Clinical laboratories could play a key role in helping users collect their samples correctly, interpret results, and transfer flu test data to their health records
Clinical laboratories may have another opportunity to provide service to their clients and the physicians who treat them. With the success of at-home COVID-19 testing, consumer demand for self-tests is changing and advances in diagnostic technology now make it feasible to make more influenza (flu) tests available for consumers to buy and use at home.
At-home tests for SARS-CoV-2 can be found at pharmacies all across America. But that’s not the case with tests for influenza.
Should self-test flu kits eventually become available and common, clinical laboratories could offer the service of helping consumers understand:
that the test was conducted correctly (specimen collection and analysis),
“Home flu testing would ensure that those who do need and receive antiviral medication for influenza are the ones who need it the most,” and that “we are making our treatment decisions based on data,” infectious disease specialist Christina Yen, MD (above), University of Texas Southwestern Medical Center, told STAT News. At-home flu self-tests could also bring opportunities for clinical laboratories to provide service to healthcare consumers and the physicians who treat them. (Photo copyright: UT Southwestern Medical Center.)
Pros and Cons of Consumers Doing At-home Influenza Testing
According to the federal Centers for Disease Control and Prevention (CDC), COVID-19 and influenza are both upper respiratory illnesses with similar symptoms. So, why don’t we have more at-home flu tests available? Partly because at-home testing is a relatively new phenomenon in modern healthcare.
“It’s really rare, and it’s really new that people are allowed to know about what’s happening inside their body without a physician in the middle,” Harvard epidemiologist Michael Mina, MD, PhD, told STAT News. The article uses the example of at-home pregnancy tests. Despite a prototype for an at-home pregnancy test being created in 1967, it took another decade before an over-the-counter pregnancy test became available to the public.
“The general thinking was, ‘How could a woman possibly know what to do if she found out she was pregnant on her own without a doctor in the room?’ That is a ridiculous concern because women have been doing that for millions of years,” Mina added.
So, why be cautious when it comes to giving patients the option of at-home flu testing?
There are some cons to at-home influenza tests. Average citizens are not clinical laboratory professionals. They might obtain too little sample for an accurate reading or read the results incorrectly. Then, there is the possibility for false-negatives or false-positives.
An at-home test user is not likely to consider the possibility of a false result, however clinicians look at the situation with more nuance. If the patient was still symptomatic or in a high-risk community, the provider could administer a more sensitive medical laboratory test to confirm the previous test results.
“In a Facebook post from mid-November with hundreds of responses, concertgoers compared symptoms and positive test results, many of those from tests taken at home. But those data weren’t added to state public health tallies of COVID’s spread,” STAT News noted.
The larger concern is that samples obtained by at-home self-test users are not submitted for genomic sequencing. This could lead to incomplete data and delay identifying new variants of the coronavirus in communities.
Another barrier to at-home flu testing is that rapid influenza diagnostic testing can be unreliable. In 2009, the rapid influenza tests could only detect the H1N1 influenza virus in a mere 11% of samples, STAT News reported. Because of this, the FDA now requires manufacturers to test their rapid tests against eight different strains that change every year depending upon which strains are prevalent. This could present a problem if individuals use leftover tests from the previous flu season.
Do Pros of At-home Testing Outweigh the Cons?
At-home testing is convenient and makes testing more accessible to patients who may not be able to get to a clinic. Being able to test at home also encourages individuals to take precautions necessary to stop the spread of whichever illness they may have. Given the similarities in symptoms between influenza and COVID-19, people could benefit from having tools at home that correctly identify their illness.
At-home COVID-19 tests are here to stay, and at-home influenza tests may be on the way soon. Clinical laboratories could play an important role in educating the public on the correct handling of these tests.
Healthcare attorneys advise medical laboratory leaders to ensure staff understand difference between EKRA and other federal fraud laws, such as the Anti-kickback Statute
More than four years have passed since Congress passed the law and yet the Eliminating Kickbacks in Recovery Act of 2018 (EKRA) continues to cause anxiety and confusion. In particular are the differences in the safe harbors between the federal Anti-Kickback Statute (AKS) and Stark Law versus EKRA. This creates uncertainty among clinical laboratory leaders as they try to understand how these disparate federal laws affect business referrals for medical testing.
According to a news alert from Tampa Bay, Florida-based law firm, Holland and Knight, “EKRA was enacted as part of comprehensive legislation designed to address the opioid crisis and fraudulent practices occurring in the sober home industry.” However, “In the four years since EKRA’s enactment, US Department of Justice (DOJ) enforcement actions have broadened EKRA’s scope beyond reducing fraud in the addiction treatment industry to include all clinical laboratory activities, including COVID-19 testing.”
It is important that medical laboratory leaders understand this law. New cases are showing up and it would be wise for clinical laboratory managers to review their EKRA/AKS/Stark Law compliance with their legal counsels.
“Keeping in mind that [EKRA is] a criminal statute, clinical laboratories need to take steps to demonstrate that they’re not intending to break the law,” said attorney David Gee, a partner at Davis Wright Tremaine, in an exclusive interview with The Dark Report. “[Lab leaders should] think about what they can do to make their sales compensation program avoid the things the government has had such a problem with, even if they’re not sure exactly how to compensate under the language of EKRA or how they’re supposed to develop a useful incentive compensation plan when they can’t pay commissions.” David Gee will be speaking about laboratory regulations and compliance at the upcoming Executive War College in New Orleans on April 25-26, 2023. (Photo copyright: Davis Wright Tremaine.)
How Does EKRA Affect Clinical Laboratories?
The federal EKRA statute—originally enacted to address healthcare fraud in addiction treatment facilities—was “expansively drafted to also apply to clinical laboratories,” according to New York-based law firm, Epstein Becker and Green. As such, EKRA “applies to improper referrals for any ‘service,’ regardless of the payor. … public as well as private insurance plans, and even self-pay patients, fall within the reach of the statute.”
In “Revised Stark Law, Anti-Kickback Statute Rules Are Good News for Labs,” Dark Daily’s sister publication The Dark Report noted that EKRA creates criminal penalties for any individual who solicits or receives any remuneration for referring a patient to a recovery home, clinical treatment facility, or clinical laboratory, or who pays or offers any remuneration to induce a referral.
According to Epstein Becker and Green, EKRA:
Applies to clinical laboratories, not just toxicology labs.
Has relevance to all payers: Medicare, Medicaid, private insurance plans, and self-pay.
Is a criminal statute with “extreme penalties” such as 10 years in prison and $200,000 fine per occurrence.
Exceptions are not concurrent with AKS.
Areas being scrutinized include COVID-19 testing, toxicology, allergy, cardiac, and genetic tests.
“For many clinical laboratories, a single enforcement action could have a disastrous effect on their business. And unlike other healthcare fraud and abuse statutes, such as the AKA, exceptions are very limited,” Epstein Becker and Green legal experts noted.
“Therefore, a lab could potentially find itself protected under an AKS safe harbor and still potentially be in violation of EKRA,” they continued. “The US Department of Health and Human Services (HHS) and the DOJ have not provided any clarity regarding this statute (EKRA). Without this much needed guidance clinical laboratories have been left wondering what they need to do to avoid liability.”
EKRA versus AKS and Stark Law
HHS compared AKS and the Stark Law (but not EKRA) by noting on its website prohibition, penalties, exceptions, and applicable federal healthcare programs for each federal law:
AKS has criminal fines of up to $25,000 per violation and up to a five-year prison term, as well as civil penalties.
The Stark Law has civil penalties only.
AKS prohibits anyone from “offering, paying, soliciting, or receiving anything of value to induce or reward referrals or generate federal healthcare program business.”
The Stark Law addresses referrals from physicians and prohibits the doctors “from referring Medicare patients for designated health services to an entity with which the physician has a financial relationship.”
EKRA is more restrictive than AKS, as it prohibits some compensation that AKS allows, healthcare attorney Emily Johnson of McDonald Hopkins in Chicago told The Dark Report.
Recent enforcement actions may help lab leaders better understand EKRA’s reach. According to Holland and Knight:
Malena Lepetich of Belle Isle, Louisiana, owner and CEO of MedLogic LLC in Baton Rouge, was indicted in a $15 million healthcare fraud scheme for “allegedly offering to pay kickbacks for COVID-19 specimens and respiratory pathogen testing.”
In S-G Labs Hawaii, LLC v. Graves, a federal court concluded the laboratory recruiter’s contract “did not violate EKRA because the recruiter was not referring individual patients but rather marketing to doctors. According to the court, EKRA only prohibits percentage-based compensation to marketers based on direct patient referrals.”
In another federal case, United States v. Mark Schena, the court’s rule on prohibition of direct and indirect referrals of patients to clinical labs sent a strong signal “that EKRA most likely prohibits clinical laboratories from paying their marketers percentage-based compensation, regardless of whether the marketer targets doctors or prospective patients.”
What can medical laboratory leaders do to ensure compliance with the EKRA law?
In EKRA Compliance, Law and Regulations for 2023, Dallas law firm Oberheiden P.C., advised clinical laboratories (as well as recovery homes and clinical treatment facilities) to have EKRA policies and procedure in place, and to reach out to staff (employed and contracted) to build awareness of statute prohibitions and risks of non-compliance.
One other useful resource for clinical laboratory executives and pathologists with management oversight of their labs’ marketing and sales programs is the upcoming Executive War College on Diagnostics, Clinical Laboratory, and Pathology Management. The conference takes place on April 25-26, 2023, at the Hyatt Regency in New Orleans. A panel of attorneys with deep experience in lab law and compliance will discuss issues associated with EKRA, the Anti-Kickback Statutes, and the Stark self-referral law.
Program launched by a Rochester-area technical center is intended to provide early study for students interested in a career in clinical laboratory medicine
Acute shortages of clinical laboratory staff across all types of skills is one of the big stories of this new year. It is also triggering unconventional approaches to reach students in high school and interest them in careers as medical technologists (MTs). One such example is a high school in New York that now offers a top-level medical laboratory program designed to create interest—then train—high school students for a career in laboratory medicine.
“With the acute shortage of medical technologists, this effort by one high school to reach students early and encourage them to pursue a career in clinical laboratory medicine should be of interest to all laboratory professionals,” said Robert Michel, Editor-in-Chief of Dark Daily and its sister publication The Dark Report.
“Our juniors and seniors in high school will learn about 60 employable laboratory skills,” said Jim Payne (above), a Medical Laboratory Assisting and Phlebotomy program instructor at WEMOCO. “They learn not only medical laboratory skills, but [the skills] are transferable to biotechnology, to chemical labs, food labs, environmental labs, research, forensics, and so on. The goal is each individual student comes out skilled in all 60 skills.” Clinical laboratories may want to explore creating similar programs with high schools in their own areas. (Photo copyright: Twitter.)
Dynamic Curriculum of Clinical Laboratory Skills
During the first year of the WEMOCO program, students learn skills that Jim Payne, a Medical Laboratory Assisting and Phlebotomy program instructor at WEMOCO, stated he learned in college. These include:
The students also learn the theories and techniques behind phlebotomy and how to perform blood draws (venipuncture).
Students spend 40 hours drawing blood samples from real patients in local medical laboratories and can earn a certification as a Phlebotomy Technician after completing the necessary coursework.
During the second year of the program, students learn college-level:
They also receive their certifications in American Red Cross CPR/AED and First Aid and spend 80 hours actually working in local clinical laboratories. Upon completion of the second year of coursework, students can earn a certification as a Certified Medical Laboratory Assistant.
“In both cases, they can get jobs straight out of the program,” said Payne in the CLP podcast. “But a lot of our grads go on to college for medical laboratory careers.”
Overcoming Vocational School Stigma
Recruiting students into the program was initially challenging as some of the negative stigma surrounding non-traditional coursework had to be overcome. Vocational education is now referred to as career and technical education and the WEMOCO program is more academically focused than previous vocational studies. Students can obtain some college credits when completing the two-year program.
“With my students, when we are teaching them how to do the math around making laboratory solutions, for example, that requires algebra,” Payne explained. “And they have to actually make something with the algebra and suddenly it starts to make a lot more sense than the way that they were taught in a traditional high school.”
In addition, some students interested in the program struggled in a typical high school environment due to lack of direction, according to Payne. However, when those same students found their focus, discovered a passion, and were motivated and challenged, they flourished.
Originally, Payne gave a talk to potential enrollees. But he found there was more interest if students were given a hands-on experience at their first exposure to the program. He also lets current students interact with interested students and allows them to answer any questions in a student-friendly manner.
“Students who are interested in the program come in, they get lab coats on, they get gloves on, and they are then told a story about a case and have to perform a few experiments to try to determine what is wrong with a patient. They actually do things,” Payne explained.
Multiple Career Paths in Clinical Laboratories upon Graduation
One advantage to completing the two-year WEMOCO program is that students can explore all the different careers in clinical laboratory medicine and are offered opportunities to work in medical laboratory situations. Phlebotomy students perform 40 hours of work in a blood lab with a goal of performing 50 successful sticks, although many students perform more than that.
“I have students who are under the age of 18 drawing blood on real patients with real samples with these companies’ trainers. It’s like they have been hired,” Payne said. The medical laboratory assistant work is broken up into increments of two hours a day over the course of several months.
Another benefit to the WEMOCO program is that students are prepared for a job right out of high school, which pleases both the students and the parents. Many graduates of the program go on to college to study different fields within the clinical laboratory profession.
Attracting Young Students to the Clinical Laboratory Profession
Payne believes it is important to get young kids interested in the medical laboratory profession in the lower grade levels. His suggestions for stoking that level of interest include:
Developing programs that are age-appropriate but contain medical laboratory concepts.
Outreach programs where clinicians talk to students in the lower grades to spark interest.
Outreach programs where kids can perform simple experiments like staining onions and seeing results.
Telling stories and explaining the roles labs play in helping patients.
Holding field trips where students visit local clinical laboratories and observe medical laboratory professionals.
Opportunities for students to shadow medical laboratory technicians so the kids can imagine themselves in the profession.
Participating in local activity day/career day events.
He also believes that clinical laboratory professionals should promote their field at every opportunity.
“The biggest thing is actively advocating for the profession. Any chance I get, I’m going out and trying to talk to anyone about the clinical laboratory. Try to have some statistics in your back pocket or other things that can be a good talking point and make a powerful statement to people,” Payne suggested.
Determining unique ways to garner interest in the medical laboratory profession is a crucial step in mitigating staffing shortages. Clinical laboratory leaders may want to participate in community outreach programs and serve as advocates for their profession.
Some healthcare experts point to an “immunity gap” tied to the COVID-19 pandemic, while others suggest alternative theories such as temporary immunodeficiency brought on by COVID-19. In most cases, RSV causes “mild, cold-like symptoms,” but the CDC states it also can cause serious illness, especially for infants, young children, and older adults, leading to emergency room visits, hospitalizations, and an increased demand for clinical laboratory testing.
Pulmonology Advisor reported that the disease typically peaks between December and February, but hospitalizations this season hit their peak in November with numbers far higher than in previous years. In addition to infants and older adults, children between five and 17 years of age were “being hospitalized far in excess of their numbers in previous seasons,” the publication reported.
“Age by itself is a risk factor for more severe disease, meaning that the younger babies are usually the ones that are sick-sick,” pediatrician Asuncion Mejias, MD, PhD (above), a principal investigator with the Center for Vaccines and Immunity at Nationwide Children’s Hospital in Columbus, Ohio, told MarketWatch. Now, she added, “we are also seeing older kids, probably because they were not exposed to RSV the previous season.” Clinical laboratories in hospitals caught the brunt of those RSV inpatient admissions. (Photo copyright: Nationwide Children’s Hospital.)
Did COVID-19 Cause Immunity Gap and Surge in Respiratory Diseases?
CDC data shows that hospitalization rates linked to RSV have steadily declined since hitting their peak of 5.2 per 100,000 people in mid-November. In contrast, hospitalizations linked to the flu peaked in late November and early December at 8.7 per 100,000. Hospitalizations linked to COVID 19—which still exceed those of the other respiratory diseases—reached a plateau of 9.7 per 100,000 in early December, then saw an uptick later that month before declining in the early part of January, 2023, according to the CDC’s Respiratory Virus Hospitalization Surveillance Network (RESP-NET) dashboard.
Surveillance by the CDC’s National Center for Immunization and Respiratory Diseases (NCIRD) revealed a similar pattern: An early peak in weekly numbers for emergency room visits for RSV, followed by a spike for influenza and steadier numbers for COVID-19.
So, why was the RSV outbreak so severe?
Respiratory diseases tend to hit hardest in winter months when people are more likely to gather indoors. Beyond that, some experts have cited social distancing and masking requirements imposed in 2020 and 2021 to limit the spread of COVID 19. These measures, along with school closures, had the side effect of reducing exposure to influenza and RSV.
“It’s what’s being referred to as this ‘immunity gap’ that people have experienced from not having been exposed to our typical respiratory viruses for the last couple of years, combined with reintroduction to indoor gatherings, indoor venues, indoor school, and day care without any of the mitigation measures that we had in place for the last couple of years,” infectious disease expert Kristin Moffitt, MD, of Boston Children’s Hospital told NPR.
Term ‘Immunity Debt’ Sparks Controversy
Other experts have pushed back against the notion that pandemic-related public health measures are largely to blame for the RSV upsurge. Many have objected to the term “immunity debt,” a term Forbes reported on in November.
“Immunity debt is a made-up term that did not exist until last year,” pediatrician Dave Stukus, MD, wrote on Twitter. Stukus is a Professor of Clinical Pediatrics in the Division of Allergy and Immunology at Nationwide Children’s Hospital in Columbus, Ohio.
An article published by Texas Public Radio (TPR) suggests further grounds for skepticism, stating that “the immunity debt theory doesn’t seem to hold up to scrutiny.”
“That was sort of the great unmasking, and everybody got viral illnesses,” she told TPR. “Now we’re past that. We’ve already been through that. We should have some immunity from that and we’re having it again.”
She added that “the hospital is filled with babies who are less than a year of age who have RSV infection. Those children weren’t locked down in 2020.”
The story also noted that not all Americans complied with social distancing or masking guidelines.
“We’re not seeing [less viral illness in] states in the United States that were less strict compared to states that were stricter during mask mandates and things like that. All the states are being impacted,” Barton told TPR.
Perfect Storm of Demand for Clinical Laboratory Testing
Barton suggested that COVID-19 might have compromised people’s immune systems in ways that made them more susceptible to other respiratory diseases. For example, a study published in Nature Immunology, titled, “Immunological Dysfunction Persists for Eight Months following Initial Mild-to-Moderate SARS-CoV-2 Infection,” found that some patients who survived COVID-19 infection developed post-acute long COVID (LC, aka, COVID syndrome) which lasted longer than 12 weeks. And that “patients with LC had highly activated innate immune cells, lacked naive T and naive B cells, and showed elevated expression of type I IFN (IFN-β) and type III IFN (IFN-λ1) that remained persistently high at eight months after infection.”
Experts speaking to The Boston Globe said that multiple factors are likely to blame for the severity and early arrival of the RSV outbreak. Pediatric hospitalist and infectious disease specialist Chadi El Saleeby, MD, of Massachusetts General Hospital, said the severity of some cases might be tied to simultaneous infection with multiple viruses.
Clinical laboratories experienced a perfect storm of infectious disease testing demands during this tripledemic. Hopefully, with the arrival of spring and summer, that demand for lab tests will wane and allow for a return to a normal rate of traditional laboratory testing.
As clinical laboratory self-testing expands, sharing of test results with healthcare providers becomes even more essential to optimize health outcomes
Survey data collected by the University of Michigan’s Institute for Healthcare Policy and Innovation (IHPI) indicates that consumer interest in direct-to-consumer (DTC) medical self-testing is growing. In fact, DTC testing appears to be more popular ever, even among older adults who were asked how they feel about performing clinical laboratory self-testing and specimen collecting for certain illnesses.
According Michigan Medicine’s MHealth Lab, “82% of older adults say that in the future, they would be somewhat or very interested in taking a medical test at home.”
Dark Daily has written regularly about this trend and how leaders need a strategy to serve this class of consumer. That strategy could include collecting the self-test results from consumers and keeping a complete record of consumers’ clinical laboratory test results from inpatient, outpatient, and self-test settings.
“As more companies bring these direct-to-consumer [medical] tests to market and buy ads promoting them, it’s important for healthcare providers and policymakers to understand what patients might be purchasing, what they’re doing with the results, and how that fits into the broader clinical and regulatory picture,” said research scientist Jeffrey Kullgren, MD (above), Associate Professor of Internal Medicine and Health Management and Policy at the University of Michigan in a press release. Clinical laboratories may find opportunities to support patients’ self-testing in tandem with the physicians who treat them. (Photo copyright: University of Michigan.)
Importance of Sharing Clinical Laboratory Self-Test Results
Individuals responding to the poll were asked only about medical laboratory self-tests they had purchased themselves either online or at a retail store. Tests provided to respondents by a healthcare provider or given to them for free were not part of the survey.
The researchers discovered that 48% of respondents had purchased at least one variety of at-home health tests in the past. The types of tests bought included:
Tests for infections other than COVID-19, such as urinary tract infections or HIV (4%), and
Other types of at-home tests, including those for allergies and food sensitivities (10%).
Approximately 82% of the respondents said they would be somewhat or very interested in taking at-home medical tests and nine out of 10 believed the test results should be shared with their doctors. But only 55% of respondents who had taken an at-home medical test and received positive results for infection other than COVID-19 had shared those results with their primary care physician.
However, 90% of respondents who had purchased a self-test for cancer screening did provide their doctors with the results.
“As we have seen in COVID-19, it’s important to share results from a home test with a provider so that it can be used to guide your care and be counted in official statistics,” said Jeffrey Kullgren, MD, Associate Professor of Internal Medicine and Health Management and Policy at the University of Michigan in an IHPI press release. Kullgren, a primary care physician and healthcare researcher at Michigan Medicine and the VA Ann Arbor Healthcare System, directed the IHPI poll.
Not All Medical Self-Tests Are Regulated by the FDA
The most prominent reason for wanting to use at-home tests was convenience and 59% of those surveyed felt that the results could be trusted.
The poll also found that 53% of older adults believe at-home medical tests are regulated by the federal government, which isn’t always the case. Many at-home medical tests are reviewed by the federal US Food and Drug Administration (FDA), but not all such tests receive full FDA review.
The FDA, however, offers an online, searchable database consumers can use to determine if a certain over-the-counter test is regulated by the FDA.
“Home tests can be a convenient way for older adults to check if they have an illness, such as COVID-19” stated Indira Venkat, Senior Vice President, AARP Research in the press release. “But consumers should make sure they know whether the test they are taking is FDA-approved, and how their health or genetic information might be shared.”
Other interesting outcomes of the research include:
The purchasing of at-home COVID-19 tests was highest among those between the ages of 50 and 64 when compared to the 65 to 80 age group, but there were no age differences for other types of at-home tests.
Respondents who are married or have who more education and/or higher household incomes were more likely to have purchased at-home tests.
Blacks were less likely to buy at-home medical tests than Whites or Hispanics.
Interest for at-home tests was higher among women than men.
Advertising swayed 44% of purchasing respondents to buy a DNA test and 11% to buy a cancer screening test.
Are DTC Home Tests as Accurate as Clinical Laboratory Testing?
At-home medical self-testing and sample collection is becoming accepted and established with consumers and the medical community, which is drawing attention to the accuracy of these tests and how clinical laboratories are being affected by the trend.
The findings of this recent survey of older consumers is just the latest evidence that at-home self-testing for everything from COVID to cancer is here to stay. Clinical laboratories should be looking for ways to serve this patient population and the physicians who treat them.
