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.
Proven success at providing quality care to patients at home while lowering costs has both investors and health insurance companies intrigued
Some call it “hospital in the home.” Whatever name it is given, the high cost of keeping a patient overnight in a hospital is motivating a range of healthcare players to develop innovative ways to provide care to patients—even patients with acute conditions—in their home. This is a trend that clinical laboratories will want to watch.
With hospital beds costing $1,000 to $2,000 per night, the
economics of being treated in the comfort of their homes can be attractive to
patients. But it’s also popular with caregivers, investors, and payers, as well.
That’s why in-home healthcare services are becoming increasingly common
nationwide, and why clinical laboratories may be supplying services to more in-home
healthcare companies in the future.
One such company is DispatchHealth of Denver, Colo., which recently brought its “ER-at-Home” in-home healthcare model to cities in Texas, Massachusetts, and Washington State.
Focused primarily on seniors with high-acuity medical conditions, “Patients or caregivers contact DispatchHealth through their smartphone app, website, or phone call line and the company sends over a home care team consisting of a physician assistant or nurse practitioner, along with an [emergency] medical technician. The team has the ability to perform clinical laboratory studies, infusion, EKGs, and some higher-level procedures, such as the repair of complex lacerations,” MedCity News reported.
The DispatchHealth team arrives prepared to treat Influenza
(Flu), fever, joint or back pain, sprains, strains, eye infections, urinary
tract infections, skin rashes, and lacerations. The team also can treat more
severe conditions that cause nausea, vomiting, and diarrhea, as well as asthma
and other respiratory conditions, and illnesses of the ear, nose, and throat.
In addition, the DispatchHealth team can perform certain
clinical laboratory tests onsite, including:
High-acuity home care is a development that clinical
laboratory leaders will want to monitor because these services save people
trips to medical laboratories, urgent care centers, primary care doctors’
offices, and even emergency rooms.
“We strive to treat conditions between the ER and true emergencies—so COPD (chronic obstructive pulmonary disease) exacerbation, pneumonia, severe migraines, and other issues we can treat with IV (intravenous therapy) medication … and laboratory studies,” Mark Prather, MD, DispatchHealth Chief Executive Officer, told MedCity News, which noted the company’s partnership with Centura Health, Colorado Springs, Colo., among others.
Established in 2013 in Denver, DispatchHealth provides both
mobile and virtual healthcare, is in-network with healthcare insurance
companies, and has relationships with healthcare systems.
The company expanded this year into new markets and added
partnerships with more healthcare systems, including:
a “major nonprofit health system” in North Texas, according to a news release.
Through in-home care teams (such as shown above), DispatchHealth estimates delivery of acute care to about 80,000 patients nationwide in 2019 for a savings of $100 million in medical expenses. “Up to 50% of people who visit the emergency room every day could be treated in a lower cost setting,” said DispatchHealth Chief Executive Officer Mark Prather, MD, in a news release. (Photo copyright: Philips.)
In the Spokane market, the company’s six teams and two vehicles can see about seven patients per day for an average of 45 minutes to an hour per visit, reported the Spokesman-Review. DispatchHealth employs more than 200 people and has raised more than $33 million in growth capital financing, according to a company statement.
The project involved and recognized medical practices that
effectively and efficiently cared for Medicare beneficiaries with chronic
conditions at home.
More recently, Northwell Health Labs, a division of Northwell Health, launched LabFly, a smartphone app that enables patients to schedule blood draws at home or at work, according to a news release.
“The app is a new way to give our patients access to the quality experience they would receive at one of our patient service centers, but in their living room or place of work,” said Dwayne Breining, MD, Executive Director, Northwell Health Labs, in the news release.
Investors Are Intrigued with In-Home Care
The business of treating people in their homes or offices
has some investors excited at the opportunity.
“To us, this feels like we’re investing in Uber in 2010. This is going to revolutionize and change the entire healthcare industry,” Samir Patel, Principal and co-founder of IRA Capital told the New York Times. Patel was commenting on his firm’s investment in Heal, a Los Angeles-based in-home healthcare company that launched in 2014.
In response to being contacted by smartphone app, computer, or phone, Heal sends primary care doctors and medical assistants to treat people in their homes, workplace, or at hotels.
Heal estimates completion of more than 100,000 house calls in 2019 and savings in healthcare expenses of more than $53 million due to treating people in lower cost ways, a news release stated. The company said it has experienced a 310% growth rate over 12 months and now operates in Atlanta, Georgia, California, New York, North Virginia, and the District of Columbia.
“Ten years from now, we will think of going to the doctor’s office as dated and arbitrary as going to the store to buy diapers compared to buying diapers on Amazon,” Nick Desai, co-founder of Heal, told FierceHealthcare, which reported Heal had raised $71 million from investors.
Payers Are Onboard as Well
High-acuity home care services also seem to align with health insurance company benefits and new federal payment models. Heal’s website states their services are in-network with most Medicare Advantage plans. Heal’s smartphone app also can verify insurance coverage.
DispatchHealth explains on its website that it contracts
with major payers, including Medicare and Medicaid, and charges self-pay
customers $275.
Medical laboratory leaders should consider developing
relationships with high-acuity home healthcare companies and other care
providers that deliver care to people in unconventional ways and in
non-traditional locations.
Though medical laboratory testing is key to confirming sepsis, predictive analytics systems can identify early indications and alert caregivers, potentially saving lives
Medical laboratory testing has long been the key element in hospitals’ fight to reduce deaths caused by sepsis, a complication caused by the human body’s response to infection which can injure organs and turn fatal. But clinical laboratory testing takes time, particularly if infectious agents must be cultured in the microbiology lab. And sepsis acts so quickly, by the time the condition is diagnosed it is often too late to prevent the patient’s death.
One example is HCA Healthcare (NYSE:HCA), the for-profit corporation with 185 hospitals, 119 freestanding surgery centers, and approximately 2,000 sites of care in 21 US states and in the United Kingdom.
HCA employs an electronic information and alert system called SPOT (Sepsis Prediction and Optimization of Therapy), which is embedded in each hospital patient’s electronic health record (EHR).
SPOT receives clinical data in real time directly from
monitoring equipment at the patient’s bedside and uses predictive analytics to examine
the data, including medical laboratory test results. If the data indicate that
sepsis is present, SPOT alerts physicians and other caregivers.
With SPOT, HCA’s physicians have been detecting sepsis in
its earliest stages and saving lives. This lends support to the growing belief
that AI and machine learning can improve speed to diagnosis and diagnostic
accuracy, which Dark Daily has covered in multiple
e-briefings.
SPOT displays its data on screens that are monitored 24/7 (shown above). The clinical data include the patient’s vital signs as well as medical laboratory test results and nursing reports. HCA says the system has been used on about 2.5 million patients and has helped save up to 8,000 lives, Business Wire reported. (Photo copyright: HCA.)
Code Sepsis
HCA began developing the software in 2016. It was initially deployed in 2018 at TriStar Centennial Medical Center, HCA’s flagship hospital in Nashville,The Tennessean reported. It is now installed in most of the hospitals owned or operated by HCA.
Michael Nottidge, MD, is ICC Division Medical Director for Critical Care at HCA Healthcare Physician Services Group, and a critical care physician at TriStar Centennial. Nottidge told The Tennessean that unlike a heart attack or stroke, “sepsis begins quietly, then builds into a dangerous crescendo.”
Since its implementation, “[SPOT] has alerted clinicians to
a septic patient nearly every day, often hours sooner than they would have been
detected otherwise,” Nottidge told The Tennessean.
HCA’s SPOT system uses machine learning to ingest “millions of data points on which patients do and do not develop sepsis,” according to an HCA blog post. “Those computers monitor clinical data every second of a patient’s hospitalization. When a pattern of data consistent with sepsis risk occurs, it will signal with an alert to trained technicians who call a ‘code sepsis.’”
More Accurate than Clinicians
The federal Centers for Disease Control and Prevention (CDC) estimates that more than 250,000 Americans die from sepsis each year. The Sepsis Alliance describes the life-threatening complication as the “leading cause of death in US hospitals.”
Early detection and treatment are key to reducing sepsis mortalities. However, a study in the journal Clinical Medicine reported that, despite recent advances in identifying at-risk patients, “there is still no molecular signature able to diagnose sepsis.”
And according to a study published in Critical Care Medicine, the survival rate is about 80% when treatment is administered in the first hour, but each hour of delay in treatment decreases the average survival rate by 7.6%.
In an interview with Becker’s Hospital Review, HCA’s Chief Medical Officer and President of Clinical Services, Jonathan Perlin, MD, PhD, touted SPOT’s reliability, having “very few false positives. In fact, it is more than 50% more accurate at excluding patients who don’t have sepsis than even the best clinician.”
Perlin also told The Tennessean that SPOT can detect
sepsis “about eight to 10 hours before clinicians ever could.”
“It’s no coincidence that we call the technology ‘SPOT’—a common name for a child’s dog—because it really does act as our sepsis sniffer,” said Jonathan Perlin, MD, PhD (above), in the HCA blog post. “The whole point is for it to sniff smoke and put the ‘fire’ out before it becomes catastrophic. With SPOT, we’re identifying at least one-third more cases of sepsis that would not previously have come to caregivers’ attention until it was too late.” [Photo copyright: Nashville Business Journal.)
Other Healthcare Providers Using AI-Enabled Early-Warning
Tools
In November 2018, the emergency department at Duke University Hospital in Durham, N.C., began a pilot program to test an AI-enabled system dubbed Sepsis Watch, reported Health Data Management. The software, developed by the Duke Institute for Health Innovation, “was trained via deep learning to identify cases based on dozens of variables, including vital signs, medical laboratory test results, and medical histories,” reported IEEE Spectrum. “In operation, it pulls information from patients’ medical records every five minutes to evaluate their conditions, offering intensive real-time analysis that human doctors can’t provide.”
Earlier this year, Sentara Norfolk General Hospital in Norfolk, Va., installed an AI-enabled sepsis-alert system developed by Jvion, a maker of predictive analytics software. “The new AI tool grabs about 4,500 pieces of data about a patient that live in the electronic record—body temperature, heart rate, blood tests, past medical history, gender, where they live and so on—and runs it all through an algorithm that assesses risk for developing sepsis,” reported The Virginian Pilot.
Geisinger Health System, which operates 13 hospitals in Pennsylvania and New Jersey, is working on its own system to identify sepsis risk. It announced in a September news release that it had teamed with IBM to develop a predictive model using a decade’s worth of data from thousands of Geisinger patients.
“The model helped researchers identify clinical biomarkers associated with higher rates of mortality from sepsis by predicting death or survival of patients in the test data,” Geisinger stated in the news release. “The project revealed descriptive and clinical features such as age, prior cancer diagnosis, decreased blood pressure, number of hospital transfers, and time spent on vasopressor medicines, and even the type of pathogen, all key factors linked to sepsis deaths.”
So, can artificial intelligence and predictive analytics
added to medical laboratory test results help prevent sepsis-related deaths in
all hospitals? Perhaps so. Systems like SPOT, Sepsis Watch, and others
certainly are logging impressive results.
It may not be long before similar technologies are aiding
pathologists, microbiologists, and clinical laboratories achieve improved
diagnostic and test accuracy as well.
The self-cleaning material has been proven to repel even the deadliest forms of antibiotic resistant (ABR) superbugs and viruses. This ultimate non-stick coating is a chemically treated form of transparent plastic wrap which can be adhered to surfaces prone to gathering germs, such as door handles, railings, and intravenous therapy (IV) stands.
“We developed the wrap to address the major threat that is posed by multi-drug resistant bacteria,” Leyla Soleymani, PhD, Associate Professor at McMaster University and one of the leaders of the study, told CNN. “Given the limited treatment options for these bugs, it is key to reduce their spread from one person to another.”
According to research published in the peer-reviewed Southern Medical Journal, “KPC-producing bacteria are a group of emerging highly drug-resistant Gram-negative bacilli causing infections associated with significant morbidity and mortality.”
Were those surfaces covered in this new bacterial-resistant
coating, life-threatening infections in hospital ICUs could be prevented.
Taking Inspiration from Nature
In designing their new anti-microbial wrap, McMaster researchers took their inspiration from natural lotus leaves, which are effectively water-resistant and self-cleaning thanks to microscopic wrinkles that repel external molecules. Substances that come in contact with surfaces covered in the new non-stick coating—such as a water, blood, or germs—simply bounce off. They do not adhere to the material.
The “shrink-wrap” is flexible, durable, and inexpensive to
manufacture. And, the researchers hope to locate a commercial partner to
develop useful applications for their discovery.
“We’re structurally tuning that plastic,” Soleymani told SciTechDaily. “This material gives us something that can be applied to all kinds of things.”
In the video above, Leyla Soleymani, PhD, Associate Professor at McMaster University, explains how “The new plastic surface—a treated form of conventional transparent wrap—can be shrink-wrapped onto door handles, railings, IV stands, and other surfaces that can be magnets for bacteria such as MRSA and C. difficile. This may be technology that has great value to clinical laboratories and microbiology laboratories. Click here to watch the video. (Image and video copyright: McMaster University/YouTube.)
Industries Outside of Healthcare Also Would Benefit
According to the US Centers for Disease Control and Prevention (CDC), at least 2.8 million people get an antibiotic-resistant infection in the US each year. More than 35,000 people die from these infections, making it one of the biggest health challenges of our time and a threat that needs to be eradicated. This innovative plastic coating could help alleviate these types of infections.
And it’s not just for healthcare. The researchers said the coating could be beneficial to the food industry as well. The plastic surface could help curtail the accidental transfer of bacteria, such as E. coli, Salmonella, and Listeria in food preparation and packaging, according to the published study.
“We can see this technology being used in all kinds of institutional and domestic settings,” Tohid Didar, PhD, Assistant Professor at McMaster University and co-author of the study, told SciTechDaily. “As the world confronts the crisis of anti-microbial resistance, we hope it will become an important part of the anti-bacterial toolbox.”
Clinical laboratories also are tasked with preventing the
transference of dangerous bacteria to patients and lab personnel. Constant
diligence in application of cleaning protocols is key. If this new anti-bacterial
shrink wrap becomes widely available, medical laboratory managers and
microbiologists will have a new tool to fight bacterial contamination.
Thus, clinical laboratory leaders must constantly be on
guard against being drawn into potentially fraudulent activities. For example,
schemes involving substance-use
disorder (SUD), which are the latest healthcare-related scams to draw the
attention of the DOJ.
Lack of Oversight in Substance-Use Disorder (SUD) Leads
to Fraud
According to four experts who co-authored a blog post in Health
Affairs, America’s opioid epidemic has affected more than 20 million
lives and become a “hot spot” for healthcare fraud.
“Substance-use disorder (SUD) treatment was a $9 billion per year industry in 1986 and is now a $35 billion industry that is expected to reach $42 billion in 2020,” they wrote. Thus, it has given rise to escalating opioid-related scams by unethical clinical laboratories, healthcare providers, and recovery-house operators.
“While current regulations around SUD treatment aim to
protect patient safety instead of criminalize addiction treatment, they vary by
state—and in some states, patient protections are limited,” they explained.
“This lack of oversight invites deceptive business practices, insurance fraud,
patient neglect, and ultimately, treatment malpractice that can damage lives
and tear families apart.”
In December 2019, the US Department of Health and Human
Services (HHS) Office of the Inspector General (OIG) released its Semiannual
Report to Congress. The report details the $5.9 billion HHS recovered from
healthcare fraud investigations during fiscal year 2019, more than double the
amount of the prior year.
“Medicaid fraud is not a victimless crime,” US Attorney Michael Stuart (above) said in the DOJ press release. “In [the Acadia Healthcare] case, every dime in false billings was doubled for a total settlement that represents twice the harm caused. This is a strong message and a massive penalty. The message is clear—if you are cheating the system and we find you, you’ll not only pay for the damage done, but far more.” (Photo copyright: Wikipedia.)
The Health Affairs authors focused on the major
players in addiction treatment-related fraud that were highlighted in a 2018 Government Accountability
Office (GAO) report. They are:
SUD treatment providers who take advantage of
“gaps in regulations and quality assurance to offer substandard and fraudulent
care that endangers patients and wastes money.”
Unlicensed patient brokers who SUD providers pay
to transport addicts to them, often from hundreds of miles away.
Disreputable recovery house or “sober home”
operators who are subsidized financially by fraudulent SUD providers.
One example the GAO report outlined involved SUD providers in Florida who funded their illegal operations by billing patients’ insurance hundreds of thousands of dollars in unnecessary drug testing over the course of several months.
“At the very moment that ethical healthcare providers are
working harder than ever to address the opioid crisis, unethical actors—such as
providers engaged in fraud—pose a growing problem,” the Health Affairs authors
stated.
Opioid Crisis Turns Urine Screening into ‘Liquid Gold’
Kaiser
Health News (KHN) reported that many doctors who prescribe
opioids began making drug screenings routine in their practices after being
persuaded that doing so would keep them in good standing with licensing boards
and law enforcement, while also reducing their liability and preventing patient
abuse of prescription pills.
In some instances, doctors opened their own clinical laboratories,
KHN stated.
KHN described the nation’s painkiller addiction as turning urine screening into “liquid gold,” particularly for doctors who operate their own clinical laboratories. In 2014 and 2015, Medicare paid $1 million or more for drug-related tests billed by healthcare workers at more than 50 pain management practices in the US, KHN reported.
“It was almost a license to steal. You had such a lucrative possibility, it was tempting to sell as many [tests] as you can,” Charles Root, PhD, Senior Consultant at consulting firm CodeMap, told KHN. CodeMap provides publications, tools, and services that help healthcare professionals navigate the federal Medicare program and has tracked the increase in medical testing laboratories in doctors’ offices, KHN noted.
The graphic above is built on data from CodeMap. It illustrates the “explosive” growth in certain urine tests to “detect and quantify a variety of drugs,” according to KHN. This has led some providers to open clinical laboratories in their offices to capture the increasing revenue generated by this testing. (Image copyright: Kaiser Health News.)
Federal officials have taken notice of physicians whose
priority is testing patients, not treating them. Jason Mehta, JD, who at
that time was Assistant US Attorney in Jacksonville, Fla., told KHN, “We’re
focused on the fact that many physicians are making more money on testing than
treating patients. It is troubling to see providers test everyone for every
class of drugs every time they come in.”
Clinical laboratories have an important role to play in
identifying fraud and solving the opioid epidemic. Not only are lab leaders ideally
positioned to help providers better understand drug test ordering and
interpretation, but also to help develop value-based interventions within the
continuum of care for this national health crisis.
