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.
Many companies want to adapt consumer wearables to monitor health conditions, including biomarkers tested by medical laboratories
Clinical laboratory managers know that wearable devices for monitoring biophysical functions or measuring biomarkers are becoming more complex and capable thanks to advances in miniaturization, informatics, software, and artificial intelligence machine learning that enable new functions to be developed and proved to be accurate.
In September, Fitbit (NYSE:FIT), took that a step further. The San Francisco-based maker of personal fitness technology, “received 510(k) clearance from the US Food and Drug Administration (FDA), as well as Conformité Européenne (CE marking) in the European Union, for its electrocardiogram (ECG) app to assess heart rhythm for atrial fibrillation (AFib),” according to a press release.
The fact that Google is currently in the process of acquiring Fitbit for $2.1 billion may indicate that wearable devices to help physicians and patients diagnose and monitor health conditions will be big business in the future.
Helping Doctors ‘Stay Better Connected’ to Their Patients
“Helping people understand and manage their heart health has always been a priority for Fitbit, and our new ECG app is designed for those users who want to assess themselves in the moment and review the reading later with their doctor,” said Eric Friedman, Fitbit co-founder and Chief Technology Officer, in the press release.
Prior to submitting the device for approval to regulatory agencies, Fitbit conducted the clinical trial in regions throughout the US to evaluate the device’s ability to accurately detect AFib from normal sinus rhythm and generate ECG traces. The researchers proved that their algorithm was able to detect 98.7% of AFib cases (sensitivity) and was able to accurately identify normal sinus rhythms (specificity) in 100% of the cases.
Venkatesh Raman, MD, interventional cardiologist and Medical Director of the Cardiac Catheterization Lab at 609-bed MedStar Georgetown University Hospital, was Principal Investigator for the clinical study on Fitbit’s ECG app. “Physicians are often flying blind as to the day-to-day lives of our patients in between office visits. I’ve long believed in the potential for wearable devices to help us stay better connected, and use real-world, individual data to deliver more informed, personalized care,” he said in the press release.
“Given the toll that AFib continues to take on individuals and families around the world,” Raman continued, “I’m very enthusiastic about the potential of this tool to help people detect possible AFib—a clinically important rhythm abnormality—even after they leave the physician’s office.”
Fitbit ECG App Receives European CE Marking
In addition to receiving approval for the Fitbit ECG app in the US, the device also received CE marking (Conformité Européenne) for use in some European countries.
In October 2020, the app was made available to Fitbit Sense users in the US, Austria, Belgium, Czech Republic, France, Germany, Ireland, Italy, Luxembourg, the Netherlands, Poland, Portugal, Romania, Spain, Sweden, Switzerland, and the United Kingdom. The device also received approval for use in Hong Kong and India.
It is estimated that more than 33.5 million people globally have AFib, an irregular heart rhythm (arrhythmia) that can lead to stroke, blood clots, or heart failure. The American Heart Association estimates that at least 2.7 million Americans currently live with the condition. The most common symptoms experienced by those with the condition are:
Irregular heartbeat,
Heart palpitations (rapid, fluttering, quivering or pounding),
Lightheadedness,
Extreme fatigue,
Shortness of breath, and
Chest pain.
Risk factors for AFib include advancing age, high blood pressure, obesity, diabetes, European ancestry, hyperthyroidism, chronic kidney disease, alcohol use, smoking, and known heart issues such as heart failure, ischemic heart disease, and enlargement of the chambers on the left side of the heart.
According to the Centers for Disease Control and Prevention (CDC), there are more than 454,000 hospitalizations annually in the US that list AFib as the primary diagnosis. In 2018, AFib was mentioned on 175,326 death certificates with the condition being the underlying cause of death in 25,845 of those cases.
The CDC reports that cases are increasing and projects that by 2030 12.1 million people in the US will have AFib. Many people are asymptomatic of the illness and do not know they have it, which can make AFib more difficult to diagnose.
“Early detection of AFib is critical, and I’m incredibly excited that we are making these innovations accessible to people around the world to help them improve their heart health, prevent more serious conditions, and potentially save lives,” Friedman said, in a statement.
Clinical laboratory managers should monitor these developments closely. Fitbit’s FDA clearance and CE Marking of its ECG app suggest this trend is accelerating.
Taft Foley, III, says he got the idea for the mobile lab after waiting on a COVID-19 testing line that went ‘around the entire building’
In a remarkable example of ingenuity and observation, Texas high school student Taft Foley, III, is bringing COVID-19 testing to underserved patients, wherever they may be. He launched a medical lab company, then developed a mobile clinical laboratory which performs rapid antigen tests that can detect the presence of antigen in about 15 minutes.
Foley—who recently became an EMT after graduating from the Texas EMS Academy—designed his mobile medical lab to use Quidel Sofia SARS Antigen FIA tests (nasal swabs). Results are sent to patients by text or e-mail. Foley also works with CLIA-certified Baylor Genetics Laboratories on COVID-19 (SARS-CoV-2) RT-PCR molecular testing, which gives his customers results in 24 to 48 hours, Forbes reported.
Foley, who is 18-years-old and an Eagle Scout, said he got the idea to launch the mobile COVID-19 testing business after he went for a coronavirus test and had to wait on a line that “wrapped around the entire building,” ABC13 reported. “I said to myself, ‘There needs to be a better way,’” Foley told ABC13.
Forbes reported that Texas Mobile Medical Labs allocates a portion of test fees paid ($100 to $150/test) to help provide tests to the homeless and others who need them, such as veterans and senior citizens.
“The (majority of) tests have been done at businesses who appreciate our mobile capabilities. We arrive and test all employees onsite and have their results back in 15 minutes,” Foley told Forbes.
Other States with Mobile COVID-19 Testing
Texas is not the only state where savvy entrepreneurs like Foley and health agencies are offering mobile COVID-19 testing.
In May, Florida Gov. Ron DeSantis announced Statlab Mobile, a COVID-19 mobile laboratory out of Miami that tests people in skilled nursing and long-term care facilities and other areas of the Sunshine State.
“We believe this will be a game-changer (in long-term care),” DeSantis told the Miami Herald.
“The idea was to bring help to those who are vulnerable, those who can’t otherwise get the kind of medical information they would otherwise love to have,” Bryan Wilson, Statlab Chief Executive Officer, told Patch, which noted the tests are free.
Mobile COVID Testing in Other States
Mobile medical laboratories are being deployed to help handle surges of COVID-19 cases in Massachusetts, New Jersey, and Arizona, as well.
In Massachusetts, testing vans operated by American Family Care (AFC), an urgent care provider, started heading out in November to schools and businesses state-wide with a goal to test at least 100 to 150 people daily for COVID-19, according to The Reminder.
The vans are staffed by medical providers who test people with Abbott’s BinaxNOW COVID-19 Ag Card, AFC told The Reminder. The rapid antigen test offers results in 15 minutes.
In September, Dark Daily reported that the US federal Department of Health and Human Services (HHS) awarded a $760 million contract to Abbott for 150 million rapid antigen tests to aid in detection of COVID-19 as workplaces and schools reopen.
“We’ve had several companies who would like to schedule their employees to be tested on a regular basis. But they also want to be able to make sure that if there is a potential contamination within their businesses, they have a resource to utilize to make sure they can test people right away,” Jim Brennan, Owner/CEO of Medvest, LLC, AFC urgent care’s parent company, told The Reminder.
And in Phoenix, a COVID-19 mobile medical van provides testing to underserved communities. The City of Phoenix, along with staff from the Vincere Cancer Center, use Quidel’s Sofia SARS Antigen FIA test at public and private locations and at family services centers, AZ Central reported.
Clearly, mobile COVID-19 testing labs are here to stay. They serve seniors and vulnerable populations challenged to access clinical laboratory testing at traditional locations and at COVID-19 drive-through sites. And on larger scales, mobile medical laboratories have become key resources to address coronavirus case surges and to conveniently test people at businesses and schools to help identify symptomatic individuals who should be quarantined.
Clinical laboratory managers may be impressed by how quickly mobile testing companies and entrepreneurs form partnerships with public health agencies toward making COVID-19 tests available to all at places where people live and work.