Questions remain, however, over how much of the funding will actually reach hospital and health system clinical laboratories
For many cash-strapped clinical laboratories in America, the second round of stimulus funds cannot come soon enough. Thus, lab leaders are encouraged by news that Congress’ $484-billion Paycheck Protection Program and Healthcare Enhancement Act (H.R.266) includes almost $11 billion that will go to states for COVID-19 testing. But how much of that funding will reach the nation’s hospital and health system clinical laboratories?
The Department of Health and Human Services (HHS) announced the new influx of money to the states on May 18. In a news release outlining the initiative, the HHS said the Centers for Disease Control and Prevention (CDC) will deliver $10.25 billion to states, territories, and local jurisdictions to expand testing capacity and testing-related activities.
To qualify for the additional funding, governors or “designee of each State, locality, territory, tribe, or tribal organization receiving funds” must submit to HHS its plan for COVID-19 testing, including goals for the remainder of calendar year 2020, to include:
“Number of tests needed, month-by-month to include diagnostic, serological, and other tests, as appropriate;
“Month-by-month estimates of laboratory and testing capacity, including related to workforce, equipment and supplies, and available tests;
“Description of how the resources will be used for testing, including easing any COVID-19 community mitigation policies.”
“As the nation cautiously begins the phased approach to reopening, this considerable investment in expanding both testing and contact tracing capacity for states, localities, territories, and tribal communities is essential,” said CDC Director Robert R. Redfield, MD, in the HHS statement. “Readily accessible testing is a critical component of a four-pronged public health strategy—including rigorous contact tracing, isolation of confirmed cases, and quarantine.” (Photo copyright: Center for Disease Control and Prevention.)
Funding Should Go Directly to Clinical Laboratories, Says ACLA
The American Clinical Laboratory Association (ACLA), argues the funding needs to go directly to clinical laboratories to help offset the “significant investments” labs have made to ramp up testing capacity during the pandemic.
“Direct federal funding for laboratories performing COVID-19 testing is critical to meet the continued demand for testing,” ACLA President Julie Khani, MPA, said in a statement. “Across the country, laboratories have made significant investments to expand capacity, including purchasing new platforms, retraining staff, and managing the skyrocketing cost of supplies. To continue to make these investments and expand patient access to high-quality testing in every community, laboratories will need designated resources. Without sustainable funding, we cannot achieve sustainable testing.”
Some States Are Increasing Testing, While Others Are Not
Since the first cases of COVID-19 were reported in January, the United States has slowly but significantly ramped up testing capacity. As reported in the Washington Post, states such as Georgia, Oklahoma, and Utah are encouraging residents to get tested even if they are not experiencing coronavirus symptoms. But other states have maintained more restrictive testing policies, even as their testing capacity has increased.
“A lot of states put in very, very restrictive testing policies … because they didn’t have any tests. And they’ve either not relaxed those or the word is not getting out,” Ashish Jha, MD, MPA, Director of the Harvard Global Health Institute, told the Washington Post. “We want to be at a point where everybody who has mild symptoms is tested. That is critical. That is still not happening in a lot of places.”
Meanwhile, Quest Diagnostics and LabCorp continue to expand their diagnostic and antibody testing capabilities.
On May 18, Quest announced it had performed approximately 2.15 million COVID-19 molecular diagnostic tests since March 9 and had a diagnostic capability of 70,000 test each day. The company said it expected to have the capacity to perform 100,000 tests a day in June.
LabCorp’s website lists its molecular test capacity at more than 75,000 tests per day as of May 22, with a capacity for conducting at least 200,000 antibody tests per day. Unlike molecular testing that detects the presence of the SARS-CoV-2 coronavirus, antibody tests detect proteins produced by the body in response to a COVID-19 infection.
As states reopen, and hospitals and healthcare systems resume elective surgeries and routine office visits, clinical laboratories and anatomic pathology groups should begin to see a return to normal specimen flow. Nonetheless, the federal government should continue to compensate laboratories performing COVID-19 testing for the added costs associated with meeting the ongoing and growing demand.
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.
Christopher Freer, DO (above), an emergency physician at St. Barnabas Hospital in the Bronx and Director of Emergency Medicine at RWJBarnabas Health, told CNBC that emergency departments are seeing patients with severe issues, such as stroke and appendicitis, but that those with milder symptoms appear to be staying away. “Even with coronavirus, we still have healthy people who get an illness and need to go to the emergency room,” he said. “Heart attacks don’t stop.” (Photo copyright: USA Today.)
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.”
However, David Brown, MD, Chief of Emergency Medicine at Massachusetts General Hospital in Boston, argues the number of people having heart-related issues is unlikely to have dropped during the pandemic.
“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.
Pathologists in medical laboratories creating laboratory-developed tests (LDTs) should be aware that some in the scientific community want more transparency about technology and methods
Developers of clinical laboratory tests and medical diagnostic technologies might soon be feeling the pressure to increase their push for transparency and standards that ultimately would make replication easier.
That’s thanks to a review project’s inability to reproduce results from three of five high-profile cancer studies.
The review project is called the Reproducibility Project: Cancer Biology and is a collaboration between network provider Science Exchange of Palo Alto, Calif., and the Center for Open Science in Charlottesville, Va. They attempted to independently replicate selected results from high-profile cancer biology papers in an open fashion. (more…)
JAMA study finds that most workers with access to web-based price comparison tools did not use them, nor did they spend less on medical care than other workers
Can shopping tools designed to help patients compare providers (including medical laboratories), quality, and prices, make a contribution to reducing the increase in healthcare costs? A new study suggests that such shopping tools make only modest contributions to controlling the cost of care.
Published May 3 in the Journal of the American Medical Association (JAMA), the study found that only 10% of the 150,000 employees at two large companies offering web-based transparency tools logged on to compare healthcare costs during the calendar year. In addition, providing workers with the ability to shop for healthcare services did not bring down employees’ average outpatient spending. Instead, employees with access to transparency tools spent slightly more than workers who could not price shop.
“Our findings temper the enthusiasm around the idea that price transparency is some sort of panacea … that price transparency alone, coupled with high deductible health plans, are going to lead to reduced spending,” stated Sunita Desai, PhD, a Seidman Fellow in Healthcare Policy at Harvard Medical School who led the study. She was quoted in a Washington Post article. (more…)
U.S. Patent and Trademark Office will hold hearings to determine whether University of California Berkeley, or Broad Institute of Harvard and MIT, should receive patents for new genomic engineering technique
In the race to master gene-editing in ways that will advance genetic medicine and patient care, one of the hottest technologies is CRISPR, which stands for Clustered Regularly Interspaced Short Palindromic Repeats. But now a patent fight has the potential to complicate how pathologists and other scientists use this exciting technology.
This dispute over the CRISPR patent—a tool that has been hailed as one of the biggest biotech breakthroughs of the decade—will likely be settled in the coming months by the United States Patent and Trademark Office (USPTO).
The USPTO will be reviewing key patents awarded for what is called CRISPR/Cas9. The technology is already generating novel therapies for diseases, which should create new opportunities for pathologists and medical laboratories. (more…)
