessions on artificial intelligence at this year’s Executive War College. “There will be a number of sessions this year where clinical labs discuss their success deploying various AI solutions,” Michel said.
Force 3: Financial stress across the entire US healthcare system
“It’s recognized that a significant number of US hospitals and integrated delivery networks (IDNs) are struggling to maintain adequate operating margins,” Michel noted. “This obviously impacts the clinical laboratories serving these hospitals. If the hospitals’ cash flows and operating profit margins are being squeezed, typically the administration comes to the lab team and says, ‘Your budget for next year will be x% less than this year.’
“There are many IDNs and hospital labs where budget cuts have happened for multiple years,” Michel continued. “As a consequence, labs in these hospitals must be nimble to maintain a high-quality menu of diagnostic tests. Several years of such budget cuts by the parent hospital can undermine the ability of the clinical lab team to offer competitive salary packages to attract and retain the clinical lab scientists, pathologists, and clinical chemists they need.”
Recognizing Opportunities in Today’s Lab Market
The good news is that—despite the negative forces acting upon the US healthcare system today—clinical laboratories, genetic testing companies, and anatomic pathology groups have a path forward.
“This path forward is informed by two longstanding precepts recognized by innovative managers. One precept is ‘Change creates new winners and losers.’ The other precept is ‘Change creates opportunity,’” Michel said. “Savvy lab leaders recognize the powerful truths in each precept.
“As healthcare has changed over the past four decades, nearly all the regional and national laboratories that were dominant in 1990, for example, don’t exist today!” he noted. “And yet, even as these lab organizations disappeared, new clinical lab organizations emerged that recognized healthcare’s changes and organized themselves to serve the changing needs of hospitals, office-based physicians, payers, and patients.”
All of these critical topics and more will be covered during the 30th Annual Executive War College on Diagnostics, Clinical Laboratory, and Pathology Management on April 29-30, 2025, at the Hyatt Regency in New Orleans. Signup today to bring your lab’s management team by registering at https://www.executivewarcollege.com.
However, effective communication can bring more harmony to medical lab managers and scientists when it comes to compliance
Depending on how lab professionals view it, clinical laboratory regulations can be characterized as a series of checklists to fill out or an opportunity to grow an organization.
Leaning into the latter option will preserve regulatory compliance while also ensuring the operational health of the clinical laboratory.
At the Lab Manager Leadership Summit, Kelly VanBemmel, MS, MB(ASCP)CM (above) pressed attendees to open the lines of communication between bench scientists and lab managers when it comes to clinical laboratory regulations. (Photo copyright: Scott Wallask.)
‘There’s a Gap’ in How Both Sides View Regulatory Compliance
VanBemmel spent her presentation aiming to bridge the rift between how bench scientists look at clinical laboratory regulations compared to the views of medical lab managers.
“There’s a gap between how staff experience regulations and how management does,” she noted. “Staff typically think of compliance as a checklist to do their jobs.” Managers, however, need to understand a wider compliance picture. She illustrated her point by comparing views on the following regulatory bodies.
Staff understand that the FDA clears tests and devices for use in non-research environments, though not all consumables or equipment are in that setting.
Managers understand that the FDA develops rules and guidance for CLIA complexity categorization.
Communication Leads to Common Ground with Clinical Laboratory Regulations
Given the above differences among managers and staff, VanBemmel explained that both sides must frequently talk to each other to fill in the missing details.
“When you’re in the thick of regulations, communication becomes critical,” she said.
For example, bench staff may feel it is solely their manager’s responsibility to comply with clinical laboratory regulations. Savvy lab leaders will point out non-compliant conditions—such as diagnostic analyzer malfunctions and sample cross contamination—over which bench staff have direct control, helping workers better understand their responsibility when it comes to compliance.
On the other hand, lazy communication from managers to their bench scientists can stunt compliance efforts. She recalled a prior supervisor who often answered questions about regulations by asking: What does the standard operation procedure state?
“That answer wasn’t particularly helpful,” VanBemmel recalled. “That made me think that my supervisor didn’t understand nuance.”
Thorough communication builds greater trust, and seasoned clinical laboratory professionals of all ranks will quickly recognize the compliance benefits when the worker-manager relationship gels.
