The clinics are part of a growing trend among large retailers to open full-service healthcare clinics where consumers seek out other goods and services
Major retail chains continue to partner with local health systems and other healthcare companies to expand the range of primary care services delivered in their stores. The latest such collaboration is a partnership between Walmart (NYSE:WMT) and Oak Street Health (NYSE:OSH) at three locations in Texas.
Why is this trend important for clinical laboratories to follow? Because after 15 years, retail chains are moving past the simple walk-in clinic model of using a nurse practitioner to provide limited diagnoses that produce prescriptions at chain store pharmacies and other retail locations. They are now partnering with local health systems to provide full healthcare services that are delivered by physicians. These medical services include many common clinical laboratory tests.
The new OSH clinics, located in Walmart Supercenters, are open and accepting patients via walk-in, same day, and scheduled appointments. The clinics are located in the Dallas-Fort Worth area at:
Arlington Walmart, 4801 S Cooper St, Arlington, TX, 76017
Carrollton Walmart, 1213 E Trinity Mills Rd, Carrollton, TX, 75006
The clinics offer comprehensive, preventative, and urgent care services to consumers, including:
Primary care
Optometry
X-rays
Dental
Behavioral counseling
Hearing services
Nutrition and fitness
As well as clinical laboratory testing, including:
A1C
Lipid
Pregnancy
Strep
Mono
Flu
Drug screenings, and more.
“While all members of the community—from toddlers to seniors—are welcome at these clinics, Oak Street Health’s focus in its growing network of more than 60 primary care centers remains adults on Medicare,” states an OSH press release.
This partnership between Walmart and Oak Street Health means clinical labs in that area will need to follow their patients to be able to collect the specimens and perform the lab tests for patients seen in Walmart Health clinics.
Oak Street Health Brings Value-based Medicine to 11 States
“It is our mission at Oak Street Health to rebuild healthcare as it should be, and that aligns directly with Walmart’s history of providing accessible and equitable healthcare in communities across the country,” said Mike Pykosz, CEO of Oak Street Health, in the press release. “We look forward to becoming a positive addition to the neighborhood in these new markets and providing an unmatched healthcare experience in a convenient location.”
Both companies are planning to extend their relationship beyond these three locations and open additional clinics in other regions.
“We’ve proudly served customers at these three former Walmart Care Clinic locations for the last five years, and we are excited to bring this evolved approach to healthcare to our customers at these locations with Oak Street Health,” said Marcus Osborne, Senior Vice President, Walmart Health, in the press release. “As we grow Walmart Health locations in other markets, we think Oak Street Health’s innovative value-based healthcare model will help us continue to deliver on our live better promise at these locations.”
The majority of Oak Street Health consumers are Medicare Advantage patients, but OSH does accept most major and commonly-accepted insurance plans, Healthcare Dive reported.
There is evidence that savvy investors believe moving primary care into retail stores and other non-traditional locations can be a big winner. In its third quarter report, Oak Street Health released very strong numbers for their third quarter, which ended September 30. Their total reported revenue for the quarter was $217.9 million, which accounted for a 57% increase over last year’s third quarter earnings, Yahoo Finance reported.
OSH’s capitation revenue totaled $211.8 million, according to the report, which was a 59% increase year over year. Law Insider defines capitation revenues as “all payments from managed care organizations, where payment is made periodically on a per member basis for the partial or total medical care needs of a patient, co-payments, and all HMO incentive bonuses.”
In its third quarter statement, Oak Street Health also reported caring for approximately 59,500 at-risk patients, which represented 66% of its total patients.
“Our strong third quarter results were highlighted by 38% growth in at-risk patients, 57% revenue growth, and the resumption of new center openings, as we opened 13 centers during the quarter amidst continued uncertainty related to the COVID-19 pandemic,” said Pykosz in a statement, Yahoo Finance reported. “Looking ahead, we continue to be excited by the ample opportunity to drive continued de novo expansion across both new and existing markets, as well as the complementary growth opportunities presented by our Walmart collaboration and CMS’ Direct Contracting program.”
As we wrote in the May Dark Daily e-briefing, “Clinical laboratory leaders may want to explore partnerships with Walmart and other retailers that are developing healthcare centers to deliver primary care services in places where masses of people shop for everyday items. Especially given that these big-box retailers remain open during healthcare crises like the COVID-19 pandemic.”
This is even more critical now, as more retailers partner with health systems to provide expanded primary care and clinical laboratory services.
Clinical laboratory professionals should note that one case study describes a COVID-positive cancer patient shedding infectious particles for five months, which is much longer than expected
Just when researchers start believing they understand COVID-19 infections, something happens that reveals there is still more to learn. These additional findings are relevant for clinical laboratory managers and pathologists because the new insights often may play a role in how SARS-CoV-2 results should be interpreted for individual patients.
Researchers recently described a case where, in February, a 71-year-old woman underwent surgery related to her 10-year battle with cancer. While she was in the hospital, she was found to be positive for the SARS-CoV-2 coronavirus, though she showed no respiratory or systemic symptoms. Nevertheless, the hospital isolated her and monitored the infection.
To everyone’s surprise, the patient remained positive for five months. She underwent 15 COVID-19 tests from various diagnostics companies, as well as receiving two doses of convalescent plasma therapy, but she remained positive for the coronavirus into June.
In their published study, they wrote, “Although it is difficult to extrapolate from a single individual, our data suggest that long-term shedding of infectious virus may be a concern in certain immunocompromised people. Given that immunocompromised individuals could have prolonged shedding and may not have typical symptoms of COVID-19, symptom-based strategies for testing and discontinuing transmission-based precautions, as recommended by the Centers for Disease Control and Prevention (CDC), may fail to detect whether certain individuals are shedding infectious virus.”
Clinical laboratory professionals and pathologists will find it significant that patients with major health conditions may be shedding viral material for weeks longer than originally thought. This is relevant because it may be prudent to COVID test patients who present with compromised immune systems, and who are asymptomatic, and then repeat that testing at appropriate intervals.
Immunocompromised Patients May Handle COVID-19 Differently
The NIAID researchers believe the reason the patient continued to shed infectious virus for so long was because she was immunocompromised. They wrote, “Many current infection control guidelines assume that persistently PCR-positive individuals are shedding residual RNA and not infectious virus, with immunocompromised people thought to remain infectious for no longer than 20 days after symptom onset. Here we show that certain individuals may shed infectious, replication-competent virus for much longer than previously recognized. Although infectious virus could be detected up to day 70, sgRNA, a molecular marker for active SARS-CoV-2 replication, could be detected up until day 105.”
In the United States, some three million people have compromised or weakened immune systems. This is a significant population, Science Alert reported.
“As the virus continues to spread, more people with a range of immunosuppressing disorders will become infected, and it’s more important to understand how SARS-CoV-2 behaves in those populations,” Vincent Munster, PhD, Chief, Virus Ecology Unit at the National Institute of Allergy and Infectious Diseases and co-author of the NIAID study, told Science Alert.
The NIAID study findings match knowledge about other coronaviruses. For example, Science Alert reported that immunocompromised people with Middle East Respiratory Syndrome (MERS) have been shown to shed common seasonal coronaviruses for up to a month following infection.
That study included 303 patients, of which 193 were symptomatic. During the course of the study, 21 of the asymptomatic patients developed symptoms, however, the viral load was similar in all of the patients, regardless of symptoms.
“Isolation of asymptomatic patients may be necessary to control the spread of SARS-CoV-2,” concluded the JAMA researchers. But how long should asymptomatic patients remain isolated?
Official Guidance Is Based on Symptoms
The CDC updated its guidelines for who should isolate and for how long in October. The guidelines cover:
People who have or had COVID-19 and had symptoms;
People who tested positive for COVID-19 but did not have symptoms;
People who either had severe symptoms of COVID-19 or who have a compromised immune system;
People who were exposed to COVID-19, and
People who have been reinfected.
Regarding those who are immunocompromised and had COVID-19, the CDC says they “may require testing to determine when they can be around others.”
In addition to noting that people who are immunocompromised may require additional testing, the CDC is also continuously updating its published list of people who are at risk for complications and severe illness if they contract COVID-19. However, as the NIAID study showed, even those with underlying medical conditions can be asymptomatic.
And as the NIAID researchers note, there is more to learn. “Understanding the mechanism of virus persistence and eventual clearance will be essential for providing appropriate treatment and preventing transmission of SARS-CoV-2 because persistent infection and prolonged shedding of infectious SARS-CoV-2 might occur more frequently. Because immunocompromised individuals are often cohorted in hospital settings, a more nuanced approach to testing these individuals is warranted, and the presence of persistently positive people by performing SARS-CoV-2 gRNA and sgRNA analyses on clinical samples should be investigated.”
SARS-CoV-2 Science Is Young
An additional takeaway for pathology lab professionals is the reminder that the scientific research surrounding the novel coronavirus that causes COVID-19 is very young. New insights and understanding will continue to emerge, probably for many years.
One reason why the development of vaccines for COVID-19 has been so quick is that it built on scientific knowledge of the first SARS outbreak and MERS. It’s interesting to note that both SARS and MERS are relatively new as well: SARS emerged in 2002 and MERS in 2012. Compared to a disease like HIV, which was first identified in 1959, scientists have only been working on these particular coronaviruses for a short period of time.
The NIAID study is yet another example of new knowledge and insights emerging about how SARS-CoV-2 infects individuals. Collectively, these findings make it challenging for medical laboratory professionals to stay current with everything relevant and associated with the proper interpretation of COVID-19 test results.
What is not clear is how Aetna might engage independent clinical laboratories as in-network providers for this health insurance plan
For years, Dark Daily and its sister publication The Dark Report have regularly predicted that the traditional fee-for-service reimbursement model of indemnity health insurance that requires beneficiaries to pay a co-pay is on the way out. What is not known is how the nation’s biggest health insurers plan to reinvent themselves, as value-based reimbursement for providers becomes more common.
That may be clearer now, at least for one insurance giant. Aetna recently announced it was incorporating CVS Health services provided at CVS-owned pharmacies and retail clinics into a healthcare plan for individuals in the greater Kansas City, Mo., area.
The Aetna Connected Plan “combines CVS Health services—including free one to two-day prescription delivery and 20% discounts on thousands of health-related items—with Aetna’s cost-saving I-35 Performance Network to deliver a more convenient and connected member experience, along with up to 20% premium savings compared to comparable PPO products in the market,” states a CVS Health press release.
Members can schedule appointments at CVS Health MinuteClinics, request consultations at CVS HealthHUBs for no copay, and access other services, including telehealth visits, through CVS pharmacies. Essentially, Aetna made network providers for this range of CVS-owned health services.
CVS Health services, according to the press release, include:
$0 copay at local HealthHUB and MinuteClinic locations,
Free one to two-day prescription delivery,
20% discounts on thousands of health-related items in-store and online,
The Aetna health plan will be made available next year to employers with 101 or more workers in three counties in Missouri (Clay, Jackson, and Platte) and two counties in Kansas (Johnson and Wyandotte). Aetna claims the premiums for their new plan are 20% less expensive than other similar plans for the region, MedCity News reported.
AMA Expressed Concerns over CVS Purchase of Aetna
CVS acquired Aetna for $70 billion in late 2018 and the two companies have been working to integrate their businesses ever since.
There are currently more than 1,000 CVS MinuteClinics located throughout 33 states and the District of Columbia. CVS began opening HealthHUB clinics in the Houston area last year and plans to open more than 1,500 HealthHUBs by the end of 2021, the Houston Chronicle reported.
Critics of the 2018 purchase of Aetna by CVS were concerned that CVS would somehow use Aetna’s 40 million members to drive revenue for its stores. Many groups, including the American Medical Association (AMA), Consumers Union, and pharmacy organizations were opposed to the merger due to anticompetitive concerns.
The AMA felt the merger would reduce competition in some pharmaceutical markets, which could lead to higher premiums and lower the quality of some insurance products. The organization also believed that the merger “faced enormous implementation challenges and was unlikely to realize efficiencies that benefit patients,” the AMA noted in a statement.
“We are very concerned about the consolidation in healthcare because we know that as healthcare systems consolidate, prices tend to go up,” AMA President Barbara McAneny, MD said in the statement. “And we are very concerned that with the CVS purchase of Aetna that drug prices will continue to rise and that is a major pain point of patients all across the country.”
The AMA also stressed concerns regarding how the lack of competition could have negative impacts on the pharmaceutical industry.
“It’s also causing harm to a lot of the parts of the industry,” McAneny added. “Independent pharmacies are going out of business and this consolidation makes them (CVS) just such a stronger player in that market that competition is really difficult.”
Despite the opposition, the CVS and Aetna merger received final approved from regulators last year. Before the merger was approved, the two companies had to convince state attorneys general, antitrust regulators, and Congress that the consolidation would not result in anticompetitive practices and impair independent drugstores and other national chains.
Will Aetna Engage Independent Clinical Laboratories?
Aetna’s new health plan is another example of how the nation’s biggest health insurers are adapting away from fee-for-service and to value-based reimbursement for healthcare providers. Clinical laboratory managers will want to watch how CVS and Aetna do or do not work with independent laboratory companies to collect lab specimens at the pharmacies and provide testing.
Healthcare policymakers continue to support the move from expensive hospitals to outpatient, ambulatory, and home health settings in ways that will change where and how medical laboratories collect lab specimens
Clinical laboratories have adapted to many changes in the past decade and the increased demand for home healthcare is one of them. Thus, predictions from the US federal Government Accountability Office (GAO) that the number of home care jobs in the US will grow by 40% in the next 10 years will be of interest to medical laboratory managers.
Though “home care” and “home healthcare” differ in their cost and coverages, the GAO clearly expects the trend for treating people outside of expensive hospitals to continue and likely accelerate, requiring the nation’s medical laboratories to find new ways to provide services to the physicians they support, while also creating new systems for collecting laboratory specimens from patients being treated in their homes.
The federal agency attributes the growth in home care to demand from older adults and people with disabilities, the GAO said in its recently released report, titled, “Fair Labor Standards Act Observations on the Effects of the Home Care Rule.” Other experts concur. This is also significant for clinical laboratories because Medicare patients typically use more clinical lab testing services than younger people enrolled in commercial health plans.
“We believe [the GAO’s report] serves as a positive for home health and a negative for hospitals and other brick-and mortar care,” Laffer Healthcare Intelligence (Laffer) wrote in an e-mail to Dark Daily. “While COVID-19 has disrupted demand in some ways, growth in this industry (home care) is expected to grow substantially over time.”
How Home Care Differs from Home Healthcare
Home care differs from home healthcare in significant ways. In its report, the GAO defined home care as “non-medical” help by personal care and home health aides with “activities of daily living such as dressing, grooming, eating, or bathing.”
By contrast, according to Medicare, “In general, the goal of home healthcare is to provide treatment for an illness or injury … Home health care may also help you maintain your current condition or level of function, or to slow decline.”
While Medicare covers much of home healthcare, consumers usually pay out-of-pocket for home care, although some Medicaid programs may cover home care services for those eligible to receive them “as an alternative to institutional care,” the GAO report noted.
The annual median cost of home care is $53,000, while the average cost of a semi-private room in a nursing home facility is $90,000/year, according to a Genworth cost-of-care study on long-term care the GAO-cited in its report.
More than three million people work in home care, “one of the nation’s fastest growing industries,” the GAO report noted, citing 2018 data.
Growth in Home Care Mirrors Growth in Home Healthcare
“If home care is booming, so, too, will home healthcare—a setting that has much lower costs for services than acute care hospitals,” said Robert Michel, Editor-in-Chief of Dark Daily and its sister publication The Dark Report. “And one issue for clinical labs is that they will need a way to cost effectively collect specimens from patients who are being provided healthcare and personal care services in their homes.”
The GAO report predicts a huge increase in home care employment by 2030. With more patients opting to be treated at home for high-acuity and chronic healthcare conditions, such massive growth may be coming for home healthcare as well. For clinical laboratory managers, this is a call to step up outreach to the homebound by working with home care and home healthcare providers.
Researchers conducted antibody testing on ‘remainder plasma,’ which could inform strategies for ongoing SARS-CoV-2 clinical laboratory surveillance testing
In a clever use of stored clinical laboratory specimens, researchers in California conducted a nationwide seroprevalence survey—serology testing to determine the number of people in a population that carry a specific disease—that used “remainder plasma” from dialysis patients to look for antibodies to the COVID-19 infection. They found that—as of July—fewer than one in 10 adults tested had acquired antibodies to the SARS-CoV-2 coronavirus.
According to Julie Parsonnet, MD, Stanford Professor of Medicine and of Epidemiology and Population Health, and a study author, this indicates that the US population is a long way from herd immunity to COVID-19. “This is the largest study to date to confirm that we are nowhere near herd immunity,” she said in a Stanford Medicine press release.
Herd immunity is the point at which a large part of the population becomes immune to a specific disease. Scientists, according to the Stanford press release, estimate that 60%-70% of the population must have antibodies to the coronavirus before COVID-19 fades.
Dense Urban Populations at Greater Risk for COVID-19
The Stanford researchers analyzed samples of remainder plasma from 28,503 randomly selected patients receiving dialysis in July at more than 1,300 dialysis facilities in 46 states. They found that 8% of people were positive for COVID-19 antibodies, which when standardized to the US adult population, equals 9.3% nationwide, the study notes.
However, they also found that people living in densely populated areas were 10 times more likely to show evidence of past COVID-19 infection, and that people living in predominantly black and Hispanic neighborhoods were two to three times more likely to be seropositive than those in white neighborhoods, the researchers wrote.
Of the use of remainder plasma for their study, the researchers wrote, “Testing remainder plasma from monthly samples obtained for routine care of patients on dialysis for SARS-CoV-2 antibodies therefore represents a practical approach to a population-representative surveillance strategy, informing risks faced by a susceptible population while ensuring representation from racial and ethnic minorities.
“In addition, seroprevalence surveys in patients receiving dialysis can be linked to patient-level and community-level data to enable evaluation and quantification of differences in SARS-CoV-2 prevalence by demographic and neighborhood strata, and thus facilitate effective mitigation strategies targeting the highest-risk individuals and communities,” added the researchers.
When standardized to the US dialysis population, seroprevalence ranged from 3.5% (95% CI, 3.1-3.9) in the West to 27.2% (95% CI, 25.9-28.5) in the Northeast.
Large variations in seroprevalence by state were seen, with early COVID-19 hot spots such as New York (33.6%), Louisiana (17.6%), and Illinois (17.5%) having higher rates than neighboring states—Pennsylvania (6.4%), Arkansas (1.9%), and Missouri (1.9%).
When compared with other measures of SARS-CoV-2 spread, seroprevalence correlated best with deaths per 100,000 population.
Nearly 10% of COVID-Positives Are Undiagnosed
In another important finding that compared seroprevalence and case counts per 100,000 population as of June 15, the study reports that only 9.2% of the COVID-19 seropositives had been diagnosed with the disease.
Because dialysis patients get monthly laboratory blood tests that generate leftover blood plasma samples, researchers believe this remainder plasma can serve an important role in tracking COVID-19’s prevalence in the general population.
“Not only is this patient population representative of the US population, but they are one of the few groups of people who can be repeatedly tested,” said Anand in the Stanford press release. “This is a potential strategy for ongoing SARS-CoV-2 antibody testing and surveillance.”
“Questions remain around the longevity of the immune response and correlates of protection, but high-quality longitudinal serosurveillance with accompanying clinical data can help to provide the answers,” they wrote. “Anand and colleagues deserve credit for pioneering a scalable sampling strategy that offers a blueprint for standardized national serosurveillance in the USA and other countries with a large haemodialysing population.”
Pandemic Fatigue and the Vaccine
While the promised vaccine provides hope for an end to the pandemic, experts say the battle is far from won.
“We are still in the middle of the fight,” epidemiologist Eli Rosenberg, PhD, Associate Professor at the University at Albany in New York, who was not part of the Stanford study, told the Washington Post, “We’re all tired, and we’re all hoping for a vaccine. This shows us how it’s not over here, not even by a long shot.”
What is obvious is that clinical laboratories will continue to play a vital role in response to the COVID-19 pandemic. In fact, just as the management and scientific team at Ascend Clinical Laboratories recognized that remainder plasma from testing dialysis patients could be the foundation of a national seroprevalence survey for COVID-19, other clinical laboratories in different regions of the United States may have similar resources that can be adapted as tools to study and understand the SARS-CoV-2 pandemic.
Noninvasive diagnostic technology developed for space travelers and warfighters might eventually be used by clinical laboratories and physician office labs
To solve the problem of how to perform clinical laboratory tests on astronauts living for months at a time in the International Space Station (ISS), researchers associated with the National Aeronautics and Space Administration (NASA) are developing diagnostic tests that use human breath as the specimen. Last month, the research team unveiled the aptly named “E-Nose,” a prototype device designed to perform diagnostic tests using breath specimens
Clinical laboratory professionals and pathologists know that breath contains biological specimens which are useful biomarkers for detecting specific diseases, and that diagnostic tests based on breath have been around for a long time.
For example, the link between Helicobacter pylori (H pylori), a spiral bacterium, and stomach ulcers was discovered in the mid-1990s. Today, a diagnostic test that identifies the presence of ammonia and other volatile chemicals produced by H pylori is based on analysis of breath specimens.
Another biomarker is nitrogen oxide (NO), which when found in higher-than-normal concentrations in breath, could be an indicator of asthma. Other volatile biomarkers in breath may indicate infection, metabolic conditions, and inflammatory diseases.
Diagnosing a ‘Battery of Illnesses and Abnormalities’
In October, NASA demonstrated its new hand-held device—fully dubbed the E-Nose Breath Analyzer. Though still under development, the E-Nose device “will have the capability of analyzing compounds found within a person’s breath to diagnose a battery of illnesses and abnormalities including respiratory illnesses, infectious diseases, and cardiovascular conditions,” according to an Air Force news release.
If it develops into a standard diagnostic tool for doctors, could E-Nose have an impact on the revenue of clinical laboratories that perform traditional diagnostic testing?
“The [E-Nose] technology is designed to make rapid measurements—in less than five minutes, at the point of care—in a way that is completely non-invasive. When fully realized, the NASA E-Nose will open a new realm of medical care to both the warfighter and potential space travelers,” Loftus said.
Can NASA Advance E-Nose for Clinical Use?
According to NASA research presented at the DGMC, the E-Nose “utilizes an array of chemical sensors combined with humidity, temperature and pressure” for its real-time breath analysis. E-nose can detect 16 different chemicals in seconds at room temperature, including:
Methane
Hydrazine
Nitrogen dioxide
Hydrazoic acid
Sulfur trioxide
Hydrogen chloride
Formaldehyde
Acetone
Benzene
Chlorine gas
Hydrogen cyanide
Malathion
Diazinon
Toluene
Nitro toluene
Hydrogen peroxide
According to NASA’s presentation materials, the E-Nose underwent extensive research and development:
Work started at the NASA Ames Research Center in 2002.
The device includes the most well-developed Nano Chemical Sensor System in the world to date, which was tested aboard a Navy Satellite in 2007 for 12 months; deployed on the International Space Station (cabin air quality monitor); and field-tested by the Department of Homeland Security for various threats.
It was featured in 35 peer-reviewed journals, and
Involves nine United States patents.
“As with past technology that has been developed by the Air Force at DGMC, NASA medical research can improve civilian care throughout the country,” Bradley Williams, MD, 60th Medical Group Clinical Research Administrator, said in the Air Force statement. “The Air Force and NASA share the same altruistic medical research mission. Together, we seek to develop the future medical care which will be needed by the US Space Force, and which will also be very useful to the rest of the nation’s hospitals.”
Medical laboratory and pathology group managers would be wise to keep a close eye on the development of the E-Nose Breath Analyzer and similar technologies that have the potential to cut into diagnostic testing revenue streams. Especially if these devices can detect everything from infections to cancer.