Clinical laboratories should prepare to receive test orders from these mini-medical centers, based on consumer demand for quick, inexpensive, local healthcare
Is the era of clinical laboratory testing offered in retail stores soon to arrive? Dark Daily as long as 10 years ago predicted that walk-in clinics featuring a nurse or nurse practitioner who could diagnose and prescribe for a limited number of health conditions—which had a remedy that could be purchased at the pharmacy in the retail store—would be the door-openers to locating more sophisticated clinical services in retail settings.
Since then, we’ve covered many such openings—including free standing urgent care clinics opening in urban settings to service the consumer demands of busy patients—which have impacted clinical laboratories and anatomic pathology groups in predictable ways.
The premise of the collaboration was based around the belief that consumers would welcome the opportunity and benefits of receiving basic healthcare services in a facility located next to a pharmacy. The Walgreens/MedExpress agreement, however, also indicates that two of the largest healthcare organizations in the world believe consumers would also be interested in visiting physicians who provided more sophisticated medical services, including critical care, in retail settings.
To date, Walgreens has opened MedExpress clinics in 15 locations in six states, including: Minnesota, Nebraska, Nevada, Texas, Virginia, and West Virginia. More such clinics are expected to open this year as part of the collaboration.
“MedExpress is a resource for busy families and employers that need timely access to affordable, high-quality healthcare close to home and work,” Fred Hinz (above), VP of Operations at MedExpress told Drug Store News. “Being connected to Walgreens will enable our patients to receive quality care and purchase any other items they need, all in one trip.” It also will likely result in increased orders for clinical laboratory testing from retail locations. (Photo copyright: Grand Island Independent.)
Future Health System Delivers Critical Care from Retail Locations
Motivated by consumer demand for convenient, high-quality healthcare, the urgent care market in the United States continues to grow. This trend will eventually influence clinical laboratories and anatomic pathology groups seeking to service these providers. It will be a dynamic market as new participants and mergers compete for leverage in this profitable business.
“This is just part of developing an overall higher-performing local health system,” Forbes reported UnitedHealth CEO David Wichmann telling analysts during the company’s earning call last month. “It’d just be one component that may be nested inside a local care delivery market with ambulatory surgical capacities and house calls and things of that nature. This is the future health system that we see delivering considerable value to people.”
The speedy growth in the number of and profitability of urgent care centers is another confirmation that this healthcare trend has legs. And experts believe the growth will continue and accelerate.
A recent report by market research and consulting firm MarketsandMarkets (MnM) predicts the global urgent care market should reach $25.93 billion (US) by the year 2023. The current value of the industry is $20 billion. The growth rate for the industry is expected to be 5.3% with North America being the region accounting for the highest amount of that growth.
The MnM report attributes the rise in the urgent care market to many factors, including:
Growing investments in urgent care;
Strategic developments between urgent care providers and hospitals;
Access to affordable care;
Convenience of shorter wait times; and,
Increase in the geriatric population.
The report projects that the biggest hurdle facing the urgent care industry will be the lack of a skilled workforce.
Urgent Care a Growth Industry According to Experts
There are currently more than 7,500 urgent care facilities in the United States, according to an Urgent Care Association (UCA) white paper.
According to the UCA, the top six urgent care organizations in the US each have more than 100 locations. Those companies include:
A 2017 UCA benchmarking report states that only 3% of patients who are seen at an urgent care facility were diverted to an emergency room in 2016. The top diagnosis codes for visits during that year were:
A report by Becker’s Hospital Review states that urgent care visits account for 19% of all healthcare visits in the US.
Urgent Care Centers Badly Needed and Highly Profitable
Last year, strategy consulting firm Health Systems Advisors (HSA) commissioned a study regarding the current and future need for urgent care centers. According to Becker’s Hospital Review, the HSA study stated that:
“With the recent rise of urgent care development, there is an estimated 22% unmet need for urgent care in markets where urgent care sites could be financially viable;
“The unmet demand is so large that approximately 1,600 new urgent care sites can be supported generating nearly $3.5 billion in revenue; and,
“For health systems seeking to grow, the urgent care channel presents a unique opportunity to grow their revenue, influence patients’ downstream choices, and create a better experience for individuals desiring more convenience and better access.”
And data collected by FAIR Health indicates that, between 2007 and 2016, insurance claims for urgent care visits grew by a whopping 1,725%! Claims for emergency room visits increased by 229% during the same time period. FAIR Health is a non-profit organization that examines insurance claims for medical services for the purpose of bringing transparency to healthcare costs and insurance information.
Opportunities for Clinical Laboratories to Support Physicians
Clinical laboratories and pathology groups should pay attention to the burgeoning trend in urgent care, as those facilities order medical tests that will require processing, reading, and analyzing.
Exploring opportunities to serve urgent care centers offers clinical laboratories potential revenue streams and opportunities to serve the physicians practices and medical communities they support.
Primary care is shifting from traditional office visits to urgent care and walk-in clinics even as large hospital groups continue to buy up independent physician practices, altering where and from whom clinical laboratories receive referrals and test orders
Medical test ordering and referrals from office-based physicians are the financial foundation of the clinical laboratory industry. Thus, recent trends reshaping how and where physicians practice medicine, and the ownership of their medical groups, could have both beneficial and adverse implications for medical laboratories and anatomic pathology groups.
Primary care doctors who own their own medical practices are disappearing from the healthcare landscape at an impressive rate, as large hospital groups expand their share of the primary care market. According to the New York Times (NYT), in 2010, large hospital groups employed 23% of the nation’s primary care physicians. By 2016, that number had increased to 43%.
However, office visits to primary care physicians fell by 18% between 2012 and 2016, according to a report by Health Care Cost Institute (HCCI). During the same period, visits to specialists rose 31%.
Walk-In and Urgent Care Clinics Replacing Traditional Office Visits
The number of retail or walk-in clinics in the United States has increased by 14 times over the past decade, according to Statista, a provider of market and consumer data. In 2008, there were only 200 retail clinics in the country. Current projections indicate there will be 2,800 walk-in clinics located throughout the country by the end of this year.
In 2010, retail clinic sales totaled $518 million. By the end of 2016, retail clinic sales were more than $1.4 billion representing an increase of 20.3% per year during that time period, according to the Kalorama report, “Retail Clinics 2017: The Game-Changer in Healthcare.”
“There is huge consolidation in the market right now,” Jeffrey D. Le Benger, MD, FACS (above), Chief Executive Officer of Summit Medical Group in New Jersey, told the NYT. “Everyone is fighting for the primary care patient.” (Photo copyright: Gannett.)
Retail or walk-in health clinics were originally intended for uninsured and underinsured individuals who sought an affordable option for medical services. These clinics are designed to treat non-emergency situations, such as burns, sprains, and minor infections or illnesses. Services at these clinics are usually administered by a nurse practitioner.
Retail walk-in clinics often are located inside larger, popular stores. Examples include:
In contrast, urgent care clinics are equipped to handle more serious, non-emergency injuries and conditions and are generally staffed by physicians. The Urgent Care Association of America states that there are more than 7,500 urgent care centers in the US with an annual revenue of $18 billion. This industry is expected to grow by 5.8% in 2018. The largest urgent care group in the country—MedExpress Urgent Care in Morgantown, W.Va.—has 252 locations in 22 states.
Another growing urgent care center—ZoomCare of Portland, Ore.—has 36 locations in Oregon and Washington State. Services offered include: urgent care, primary care, pediatrics, gynecology, orthopedics, dermatology, dental care, ear nose and throat, chiropractic, podiatry, physical therapy, mental health, immunity, imaging, internal medicine, clinical laboratory, and prescriptions. They offer convenient, extended hours and some locations are open seven days a week.
“Our customers are looking for world-class conveniences,” Albert DiPiero, MD, co-founder and Chief Medical Officer at ZoomCare, told Portland Monthly.
ZoomCare lists its menu of services/cost for both insured and self-pay patients on its website. Basic medical laboratory tests include:
Strep-$50;
Urine-$20;
Mononucleosis test-$20;
Pregnancy-$20; and,
Influenza A/B-$40.
The website states that half of ZoomCare’s medications cost less than $10, and five out of six of the medicines are less than $20.
With such low costs and easy accessibility, it’s understandable why the number of patients seeking care in non-traditional office settings is growing. Clinical laboratories must accept and support these new sites of healthcare delivery to ensure continued procurement of lab test referrals. Staying on top of these trends and adjusting to consumer demand will help labs thrive and survive in healthcare’s ever-changing landscape.
Since the first retail clinic opened in Minneapolis in 2001, there has been a steady increase in the number of such clinics, typically located in retail pharmacies and chain retailers
In Minnesota, UnitedHealth Group (NYSE:UNH) is preparing to substantially increase the number of urgent care clinics it operates in the state. These retail-style clinics will be operated by MedExpress, a company that UnitedHealth acquired in 2015.
UnitedHealth’s decision to expand the number of MedExpress retail clinics it operates, both in Minnesota and nationally, is a sign to clinical laboratory managers and pathologists that consumer demand for health services delivered by a retail clinic continues to increase. (more…)
This is good news for clinical laboratories that already perform medical testing for telehealth providers and an opportunity for medical labs that do not, it is an opportunity to do so
Telemedicine visits have become commonplace since the arrival of COVID-19. Before the pandemic, telehealth was primarily used to give remote patients access to quality healthcare providers. But three years later both patients and physicians are becoming increasingly comfortable with virtual office visits, especially among Millennial and Gen Z patients and doctors.
Now, a recent study by the Perelman School of Medicine at the University of Pennsylvania (Penn Medicine) suggests that there could be a significant financial advantage for hospitals that conduct telemedicine. This would be a boon to clinical laboratories that perform medical testing for telemedicine providers.
According to Digital Health News, in July 2017 Penn Medicine launched a 24/7/365 copayment-free telemedicine program for its employees called Penn Medicine OnDemand. To engage with a telemedicine provider, patients must have a smartphone or tablet with a front-facing camera and updated operating system.
Telemedicine Visits Cost Less than In-Office Doctor Appointments
An analysis of the OnDemand program’s data collected from its inception through the end of 2019 found that the telemedicine appointment per-visit cost averaged around $380, whereas the cost of an in-person visit at an emergency department, primary care office, or urgent care clinic averaged around $493.
Typically, Penn Medicine’s employees used the telemedicine program for common, low risk health complaints. Healthcare conditions that many patients might otherwise not seek treatment for if an in-office visit was inconvenient.
“The data we analyzed pre-date the pandemic. It was a time when people were just putting a toe in the water and wondering, ‘Let me see if telemedicine could treat my needs,’” Krisda Chaiyachati MD, an internal medicine physician and Adjunct Assistant Professor at Penn Medicine, told Digital Health News. Chaiyachati lead the research team that conducted the telemedicine study.
“These days, people seem willing to jump in for an appropriate set of conditions,” he added. “The good news is that we made care easier while saving money, and we think the savings could be higher in the future.”
Chaiyachati and his colleagues found that telemedicine can save employers healthcare costs without sacrificing quality of care.
“The conditions most often handled by OnDemand are low acuity—non-urgent or semi-urgent issues like respiratory infections, sinus infections, and allergies—but incredibly common, so any kind of cost reduction can make a huge difference for controlling employee benefit costs,” Krisda Chaiyachati MD (above), a Penn Medicine physician and the study’s lead researcher, told Digital Health News. Clinical laboratories that already perform testing for telemedicine providers may see an increase in test orders once hospitals learn of the costs savings highlighted in the Penn Medicine study. (Photo copyright: Penn Medicine.)
Telemedicine on the Rise
The idea is not new. In late 2018, Planned Parenthood launched the Planned Parenthood Direct mobile app in New York State. The app provides New York patients with access to birth control, emergency contraception, and UTI treatment with no in-person visit required.
The program has since expanded across the country. Users of the app can connect with a physician to go over symptoms/needs, and the be sent a prescription within a business day to the pharmacy of their choice.
The concept is similar to Penn Medicine OnDemand, which gives patients 24/7 year around access to treatment for common and low-acuity medical issues in a convenient, virtual process.
Telemedicine was on the rise in other parts of the healthcare industry before the pandemic. According to “The State of Telehealth Before and After the COVID-19 Pandemic” published by Julia Shaver, MD, Kaiser Permanente, in the journal Primary Care: Clinics in Office Practice, 76% of US hospital systems had utilized some form of telemedicine by 2018. This rate grew exponentially while the healthcare system had to navigate a world with COVID-19 on the rise.
And, apparently, quality of care does not suffer when moved from in-person to virtual settings. Two studies conducted by The University of Rochester Medical Center (URMC) found telemedicine to be effective and that “common concerns about telemedicine don’t hold up to scrutiny,” according a news release.
In her New England Journal of Medicine (NEJM) paper on the studies, Kathleen Fear, PhD, URMC’s Director of Data Analytics, Health Lab, and her co-authors, wrote: “Three beliefs—that telemedicine will reduce access for the most vulnerable patients; that reimbursement parity will encourage overuse of telemedicine; and that telemedicine is an ineffective way to care for patients—have for years formed the backbone of opposition to the widespread adoption of telemedicine.”
However, URMC’s study found the opposite to be true. The NEJM authors wrote, “there is no support for these three common notions about telemedicine. At URMC, the most vulnerable patients had the highest uptake of telemedicine; not only did they complete a disproportionate share of telemedicine visits, but they also did so with lower no-show and cancellation rates. It is clear that … telemedicine makes medical care more accessible to patients who previously have experienced substantial barriers to care.
“Importantly, this access does not come at the expense of effectiveness. Providers do not order excessive amounts of additional testing to make up for the limitations of virtual visits. Patients do not end up in the ER or the hospital because their needs are not met during a telemedicine visit, and they also do not end up requiring additional in-person follow-up visits to supplement their telemedicine visit,” the NEJM authors concluded.
“Not only did our most vulnerable patients not get left behind—they were among those engaging the most with, and benefiting the most from, telemedicine services. We did not see worse outcomes or increased costs, or patients needing an increased amount of in-person follow up. Nor did we find evidence of overuse. This is good care, and it is equitable care for vulnerable populations,” Fear said in the news release.
“For patients, the message is clear and reassuring: Telemedicine is an effective and efficient way of receiving many kinds of healthcare,” she added.
Opportunities for Clinical Laboratories
Dark Daily has covered the fast growing world of telemedicine in many ebriefs over the years.
As telemedicine broadens its reach across the healthcare world, clinical laboratories and pathology groups would be wise to seek collaboration with health plans and providers of telemedicine to figure out where sample collection and testing fits into this new virtual healthcare space.
Federal regulators continue to recognize value of clinical laboratory testing in near-patient settings
To help in the diagnosis and management of two sexually-transmitted diseases, another point-of-care diagnostic test will soon be available for use in physician’s offices, urgent care clinics, and other healthcare settings. The federal Food and Drug Administration (FDA) announced it granted a CLIA waiver for the binx health io CT/NG assay, a molecular platform used to detect sexually transmitted diseases—chlamydia and gonorrhea—at the point of care (POC).
This will be welcome news to many medical professionals, as it indicates federal regulators recognize the value of diagnostic testing in near-patient settings.
Allows Non-Laboratorian Processing at Point of Care
In 2019, binx health received FDA 510k clearance to market its binx io rapid point-of-care (POC) platform for women’s health. “The binx io platform is a rapid, qualitative, fully-automated test, designed to be easy to use, and intended for use in POC or clinical laboratory settings … In the company’s recently completed 1,523-person, multi-center clinical study, 96% of patient samples were processed on the binx io by non-laboratorians in a POC setting,” a binx press release noted.
According to the Boston-based biotech company’s website, the binx io platform (above) combines ultra-rapid, polymerase chain reaction (PCR) amplification with binx health’s proprietary and highly sensitive electrochemical detection technology. The io instrument processes a single-use, CT/NG cartridge that contains all reagents for testing self- or clinician-collected vaginal swabs and male urine samples. No sample preparation is required. Test results are available in less than 30 minutes. (Photo copyright: binx health.)
“With ever-increasing sexually transmitted infection rates, point-of-care and CLIA-waived platforms like the binx io are essential additions to our sexually-transmitted-infection-control toolbox, which will increase accessibility and decrease the burden on traditional healthcare settings,” Barbara Van Der Pol, PhD, Professor of Medicine and Public Health at University of Alabama at Birmingham, said in a binx press release.
According to binx, the Centers for Disease Control and Prevention (CDC) estimates that one in five people in the US has a sexually-transmitted disease (STD), with an estimated 108 million Americans potentially in need of routine STD testing. Additionally, chlamydia and gonorrhea are the two most treated STDs globally.
Study Finds Binx Health POC Assay Comparable to Traditional Clinical Laboratory NAATs
Van Der Pol led a team of researchers who compared the binx io chlamydia/gonorrhea POC assay to three commercially-available nucleic acid amplification tests (NAATs). The binx-funded study, published in JAMA Network Open, analyzed swab samples from 1,523 women (53.6% with symptoms) and urine samples from 922 men (33.4% symptomatic) who presented to 11 clinics in nine cities across the US.
The molecular point-of-care assay proved on par with laboratory-based molecular diagnostics for vaginal swab samples, while male urine samples were associated with “good performance.”
For chlamydia:
Sensitivity of the new POC assay was 96.1% (95% CI, 91.2%-98.3%) for women and 92.5% (95% CI, 86.4%-96.0%) for men.
Specificity of the new POC assay was 99.1% (95% CI, 98.4%-99.5%) for women and 99.3% (95% CI, 98.4%-99.7%) for men.
For gonorrhea:
Sensitivity estimates were 100.0% (95% CI, 92.1%-100.0%) for women and 97.3% (95% CI, 90.7%-99.3%) for men.
Specificity estimates were 99.9% (95% CI, 99.5%-100%) for women and 100% (95% CI, 95.5%-100%) for men.
Van Der Pol told Reuters News, “The bottom line is that chlamydia and gonorrhea are still the most frequently reported notifiable diseases in the US, and it costs us in the $5 billion to $6 billion range to manage the consequences of untreated infections. Unfortunately, about 70% of women who are infected don’t have any symptoms, so they don’t know they need to be tested.”
“The ability to diagnose at a point-of-care setting will help with more quickly and appropriately treating sexually-transmitted infections, which is a major milestone in helping patients,” said Tim Stenzel, MD, PhD (above), Director of the Office of In Vitro Diagnostics and Radiological Health at the FDA’s Center for Devices and Radiological Health, in the FDA announcement. “More convenient testing with quicker results can help patients get access to the most appropriate treatment. According to the CDC, one in five Americans are diagnosed with sexually-transmitted infections every year, which is why access to faster diagnostic results and faster, more appropriate treatments will make significant strides in combatting these infections,” he added. As point-of-care testing for specific diseases increases, clinical laboratories that process these tests may see a decrease in specimen processing orders. (Photo copyright: Duke University.)
The CLIA waiver allows binx to distribute the chlamydia/gonorrhea test to 220,000 CLIA-waived locations across the US through the company’s national commercial distribution partnership with McKesson. Obstetrician/gynecologist and primary care offices, urgent care facilities, community health clinics, STD clinics, and retail settings are all potential testing sites.
Binx says its testing platform can improve health outcomes by:
Increasing treatment compliance,
Limiting onward transmission,
Minimizing the risk of untreated conditions, and
Ensuring the right treatment is provided.
In the binx health press release, binx CEO Jeffrey Luber, JD, said, “The io instrument’s demonstrated clinical effectiveness, ease of operation, and patient convenience make it a much-needed tool with transformative implications for public health, especially now during the COVID-19 pandemic, where STI [sexually-transmitted infection] prevention services nationwide have been dramatically reduced or cut altogether as resources have been allocated to focus on the COVID response.”
Should Clinical Laboratories Be Concerned about POCT?
It happens often: after consulting with his or her doctor, a patient visits a clinical laboratory and leaves a specimen. The test results arrive at the doctor’s office in a few days, but the patient never returns for treatment. That is why point-of-care tests (POCTs) came to be developed in the first place. With the patient in the clinic, a positive test result means treatment can begin immediately.
As the US healthcare system continues toward more integration of care and reimbursement based on value, rather than fee-for-service, point-of-care testing enables physicians and other healthcare providers to diagnose, test, and prescribe treatment all in one visit.
Thus, it is a positive step for healthcare providers. However, clinical laboratories may view the FDA’s increasing endorsement of waived point-of-care testing as a trend that is unfavorable because it diverts specimens away from central laboratories.
There also are critics within the medical laboratory profession who point out that waived tests—often performed by individuals with little or no training in laboratory medicine—have much greater potential for an inaccurate or unreliable result, when compared to the same assay run in a complex, CLIA-certified clinical laboratory.
