Trifecta of forces at work that will affect the clinical laboratory and pathology industries have been described as a ‘perfect storm’ requiring lab and practice managers to be well informed
Digital pathology, artificial intelligence (AI) in healthcare, and the perfect storm of changing federal regulations, took centerstage at the 29th Executive War College on Diagnostics, Clinical Laboratory, and Pathology Management in New Orleans this week, where more than 1,000 clinical laboratory and pathology leaders convened over three days.
This was the largest number of people ever onsite for what has become the world’s largest event focused exclusively on lab management topics and solutions. Perhaps the highlight of the week was the federal Food and Drug Administration’s (FDA’s) announcement of its final rule on Laboratory Developed Tests (LDTs). Overall, the conference featured more than 120 speakers, many of them national thought leaders on the topic of clinical lab and pathology management. More than 65% of the audience onsite were executive level lab managers.
“The level of interest in the annual Executive War College is testimony to the ongoing need for dynamic, engaging, and highly relevant conference events,” said Robert Michel (above), Editor-in-Chief of Dark Daily and its sister publication The Dark Report, and founder of the Executive War College. “These in-person gatherings present great opportunities for clinical laboratory and pathology managers and leaders to network and speak with people they otherwise might not meet.” (Photo copyright: Dark Intelligence Group.)
Demonstrating Clinical Value
For those who missed the action onsite, the following is a synopsis of the highlights this week.
Lâle White, Executive Chair and CEO of XiFin, spoke about the future of clinical laboratory testing and the factors reshaping the industry. There are multiple dynamics impacting healthcare economics and outcomes—namely rising costs, decreasing reimbursements, and the move to a more consumer-focused healthcare. But it is up to labs, she said, to ensure their services are not simply viewed as a commodity.
“Laboratory diagnostics have the potential to change the economics of healthcare by really gaining efficiencies,” she noted. “And it’s up to labs to demonstrate clinical value by helping physicians manage two key diagnostic decision points—what tests to order, and what to do with the results.”
But even as labs find ways to increase the value offered to clinicians, there are other disruptive factors in play. Consumer-oriented tech companies such as Google, Apple, and Amazon are democratizing access to patient data in unforeseen ways, and Medicare Advantage plans are changing the way claims are processed and paid.
Clinical labs are fundamental components of the public health infrastructure. So, the CDC plans on focusing on delivering high-quality laboratory science, supported by reliable diagnostics and informatics for disease outbreaks and exposures, and engaging with public and private sector partners.
The history of MolDX and Z-Codes were the topics discussed by Gabriel Bien-Willner, MD, PhD, Chief Medical Officer for healthcare claims and transaction processing company Palmetto GBA. Molecular testing is highly complex, and the lack of well-defined billing codes and standardization makes it difficult to know if a given test is reasonable and necessary.
Z-Codes were established to clarify what molecular testing was performed—and why—prompting payers to require both Z-Codes and Current Procedural Terminology (CPT) codes when processing molecular test claims. Medicare’s MolDX program further streamlines the claims process by utilizing expertise in the molecular diagnostics space to help payers develop coverage policies and reimbursement for these tests.
FDA Final Rule on LDT Regulation
Timothy Stenzel, MD, PhD, CEO of Grey Haven Consulting and former director of the FDA’s Office of In Vitro Diagnostics reviewed the latest updates from the FDA’s Final Rule on LDT (laboratory developed test) regulation. Prior to the FDA releasing its final rule, some experts suggested that the new regulations could result in up to 90% of labs discontinuing their LDT programs, impacting innovation, and patient care.
However, the final rule on LDTs is very different from the original proposed rule which created controversy. The final rule actually lowers the regulatory burden to the point that some labs may not have to submit their LDTs at all. The FDA is reviewing dozens of multi-cancer detection assays, some of which have launched clinically as LDTs. The agency is likely to approve those that accurately detect cancers for which there is no formal screening program.
Stenzel explained the FDA’s plan to down-classify most in vitro diagnostic tests, changing them from Class III to Class II, and exempting more than 1,000 assays from FDA review. He also discussed the highlights of the Quality Management System Regulation (QMSR). Launched in January, the QMSR bought FDA requirements in line with ISO 13485, making compliance easier for medical device manufacturers and test developers working internationally.
Looming Perfect Storm of Regulatory Changes
To close out Day 1, Michel took to the stage again with a warning to clinical laboratories about the looming “Perfect Storm” trifecta—the final FDA ruling on LDTs, Z-Code requirements for genetic testing, and updates to CLIA ’92 that could result in patient data being considered a specimen.
Laboratory leaders must think strategically if their labs are to survive the fallout, because the financial stress felt by labs in recent years will only be exacerbated by macroeconomic trends such as:
Staff shortages,
Rising costs,
Decreasing and delayed reimbursements, and
Tightening supply chains.
Lab administrators looking for ways to remain profitable and prosperous should look beyond the transactional Clinical Lab 1.0 fee-for-service model and adopt Clinical Lab 2.0, which embraces HEDIS (Healthcare Effectiveness Data and Information Set) scores and STAR ratings to offer more value to Medicare Advantage and other payers.
Wednesday’s General Session agenda was packed with information about the rise of artificial intelligence, big data, and precision medicine in healthcare. Taking centerstage on the program’s final day was Michael Simpson, President and CEO of Clinisys. Simpson gave a global perspective on healthcare data as the new driver of innovation in diagnostics and patient care.
This is one more example of how Silicon Valley companies are lining up collaborations with in vitro diagnostics companies to gain a foothold in the clinical laboratory marketplace
For years, Apple, Google, and other Silicon Valley companies have taken progressive steps to become more engaged in healthcare. One recent example of a Silicon Valley company willing to invest in clinical laboratory testing came last year in the form of a $10 million grant Apple (NASDAQ:AAPL) made to COPAN Diagnostics of Murrieta, Calif., to increase the speed and production of the company’s COVID-19 sample collection and transport products.
The interesting aspect of this collaboration was that Apple’s primary role was to help COPAN:
streamline workflow and speed of throughput,
help with the incoming supply chain, and
help develop outgoing supply chain solutions—along with some capital investment.
From the start of the pandemic in the winter of 2020, SARS-CoV-2 sample collection kits were one of many items that were in short supply here in the United States. To help address those shortfalls, teams at Apple, COPAN, and multiple other companies across the US worked to improve the work processes, automation, and machinery COPAN uses in its manufacturing and production sites. This collaboration increased production by nearly 4,000% between April 2020 and February 2021, an Apple news release reported.
In the news release, Jeff Williams (above), Apple’s Chief Operating Officer, said, “We are proud our Advanced Manufacturing Fund is supporting companies like COPAN who are playing a critical role in the fight against COVID-19 and assisting healthcare professionals and communities across the country. This collaboration helped produce, ship, and deliver millions of sample collection kits to hospitals from coast to coast—and we believe it is this unique combination of American manufacturing and innovation that will help us emerge from this crisis and build a safer world for us all.” (Photo copyright: Apple Insider.)
Healthcare Has Long Been a Target for Big Tech
Investment in different sectors of the US healthcare system by one of the Big Tech companies is not unusual. Apple, Google, Amazon, and Microsoft have looked for ways to expand their respective footholds in the healthcare marketplace for years.
In “How the ‘Big 4’ Tech Companies Are Leading Healthcare Innovation”—published a full year before the COVID-19 pandemic began—Healthcare Weekly noted that, “At a high level, each of the ‘Big 4’ tech companies are leveraging their own core business strengths to reinvent healthcare by developing and collaborating on new tools for patients, care providers, and insurers that will position them for healthcare domination.”
In 2017, Apple announced the launch of the Advanced Manufacturing Fund, saying that the $1 billion fund was a way to give back to communities through job creation. “By doing that, we can be the ripple in the pond. Because if we can create many manufacturing jobs around, those manufacturing jobs create more jobs around them because you have a service industry that builds up around them,” Apple’s CEO Tim Cook told CNBC at that time.
In 2018, Apple boosted the fund from $1 billion to $5 billion, the Mac Observer reported.
Apple’s $10 million investment enabled COPAN Diagnostics to expand into a new facility as well as hire 250 new employees. “We are proud our Advanced Manufacturing Fund is supporting companies like COPAN who are playing a critical role in the fight against COVID-19 and assisting healthcare professionals and communities across the country,” Williams said in the news release.
COPAN and the On-Going Need for COVID-19 Test Kits
COPAN Diagnostics was founded in 1979 in Mantua, Italy, and is now a global force in the manufacture of many sample collection and transport products such as instruments, automation, swabs, pipettes, and, of course, SARS-CoV-2 sample collection and transport kits. At the time of Apple’s investment, COPAN was producing sample collection and transport products at its Murrieta, Calif., facility. But demand for these products far outweighed the supply.
In an interview, Norman Sharples, CEO of COPAN Diagnostics and head of operations for North and South America, said he was hoping to increase production in the earliest days of the pandemic when Jeff Williams, COO at Apple, contacted him regarding the Advanced Manufacturing Fund. Along with the $10 million grant, Williams offered experts in engineering and sourcing to help COPAN increase production, the San Diego Union-Tribune reported.
The result was a new manufacturing facility in Carlsbad, Calif., which increased COPAN’S production of its sample collection and transport products used in SARS-CoV-2 testing by nearly 4,000%.
“From taking the keys to the building to actually getting the California department for public inspection, which allows us to go live and sell the product, that was just over 30 days, which is an incredible campaign that Apple helped us with,” Sharples told the San Diego Union-Tribune, adding, “It wasn’t just the funding. It was [the experts from Apple] applying their know-how and expertise to tilt this up very fast.”
Even as COVID-19 vaccines roll out, demand for SARS-CoV-2 tests—along with the necessary specimen collection and transport supplies—will likely continue. As the economy reopens, workers return to offices, and students return to in-person schools, precautionary screening for COVID-19 will remain necessary. “I think demand is going to flatten a little bit, but in any case, the baseline is going to be high because of surveillance,” Sharples said. “The back-to-work programs will drive more surveillance.”
Pandemic Increases Big Tech’s Dominance in Healthcare
Where many businesses and entire industries struggled with the pandemic, Big Tech apparently did not. In late October 2020, CBS News reported, “America’s largest technology companies are thriving despite the economy’s woes, according to earnings posted by Google-parent Alphabet, Amazon, Apple, Facebook, and Twitter on Thursday.”
Along with growing profits, Big Tech companies also consolidated their dominance. “As the pandemic made us even more dependent on digital technology, it has made the systemic importance and enormous power of the tech giants even more apparent,” according to an article in SciencesPo, titled, “Is the COVID-19 Pandemic a Victory for Big Tech?”
Might Big Tech Investments Target Clinical Laboratory Testing?
There’s no reason to believe that the big technology companies will slow their investment in healthcare anytime soon, and that investment may benefit clinical laboratories. In fact, in “11 Recent Big Tech Partnerships in Healthcare,” Becker’s Hospital Review listed several technology companies that will likely affect pathology laboratories.
Big Tech investment in genetic testing, artificial intelligence, telehealth, and other technologies may alter how clinical laboratories operate and revolutionize the healthcare industry.
Strategists agree that big tech is disrupting healthcare,
so how will clinical laboratories and anatomic pathology groups serve virtual
healthcare customers?
Visionary XPRIZE founder Peter Diamandis, MD, sees big tech as “the doctor of the future.” In an interview with Fast Company promoting his new book, “The Future Is Faster Than You Think,” Diamandis, who is the Executive Chairman of the XPRIZE Foundation, said that the healthcare industry is “phenomenally broken” and that Apple, Amazon, and Google could do “a thousandfold” better job.
Diamandis, who also founded Singularity University, a global learning and innovation community that uses exponential technologies to tackle worldwide challenges, according to its website, said, “We’re going to see Apple and Amazon and Google and all the data-driven companies that are in our homes right now become our healthcare providers.”
If this prediction becomes reality, it will bring significant changes in the traditional ways that consumers and patients have selected providers and access healthcare services. In turn, this will require all clinical laboratories and pathology groups to develop business strategies in response to these developments.
Amazon Arrives in Healthcare Markets
Several widely-publicized business initiatives by Amazon, Google, and Apple substantiate these predictions. According to an Amazon blog, healthcare insurers, providers, and pharmacy benefit managers are already operating HIPAA-eligible Amazon Alexa for:
Alexa also enables HIPAA-compliant blood glucose updates as part of the Livongo for Diabetes program. “Our members now have the ability to hear their last blood glucose check by simply asking Alexa,” said Jennifer Schneider, MD, President of Livongo, a digital health company, in a news release.
And Cigna’s “Answers By Cigna” Alexa “skill” gives members who install the option responses to 150 commonly asked health insurance questions, explained a Cigna news release.
“Google plans to disrupt healthcare and use data and artificial intelligence,” Toby Cosgrove, Executive Advisor to the Google Cloud team and former Cleveland Clinic President, told B2B information platform PYMNTs.com.
PYMNTs speculated that Google, which recently acquired Fitbit, could be aiming at connecting consumers’ Fitbit fitness watch data with their electronic health records (EHRs).
“Ultimately what’s best is human and AI collaboratively,” Peter Diamandis, MD, founder of XPRIZE Foundation and Singularity University told Fast Company. “But I think for reading x-rays, MRIs, CT scans, genome data, and so forth, that once we put human ego aside, machine learning is a much better way to do that.” (Photo copyright: SALT.)
Apple Works with Insurers, Integrating Health Data
The Apple Watch health app also enables people to access medical laboratory test results and vaccination records, and “sync up” information with some hospitals, Business Insider explained.
Virtual Care, a Payer Priority: Survey
Should healthcare providers feel threatened by the tech giants? Not necessarily. However, employers and payers surveyed by the National Business Group on Health (NBGH), an employer advocacy organization, said they want to see more virtual care solutions, a news release stated.
“One of the challenges employers face in managing their healthcare costs is that healthcare is delivered locally, and change is not scalable. It’s a market-by-market effort,” said Brian Marcotte, President and CEO of the NBGH, in the news release. “Employers are turning to market-specific solutions to drive meaningful changes in the healthcare delivery system.
“Virtual care solutions bring healthcare to the consumer
rather than the consumer to healthcare,” Marcotte continue. “They continue to
gain momentum as employers seek different ways to deliver cost effective,
quality healthcare while improving access and the consumer experience.”
“In AI, there are three trends to watch,” said health strategist Ted Schwab (above) while speaking at the 2019 Executive War College. “The first major AI trend will affect clinical laboratories and pathologists. It involves how diagnosis will be done on the Internet and via telehealth. The second AI trend is care delivery, such as what we’ve seen with Amazon’s Alexa—you should know that Amazon’s business strategy is to disrupt healthcare. And the third AI trend involves biological engineering,” he concluded. (Photo copyright: Dark Daily.)
“If you use Google in the United States to check symptoms,
you’ll get five-million to 11-million hits,” Schwab told The Dark Report.
“Clearly, there’s plenty of talk about symptom checkers, and if you go online
now, you’ll find 350 different electronic applications that will give you
medical advice—meaning you’ll get a diagnosis over the internet. These
applications are winding their way somewhere through the regulatory process.
“The FDA just released a report saying it plans to regulate
internet doctors, not telehealth doctors and not virtual doctors,” he
continued. “Instead, they’re going to regulate machines. This news is
significant because, today, within an hour of receiving emergency care, 45% of
Americans have googled their condition, so the cat is out of the bag as it
pertains to us going online for our medical care.”
Be Proactive, Not Reactive, Health Leaders Say
Healthcare leaders need to work on improving access to primary care, instead of becoming defensive or reactive to tech companies, several healthcare CEOs told Becker’s Hospital Review.
Clinical laboratory leaders are advised to keep an eye on
these virtual healthcare trends and be open to assisting doctors engaged in
telehealth services and online diagnostic activities.
The software applications (apps) and hardware monitoring devices involved in digital therapeutics enable physicians and patients to target and alter specific behaviors that affect certain medical conditions, such as substance abuse or depression. Combined with or without drugs, digital therapeutics are achieving positive results, according to the United Kingdom’s PwC (PricewaterhouseCoopers) Health Research Institute (PwC HRI).
The report goes on to state that digital therapeutics “is
reshaping the landscape for new medicines, product reimbursement and regulatory
oversight … [and that] new data sharing processes and payment models will be
established to integrate these products into the broader treatment arsenal and
regulatory structure for drug and device approvals.
“Connected health services,” the report continues, “enabled by devices that transmit data or connect to the Internet, give additional visibility into care delivery and new ways to improve patient outcomes.”
Digital therapeutics combine apps and monitoring devices for
the management and treatment of medical conditions. While similar to customer
wellness apps, digital therapeutics focus on specific clinical outcomes.
The non-profit Digital Therapeutics Alliance says that, unlike common “wellness” apps, digital therapeutics “possess the unique ability to incorporate additional functionalities into a comprehensive portfolio of synchronous products and services. This includes potential integration with mobile health platforms; the provision of complementary diagnostic or adherence interventions; the ability to pair with devices, sensors, or wearables; the delivery of interventions remotely; and integration into electronic prescribing, dispensing, and medical record platforms.”
“Digital therapeutics are the next frontier,” Sai Jasti, Chief Data and Analytics Officer, GlaxoSmithKline (NYSE:GSK), told PwC HRI. “I think we will see a lot more collaboration between pharmaceutical and technology companies to drive this forward, ultimately to the benefit of patients.”
Digital Therapeutics That Already Have FDA Approval
Digital therapeutics and their connected devices are subject
to the approval process of the federal Food and Drug Administration (FDA), and
some have already received that coveted clearance:
reSET from Pear Therapeutics is a 90-day prescription digital therapeutic (PDT) for substance use disorder (SUD). The Boston-based company also worked with Sandoz Inc., a division of Novartis, to receive FDA approval for reSET-O, a PDT for treating individuals with Opioid Use Disorder (OUD).
“Digital technologies and data science have incredible potential to unlock the next chapter of medical innovation and to help individuals finally take control of their own health in a meaningful way,” said Richard Francis, Division Head and CEO, Sandoz, in a press release. “New digital therapeutics such as reSET-O also have the potential to fundamentally change how patients interact with their therapies and thus improve patient outcomes.”
Both reSET and reSET-O are software mobile apps that use cognitive behavioral therapy (CBT) to help individuals struggling with addictions.
“Nearly 50,000 drug overdose deaths involving opioids, including prescription pain medications and heroin, took place in the U.S. in 2017,” said Corey McCann, MD, PhD, President and CEO of Pear Therapeutics, in the press release following receiving FDA approval. “There is an urgent need for new and innovative therapeutics to address this public health epidemic. This groundbreaking decision by the FDA ushers in a new standard for treating patients with Opioid Use Disorder and it signals a new path for therapeutic software to be used in conjunction with pharmacotherapy to improve efficacy.”
Natural
Cycles is a birth control app created by a Sweden-based company of the same
name. It was approved by the FDA in 2018. This mobile app helps women track
their fertility to prevent unwanted pregnancies via the rhythm method. The app
analyzes data from past menstrual cycles and body temperature readings to
determine when the user is most fertile. On the days the user is most likely to
be ovulating, the app displays “Use Protection” on the mobile device’s screen.
“We know that women are more likely to use contraceptive methods when they have a variety of methods available to them, and the reality is that not every method is going to work for every woman,” Rebecca Simmons, PhD, Research Assistant Professor, Department of Obstetrics and Gynecology, University of Utah, told Health. “This is really exciting, in the sense that the more methods we have, the more likely it is that people can find something that works for them—and then can avoid unwanted pregnancy.”
Apple, headquartered in Cupertino, Calif., received FDA clearance in 2018 for an electrocardiogram (ECG) app for its Apple Watch Series 4 that allows users to take an ECG from their wrist to detect irregular heart rhythms and atrial fibrillation (AFIB).
“The role that technology plays in allowing patients to capture meaningful data about what’s happening with their heart—at the moment when it’s happening, like the functionality of an on-demand ECG—could be significant in new clinical care models and shared decision-making between people and their healthcare providers,” said Nancy Brown, CEO of the American Heart Association, in a press release.
Patients, Providers, and Big Pharma All Like Digital
Therapeutics
There is some evidence that patients and healthcare
providers are intrigued and willing to try digital therapeutics. In a PwC HRI survey,
more than 50% of respondents said they “would be somewhat or very likely to try
an FDA-approved app or online tool for treatment of a medical condition.”
The graphic above is taken from the PwC HRI 2019 annual report on digital therapeutics and connected care. It shows that “a majority of consumers surveyed are interested in FDA approved digital apps or online tools to treat their medical conditions.” (Graphic copyright: PwC HRI.)
Pharmaceutical companies also are interested in digital therapeutics. A 2018 PwC HRI survey found that 80% of pharmaceutical executives had plans to invest in digital therapeutics in the near future.
With precision medicine and pharmacogenetics, clinical laboratories
could play an essential role in supporting digital therapeutics in the future. But
to truly be competitive in this space and take advantage of the opportunity, medical
laboratories will need to increase their information technology and digital
capabilities.
Mobile, wearable, mHealth monitoring devices are a key element of many employer fitness programs and clinical laboratories can play an important role in their success
For years Dark Daily has encouraged clinical laboratories to get involved in corporate wellness programs as a way to support their local communities and increase revenues. Now, leveraging the popularity of mobile health (mHealth) wearable devices, UnitedHealthcare (UHC) has found a new way to incentivize employees participating in the insurer’s Motion walking program. UHC is offering free Apple Watches to employees willing to meet or exceed certain fitness goals.
This is the latest wrinkle in a well-established trend of incentivizing
beneficiaries to meet healthcare goals, such as stopping smoking, losing
weight, reducing cholesterol, and lowering blood pressure.
It’s an intriguing gamble by UHC and presents another opportunity for medical laboratories that are equipped to monitor and validate participants’ progress and physical conditions.
How to Get a Free Apple
Watch and FIT at the Same Time
CNBC reported that UHC’s Motion program participants number in the hundreds of thousands. And, according to a UHC news release, they can earn cash rewards up to $1,000 per year. The idea is that participants pay off the cost of their “free” Apple Watch one day at a time by achieving activity goals set in UHC’s FIT tracking method. Those goals include:
Frequency:
500 steps in seven minutes; six times a day, at least one hour apart;
Intensity:
3,000 steps in 30 minutes; and,
Tenacity:
10,000 steps in one day.
“UnitedHealthcare Motion is part of our consumer-focused strategy that is driving toward a simple, integrated, mobile-centric ecosystem that delivers value to consumers,” said Steve Nelson, CEO of UnitedHealthcare, in a news release. “Smartwatches and activity trackers stand alongside transparency in physician selection and medical costs, easy virtual visits with healthcare professionals, and digital coaching and online wellness programs, all of which are designed to support consumers in enhancing their health and improving how they navigate the healthcare system.” Clinical laboratories play a key role in this healthcare strategy. (Graphic copyright: UnitedHealthcare.)
Though hundreds of thousands of beneficiaries are eligible to participate in UHC’s Motion program through their employers, only 45% of those eligible have enrolled in Motion, Fox Business reported.
UHC hopes the offer of a free Apple Watch (which has
applications to track minutes of exercise, a heart rate monitor, and more) will
encourage people to sign up and then progress toward the Motion program’s FIT
goals.
As people meet these goals, they earn $4/day toward the cost
of the Apple Watch. Participants, who do not take enough steps in a six-month period
could be required to repay a percentage of the cost of the smartwatch.
Motion participants who already own an Apple Watch can still
earn up to $1,000 per year in cash rewards for achieving the FIT goals.
“UnitedHealthcare Motion’s success affirms that wearables can play an important role in helping people enhance their well-being and supporting and motivating them to stay engaged in their health,” said Rebecca Madsen, Chief Consumer Officer of UnitedHealthcare, in the UHC news release. (Photo copyright: University of Pennsylvania.)
Impact of mHealth
Programs/Technology Not Clear
Chronic diseases, including diabetes and heart disease, annually cost the US healthcare system $190 billion and employers $126 billion in lost productivity, according to the Centers for Disease Control and Prevention (CDC).
However, some researchers say it’s too early for mHealth
wearables, medication apps, physician virtual engagement, and other digital tools
(many launched within the past five to seven years) to effect key indicators,
such as obesity, life expectancy, and smoking cessation.
“Some of the benefits of these new tools won’t be realized for a long time. It’s really hard to tease out the impact of digital health. Maybe we’re helping people, but we’re not detecting it,” James Murphy, MD, Associate Professor, University of California San Diego Health and radiation oncologist, told CNBC.
Nevertheless, it behooves medical laboratories to develop
procedures for analyzing and reporting data that could impact people who use
wearable mHealth devices to participate in employer wellness programs.
For example, labs could contact insurance companies with
information about biomarkers that provide views into an individual’s progress
toward personal health goals.
Data-driven recommendations from medical laboratories about
tests for chronic conditions such as heart disease and diabetes will likely be
welcomed by payers.
