Drone program will enable delivery of medical laboratory samples during the day, rather than just at night, allowing daytime sample processing that will increase efficiency and shorten time to results
Healthcare network clinical laboratories continue to explore the use of unmanned aerial vehicles (UAVs), commonly known as drones, to safely deliver medical supplies and clinical laboratory specimens between locations. Dark Daily has covered several similar pioneering drone programs taking place around the world in recent years.
The latest medical laboratory company to launch a drone delivery program is Interpath Laboratory, an independent full-service medical laboratory in the Pacific Northwest.
In partnership with Arizona-based Spright—the drone division of Air Methods, a patient transport company with 300 bases in 48 states—Interpath recently announced the launch of its drone delivery pilot program for delivering lab testing specimens from Yellowhawk Tribal Health Center to Interpath’s medical laboratory in Pendleton, Oregon.
The two organizations hope the initiative will expedite the turnaround time needed for test results, thus allowing for timelier diagnoses and improving patient care and outcomes.
“Many communities located in remote or rural areas lack timely and convenient access to essential medical supplies and service,” said Joe Resnik (above), president of Spright in a press release. “We look forward to this proof-of-concept, showcasing drone delivery’s ability to solve many of healthcare’s existing access and efficiency challenges, while also improving patient care and experience.” (Photo copyright: KVS Technologies.)
Replacing Automobile-based Medical Laboratory Specimen Delivery
“If this pilot program is successful and we are able to utilize this service, our patients have the opportunity to benefit from more rapid test results and access follow-up medical procedures and services,” stated Aaron Hines, CEO of Yellowhawk Tribal Health Center in a press release. “This project could help us further our mission of providing high-quality, primary healthcare for the Confederated Tribes of the Umatilla Indian Reservation (CTUIR).”
Currently, patient samples taken throughout the day at various Yellowhawk facilities are picked up and delivered to Interpath’s clinical laboratory in the evening via gasoline-powered vehicles. A successful drone service would allow lab test specimens to be repeatedly picked up and delivered to the lab for analysis throughout the day.
“Medical laboratory services in rural areas frequently must invest intensive time and resources into sample pick-up,” said Tom Kennedy, president of Interpath Laboratory, in the press release. “We anticipate Spright’s drone delivery service will alleviate many of the drawbacks and costs associated with automobile-based delivery. This initiative represents an example of our embrace of innovative solutions that provide more efficient and effective services to our clients.”
In February, Spright held test flights that transported clinical laboratory specimens from Yellowhawk Tribal Health Center to Interpath’s main medical laboratory in Pendleton, Ore. The 15-mile flight used a Wingcopter 198 drone (above) which employs beyond-visual-line-of-sight (BVLOS) technology. Manufactured in Germany, the Wingcopter 198 has a wingspan of five feet ten inches and can carry up to 13 pounds. It has a range of 46 to 68 miles, and a maximum speed of approximately 62 to 90 miles per hour, depending on the weight of its load. (Photo copyright: sUAS News.)
Other Clinical Laboratory Drone Deliver Programs Worldwide
Innovative approaches, such as the utilization of drones to make clinical laboratory specimen deliveries, can help circumvent many of the challenges in delivering healthcare to rural areas. But UAV delivery networks work equally well for faster specimen transferals in urban environments as well, leading to timelier diagnoses of diseases and ultimately to better patient outcomes.
Potentially increasing the revenue write-off burden for clinical laboratories, HRSA changes, insurance contracting, policy and coverage questions for genetic and genomic testing, and patient relationship disconnects will expose cracks in lab test claim generation and billing processes
Last year it was estimated that collection agencies held $140 billion in unpaid medical bills, in addition to the amount of unpaid bills in pre-collection status, according to a New York Times report. More recently, the American Hospital Association showed that hospitals have provided upwards of $700 billion in uncompensated care since 2000, with over $40 billion in 2019 alone.
Because strategies to collect the unpaid can be complicated and time-consuming, many healthcare organizations, including clinical laboratories, choose to write off these uncollectible bills. Dark Daily and The Dark Report have covered clinical laboratory revenue challenges for many years. In considering the paths forward, software-as-a-service (SaaS) provider FrontRunner Healthcare (FrontRunnerHC) recently provided snapshots into the how and where of improved collections.
Fixing Data Issues that Lead to Forfeited Clinical Laboratory Revenue
The underpinnings of unpaid lab tests are many. In a recent interview with Dark Daily, FrontRunnerHC CEO and Founder John (JD) Donnelly estimated that about one-third of claims (prior to submission) include incorrect or missing patient information, such as insurance policy identification or demographics. These gaps undermine an organization’s ability to get paid. Donnelly estimates that bad-debt write-offs for commercial payer claims average over 15% of charges. To address these challenges, the company’s clean claims SaaS provides “instantaneous” patient insurance, demographic, and financial information.
Whether lower-dollar accessions such as routine testing, or the higher-dollar accessions of genetic tests, uncollected payments add up. Donnelly said that, in 2021, almost one-third of the company’s clients uncovered revenue ranging from $1 million to over $90 million using the software. Donnelly also estimated that the return for clients averages eight times the value of the investment in using the automated solution.
In one example, Sonora Quest, a joint venture between Banner Health and Quest Diagnostics, reported a 10-15% decline in write-offs due to aged claims, a savings of over $1million annually, as published in a case study. “As an aside, in a presentation at the Executive War College last November, they also attributed improvements in patient satisfaction measures to the software, including a 65% decrease in abandoned calls, 28% improvement in their call service factor, and 19% decrease in patient call volumes,” stated Donnelly.
Questions About Cost of Care Likely Cause Stress for Patients
As many know, nonpay issues are problematic not only for lab businesses and anatomic pathology practices but also for patients and their families who have little predictability with their cost of care in the midst of stressful health events. “From the time a patient is registered to the time the claim is paid, there are more challenges than people realize that jeopardize the patient’s experience as well as the provider’s ability to get reimbursed,” Donnelly explained. Medical laboratory administrators have struggled to respond, often by using traditional manual methods such as call centers, or more recently by considering the use of data automation tools.
From the patient payment perspective, Donnelly said, a good strategy is having the ability, on demand, to understand each patient’s specific financial situation and likelihood to pay. For example, using FrontRunnerHC’s software to gauge patients’ propensity to pay and determine financial disposition strategies, lab administrators may choose to offer payment plans or hardship discounts to those falling under the federal poverty level (FPL). Or they may choose to send a collection agency only the past-due accounts for patients who have a low likelihood to pay rather than sending them all past due accounts and focus in-house efforts on the others. One genetics lab client who recently started leveraging these software capabilities “is already seeing more than 5% in incremental net collections,” according to Donnelly.
Further, an estimated 2 million people switch insurance plans each month, reported Axios. “That velocity of change is tough for providers to manage, but it’s critical as insurance eligibility and registration issues are the number one reason for claims denials,” Donnelly said.
For a sense of the magnitude of the problem, “Between 25 and 33 cents of every dollar you spend on medical care pays for health care’s back office,” wrote Dana Miller Ervin in September 2021 for a series of investigations called “The Price We Pay,” published at WFAE 90.7 news in Charlotte, North Carolina. “Every medical provider and laboratory in the country has to negotiate with insurance companies. And since there are 900 health insurers, 6,000 hospitals and more than 100,000 physician practices—many of which are independent of larger systems—there are hundreds of thousands of negotiations.”
New Clinical Laboratory Business Challenges Making News Now
All these issues affecting revenue cycle management (RCM) for independent clinical laboratories, hospital and health system laboratories, and physician office laboratories could be compounded by three emerging issues.
Donnelly said that many lab clients have yet to be reimbursed for COVID tests they have performed, despite their HRSA-required due diligence prior to submitting the claims before the deadline. To avoid additional reimbursement risk, many labs have made the decision to stop testing the uninsured or charge them for it, ABC News reported in late March. As of early April, however, Congress was in discussions to re-fund at least some of the Uninsured Program, reported Politico.
Secondly, and also daunting, are the questions surrounding payer coverage and reimbursement for genetic tests and genomic testing. Thanks to high-deductible health plans (HDHPs), clinical laboratories and anatomic pathology groups increasingly must collect deductibles that may be the full amount of the test – and directly from patients rather than from insurance companies. Therefore, there is more demand from patients to understand their expected cost before the test, Donnelly added.
Problems can arise, for both labs and patients, if they don’t know whether a test has been preauthorized for medical necessity or if they lack accurate insurance information such as in-network or out-of-network. “Getting all the needed and accurate info upfront prior to it going into the LIS [Laboratory Information System] can be a reimbursement game changer,” stated Donnelly.
“For a high complexity, high-throughput diagnostic lab, an efficient workflow is critical,” stated Kyle Koeppler, President of nuCARE Medical Solutions Inc., a FrontRunnerHC client. “Capturing the correct patient demographics and insurance information at patient intake increases the accuracy of every order and makes every process involving patient information much more efficient,” Koeppler shared. “It’s simply too costly to risk having inaccurate information at intake.”
And lest we forget, the Protecting Access to Medicare Act (PAMA) is looming with its reimbursement cuts planned through 2026, and requirements of many labs to report private payer rates on a test-by-test basis. While delayed again, the 2023 PAMA reporting requirements and payment cuts must not be ignored, and planning is needed in order to ensure appropriate reimbursement, Donnelly added.
Addressing Long Payment Cycles for Claims, Dead Ends, and Decreased Collection Rates
The CAQH report cites that data automation resulted in efficiency savings of $122 billion annually for the US healthcare system in 2020 yet “meaningful opportunities for additional savings remain.”
Data automation can reduce the burden of labor-intensive functions in coding, billing, filing appeals, and collecting from payers and patients and, therefore, reduce overall RCM costs. The Council for Affordable Quality Healthcare’s (CAQH) 2020 Index reported, “Considering the millions of times these transactions occur every day, the savings potential across the healthcare economy [from streamlining administrative processes] is significant.”
“One way to avoid potential write-offs is by reworking a claim, but the rework is often left undone,” stated John (JD) Donnelly (above), CEO and Founder of FrontRunnerHC. “The better way to avoid a potential write-off is to ensure you’ve got a clean claim in the first place.” (Photo copyright: FrontRunnerHC.)
The intended outcome is an increase in the total amount of revenue collected from the same number of claims.
To that end, FrontRunnerHC’s software links critical data within its partner ecosystem. This ecosystem includes the well-established credit reporting agencies as well as data available through connected healthcare payers and providers equipped with electronic data interchange (EDI) capabilities. “While an employee may be able to manually work about six accessions in an hour, clients can process approximately 40,000 patients in an hour through software automation, leaving staff to work on more value-added initiatives,” stated Donnelly.
Ideally, missing and inaccurate patient information or insurance verification, which are crucial for producing prompt payments and clean claims, should be corrected before a specimen is collected, Donnelly said. However, if the laboratory is nursing aging accounts receivable (AR), Donnelly advises an audit and cleanup of the AR backlog as a first step to quickly fix information errors and reduce write-offs. “In your AR bucket of $10 million, you may have $3 million that’s collectible or $9.8 million that’s collectible. By leveraging software to clean up what can be collected, clients can go after the money they deserve.”
Improve Collections Through Data Automation While Assisting in the Patient Financial Journey
With the rise of telehealth/telemedicine, healthcare consumerism, and care delivered to nontraditional sites, it makes sense that the idea of the clinical laboratory as a silent partner in healthcare could be changing.
“Could we one day see patients asked for not only their preferred pharmacy but their preferred clinical laboratory as well?” Donnelly pondered and added, “I think the answer is yes, and it’s sooner than many think.”
Understanding the patient’s experience is a key step in providing patient-centered care. Therefore, patient experience programs that originate at clinical laboratories where specimens are processed, but before specimens have been collected, could make these labs more visible in their markets and enable them to capitalize on the advantages of data automation to sustainably improve revenue cycle management.
“The patient’s financial journey which runs in parallel to their clinical journey can get pretty bumpy, and those bumps impact their overall experience as well as the provider’s bottom line,” added Donnelly. “Getting accurate patient information upfront and catching any changes to the information as needed throughout the process helps clients create a smoother patient journey by enabling them to quickly manage through the bumps or eliminate them altogether.”
—Liz Carey
This article was produced in collaboration with FrontRunnerHC.
Last-minute court injunction stopped a mass walkout, but allied health workers continue to push country’s District Health Boards for improvements
In New Zealand, the unprecedented surge in PCR COVID-19 testing due to the SARS-CoV-2 Omicron variant appears to have pushed the country’s 10,000 healthcare workers—including 4,000 medical laboratory scientists and technicians—to the breaking point.
On March 3, just 24 hours before the first of two walkouts was scheduled to begin, New Zealand’s Employment Court banned the strike that would have shut down medical laboratories in the country’s mixed public-private healthcare system. Medical laboratory workers make up 40% of the nation’s 10,000 healthcare workers who planned the nationwide strike to protest low pay and poor working conditions, according to 1News.
New Zealand’s Public Service Association (PSA) is the country’s largest trade union representing more than 80,000 workers across government, state-owned enterprises, local councils, health boards, and community groups.
The PSA’s 10,000 health workers (which includes 4,000 medical laboratory workers) had planned to strike on March 4-5 and March 18-19, but, according to the New Zealand Herald the Employment Court stopped the walkouts due to the rise in COVID-19-related hospitalizations.
The Herald noted, however, that PSA union members in Auckland had already postponed their walkout after county District Health Boards (DHB) expressed concern over patient safety.
“Striking has always been our last resort, and our members in Auckland continue to demonstrate their commitment to providing quality healthcare to New Zealanders by working tomorrow,” PSA Organizer Will Matthews told the Herald.
He insisted, however, that DHBs need to respond to workers’ concerns. “The depth of feeling from our members, and the support for industrial action nationwide is unprecedented,” Matthews told 1News. “We are now in a position where strike action is our only remaining option to get the DHBs and the government to listen.”
In an interview with Stuff, medical laboratory scientist Terry Taylor (above), president of the New Zealand Institute of Medical Laboratory Science, acknowledged laboratory workers’ commitment to doing the work, but he is concerned about the next big testing surge. “Goodwill only goes a certain distance in the end when people are knackered and not getting what they need. At the moment, we have the capability to do 50,000 to 60,000 [tests] per day throughout the whole country, but we couldn’t run that for more than a week. We’d be dead, we’d be overrun,” he said. Clinical laboratory leaders in this country may want to make note of Taylor’s concerns, as laboratory conditions in this country become stressed as well. (Photo copyright: Newshub.)
While no new strike dates have been set, Matthews said striking workers would include contact tracers and laboratory staff as well as nearly 70 other groups of healthcare workers, many of whom “don’t even earn a living wage.” According to Peoples Dispatch, allied health workers are working under the terms of a contract that expired in 2020.
The starting salary for a DHB medical laboratory scientist after completing a four-year degree is NZ$56,773 (US$39,519), while lab assistants and technicians start out at less than NZ$50,000 (US$34,804), Stuff reported.
In an interview with 1News, Taylor maintained that diagnostic labs in New Zealand have long been understaffed, undervalued, and their workers poorly treated. The COVID-19 pandemic, he says, has exacerbated an ongoing problem. Issues such as space constraints, for example, have become even more problematic.
“We’ve got extra machinery that’s come into the labs, we don’t get any more space, all these consumables sitting all over hallways and corridors, extra staff coming in to do the stuff,” Taylor told RNZ. “So, we’ve lost all our tearooms, we’ve lost all our office space, our conditions are markedly less than they should be.”
1News points out that the country’s medical laboratory scientists and technicians are processing more than 20,000 PCR COVID-19 tests per day in addition to running 120,000 other samples and 200,000 diagnostic tests. At the end of March 2020, the average number of COVID-19 tests processed per day was 1,777.
While New Zealand has preached to its citizens the need for widespread PCR testing, Taylor argued in February 2022 that the country must change its approach to offering PCR testing only to symptomatic individuals and close contacts.
“To run our diagnostic laboratories into the ground with endless irrelevant testing is a direct reflection of poor foresight, planning, and respect for the role of this critical health workforce,” Taylor told Newshub.
Necessity of Rewarding All Medical Laboratory Personnel
Medical laboratory scientist Bryan Raill is president of Apex, a specialist union of allied, scientific and technical employees. Raill told 1News the long-term solution is for the government to address pay equity, staffing levels, and worker wellbeing in the country’s historically undervalued medical laboratories.
“Medical laboratory scientists and technicians have to be fairly rewarded for the training, skill, and expertise they bring to the health system,” Raill said. “Medical laboratory scientists need a timely, fair, and equitable process to determine their worth.”
While the stresses on New Zealand medical laboratory workers are not identical, US clinical laboratory leaders will want to monitor the lengths to which New Zealand’s laboratory workers are willing to go to force improvements in their working conditions, staffing, and pay.
As the noted above, the government-funded health system is continually strapped for funds. Consequently, the health districts often defer capital investment in hospitals and medical laboratories. That is one reason why lab staff can find themselves working in space that is inadequate for the volume of specimens which need to be tested daily.
Supplychain shortages involving clinical laboratory products may not ease up any time soon, as China’s largest shipping province is once again in COVID-19 lockdown
Following two years of extremely high demand, pathology laboratories as well as non-medical labs in the United Kingdom (UK) and Europe are experiencing significant shortages of laboratory resources as well as rising costs. That’s according to a recently released survey by Starlab Group, a European supplier of lab products.
In its latest annual “mood barometer” survey of around 200 lab professionals in the UK, Germany, Austria, Italy, and France, Starlab Group received reports of “empty warehouses” and a current shortage of much needed lab equipment, reportedly as a result of rising costs, high demand, and stockpiling of critical materials needed by pathology laboratories during the COVID-19 pandemic, according to Laboratory News.
The survey respondents, who represented both medical laboratories and research labs, noted experiencing more pressure from staff shortages and insufficient supplies required to meet testing demands in 2021 as compared to 2020. For example, only 23% of respondents said they had enough liquid handling materials—such as protective gloves and pipettes—in 2021, down from 39% who responded to the same question in 2020.
“The entire laboratory industry has been in a vicious circle for two years. While more and more materials are needed, there’s a lack of supplies. At the same time, laboratories want to stockpile material, putting additional pressure on demand, suppliers, and prices,” Denise Fane de Salis, Starlab’s UK Managing Director and Area Head for Northern Europe, told Process Engineering. “Institutes that perform important basic work cannot keep up with the price competition triggered by COVID-19 and are particularly suffering from this situation,” she added.
“COVID-19 is the largest, but by no means the only challenge facing Europe’s laboratories,” Denise Fane de Salis (above), Starlab’s UK Managing Director and Area Head for Northern Europe, told Laboratory News. “The mood barometer we commissioned once again clearly shows that we need to look at the entire range of laboratory work. The laboratory sector is not only essential in medicine and research. Diagnostics have long since encompassed almost all areas of life and the economy.” Those in this country responsible for clinical laboratory supply chains should consider what Salis is advising. (Photo copyright: Starlab UK.)
Lab Supply Shortages Worsen in 2021
With a UK office in Milton Keynes, Starlab’s network of distributors specialize in liquid handling products including pipette tips, multi-channel pipettes, and cell culture tubes, as well as PCR test consumables and nitrile and latex gloves.
According to Laboratory News, Starlab’s 2021 annual survey, released in March 2022, found that:
64% cited late deliveries contributing to supply woes.
58% noted medical labs getting preference over research labs, up from 46% in 2020.
57% said demand for liquid handling products was the same as 2020.
30% of respondents said material requirements were up 50% in 2021, compared to 2020.
76% reported dealing with rising prices in lab operations.
29% expect their need for materials to increase by 25% in 2022, and 3% said the increase may go as high as 50%.
17% of respondents said they foresee challenges stemming from staff shortages, with 8% fearing employee burnout.
UK-European Medical Laboratories on Waiting Lists for Supplies
Could import of lab equipment and consumables from Asia and other areas outside UK have contributed to the shortages?
“A substantial portion of the world’s clinical laboratory automation, analyzers, instruments, and test kits are manufactured outside UK. Thus, UK labs may face a more acute shortage of lab equipment, tests, and consumables because governments in countries that manufacture these products are taking ‘first dibs’ on production, leaving less to ship to other countries,” said Robert Michel, Editor-in-Chief of Dark Daily and our sister publication The Dark Report.
Indeed, a statement on Starlab’s website describes challenges the company faces meeting customers’ requests for supplies.
“The pandemic also has an impact on our products that are manufactured in other countries. This particularly affects goods that we ship from the Asian region to Europe by sea freight. Due to the capacity restrictions on the ships, we expect additional costs for the transport of goods at any time. Unfortunately, the situation is not expected to ease for the time-being,” Starlab said.
Furthermore, economists are forecasting probable ongoing supply chain effects from a new SARS-CoV-2 outbreak in China.
Lockdown of China’s Largest Shipping Province Threatens Supply Chains Worldwide
According to Bloomberg News, “Shenzhen’s 17.5 million residents [were] put into lockdown on [March 13] for at least a week. The city is located in Guangdong, the manufacturing powerhouse province, which has a gross domestic product of $1.96 trillion—around that of Spain and South Korea—and which accounts for 11% of China’s economy … Guangdong’s $795 billion worth of exports in 2021 accounted for 23% of China’s shipments that year, the most of any province.”
Bloomberg noted that “restrictions in Shenzhen could inflict the heaviest coronavirus-related blow to growth since a nationwide lockdown in 2020, with the additional threat of sending supply shocks rippling around the world.”
“Given that China is a major global manufacturing hub and one of the most important links in global supply chains, the country’s COVID policy can have notably spillovers to its trading partners’ activity and the global economy,” Tuuli McCully, Head of Asia-Pacific Economies, Scotiabank, told Bloomberg News.
Wise medical laboratory leaders will remain apprised of supply chain developments and possible lockdowns in Asia while also locating and possibly securing new sources for test materials and laboratory equipment in anticipation of future supply shortages.
Clinical laboratory scientists should also know experts warn that ‘herd resistance’ is more likely than ‘herd immunity’ due to low vaccination rates in many parts of the world
Scientists estimate 73% of the US population may be immune to the SARS-CoV-2 omicron variant. Whether the nation is approaching “herd immunity” against the disease, however, remains open to debate, the Associated Press (AP) reported. These estimates are relevant to medical laboratories doing serology tests for COVID-19, as different individuals will have different immune system responses to COVID-19 infections and vaccines.
More than two years into the COVID-19 pandemic in the United States, the CDC’s COVID Data Tracker shows the number of daily cases dropped to fewer than 50,000 as of March 4, 2022, after reaching a high of 928,125 on January 3, 2022.
Meanwhile, the seven-day death rate per 100,000 people stands at 2.78. That’s significantly above the seven-day death rate reached last July of .45, but well below the 7.21 mark recorded on January 13, 2021.
“We’re clearly entering a new phase of the pandemic,” William Morice, II, MD, PhD, Department of Laboratory Medicine and Pathology at Mayo Clinic in Rochester, Minn., told KARE11, an NBC affiliate.
Is Herd Immunity Achievable?
According to the AP, an estimated 73% of the US population is likely to be immune to the Omicron variant due to vaccination or natural immunity from contracting the disease. That calculation was done for the media outlet by the Institute for Health Metrics and Evaluation (IHME) at the University of Washington in Seattle. The IHME anticipates immunity to Omicron could rise to 80% this month, as more people receive vaccination booster shots or become vaccinated.
“Herd immunity is an elusive concept and doesn’t apply to coronavirus,” he told the Associated Press (AP).
Milton maintains populations are moving toward “herd resistance,” rather than “herd immunity.” This will transform COVID-19 into a permanent fixture with seasonal outbreaks similar to influenza.
Epidemiologist, Ali Mokdad, PhD (above), Chief Strategy Officer for Population Health and Professor of Health Metrics Science at the University of Washington in Seattle, believes the US is now much better positioned to withstand the next wave of COVID-19 cases. “I am optimistic even if we have a surge in summer, cases will go up, but hospitalizations and deaths will not,” he told the Associated Press (AP). Mokdad worked on the IHME model that calculated the 73% Omicron-immunity figure for the AP. However, he recommends continued vigilance toward COVID-19. “We’ve reached a much better position for the coming months, but with waning immunity we shouldn’t take it for granted,” he added. And so, clinical laboratories can expect to continue to play a vital role in the fight against the spread of the SARS-CoV-2 coronavirus. (Photo copyright: University of Washington.)
Herd Immunity Varies, according to the WHO
Because antibodies that developed from vaccines—or natural immunity from a previous infection—diminish over time, waning protection means even those boosted or recently recovered from COVID-19 could be reinfected. In addition, vaccination rates vary widely around the world. Our World in Data estimates only 13.6% of people in low-income countries had received one dose of the COVID-19 vaccine as of March 7, 2022.
The World Health Organization (WHO) points out that herd immunity levels vary with different diseases. Herd immunity against measles requires about 95% of a population to be vaccinated, while the threshold for polio is about 80%.
“The proportion of the population that must be vaccinated against COVID-19 to begin inducing herd immunity is not known. This is an important area of research and will likely vary according to the community, the vaccine, the populations prioritized for vaccination, and other factors,” the WHO website states.
Living with COVID-19
Nonetheless, the US appears to be moving into a new “normal” phase of living with the disease.
In an interview with Reuters, US infectious disease expert Anthony Fauci, MD, Director of the National Institute of Allergy and Infectious Diseases (NIAID) acknowledged a need for returning to normal living even though portions of the population—immunocompromised individuals and the unvaccinated, including children under age five who are not eligible for vaccination—remain vulnerable to more severe COVID-19.
“The fact that the world and the United States—and particularly certain parts of the United States—are just up to here with COVID, they just really need to somehow get their life back,” Fauci said. “You don’t want to be reckless and throw everything aside, but you’ve got to start inching towards that. There’s no perfect solution to this.”
Most states have lifted coronavirus-related restrictions, including masking requirements. As COVID-19 cases drop in California, Gov. Gavin Newsom put in motion a plan called SMARTER (Shots, Masks, Awareness, Readiness, Testing, Education, and Rx) that no longer responds to COVID-19 as a crisis, but instead emphasizes prevention, surveillance, and rapid response to future variant-based surges in cases.
“We have all come to understand what was not understood at the beginning of this crisis, that there’s no ending, that there’s not a moment where we declare victory,” Newsom told USA Today.
Mayo Clinic’s Morice agrees. “It can’t be out of sight, out of mind, per se, but it at least gives us hope that we can get back to some level of normalcy here over the course of the year,” he said.
Since clinical laboratories played a critical role in assay development and COVID-19 testing, medical laboratory leaders should continue monitoring COVID-19 as it moves from pandemic to endemic status due to high vaccination rates and advances in treatment options.
The COVID-19 pandemic has raised awareness among healthcare consumers as well, about the critical role laboratory medicine plays in modern medicine and healthcare. Medical laboratory leaders and pathologists would be wise to amplify this message and stress the importance of clinical laboratory testing for many diseases and healthcare conditions.
The Department of Justice steps beyond the law’s original focus on opioid-related lab testing fraud
An interesting aspect with enforcement of the Eliminating Kickbacks in Recovery Act of 2018 (EKRA) is the government’s willingness to go after charges tied to fraudulent COVID-19 testing.
The case U.S. vs. Malena Badon Lepetich provides a good example of this approach. A grand jury indicted Lepetich on various healthcare fraud charges last year, including that she allegedly offered to pay kickbacks for referrals of specimens for COVID-19 testing.
“The government had really only used EKRA in the context of addiction treatment space,” attorney Alexander Porter, a Partner at law firm Davis Wright Tremaine in Los Angeles, said in the latest issue of The Dark Report. “The Lepetich case shows that the government’s going to use EKRA beyond that context and go into other areas where they think that it can be useful—in particular, in the area of COVID-19 testing.”
Clinical laboratories and pathology groups should take note of this development.
Attorney Alexander Porter said EKRA enforcement now goes after fraudulent COVID-19 testing. (Photo: Davis Wright Tremaine)
Defendant Allegedly Filed $10 Million in Fraudulent Lab Claims
Lepetich was the owner of MedLogic, a clinical laboratory in Baton Rouge, La.
In addition to the fraudulent COVID-19 testing charges, she allegedly solicited and received kickbacks in exchange for referrals of urine specimens for medically unnecessary tests, according to the U.S. Department of Justice (DOJ).
EKRA Provisions Rose from the Opioid Crisis in the U.S.
EKRA is a criminal law that falls under the Communities and Patients Act, which lifted restrictions on medications for opioid treatment and sought to limit overprescribing of opioid painkillers. Originally, EKRA targeted fraudulent practices at sober homes and substance abuse treatment centers. However, the final draft of the bill added clinical laboratories to the list of providers under potential scrutiny.
At the time Congress passed EKRA, the law was primarily aimed at fraudulent activity in opioid treatment centers, including related lab testing.
Thus, the government’s use of EKRA in the COVID-19 charges against Lepetich case is newsworthy and establishes a precedent, noted Porter. He’ll speak about EKRA at the 2022 Executive War College on Laboratory and Pathology Management. The event takes place April 27-28 in New Orleans.
A contentious part of EKRA for clinical laboratories and pathology groups is that certain conduct protected under the federal Anti-Kickback Statute is treated as a criminal offense under EKRA. Some common lab practices come under that confusing designation, such as paying lab sales reps on a commission-based formula based on testing volumes they generate.
