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Clinical Laboratories and Pathology Groups

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News, Analysis, Trends, Management Innovations for
Clinical Laboratories and Pathology Groups

Hosted by Robert Michel
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Federal Government Is Sending Nearly $11 Billion to States for COVID-19 Clinical Laboratory Testing and Testing-Related Activities

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?

Dark Daily previously reported on the deteriorating financial conditions at clinical and pathology laboratories nationwide. (See, “COVID-19 Triggers a Cash Flow Crash at Clinical Labs Totaling US $5.2 Billion in Past Seven Weeks; Many Labs Are at Brink of Financial Collapse,” May 4, 2020.) This critical situation is the result of a severe decline in the flow of specimens for routine testing to medical laboratories which, at the same time, are struggling with increasing costs to meet the demand for COVID-19 testing.

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.

—Andrea Downing Peck

Related Information:

HHS Delivers Funding to Expand Testing Capacity for States, Territories, Tribes

As Coronavirus Testing Expands a New Problem Arises: Not Enough People to Test

Quest Diagnostics Performs and Reports Results of 2.15 Million COVID-19 Diagnostic Tests and 975,000 Antibody Tests to Date

ACLA Statement on Expanding Access to Testing

COVID-19 Triggers a Cash Flow Crash at Clinical Labs Totaling $5.2 Billion in Past Seven Weeks; Many Labs Are at Brink of Financial Collapse

Harvard ‘Roadmap’ to Recovery Calls for ‘Massive’ Increase in Clinical Laboratory COVID-19 Testing in Four-Phase Blueprint for Reopening Economy

Report’s authors claim the US needs to be testing 20-million people per day in order to achieve ‘full pandemic resilience’ by August

Medical laboratory scientists and clinical laboratory leaders know that the US’ inability to provide widespread diagnostic testing to detect SARS-CoV-2—the novel coronavirus that causes the COVID-19 illness—in the early stages of the outbreak was a major public health failure. Now a Harvard University report argues the US will need to deliver five million tests per day by early June—more than the total number of people tested nationwide to date—to safely begin reopening the economy.

The report released by Harvard’s Edmond J. Safra Center for Ethics at Harvard University, titled, “Roadmap to Pandemic Resilience,” outlines a four-phase, three-pronged plan that includes a “massive” scale-up in clinical laboratory diagnostic testing, contact tracing, isolation, and quarantine to ensure a “path to pandemic resilience for a free society.” The approach to reopening the nation would span through August, during which 20% of at-home workers would return to offices and schools.

“We need to deliver five million tests per day by early June to deliver a safe social reopening,” the report’s authors state. “This number will need to increase over time (ideally by late July) to 20 million a day to fully remobilize the economy. We acknowledge that even this number may not be high enough to protect public health. In that considerably less likely eventuality, we will need to scale-up testing much further. By the time we know if we need to do that, we should be in a better position to know how to do it. In any situation, achieving these numbers depends on testing innovation.”

The report is the work of a diverse group of experts in economics, public health, technology, and ethics, from major universities and big technology companies (Apple, Microsoft) with support from The Rockefeller Foundation.

“This is the first plan to show operationally how we can scale up COVID-19 testing sufficiently to safely reopen the economy—while safeguarding fundamental American democratic principles of protecting civil rights and liberties,” Danielle Allen, PhD (above), Director of Harvard University’s Edmond J. Safra Center for Ethics, said in a statement that noted it was “in response to the US Department of Health and Human Service’s Report to Congress on its COVID-19 strategic testing plan.” (Photo copyright: Harvard University.)

Under Harvard’s Roadmap plan, massive-scale testing would involve rapid development of:

  • Streamlined sample collection (for example) involving saliva samples (spit kits) rather than deep nasal swabs that have to be taken by healthcare workers;
  • Transportation logistics systems able to rapidly collect and distribute samples for testing;
  • Mega-testing labs, each able to perform in the range of one million tests per day, with automation, streamlined methods, and tightly managed supply chains;
  • Information systems to rapidly transmit test results; and
  • Technology necessary to certify testing status.

“The unique value of this approach is that it will prevent cycles of opening up and shutting down,” Anne-Marie Slaughter, CEO of New America, said in the statement. “It allows us to mobilize and re-open progressively the parts of the economy that have been shut down, protect our frontline workers, and contain the virus to levels where it can be effectively managed and treated until we can find a vaccine.”

Is Expanding Clinical Laboratory Testing Even Possible?

But is such a plan realistic? Perhaps not. When questioned by NBC News about the timeline for “broad-based coronavirus testing” that was suggested as part of the Trump Administration’s three-phase plan to reopen the states, former FDA Commissioner Scott Gottlieb, MD, said, “We’re not going to be there. We’re not going to be there in May, we’re not going to be there in June, hopefully, we’ll be there by September.”

Ramping up US testing has been an ongoing battle. The CDC’s flawed test kit delayed testing at public-health labs and federal regulatory red tape stymied commercial laboratories from developing their own COVID-19 diagnostic tests. In addition, as Dark Daily reported, quality issues have affected COVID-19 tests offered by some in vitro diagnostics companies and individual medical laboratories in the US and other countries. (See, “Chinese Firm to Replace Clinical Laboratory Test Kits After Spanish Health Authorities Report Tests from China’s Shenzen Bioeasy Were Only 30% Accurate,” April 3, 2020.)

In recent weeks, however, US testing capabilities have improved. Quest Diagnostics, which had come under fire for its testing backlog in California, announced it now has the capacity to perform 50,000 diagnostic COVID-19 tests per day or 350,000 tests per week with less than a two-day turnaround for results. “Our test capacity outpaces demand and we have not experienced a test backlog for about a week,” Quest said in a statement.

And the FDA authorized the first diagnostic test with a home collection option for COVID-19 to LabCorp. Dark Daily reported on this development in “FDA Issues First Approval for At-Home COVID-19 Test to LabCorp’s Pixel; Other Clinical Laboratory-Developed At-Home Test Kits May Soon Be Available to General Public.”

CDC ‘Modifies’ Its Guidelines for Declaring a Person ‘Recovered’ from COVID-19

Furthermore, the CDC modified its guidance on the medical and testing criteria that must be met for a person to be considered recovered from COVID-19, which initially required two negative test results before a patient could be declared “confirmed recovered” from the virus. The CDC added a non-testing strategy that allowed states to begin counting “discharged” patients who did not have easy access to additional testing as recovered from the virus.

Under the non-test-based strategy, a person may be considered recovered if:

  • At least three days (72 hours) have passed since recovery, defined as resolution of fever without the use of fever-reducing medications;
  • Improvement in respiratory symptoms (e.g., cough, shortness of breath); and,
  • At least seven days have passed since symptoms first appeared.

For now, however, the focus will likely remain on testing for those who are infected, rather than for finding those who have recovered. As of May 30, the COVID Tracking Project reported that only 16,495,443 million tests had been conducted in the US, with 1,759,693 of those test showing positive for COVID-19. That’s closing in on the 10% “test-positivity rate” recommended by the WHO for controlling a pandemic, but it’s not quite there.

As testing for COVID-19 grows exponentially, clinical laboratories should anticipate playing an increasingly important role in the nation’s response to the COVID-19 pandemic.

—Andrea Downing Peck

Related Information:

Roadmap to Pandemic Resilience

Pandemic Resilience Roadmap

Quest Diagnostic Media Statement about COVID-19 Testing

Ex-FDA Chief Says U.S. Not Likely to Have Broad-Based Coronavirus Testing Until September

CDC: Discontinuation of Isolation for Persons with COVID -19 Not in Healthcare Settings

Quest Diagnostics COVID-19 Diagnostic Testing Figures

Summary of Recent Changes: March 23, 2020

The COVID Tracking Project: US Historical Data

Coronavirus Testing Needs to Triple Before the U.S. Can Reopen, Experts Say

Chinese Firm to Replace Clinical Laboratory Test Kits After Spanish Health Authorities Report Tests from China’s Shenzen Bioeasy Were Only 30% Accurate

FDA Issues First Approval for At-Home COVID-19 Test to LabCorp’s Pixel; Other Clinical Laboratory-Developed At-Home Test Kits May Soon Be Available to General Public

What Makes US Healthcare So Expensive? It’s Price, Not Overutilization, Say Researchers at IHME and UCLA

Recent studies exploring the economics behind the high price of US healthcare independently point to the price of labor, goods, services, administrative costs, and pharmaceuticals as primary reason why the US spends almost twice as much as peer countries on healthcare

It is regularly reported that the cost of healthcare in the United States is notably more expensive that in most developed nations. Overutilization of medical services in this country is often given as a reason why this is true. But the findings of a new research study suggest that the reason healthcare in the US is expensive is not due to overutilization. Rather, it is because of the much higher prices American patients pay for services, including clinical laboratory testing.

This recent study contradicts the claims of some experts who say overutilization is to blame for the high cost of healthcare in the United States. The research was conducted by researchers at the Institute for Health Metrics and Evaluation (IHME) in Seattle and the UCLA David Geffen School of Medicine. They attribute the overarching factor in high healthcare costs not to high utilization of services—such as clinical laboratory and anatomic pathology testing—or increased rates of illness.

Instead, the researchers found that it’s simply a matter of higher prices for healthcare delivered in this nation, compared to other healthcare systems around the globe. This is what makes America’s healthcare system so expensive. And, lacking financial incentives for stakeholders to lower prices, these researchers suggest that continued high costs could negatively impact providers’ quality of care.

High Cost of Diagnostic Services, including Medical Laboratory Testing

The IHME/UCLA researchers published their findings in the Journal of the American Medical Association (JAMA), in which they argued that increases in US healthcare cost are independent of increases in:

  • Disease prevalence;
  • US population age;
  • Use of healthcare services; or,
  • Overall population size.

Joseph L. Dieleman, PhD, Assistant Professor at IHME and lead researcher on the investigation, stated, “After adjustments for price inflation, annual healthcare spending on inpatient, ambulatory, retail pharmaceutical, nursing facility, emergency department, and dental care increased by $933.5 billion between 1996 and 2013—from $1.2 trillion to $2.1 trillion.”

Data produced by the study identified one overlying factor in increased spending—increased prices. According to Dieleman, health spending in 2015 “reached $3.2 trillion and constituted 17.8% of the US economy.”

In an editorial response to Dieleman’s investigation, also published in JAMA, Patrick H. Conway, MD, MSc (above), President and CEO of Blue Cross Blue Shield of North Carolina in Durham, stated that “the United States is on an unsustainable growth path in terms of healthcare costs and must get costs under control.” He added that data from Dieleman’s study has important implications for quality of healthcare, which may include medical laboratory diagnostics. (Photo copyright: Duke University.)

Price Spirals and Artificial Price Hikes: No Real Incentive for Regulation

Pricing for medical care is notoriously opaque. Patients are often unaware of the cost of services until the bill arrives. This lack of transparency prevents patients from comparing prices between healthcare providers and medical laboratories.

To try and create some cost transparency for consumers, Conway noted that some states, such as Maryland and Vermont, have adopted multi-payer payment models or all-payer rate settings. However, there could be resistance to such reforms, according to some experts.

Health economist Austin Frakt, PhD; and Aaron E. Carroll, MD, MS, Vice Chair for Health Policy and Outcomes Research, and Director of the Center for Health Policy and Professionalism Research at Indiana University School of Medicine, co-authored a New York Times article that agrees with Conway’s assertion. In it, they state that attempts to create regulation for healthcare prices “would be met with resistance from all those who directly benefit from high prices, including physicians, hospitals, pharmaceutical companies—and pretty much every other provider of healthcare in the United States.”

No Incentive to Lower the Prices of Medical Services

An opinion piece in the Wall Street Journal, Keith Lemer, CEO, WellNet Healthcare Group, shared a similar view. He stating that insurers and preferred provider organizations (PPOs) have no “natural incentive to keep provider prices down.” Lemer looks at the Affordable Care Act and its establishment of a medical loss ratio rule, which “requires insurers covering individuals and small businesses to spend at least 80 cents of every premium dollar on medical expenses.”

Lemer uses the cost of a routine blood test as an example, stating that when providers raise costs of such tests, “insurers can charge higher premiums, while also boosting the value of their 20% share,” which goes “towards administrative costs and profits.”

Lemer argues that the deck is stacked against consumers, and that the medical loss ratio “encourages insurers to ignore providers” artificial price hikes,” while attracting customers “with the promise of steep discounts through their PPO plans.” The resulting affect is what Lemer calls a “price spiral” that’s difficult to escape.

Higher Costs Do Not Equate to Better Care

A special JAMA communication from Irene Papanicolas, PhD, and other members of the Department of Health Policy and Management, Harvard T. H. Chan School of Public Health, Harvard Global Health Institute, and Department of Health Policy at the London School of Economics and Political Science, reports that higher US costs do not coincide with better care.

In comparison to 10 other high-income countries the US spends “approximately twice as much,” Papanicolas noted. She added that despite the higher spending in the US, the nation “performs poorly in areas such as healthcare coverage and health outcomes.”

To illustrate the difference in average costs, Papanicolas and colleagues listed “comparison prices” on a series of healthcare services between countries in 2013. For example, the price of a single computed tomography (CT) scan varies widely:

  • $896 (US);
  • $97 (Canada);
  • $279 (Netherlands); and,
  • $500 (Australia).

The high prices of clinical laboratory (AKA, pathology laboratory in Australia) diagnostics have already caused a sharp decline in the use of important imaging utilization and are at risk of affecting other aspects of clinical pathology, such as anatomic pathology (histopathology in AU) services.

PricewaterhouseCoopers (PwC) Health Research Institute’s annual medical cost report predicts 2018 medical costs will rise by 6.5% and that “price continues to be a major driver of healthcare costs” that are outpacing the economy. PwC recommends “increasing collaboration across the industry” to address the growing issue of rising medical costs and shift the burden of cost away from patients.

Clinical Laboratories Contribute to High Costs

Although US healthcare cost is a topic of intense conversation, little change may come if there is no incentive to change. Each of the recent JAMA published articles ends on the same repeated note: a plea for active debate among policy makers, healthcare providers, patients, insurers, and politicians, with the goal of decreasing healthcare costs, without sacrificing patient care.

This is also true for clinical laboratory and anatomic pathology stakeholders, which are critical aspects of the healthcare continuum, and therefore, contribute to the overall financial burden on healthcare consumers.

Amanda Warren

Related Information:

Why the US Spends So Much More Than Other Nations on Healthcare

Healthcare Spending in the United States and Other High-Income Countries

Factors Associated with Increases in US Healthcare Spending, 1996-2013

Factors Associated with Increased US Healthcare Spending: Implications for Controlling Healthcare Costs (Editorial Response)

The Best Healthcare System in the World: Which One Would You Pick?

The Deception Behind Those In-Network Health ‘Discounts’

Medical Cost Trend: Behind the Numbers 2018