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.
“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.”
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.
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.
Insurance industry claims new federal price transparency regulations cost each payer as much as $13.6 million in set up and maintenance costs
Price transparency in hospital, clinical laboratory, and other service provider costs marches ever closer to reality for America’s healthcare consumers. Meanwhile, some insurers and hospital groups are working to block implementation of federal rules they argue will confuse consumers and potentially lead to higher costs.
The first is a Proposed Rule, titled, “Transparency in Coverage Proposed Rule” (CMS-9915-P) that would require payers to make public on their websites negotiated rates for in-network providers and allowed amounts paid for out-of-network providers. Insurers also would be required to make an online “tool” available to members that would provide consumers with out-of-pocket cost estimates for “all covered healthcare items and services.” The 60-day public comment period for this rule went into effect November 15, 2019.
Medical laboratories and anatomic pathology groups may want to closely monitor ongoing efforts by payers and hospital groups to block these rules, since any changes will extend to their services, as well as extend price transparency to most employer-based group health plans and health insurance issuers offering group and individual coverage.
Will Transparency Lead to Higher Healthcare Costs?
In its story on insurer claims, FierceHealthcare reported that the rule would require payers to disclose a “staggering” amount of data, leading to implementation costs 26 times more than the Trump administration’s $510,000 estimate. To comply with the federal rule, an insurer will spend as much as $13.63 million on setup and maintenance. That prediction is based on an economic analysis from economic consulting firm Bates White, which conducted the survey on behalf of The Blue Cross Blue Shield Association (BCBSA).
“Some plans have indicated they would be forced to run two sets of tools—one designed to meet member shopping needs and another implemented only to meet the requirements of the proposed rule,” the BCBSA told FierceHealthcare.
Meanwhile, the Association for Community Affiliated Plans (ACAP) argued in a letter to Centers for Medicare and Medicaid Services (CMS) Administrator Seema Verma that cost-sharing liability estimates—which are not a price quote for care—could “lead to consumer confusion and frustration.” The ACAP also asserts the transparency plan could inadvertently lead to higher healthcare cost increases.
“In the absence of quality data, consumers may determine that high cost equates to higher value, select the higher-cost providers, and ultimately drive up medical expenses, especially in circumstances where the consumer’s out-of-pocket costs have been met,” wrote ACAP Chief Executive Officer Margaret A. Murray.
“We have long supported efforts to make quality and pricing information more accessible, understandable, and actionable for consumers,” the ACHP wrote. “But they need real-time, patient-specific information tied to individual coverage benefits, not a massive published list of prices that may only frustrate consumers and likely increase costs over time.”
Hospital Associations and Healthcare Systems Bring Lawsuit Against HHS
In December 2019, several hospital associations and healthcare groups filed a lawsuit to block next year’s implementation of the hospital price transparency rule. The plaintiffs included the:
These healthcare organizations and providers joined together to argue that HHS lacks the statutory authority to require and enforce public disclosure of individually negotiated rates between commercial health insurers and hospitals. They also say consumers are likely to be confused by the information they receive.
“America’s hospitals and health systems stand with patients and are dedicated to ensuring they have the information needed to make informed healthcare decisions, including what their expected out-of-pocket costs will be,” said Rick Pollack (above), President and CEO, American Hospital Association, in a news release. “Instead of giving patients relevant information about costs, this rule will lead to widespread confusion and even more consolidation in the commercial health insurance industry.” (Photo copyright: American Hospital Association.)
In its legal response, HHS contends that hospitals are adding to consumers’ confusion by failing to provide transparency.
“They do not dispute that consumers are casting about for accurate information about prices in a complex healthcare system, yet they rely on that same complexity as an affirmative reason to deprive patients of pricing information they need to figure out their out-of-pocket expenses,” HHS said in its brief.
DePaul University Professor Anthony LoSasso, PhD, who specializes in healthcare economics, admits to being “on the fence” regarding the pros and cons of transparency plans.
“I want to think that people can benefit from price transparency. But for a variety of reasons, people don’t look at pricing info even when it’s available,” LoSasso told WTTW News in Chicago.
Nevertheless, HHS vows to continue its push for price transparency.
“Hospitals should be ashamed that they aren’t willing to provide American patients the cost of a service before they purchase it,” HHS Deputy Assistant Secretary and National Spokesperson Caitlin Oakley told Reuters in a response to the hospital groups’ lawsuit.
In light of the government’s push to make healthcare pricing more transparent, clinical laboratory and anatomic pathology leaders in hospitals and health systems would be wise to prepare for a future that includes price shopping by consumers.
Schwan’s concerns about inaccurate or unreliable COVID-19 serology tests were supported when the FDA issued more restrictive rules for these medical laboratory tests on May 4
During a conference call with investors about the company’s first-quarter results, Schwan said of the recently-launched COVID-19 antibody assays, “These tests are not worth anything, or have very little use,” according to reporting from Reuters and other publications. “Some of these companies, I tell you, this is ethically very questionable to get out with this stuff.”
On May 3, Roche announced that its own Elecsys Anti-SARS-CoV-2 antibody test for SARS-CoV-2, the coronavirus that causes the COVID-19 illness, had obtained an emergency use authorization (EUA) from the federal Food and Drug Administration (FDA). In its news release, Roche stated that “the serology test has a specificity greater than 99.8% and sensitivity of 100% (14 days post-PCR confirmation).”
In a separate interview with Bloomberg, Schwan said about antibody testing, “It is very important to pick the right test and then to validate those tests with enough patients.” He then returned to the issue of poor quality in some antibody tests for the SARS-CoV-2 virus, saying, “Unfortunately, there are a number of tests already out there in the market which are not reliable simply because they haven’t been tested sufficiently.”
In reference to the initial release of serological COVID-19 antibody tests, CEO Severin Schwan (above) said during Roche Holding’s first quarter earnings call that, “It’s a disaster. These tests are not worth anything, or have very little use,” reported CNBC. He added, “This is really what matters. Every kind of amateur could produce an antibody test. The two of us could do it overnight in the garage. That’s not the problem. The question is, does it really work? And for that, you have to do testing and validation.” (Photo copyright: Reuters/Arnd Wiegmann.)
A ‘Wild West’ of Unregulated Assays
Prior to issuing tougher rules for how a manufacturer can market a COVID-19 serological test, the FDA had listed about 200 serological tests designed to identify antibodies produced by the human immune system in response to a SARS-CoV-2 infection. This is the process of seroconversion, which is the development of detectable antibodies in a patient’s blood against a pathogen. Detection of IgG antibodies indicates exposure to SARS-CoV-2, according to ARUP Laboratories.
Public health experts have raised questions about the proliferation of such tests for the new coronavirus. Under the FDA’s previous March 16 rules—which were more relaxed than those FDA applied when granting EUAs—the agency was swamped with requests to review more than 200 COVID-19 antibody tests. The looser regulations resulted in nearly no oversight of those tests, reported the Associated Press (AP).
In comments to the AP, Eric Blank, DrPH, Senior Director of Public Health Systems and Programs for the Association for Public Health Laboratories (APHL), said, “Right now it’s a wild west show out there. It really has created a mess that’s going to take a while to clean up.”
“In the meantime,” Blank added, “you’ve got a lot of companies marketing a lot of stuff and nobody has any idea of how good it is.” Blank confirmed to Dark Daily that he made these comments and stands by them.
Calls for Closer Scrutiny of Serological Antibody Tests
In response to the FDA’s March 16 rules for COVID-19 serology tests, APHL requested the federal agency to review its looser approach to reviewing these tests. The impact of the FDA’s much tougher COVID-19 serological testing rules released on May 4 was immediate.
In a press release issued on May 2, the FDA said, “to date, the FDA has authorized 105 tests under EUAs, which include 92 molecular tests, 12 antibody tests, and one antigen test.”
Clinical laboratories in the United States still face difficult challenges if they plan to launch their own COVID-19 serology testing programs. They must select one or more tests from among the antibody and antigen tests that have an FDA EUA. However, data for each of these tests is not as comprehensive as is the data for diagnostic test kits reviewed by the FDA and cleared for market under the pre-market approval process.
This webinar was conducted by James O. Westgard, PhD, and Sten Westgard of Westgard QC, Inc., and the full program is available for free download by clicking here, or by placing this URL in your web browser: https://www.darkdaily.com/webinar/quality-issues-your-clinical-laboratory-should-know-before-you-buy-or-select-covid-19-serology-tests/.
In the webinar recording, the Westgards provide a detailed overview of what elements are required for a clinical lab to have confidence that its COVID-19 serology testing program is producing accurate, reliable results. They explain that labs must understand the unique aspects of the populations they are testing in their communities. All of these factors can then be used by labs to evaluate the different COVID-19 serology tests available for them to purchase, and to select the test that best fits their lab’s capabilities and the characteristics of the patient population that will be tested.
Another important requirement for clinical laboratories to understand is the list of steps necessary to bring up a COVID-19 serological testing program. That starts with validating the test, then bringing it into daily production. As that happens, issues associated with quality control (QC), proficiency testing (PT), and regulatory compliance take center stage, so that the clinical lab has high confidence in the accuracy and reproducibility of the COVID-19 serology test results they are using in patient care or in support of employers who are screening employees for COVID-19.
To register for the June 11 webinar, click here, or place this URL in your web browser: https://www.darkdaily.com/webinar/achieving-high-confidence-levels-in-the-quality-and-accuracy-of-your-clinical-labs-chosen-covid-19-serology-tests/.
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One popular feature is the COVID-19 Live! conference calls that happen every Tuesday and Thursday for 30 minutes at 1 PM, EDT. Visit the COVID-19 STAT Intelligence Briefings website and join us for the live calls.
In another example of giving consumers more direct access to medical laboratory tests, Walmart believes that convenience and lower prices can help it capture market share
Retail giants continue to add healthcare services—including medical laboratory testing—to their wares. It’s a trend that pressures hospital systems, clinical laboratories, pathology groups, and primary care providers to compete for customers. And, while in most instances competition is good, many local and rural healthcare providers cannot reduce their costs enough to be competitive and stay in business.
This is true at Walmart (NYSE:WMT), which recently opened its second “Health Center” in Georgia and announced prices for general healthcare services 30% to 50% below what medical providers typically charge, reported Modern Healthcare.
The services offered at the new Walmart Health Center in Calhoun, a suburb of Atlanta, include:
Primary care
Dental
Counseling
Clinical laboratory testing
X-rays
Health screening
Optometry
Hearing
Fitness and nutrition
Health insurance education and enrollment
A Walmart news release states, “This state-of-the-art facility provides quality, affordable and accessible healthcare for members of the Calhoun community so they can get the right care at the right time … in one facility at affordable, transparent pricing regardless of a patient’s insurance status.”
The fact that Walmart posts “Labs” on the Health Center’s outdoor sign may indicate the retail giant considers easy access to clinical laboratory testing a selling point that will draw customers.
“By offering clinical laboratory testing in support of primary care and urgent care, Walmart may be able to lower prices for lab tests in any market that it enters,” said Robert Michel, Editor-in-Chief of Dark Daily and its sister publication The Dark Report, and President of The Dark Intelligence Group.
The sign above on the exterior of Walmart Health Centers lists the services offered. By advertising “Labs” Walmart is confirming that growing numbers of consumers want to order their own lab tests and that the availability of lab tests gives its medical clinic a competitive advantage. (Photo copyright: Modern Healthcare.)
Healthcare Transparency and Lower Prices
The 1,500 square-foot free-standing Walmart Health Centers offer more services than the in-store Care Clinics installed in other Walmarts throughout Georgia, South Carolina, and Texas. For its healthcare services, Walmart established partnerships with “on-the-ground” health providers to offer affordable services.
“We have taken advantage of every lever that we can to bring the price of doing all of this down more than any hospital or group practice could humanly do. Our goal, just like in the stores, is to get the prices as low as we can,” Sean Slovenski, Senior Vice President and President of Walmart Health and Wellness, told Bloomberg Businessweek.
Some of the clinical laboratory prices prominently posted in the building and noted on the Health Center online price list include:
Meanwhile, the average cost to visit a primary care doctor is $106, according to Health Care Cost Institute data cited by Business Insider, which noted that Walmart’s rates “could be a steep mountain for traditional providers to climb.”
However, Rob Schreiner, Executive Vice President of WellStar Health System in Northern Georgia told Modern Healthcare that “Walmart will offer a cheaper alternative for working-class families who may not have health insurance and may not have an established relationship with a primary care provider.”
Convenient Access to Quality Healthcare Services a Major Draw
At a freestanding Walmart Health Center, people can park near the entrance and walk a few steps to the entrance, rather than traversing aisles to a Care Clinic inside a Walmart Supercenter. And for many customers, finding a Walmart Health Center may not be as complicated or stressful as visiting doctors’ offices.
That seems to be Walmart’s goal—not simply using the Health Centers to increase traffic in its stores, Slovenski said. “We are trying to solve problems for our customers. We already have the volume,” he told Forbes. “We have the locations and the right people. We are creating a supercenter for basic healthcare services.”
Walmart’s arrangement with local healthcare providers differs from traditional primary care clinics staffed by doctors who are practice owners, or who are employed by nearby hospitals and health systems.
“The whole design of the clinic is curious to most of the doctors here [in Dallas, Ga.],” Jeffrey Tharp, MD, Chief Medicine Division Officer, WellStar Medical Group, told Modern Healthcare. “We are advocating integration into our network, for instance with patients who need a cardiologist coming from Walmart to WellStar.”
Clinical laboratory leaders may want to explore partnerships with Walmart and other retailers that are developing healthcare centers to deliver primary care services in places where masses of people shop for everyday items. Especially given that these big-box retailers remain open during healthcare crises like the COVID-19 pandemic.
As federal and state officials ease many regulatory requirements to speed new COVID-19 serology tests to market with minimum data about performance, labs are left with important questions to answer on their own
Every day, elected officials at all levels of government call for a huge expansion of COVID-19 serology testing. But, as most clinical laboratory managers and pathologists know, it is a complex undertaking for a lab to select any serological test, validate it, then run it daily in support of patient care, and have confidence that the results are accurate and reproducible.
Clinical laboratories across the United States understand the volume of testing will be in the tens of millions—even hundreds of millions—of COVID-19 serology tests. That is an important financial opportunity because it gives clinical labs the opportunity to generate some cash flow to offset the 60% decline in daily routine specimens they have experienced since most states enacted shelter-in-place orders in early March.
But this big opportunity to serve physicians and patients with COVID-19 serology testing also comes with equally big risks. There are three major risks a COVID-19 serology testing program that clinical labs must successfully address, otherwise the consequences can be devastating.
Three Major Serology Testing Risks for Clinical Laboratories
Risk one comes during the time when medical laboratories shop for COVID-19 serology tests. As of this writing, about 20 such tests have an emergency use authorization (EUA) with the Food and Drug Administration (FDA) and more are expected to obtain an EUA. As is true with everything in life, not all of these tests will perform equally. The risk to the lab is that it purchases a COVID-19 assay that later proves to be unreliable, despite the lab’s rigorous validation process.
Risk two derives from the fact that new diagnostic methods are being incorporated into the serology tests that companies are submitting to the FDA for an EUA. Although the data submitted to the FDA may indicate acceptable performance to the federal agency, in actual clinical use many unexpected or unknown factors could be recognized which lower confidence that the new method utilized by this particular assay is producing accurate results. That risk would only be recognized downstream from validation and the lab would find itself dealing with unhappy physicians, patients, and employers (who were using the test to check the health of their employees).
Risk three is supply chain risk. Will the manufacturer of the COVID-19 serology test be capable of supplying all of its clinical lab customers with adequate supplies to meet each lab’s demand for this testing? New manufacturers have an unknown track record in their ability to supply their lab customers. But even the largest in vitro diagnostics (IVD) manufacturers may need to ration kits, reagents, and other consumables to the large number of medical laboratories they serve. This happened with the rapid molecular tests for COVID-19. Community laboratories capable of performing these tests could not obtain adequate supplies to serve their client physicians.
Millions Lost on Faulty COVID-19 Serology Test Kits
If there is a fourth major risk to clinical labs performing COVID-19 serology tests for physicians, patients, and employers (who are screening employees in their workplace) it is the negative publicity that can result if a lab’s choice of a COVID-19 serology test ends up generating inaccurate or unreliable test results.
The most recent example is here in the United States. On March 27, Abbott Laboratories announced that the FDA had issued an EUA for its Abbott ID NOW platform and its point-of-care rapid molecular test for COVID-19 that could produce results in less than 15 minutes. This made national news and was hailed regularly during the daily White House COVID-19 Task Force briefings.
What is important with the examples of Spain, United Kingdom, and a major IVD manufacturer is that news outlets are ready to pounce on any evidence that COVID-19 tests are returning inaccurate or unreliable results. This is a source of risk which every clinical laboratory wants to avoid.
How Clinical Laboratories Can Minimize Risk When Buying COVID-19 Serology Tests
During their upcoming webinar, James Westgard, PhD (above), and Sten Westgard of Westgard QC will address how clinical laboratory leaders can evaluate different serology COVID-19 tests by: understanding the testing architecture and intended medical use of COVID-19 testing, taking inventory of lab resources; navigating EUA, LDT, and non-EUA regulatory approval; assessing the expected performance of test methods; understanding the critical performance characteristics for COVID-19 testing; and much more. (Photo copyright: Dark Daily.)
This is an exceptional opportunity to gain an inside perspective of how your lab can address the three major risks identified above when selecting a COVID-19 serology test for use in patient care. You’ll gain essential insights about how to assess the public data on tests with an EUA.
This webinar presentation will also discuss how your lab should view all of its COVID-19 testing as a single program. That’s because your lab may test the same patient with a rapid molecular test, then later do serology tests in the days after the patient may have cleared the infection.
Register now for this critical educational opportunity by clicking here or by entering this URL in your web browser (https://www.darkdaily.com/webinar/quality-issues-your-clinical-laboratory-should-know-before-you-buy-or-select-covid-19-serology-tests/).
