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.
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
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.
Cozy relationships between hospital chief executives and healthcare companies they do business with may raise ethical questions
If hospital employees, including pathologists, wonder why their hospital uses a certain company’s products and services it may be because their Chief Executive Officer (CEO) sits on the Board of Directors of the same companies from which the hospital buys products and services. That’s the suggestion in a recent Boston Globe investigative report.
In “Boston’s Hospital Chiefs Moonlight on Corporate Boards at Rates Far Beyond the National Level,” The Boston Globe reported that, in Boston, hospital CEOs at the city’s academic medical centers frequently sit on the boards of healthcare companies with which their hospitals do business. However, because the investigative reporters did not list the healthcare companies which had Boston hospital CEOs as board members, clinical laboratory managers and pathologists cannot determine from the article if their medical laboratories are using products from those same companies.
According to The Globe, five of seven CEOs and Presidents of Boston’s major teaching hospitals also receive compensation for serving as directors of publicly traded companies. And in their roles as corporate board members, hospital CEOs often receive stock in these companies, making the value of their remuneration potentially worth millions of dollars, The Globe reported.
Not Illegal, But Is It Ethical?
The Boston Globe’s investigation noted that such moonlighting, while not unheard of elsewhere in the country, is commonplace in Boston, raising ethical concerns despite conflict-of-interest policies aimed at limiting outside relationships.
“Hospitals in Boston and elsewhere that allow this outside corporate work do so under the terms of conflict-of-interest policies,” The Globe reported. “A Globe review of more than a dozen hospital conflict-of-interest policies across the country found more similarities than differences. Almost all require hospital trustees to approve a hospital chief’s outside board work and consider certain factors, such as the amount of business a company does with the hospital and time required.
“But the policies offer limited evidence about actual practices,” The Globe added. “Trustees typically retain significant discretion over what is permitted or barred, and their deliberations are generally hidden from the public. It is hard to tell if the relative rarity of hospital chiefs in other cities holding outside directorships is because of a lack of interest or opportunity, or is the result of trustees saying no.”
Though no laws were broken, some questioned the ethics of such actions. Nevertheless, The Boston Globe wrote that “Debra O’Malley, a spokesperson for Secretary of State William Galvin’s office, said Fenwick’s actions did not appear to violate the law: She is required to disclose in writing to the state that she is a lobbyist for the hospital and the bills she lobbied on, which she did, O’Malley said. That information is publicly available.”
And though The Globe reported that Boston Children’s Hospital had “declined to answer detailed questions about [Fenwick’s] lobbying efforts,” the paper wrote that a hospital spokesperson said, “[Fenwick’s] directorships are publicly disclosed in filings with the Securities and Exchange Commission.”
Fenwick retired from Boston Children’s Hospital in March 2021. The Globe noted that at that time her Teledoc Health stock, which was compensation for her board work, was worth $8.8 million. Additionally, she had been paid $2.7 million annually as CEO of Boston Children’s Hospital.
Avoiding Conflicts of Interest
Bad optics created by a Boston hospital CEO receiving seven-figure compensation for serving on the board of directors of a publicly traded company is not new. In July 2020, former Brigham and Women’s Hospital President Elizabeth Nabel, MD, resigned from the board of biotech company Moderna (NASDAQ:MRNA) “to alleviate any potential concern about the conduct or the outcome of the COVID-19 vaccine trial when Brigham and Women’s Hospital was identified by NIH as one of the clinical sites for the Phase 3 trial,” a Moderna press release states.
On March 1, 2021, Nabel also stepped down as Brigham and Women’s Hospital president. She then rejoined the Moderna board of directors on March 10, 2021, the press release noted.
In a STAT editorial, titled, “Hospital CEOs, Med School Leaders Shouldn’t Sit on For-Profit Health Care Company Boards,” endocrinologist and former Dean of Harvard Medical School Jeffrey Flier, MD, wrote, “As dean, I vigorously supported the value of robust interactions between faculty and industry to advance innovation and human health, and still do. In my current status as a professor of medicine at Harvard, I serve on several for-profit and not-for-profit boards. I learn from this work, and I believe I am making useful contributions as a board member. But I also believe that the considerations governing such relationships should be judged differently for institutional leaders.”
Flier maintains there are multiple reasons why hospital and medical school leaders should not sit on for-profit boards despite the expertise they bring to the table, including:
The time commitment required,
The “extraordinary compensation packages” they receive in their full-time jobs,
The potential for complicated “business intersections,” and
The risks to an “institution’s reputation for integrity.”
“I recommend that hospital CEOs and academic leaders at the level of Deans and Presidents devote their full attention to their well-compensated day jobs and defer positions on the boards of for-profit companies—and the unavoidable conflicts they raise—to the post-leadership phase of their careers,” Flier wrote.
While cozy relationships between hospital and academic medical center leaders and for-profit healthcare companies may not directly impact hospital pathologists and staff, it is worth staying aware of potential conflicts of interest.
Even as some states lift stay-at-home orders, clinical laboratories and pathology groups face uncertainty about how quickly routine daily test referrals will return to normal, pre-pandemic levels
Although strokes and heart attacks do not take vacations, a large and growing number of patients with serious health issues who—in normal times—would require immediate attention are not contacting providers to get needed care. Instead, they are avoiding hospital emergency rooms and clinical laboratories for fear they’ll contract the COVID-19 coronavirus.
Starting in early March, hospitals nationwide suspended elective surgeries and procedures and reduced non-COVID-19 inpatient care to make beds available for the predicted on-rush of COVID-19 patients. However, in parts of the country, the predicted high demand for hospital beds and ventilators failed to materialize. Additionally, due to shelter-in-place orders, patients in many states postponed routine office visits with their primary care physicians.
The collective collapse in the number of elective services provided by hospitals, and the fall-off in patients visiting their doctors, is crushing the financial stability of the nation’s clinical laboratory industry.
In, “From Mid-March, Labs Saw Big Drop in Revenue,” Dark Daily’s sister publication, The Dark Report (TDR) reported on the revenue challenges facing clinical pathology groups and clinical laboratories. Kyle Fetter, Executive Vice President and General Manager of Diagnostic Services at XIFIN, a revenue cycle management company, told TDR that starting in the third week of March, labs suffered a steep decline in routine testing. By the end of March, that fall-off in revenue ranged from 44% for some AP specimens to 70% to 80% for some specialty AP work. During these same weeks, XIFIN’s data showed clinical labs experienced a drop in routine testing volume of 58%, hospital outreach testing declined by 61%, and molecular lab volume went down by 52%.
Can Clinical Laboratories Hang on Financially Until COVID-19 Goes Away?
Though most states have not met the nonbinding criteria recommended by the Trump administration for reopening, nearly 40 governors in early May began loosening stay-at-home orders, reported CNN, including allowing elective medical procedures to resume.
Patients may make up for lost time by returning to doctors’ offices for medical laboratory tests and other COVID-19-delayed procedures, and as this happens, clinical laboratories may experience a surge in routine test orders from doctors’ offices and hospital admissions once stay-at-home orders are lifted and fear of COVID-19 has passed.
According to an article published on Axios, a survey of 163 physicians conducted by SVB Leerink—an investment firm that specializes in healthcare and life sciences—found that “roughly three out of four doctors believe patient appointments will resume to normal, pre-coronavirus levels, no earlier than July, and 45% expect a rebound to occur sometime between July and September.” If so, the financial squeeze facing clinical laboratories, pathology groups, and other medical and dental professionals may continue to loosen.
Hospital Finances Are Being Particularly Stressed by Loss of Patients
The impact of stay-at-home orders on hospital systems, in particular, has been dramatic. CNBC reported that RWJBarnabas Health, an 1l-hospital 22-laboratory health system in New Jersey that has 11 emergency departments, totaled just 180 emergency room visits per day during a mid-April weekend, a sharp decline from their 280-per-day-average.
A recent Washington Post article paints an even bleaker picture. Clinicians in the United States, Spain, United Kingdom, and China anecdotally report a “silent sub-epidemic of people who need care at hospitals but dare not come in,” the article states, noting people with symptoms of appendicitis, heart attacks, stroke, infected gall bladders, and bowel obstructions are avoiding hospital emergency rooms.
“Everybody is frightened to come to the ER,” Mount Sinai Health System cardiovascular surgeon John Puskas, MD, told the Post. Though his 60-bed cardiac unit had been repurposed to care for COVID-19 patients, Puskas said the New York hospital system was seeing “dramatically fewer” cardiac patients.
Concerned that patients may be ignoring signs of heart attack or stroke rather than go to a hospital, the American College of Cardiology launched the “CardioSmart” campaign, which urges anyone experiencing heart symptoms to get prompt treatment and to continue routine appointments, using telehealth technology when available.
“Hospitals have safety measures to protect you from infection,” the CardioSmart website states. “Getting care quickly is critical. You’ll get better faster, and you’ll limit damage to your health.”
“Strokes and heart attacks don’t take a vacation just because there’s a pandemic,” Brown told The Boston Globe. “They’re still happening. They just aren’t happening as much inside the hospital, which is a major concern to me.”
Many healthcare professionals are worried about the long-term effect from pandemic-delayed preventative and elective procedures.
“The big question is are we going to see a lot more people that have bad outcomes from heart disease, from stroke, from cancer because they’ve put off what they should have had done, but were too afraid to come to the hospital?” Providence St. Joseph Health CEO Rod Hochman, MD, told CNBC.
Hochman, who is Chair-elect of the American Hospital Association (AHA), maintains the aftereffects of people putting off elective surgeries and screening procedures like colonoscopies and mammograms may be felt for years to come.
“We’re possibly going to see a blip in other disease entities as a consequence of doubling down on COVID-19,” he told CNBC.
In clinical laboratories, COVID-19 testing may have somewhat helped offset the drop in routine testing volume. However, the pandemic’s overall financial costs to labs and pathology groups will likely be felt for months to years, as patients slowly return to healthcare providers’ offices and hospitals.
A growing number of media stories claim medical lab companies that develop genetic screening assays oversell the accuracy of such tests and fail to educate parents and doctors about the risks of false positives and false negatives
In response to growing concerns by consumers about the accuracy of some proprietary genetic screening assays, several media outlets have begun reporting on this sector of the clinical laboratory industry.
What gives these news stories emotional punch is the fact that patients use these proprietary medical laboratory tests to make decisions that can be life-changing. In its story about these tests, the Boston Sunday Globe used the headline “Oversold prenatal tests spur some to choose abortions.” (more…)