Request for money upfront comes at a time when many patients already struggle with medical debt
In its reporting of healthcare trends gathering momentum, a national newspaper caused quite a stir this spring when it published a story documenting how some hospitals now require patients to pay in advance of specified surgeries and procedures. Hospitals are recognizing what clinical laboratories have long known—a larger proportion of Americans do not have the cash to pay a medical bill.
Hospitals and surgery centers are requesting advanced payment for elective procedures such as knee replacements, CT scans, and childbirth procedures, according to an Advisory Board daily briefing.
“In some cases, they may also have a contract with an insurance company. And in that contract are terms that stipulate hospitals need to collect deductibles or co-insurance before a procedure,” Evans added.
According to Bankrate’s 2024 Annual Emergency Savings Report, nearly half of all American’s would be unable to pay cash for an unplanned $1,000 bill. Therefore, one wonders why hospitals would attempt to extract payments from patients in advance of medical visits and clinical laboratory testing. Wouldn’t that just reduce the number of patients electing to undergo needed surgeries and other costly procedures? Nevertheless, it appears that many hospitals struggling financially are doing just that, according to The Wall Street Journal.
Genetic testing laboratories have a similar problem because of high-deductible health plans ($5K/year for individual, $12K/year for family). It means that many patients, even with insurance, struggle to pay a $1,000 to $5,000 bill for a genetic test.
Requesting payment from patients before healthcare visits is not new. However, the practice is on the rise and comes at a time when consumers are already struggling to make ends meet.
“Hospitals collected (in Q1 2024) about 23% of what patients owed them before they set foot in a hospital or doctor’s office. That’s up from about 20% in the same period a year earlier,” said reporter Melanie Evans (above) of The Wall Street Journal, referring to data from 1,850 hospitals analyzed by Kodiak Solutions. Genetic testing laboratories experience similar challenges getting paid due to many people struggling with high deductible health plans. (Photo copyright: LinkedIn.)
Price Transparency Behind Upfront Payments
According to a recent KFF survey of US families, “about half of adults would be unable to pay an unexpected medical bill of $500 in full without going into debt.”
Regardless, asking for payment for nonemergency care has become more common as people increasingly choose health plans with high-deductibles and amid the push for greater price transparency, according to Richard Gundling, Senior Vice President, Content and Professional Practice Guidance at Healthcare Financial Management Association (HFMA), in an interview with Advisory Board.
“It’s very common if not the norm” for hospitals to give patients a cost estimate and ask for advance payment, Gundling stated during the interview.
In fact, healthcare providers and insurers are required to shared charges and estimates as part of newly implemented federal rules. According to the American Hospital Association (AHA) those statutes and rules include:
The Hospital Price Transparency Final Rule (effective January 2021) which requires hospitals to publicly post “standard charges” via machine readable files.
The No Surprises Act which mandates the sharing of “good faith estimates” with uninsured/self-pay patients for most scheduled services and also requires insurers to provide explanation of benefits to enrollees.
According to Consumer Reports, hospitals are finding consumers less reliable payers than insurance companies. “No one would say, ‘Pay up or we won’t treat you.’ But we’re saying that, ‘You have a large out-of-pocket cost, and we want to know how are you going to pay for it,’” explained Jonathan Wiik, Vice President of Health Insights at FinThrive, a revenue cycle management company.
Razor Thin Hospital Margins
For their part, hospitals, health systems, and medical practices wrote off $17.4 billion in bad debt in 2023, Kodiak Solutions, an Indianapolis-based healthcare consulting and software company, reported in a news release.
“With the amounts that health plans require patients to pay continuing to grow, provider organizations need a strategy to avoid intensifying pressure on their already thin margins,” said Colleen Hall, Senior Vice President, Revenue Cycle, Kodiak, in the news release.
“Patient collections have become an increasingly difficult challenge for hospitals due primarily to a shift in payer mix. Because of rising deductibles and increased patient responsibility, the percentage of healthcare provider revenue collected directly from patients increased to more than 30% from less than 10% over 10 years,” the HFMA noted.
Thus, the financial tension being experienced by both patients and providers, and the need for patients to prepay for some treatment, are extreme challenges. The situation may call for clinical laboratory leaders to not only focus on quality testing and efficient workflow, but also affordability and access to services.
Inability to access clinical laboratory test results forced hospitals to suspend critical procedures and surgeries causing major disruptions to healthcare
Cyberattacks continue to shut down the ability of hospitals to process orders for clinical laboratory tests, medical imaging, and prescriptions. One such cyberattack recently took place against Ascension, the largest nonprofit Catholic health system in the United States. It took more than a month for the health network’s electronic health record (EHR) system to be fully restored, according to a cybersecurity event press release.
Immediately following the event, Ascension announced it had hired a third party company to resolve the fallout from the cyberattack.
“On Wednesday, May 8, we detected unusual activity on select technology network systems, which we now believe is due to a cybersecurity event. … Access to some systems have been interrupted … We have engaged Mandiant, a third party expert, to assist in the investigation and remediation process, and we have notified the appropriate authorities,” a press release states.
Based in Reston, Va., Mandiant is an American cybersecurity firm and a subsidiary of Google.
Cyberattacks are happening more frequently and medical professionals need to be aware that patient care can be severely disrupted by such attacks. The Ascension attack locked its employees out of the healthcare provider’s computer databases, rendering medical personnel unable to track and coordinate patient care. The health network’s EHR, phones, and databases used to order certain clinical laboratory tests, imaging services, procedures, and medications were all affected.
Hospital employees, including two doctors and a registered nurse, spoke anonymously to the Detroit Free Press regarding the issues at their facilities resulting from the cyberattack.
“It’s so, so dangerous,” said the nurse, describing the immediate aftermath of the cyberattack. “We are waiting four hours for head CT [computed tomography scan] results on somebody having a stroke or a brain bleed. We are just waiting. I don’t know why they haven’t at least paused the ambulances and accepting transfers because we physically … don’t have the capacity to care for them right now.”
“In some cases, what are supposed to be unique medical record numbers assigned to patients when they register in the emergency department at Ascension St. John [Detroit, Mich.] have been given to more than one patient at a time,” Detroit Free Press reported. “Because of that, the nurse told the Free Press she couldn’t be confident that a patient’s blood test results actually were his own.”
“We’ve started to think about these as public health issues and disasters on the scale of earthquakes or hurricanes,” Jeff Tully, MD (above), Associate Clinical Professor, Anesthesiology, and co-director of the Center for Healthcare Cybersecurity at the University of California-San Diego, told NPR. “These types of cybersecurity incidents should be thought of as a matter of when and not if,” he added. Inability to verify clinical laboratory test results or access patients’ electronic medical records endangers patients and undermines the confidence of critical healthcare workers. (Photo copyright: UC San Diego.)
Losing Track of Patients and Their Records
According to the HIPAA Journal’sH1, 2024 Healthcare Data Breach Report, “In H1 [first half of the fiscal year], 2024, 387 data breaches of 500 or more [healthcare] records were reported to OCR, which represents an 8.4% increase from H1, 2023, and a 9.3% increase from H1, 2022.”
After the Ascension cyberattack, the healthcare organization’s computer systems were inoperable, and its pharmacy services were temporarily closed. Medical orders for clinical laboratory testing, imaging tests, and prescriptions had to be handwritten on paper and faxed to appropriate departments, which led to long wait times for patients.
There were cases where singular medical record numbers were assigned to multiple patients. Staff resorted to Google documents, paper charting, and text messaging to communicate with one another. But they still lost track of some patients.
“For a lot of our nurses, they’ve never paper charted at all,” said Connie Smith, a charge capture coordinator and head of the Wisconsin Federation of Nurses and Health Professionals, in a ThinkStack blog post. “We were using forms that we pulled out of drawers that hadn’t seen the light of day in a long, long time.”
“They are texting me to find out where the patient went,” a St. John Hospital Emergency Room physician anonymously told the Free Press immediately following the Ascension cyberattack. “They don’t even know where the patient is going or if they’ve been admitted. People are getting lost.
“The pharmacy is getting requests for patient medications, and they have no idea where the patient is in the hospital,” the doctor continued. “Some of the attending physicians are putting in orders for medications, somewhat dangerous medications, and we have no idea if the medications are actually being administered. It’s a scary thing when your medical license is tied to this. If medication mistakes become lawsuits, they will follow us throughout our entire careers and that is not fair to us. It’s not fair to patients.”
According to online updates provided by Ascension, the cyberattack began when an employee downloaded a malicious file thinking it was a legitimate document. That allowed hackers to access seven of Ascension’s 25,000 servers. The resulting cyberattack stifled operations across the organization’s facilities and among its healthcare providers for weeks.
A June 12 update read, “we are pleased to announce that electronic health record (EHR) access has been restored across our ministries. This means that clinical workflow in our hospitals and clinics will function similarly to the way it did prior to the ransomware attack.” The updates did not mention how the attack was resolved or if a ransom was paid to restore the hospitals’ systems.
Preparing for System Disruptions
According to its website, St. Louis-based Ascension has 134,000 associates, 35,000 affiliated providers, and 140 hospitals serving communities in 18 states and the District of Columbia.
“Despite the challenges posed by the recent ransomware incident, patient safety continues to be our utmost priority. Our dedicated doctors, nurses, and care teams are demonstrating incredible thoughtfulness and resilience as we utilize manual and paper based systems during the ongoing disruption to normal systems,” Ascension noted in a Michigan Cybersecurity Event Update.
Clinical laboratory managers and anatomic pathology practice administrators may want to learn from Ascension’s experience and make advanced preparations that will secure patient information and enable their lab to continue functioning during a cyberattack. The Ascension cyberattack illustrates how easily computer systems containing critical information can be hacked and affect patient care.
Are ongoing protests and federal investigations into health plan practices evidence that customers have reached a tipping point?
It is not common for beneficiaries to get arrested in front of their health plan’s headquarters. But that is what happened in July, when protesters gathered outside of UnitedHealth Group (UHG) in Minnetonka, Minn., to stress their dissatisfaction with the health insurer. More than 150 protesters participated in the demonstration. Eleven were arrested and charged with misdemeanors for blocking the public street outside of the headquarters.
Their main complaint is that the insurer systemically denies care for patients. This is a situation that probably resonates with hospitals, physicians, clinical laboratory professionals, and pathologists, who often see their own claims denied by health plans, including UnitedHealthcare.
“UnitedHealth Group’s profiteering by denying care is a disgrace, leaving people across Minnesota and all of the United States without the care they desperately need,” wrote members of the People’s Action Institute in a letter to UHG’s CEO Sir Andrew Witty. People’s Action organized the protest as part of its Care Over Cost campaign.
“Health insurance coverage has expanded in America, but we are finding it is private health insurance corporations themselves that are often the largest barrier for people to receive the care they and their doctor agree they need,” Aija Nemer-Aanerud, campaign director with People’s Action told CBS News.
“We have asked UnitedHealthcare for systemic changes in their practices and they have refused,” he told Bring Me The News.
Nemer-Aanerud told CBS News that UnitedHealth Group leadership has “refused to acknowledge that prior authorizations and claim denials are a widespread problem.”
“Our mission is to help people live healthier lives and help make the health system work better for everyone,” said UnitedHealth Group CEO Sir Andrew Witty (above) during a Senate Finance Committee hearing in May, NTD reported. “Together, we are working to help enable our health system’s transition to value-based care and are empowering physicians and their care teams to deliver more personalized, high-quality care that delivers better outcomes at a lower cost.” (Photo copyright: The Business Journals.)
People’s Action Institute Demands
In the letter, the changes People’s Action urged UHG to make include:
Ceasing to deny claims for treatments recommended by medical professionals.
Overturning existing denials for recommended treatments.
Stopping the practice of using Artificial Intelligence (AI) and algorithms to deny claims in bulk.
Executing a publicly shared audit and reimbursing federal/state governments for public money diverted by claims and prior-authorization denials within Medicare and Medicaid systems.
Expediting payment of claims.
Making public the details of denied claims and prior authorizations by market, plan, state, geography, gender, disability and race.
A spokesperson for UnitedHealth Group told CBS News that the company has had several talks with People’s Action and has settled some of the organization’s issues. That spokesperson also confirmed that UHG tried to discuss specific cases, but the issues People’s Action brought up had already been resolved.
“The safety and security of our employees is a top priority. We have resolved the member-specific concerns raised by this group and remain open to a constructive dialogue about ensuring access to high-quality, affordable care,” UnitedHealthcare said in a statement.
Profits over Patients?
The People’s Action Institute is a national network of individuals and organizations who strive to help people across the US overturn medical care denials made by insurance giants. Its Care Over Cost campaign aims to influence insurers to initiate systemic changes in their practices.
The recent protest occurred as UnitedHealth Group released its second-quarter financial report claiming $7.9 billion in profits. The company provides health insurance for more than 47 million people across the country and took in $22.4 billion in profits last year.
“UnitedHealth Group’s $7.9 billion quarterly profit announcement is the result of a business model built on pocketing premiums and billions of dollars in public funds, then profiting by refusing to authorize or pay for care,” said Nemer-Aanerud in a press release. “People should not have to turn to public petitions or direct actions to get UnitedHealthcare to pay for the care they need to live.”
“UnitedHealth Group made a decision to spend billions of dollars on stock buybacks, lobbying, and executive pay instead of paying for care people need,” Nemer-Aanerud told Bring Me The News. “They are harming people for profit and should be held accountable for that choice.”
“We all pay for this convoluted system, whether it is in our health insurance premiums or in our public programs. UnitedHealth Group is making billions of dollars in profit by denying people care, including in privatized Medicare and Medicaid plans, to the point that it has prompted a federal investigation … Still, we left the meeting with hope,” they added.
Protests like this one against UnitedHealth Group serve as evidence that the current system of commercial health insurance plans could be deteriorating. This descent may cause customers of these plans to take unprecedented actions to fight for necessary medical care.
As noted earlier, hospitals, physician groups, clinical laboratories, and anatomic pathology groups that see their own claims often denied by health insurers without a clear reason for the denials are probably sympathetic to the plight of patients who are frustrated with how UnitedHealthcare denies their access to care.
Charges include $1.1 billion in alleged telemedicine and fraudulent clinical laboratory testing
Nearly 200 individuals in 25 states are facing charges for alleged participation in a variety of healthcare frauds, the US Department of Justice (DOJ) announced in a press release. This major enforcement action involves telemedicine and clinical laboratory testing as well as other healthcare schemes. In total, the DOJ is alleging the defendants are responsible for $2.75 billion in intended losses and $1.6 billion in actual losses.
The charges include:
$1.1 billion in alleged telemedicine and clinical laboratory fraud.
As part of the action, the government has seized more than $231 million in assets, including cash, luxury vehicles, and gold.
Monica Cooper, JD (above), a DOJ trial attorney and member of the Texas Strike Force, is one of two attorneys prosecuting the case against Harold Albert “Al” Knowles of Delray Beach, Fla., and Chantal Swart of Boca Raton, Fla., in the DOJ’s latest crackdown on healthcare fraud. Charges against Knowles and Swart include conspiracy to commit healthcare fraud, conspiracy to defraud the United States, and paying/receiving healthcare kickbacks in a $359 million scheme to bill Medicare for medically unnecessary genetic tests at two Houston clinical laboratories. (Photo copyright: US Department of Justice.)
Houston-Area Labs Charged in $359 Million Scheme
In one case, the government charged Florida residents Harold Albert “Al” Knowles and Chantal Swart in a $359 million scheme involving fraudulent Medicare billing for medically unnecessary genetic tests. Knowles owned two Houston-area labs—Bio Choice Laboratories, Inc. and Bios Scientific, LLC—while Swart ran a telemarketing operation. According to DOJ case summaries, the government alleges that Knowles paid kickbacks to Swart to obtain DNA samples and doctors’ orders for tests.
“Knowles, Swart, and others obtained access to tens of thousands of beneficiaries across the United States by targeting them with deceptive telemarketing campaigns,” the indictments allege. “Call center representatives—who were almost never medical professionals—often prompted beneficiaries to disclose their medical conditions and induced them to agree to genetic testing regardless of medical necessity.”
In addition, “Knowles, Swart, and others agreed that Swart and others would pay illegal kickbacks and bribes to purported telemedicine companies to obtain signed doctors’ orders for genetic testing after only a brief telemedicine visit,” the indictment stated. “Knowles and his co-conspirators knew that the purported telemedicine companies’ physicians were rarely, if ever, the beneficiaries’ treating physicians and rarely, if ever, used the genetic testing results in the beneficiaries’ treatment.”
Dallas-Area Labs Charged in $335 Million Scheme
In another case, the federal government charged that the owner of two Dallas-area clinical laboratories engaged in a $335 million Medicare billing scheme.
Keith Gray, owner of Axis Professional Labs, LLC and Kingdom Health Laboratory, LLC, “offered and paid kickbacks to marketers in exchange for their referral to Axis and Kingdom of Medicare beneficiaries’ DNA samples, personally identifiable information (including Medicare numbers), and signed doctors’ orders authorizing medically unnecessary cardio genetic testing,” the government alleged. “As part of the scheme, the marketers engaged other companies to solicit Medicare beneficiaries through telemarketing and to engage in ‘doctor chase,’ i.e., to obtain the identity of beneficiaries’ primary care physicians and pressure them to approve genetic testing orders for patients who purportedly had already been ‘qualified’ for the testing.”
Other Clinical Laboratory and Healthcare Fraud Cases
DOJ attorneys charged the owners of Innovative Genomics, a clinical laboratory in San Antonio, in a $65 million scheme to bill Medicare and the COVID-19 Uninsured Program for “medically unnecessary and otherwise non-reimbursable COVID-19 and genetic testing,” according to the indictment. Also charged were two patient recruiters who allegedly received kickbacks for referring patients.
Richard Abrazi of New York City was charged in a $60 million Medicare billing scheme. Abrazi owned two clinical laboratories: Enigma Management Corp. and Up Services Inc. Both operated as Alliance Laboratories.
“Abrazi and others engaged in a scheme to pay and receive kickbacks and bribes in exchange for laboratory tests, including genetic tests, that Enigma and Up billed to Medicare,” the indictment alleges. “Abrazi and others also allegedly paid and received kickbacks and bribes in exchange for arranging for the ordering of medically unnecessary genetic tests that were ineligible for Medicare reimbursement.”
The DOJ charged Brian Cotugno, of Auburn, Ga., and James Matthew Thorton “Bo” Potter, of Santa Rosa Beach, Fla., in a $20 million Medicare billing scheme. Cotugno, the indictment alleges, sold Medicare Beneficiary Identification Numbers (BINs) to two Alabama laboratories co-owned by Potter.
“The BINs were used to bill Medicare tens of millions of dollars for OTC COVID-19 test kits, many of which had not been requested by the beneficiaries,” the government alleged.
These are only a few of the recent cases the DOJ brought against defendants nationwide for healthcare, telemedicine, and clinical laboratory fraud. Both Dark Daily and our sister publication The Dark Report have covered these ongoing investigations for years. And we will continue to do so because it’s important that lab managers and pathology group leaders are aware of the lengths to which the DOJ is pursuing bad actors in healthcare.
Pathology groups and clinical laboratories experiencing shortages in management positions may want to consider on-demand healthcare leaders
Are “on-demand” leaders the answer to clinical laboratory and pathology group staff shortages? Perhaps. A new twist on management philosophies is gaining steam in hospitals: Hiring on-demand managers and executives to fill gaps in high-level staff. The practice is growing quickly and making its mark.
“[On-demand leadership] is really taking off,” said Adam Burns, Principal, Interim Leadership, at international executive search/leadership consulting firm WittKieffer, in a Newsweek article. “I think it’s something that’s going to be permanent in the industry. Once [health systems] start to think about all the different ways they could use somebody—when you take the org chart out of it and just think about the lists of challenges and projects and opportunities they have—it’s endless.”
Clinical lab administrators and pathologists should note that the trend of on-demand management assignments is distinctly different from the traditional locum tenens and temporary staffing that have been common in healthcare for decades. These arrangements are typically used to engage physicians and laboratory scientists to handle the daily delivery of clinical services. The on-demand management model engages individuals with proven management skills to address specific initiatives and projects that the institution would not otherwise be able to achieve.
Tight finances in many hospitals make hiring on-demand managers for short-term assignments versus long-term permanent positions a cost-effective way to deal with projects that need specific skills to be implemented. Another factor is experienced hospital administrators who retire but then want to return on a limited basis. They have desirable skills, knowledge, and energy worth retaining and on-demand positions may make that possible and affordable.
As hospitals warm up to on-demand engagements, clinical laboratories may also see benefits as the trend widens and gains more acceptance.
“The business challenges in healthcare are getting bigger every year. They’re very high stakes, because people’s lives are at stake,” Sandra Pinnavaia (above), Partner, Global Head, On-Demand Talent Strategy and Innovation at Heidrick and Struggles, told Becker’s Hospital Review. The Chicago-based global executive search and consulting firm has seen a strong increase in hospital placements and notes that healthcare is the “eighth most served industry sector in the US.” Pinnavaia says this growth helps hospitals keep up with “an evolving industry,” of leaning on temporary help. Might clinical laboratories benefit from filling empty leadership positions with on-demand leaders? (Photo copyright: Heidrick and Struggles.)
Who Are On-Demand Executives, What Positions Do They Fill?
According to Becker’s Hospital Review, an on-demand executive is “an independent and established business professional—ranging from the C-suite to the director level, or a management consultant,” who is often brought in to help with specific projects or fill gaps within an organization as needed during transitional times. Most provide temporary support without seeking full-time stability.
Top on-demand positions, Becker’s reported, include:
Financial controls,
Accounting and auditing,
Organizational design and workforce planning, and
Technology and systems implementation.
There has been a steady two-year increase of health systems “looking for senior leaders to solve specific problems rather than to hold specific titles,” Burns told Newsweek.
Occasionally, a “specialized eye” is needed for specific challenges, such as hiring a former Chief Information Security Officer (CISO) to establish an infrastructure that lasts beyond his or her stay, Newsweek noted.
“[Hiring an on-demand leader is] the most cost-effective option,” Burns said. “Organizations compare it to the cost of consulting firms, and when you compare hiring a senior leader in an on-demand capacity to hiring a consulting firm, many times it’s a third or half of the expense.”
Additionally, many hospital systems are still regrouping after the fallout from the COVID-19 pandemic. With all the consolidation that occurred to leadership teams as cost-savings efforts, many “systems lack the bench strength to source special projects from within,” Newsweek added.
Plusses for Hospitals
The benefits are numerous for hospitals according to Burns. “When health systems reflexively look inward for new projects, they can unconsciously build their tolerance for the status quo. On the other hand, a fresh, unbiased perspective can open new doors for the organization. On-demand leaders can make honest recommendations about what is best for the health system, free from internal politics or preexisting expectations,” he told Newsweek.
“The right on-demand leader can create momentum [on a project] without a long-term engagement with our system when there is no definitive construct of what an organization wants a function or role to look like,” Feby Abraham, PhD, Executive Vice President and Chief Strategy Officer at Memorial Hermann Health System in Houston, told Becker’s Hospital Review.
Further, “these roles provide opportunities for leaders with extensive healthcare experience, allow for a faster track to build momentum, and allow for developing a clearer vision for the long-term, full-time version of roles,” he added.
Plusses for On-Demanders
Pinnavaia told Becker’s Hospital Review, “[On-demand executives] are free agents, independent, and available to jump in and out of the organizations they serve, either by providing a proper coverage to a gap, like being an interim leader sitting in a gap, or to the augmentation of injecting skills and experience around a particular topic or movement in the business cycle.”
Burns notes that “numerous factors [are] fueling demand” for on-demand positions, Newsweek reported, adding that “Baby boomers are aging out of senior leadership roles and into retirement, leaving experience gaps in their wake. But after a year of vacationing and pursuing hobbies, many healthcare executives start itching for a new challenge. They become strong candidates for on-demand roles, which allow them to contribute their extensive knowledge without committing to an indefinite seat.”
It’s Not Magic
“This is a growing category, but it’s not magic,” Pinnavaia told Becker’s Hospital Review. “It takes an intermediary that advises both sides of the equation about how to make the project successful, how to structure the project, how to onboard someone, how to really make sure it’s going well. Secondly, it takes talent that has really done this before … it is a learning muscle,” she added.
Abraham agreed. “Many of the challenges revolved around crafting the role description up front, finding the right candidate, and then getting feedback to maximize the impact of that on-demand role itself,” he told Becker’s Hospital Review.
While hospitals warm to the notion of on-demand engagements, this trend may make its way into many clinical laboratories. Readers who work within hospital and healthcare settings should pay close attention. Understanding how these services are being used can provide a proper heads-up of what may come.
Do you have a story to share of your own experience? Hospital and health system laboratories using on-demand management assignments are invited to contact us to share their successes with this approach and the lessons learned.
Technology like Apple’s VR/AR headsets may prove useful to clinical laboratories in accessioning and in pathology labs during biopsy grossing
In what has been billed as a first, medical teams in the US and UK used Apple’s Extended Reality (XR) Vision Pro headset system to assist in surgical procedures. The surgeons themselves did not wear the $3,500 headset. Instead, surgical nurses used the device for touch-free access to a software application that assisted them in setting up, organizing, and performing the operations. For pathologists and clinical laboratories, in the histology laboratory, such an arrangement involving XR headsets could be used when a biopsy is at the grossing station as well.
The headset software the team used during surgery was developed by eXpanded eXistence, Inc. (eXeX), a Florida-based company whose primary product is an iOS (Apple mobile operating system) application that provides similar functions for mobile devices. eXeX adapted the iOS app to work on Apple’s Extended Reality headset.
Extended Reality is an umbrella term for augmented reality (AR) and virtual reality (VR). Apple refers to the technology as “spatial” computing.
Within the clinical laboratory, XR headsets could be used in the accessioning process as the accessioner works through the steps to confirm all required information accompanies the test requisition and that the patient’s specimen is processed/aliquoted appropriately.
“The eXeX platform, enhanced by artificial intelligence, is designed not as a medical device but as an organizational and logistics tool. It aims to streamline the management of tens of thousands of items, including equipment, tools, technologies, consumables, implants, and surgical products,” said neurosurgeon Robert Masson, MD, eXeX’s founder and CEO, in a February news release.
Masson first deployed the software in his own surgical practice. Then in March, eXeX announced that a surgical team at Cromwell Hospital in London used the system in two microsurgical spine procedures, according to a March new release.
That news garnered media coverage in the UK as well as in US-based publications that follow Apple.
“We are in a new era of surgery, and for the first time, our surgical teams have the brilliance of visual holographic guidance and maps, improving visuospatial and temporal orientation for each surgical team and for each surgery in all specialties,” said neurosurgeon Robert Masson, MD (above), eXeX’s founder and CEO, in a press release. Clinical laboratories may one day use XR headsets in the histology lab at the grossing station. (Photo copyright: Masson Spine Institute.)
Surgical Process Not Glamorous, But Important
Despite being on a cutting-edge XR platform, the eXeX software addresses “the least glamorous part” of the surgical process, Masson told Gizmodo.
“People assume that surgical healthcare has got to be sophisticated and modern,” he said. “The reality is the way we organize it is probably the most archaic of all the major industries on the planet. It’s all memorization and guesswork with scribbles on pieces of paper.”
The advantage of an XR headset is that it allows use of the eXeX software in a sterile environment, he added. “The ability to interact with digital screens and holograms and lists and maps and products unlocks all kinds of possibilities. Suddenly, you’ve got an interactive digital tool that you can use without violating the sanctity of sterility.”
Does he foresee a future when the surgeons themselves use XR headsets in the operating room? Not necessarily, Masson told Gizmodo.
“There’s always a tendency to say, ‘look at this amazing tech, let’s put a screw in with it,’” he said. “Well, we’re already putting screws in without the headset, so it doesn’t really solve a problem. People tend to think of floating spines, floating heights, you know, an overlay that tells you where to put a catheter in the liver. Honestly, it’s all unnecessary because we already do that pretty well. What we don’t do really well is stay organized.”
Other XR Apps for Healthcare
In a news release, Apple showcased other healthcare apps for its Vision Pro platform.
Epic Systems, an electronic health record (EHR) system developer, has an app called Epic Spatial Computing Concept that allows clinicians “to easily complete charting, review labs, communicate using secure chat, and complete in-basket workflows through intuitive gestures, like simply tapping their fingers to select, flicking their wrist to scroll, or using a virtual keyboard or dictation to type,” Apple stated in the news release.
Stryker, manufacturer of Mako surgical robotic arms for joint-replacement procedures, has an Apple iOS app called myMako that “allows surgeons to visualize and review patients’ Mako surgical plans at any time in a brilliant, immersive visual experience,” Apple said.
Cinematic Reality, from Siemens Healthineers, is an Apple iOS app that “allows surgeons, medical students, and patients to view immersive, interactive holograms of the human body captured through medical scans in their real-world environment,” Apple said.
New Era in Technology
For the past 20 years, manufacturing companies have installed systems at workstations with audio and video that show each step in a work process and with written checklists on the computer screen. This allows workers to check off each required step as proof that each required work element was performed.
This is similar to professional pilots who use checklists at every step in a flight process. One pilot will read the checklist items, the other will perform the step and confirm it was complete.
These procedures are generally completed on computer displays, but with the advent of XR headset technology, these types of procedures are evolving toward mobility.
To prepare for the emergence of XR-based healthcare apps, the US Food and Drug Administration (FDA) has organized a research team to devise best practices for testing these headset devices, CNBC reported.
It will be some time before XR headset technology finds its way into histology laboratories, clinical laboratories, and pathology practices, but since the rate of technology adoption accelerates exponentially, it might not take very long.
