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Clinical Laboratories and Pathology Groups

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In the Field, Clinical Laboratory Specimen Transportation is Being Complicated by the COVID-19 Pandemic

Lab leaders who adopt best practices in courier services will help ensure their lab’s supply chains remain secure

Hospital and health systems using courier services to transport patients’ biological specimens from doctors’ offices and other locations to clinical laboratories for testing and reporting are finding those services delayed or disrupted by the COVID-19 pandemic.  

Limited office hours, closed physician practices, and the need for drivers to take time for symptom checking on healthcare campuses are among the growing challenges faced by couriers transporting medical laboratory specimens during this pandemic, experts told Dark Daily.

All these developments require courier operations and logistics companies to think outside the box for solutions that address the unique challenges triggered by the SARS-CoV-2 pandemic that have disrupted the normal operations of physicians’ offices, hospitals, and other healthcare providers. For example, many clinical labs struggle to obtain enough specimen collection and specimen transport supplies to sustain both their nascent COVID-19 testing programs and their routine testing operations.

One national logistics company recognized that it could help labs with the disruption in the supply chain for laboratory supplies caused by the coronavirus outbreak. In the early weeks of the pandemic, West Haven, Conn.-based Lab Logistics and its sister company Path-Tec, took the initiative to develop collaborations and strategic partnerships with several established manufacturers of medical laboratory supplies. Now it could not only be a source of much-needed supplies for its clients, but its network of couriers could supply the increase in services for all the locations where such supplies were needed.

Meanwhile, the coronavirus outbreak caused widespread disruption to the daily activities of hospitals, health systems, physician’s offices, and other providers. According to Susan Uihlein, Senior Vice President Business Development-Hospital Couriers at Lab Logistics—a company that creates, implements, and manages courier models customized to medical laboratory, hospitals, and health systems—in response to the pandemic, there was an immediate need by one of the largest multi-regional Health Systems in New York to align courier and logistics services to meet the new realities of how its facilities would respond to patient needs. It was also necessary that logistics solutions be complementary with the health systems’ COVID-19 policies.

“This health system requested that Lab Logistics’ drivers access the hospital’s personnel tracking application upon arrival,” explained Uihlein. “The health system’s new COVID-19 policy required everyone wishing to enter the health system campus to complete a coronavirus screening process—including having a temperature reading taken—and then receive a status confirmation on a smartphone screen. This obviously impacted the couriers’ progress on their routes.”

“We have 2,600 medical-specific couriers throughout the United States, and although all couriers undergo extensive orientation regarding known infectious transport, this current situation has spotlighted how important (COVID-19) is to our clients,” Brian McArdle, President and Chief Executive Officer of Lab Logistics, told Dark Daily.

“The couriers represent us and our clients,” he continued. “They are out in the field, they are picking up, delivering, and rolling with the punches as far as what a healthcare system or a clinical laboratory needs from them—from photo IDs to wearing masks and gloves. The process keeps evolving. And we have evolved with it.”

 “Our operations team makes sure that we work with each client to flexibly react to changes in that day’s pickups and deliveries, as appropriate. There has been much optimization and on-the-fly changes,” said Uihlein.

In fact, the coronavirus pandemic resulted in a 26% increase in requests for specimen delivery, PPE, and COVID-19 related supply chain movement, according to data on the California, Louisiana, and New York City healthcare markets provided by Lab Logistics.

“Every day there have been changes to what is open and closed. We had to manage that through our proprietary healthcare dispatch system and with the couriers,” Susan Uihlein (above), Senior Vice President Business Development-Hospital Couriers at Lab Logistics, told Dark Daily. Lab Logistics transports medical specimens, supplies, and pharma for more than 350 US hospitals, healthcare systems, and clinical laboratories. (Photo copyright: LinkedIn.)

Clinical Laboratories Should Review Specimen Transport Procedures

Clearly, the COVID-19 pandemic is putting unique stresses on the logistics and transportation services operated by hospital systems, medical labs and anatomic pathology groups. That why it would be timely and appropriate for lab leaders to review/update best practices and necessary requirements that ensure efficient management of clinical laboratory specimens.

“The COVID-19 pandemic triggered heightened risks in security, custody, and transit tracking of specimens so as to maintain a heightened biosafety level, while at the same time, the pandemic dramatically reduced the daily volume of more routine lab samples,” notes a Special Edition White Paper Dark Daily produced in partnership with Lab Logistics, titled, “Specimen Management and Logistics Issues to Evaluate for Continuous Quality Improvement—3 High-Risk Medical Courier Support Services.”

Topics covered in this highly-informative white paper include:

  • Handling and tracking laboratory specimen samples;
  • Confirming medical security, chain of custody, and transit tracking;
  • Coordinating test kits, supplies, reagents, lab equipment, and instruments;
  • Approaching a medical courier service conversion.

“By utilizing a logistics system that includes a dedicated courier, medical laboratories and healthcare systems can manage all aspects of transportation specimen transport, including handling and tracking of specimens, medical security, chain of custody, tracking supply inventory, and delivery. Successfully executed, all of these functions can generate financial improvements,” notes the white paper.

Tracking Specimen Arrival and Predicting Which Tests Will Be Needed

One technology that lab and healthcare system leaders can use to control costs and staffing involves online real-time tracking of drivers to enhance test turnaround time and determine when tests will be performed.

Lab Logistics’ version of this technology uses barcode scanning, GPS (Global Positioning System) tracking, and an online portal that enables its clients to view the routes and stops a driver has made for the lab. Lab leaders can determine how many specimens are expected, and what type of tests will be required, before the specimens arrive.

“They can see the volume coming in and they can staff-up based on the information we are giving them and not over-staff. It’s really good information,” Uihlein said.

Lab Logistics’ platform also integrates with a hospital’s laboratory information system (LIS) through the lab’s barcode. “The integration makes it possible for labs to get faster information from the field into their systems and create accessioning,” Uihlein explained.

Specimen Management Improved through Route Tracking

Tracking their drivers has enabled some labs to find new routes with less stops. Mike Napolitano, former General Manager for Constitution Diagnostics Network, Sunrise Medical Laboratory, and Sonic Healthcare, discovered that modified routes enhanced his lab’s efficiency. 

“We found that some drivers were doing daily pickups and we were not getting any specimens. Some clients were on vacation, stopped using the laboratory altogether, or weren’t doing that type of laboratory work anymore,” Napolitano told the white paper researchers.

Driver tracking also enabled Ochsner Health System in Louisiana to avoid “hot shots”—one-time delivery pickups which could be 90 miles away from the lab, explained Lloyd Gravois, Assistant Vice President of Logistics-Supply Chain, in the white paper. 

Medical laboratory leaders who wish to enhance their lab’s specimen management and solve logistics issues during and after the COVID-19 pandemic are encouraged to download a copy of the Free Special Edition white paper by clicking here, or by placing this URL in their web browsers: https://www.darkdaily.com/free-special-edition-white-paper-specimen-management-and-logistics-issues-to-evaluate-for-continuous-quality-improvement-3-high-risk-medical-courier-support-services/.

—Donna Marie Pocius

Related Information:

Specimen Management and Logistics Issues to Evaluate for Continuous Quality Improvement: 3 High-Risk Medical Courier Support Services

UnitedHealthcare Announced It Would Cover Certain Pharmacogenomic Tests; However, Experts Hotly Debate the Value of Such Clinical Laboratory Testing

Though more payers are covering laboratory-developed genetic tests for conditions such as depression, the tests remain uncleared by the FDA

Clinical pathologists interested in pharmacogenetics tests for depression and other psychiatric disorders may be interested to learn that UnitedHealthcare (NYSE:UNH) announced in its Network Bulletin a change to its Molecular Pathology Policy and is now covering certain molecular diagnostics. That’s despite the federal Food and Drug Administration (FDA) warning “against the use of many genetic tests with unapproved claims to predict patient response to specific medications.”

In its Safety Communication, the FDA stated healthcare providers and clinical laboratories that “are using, or considering using, a genetic test to predict a patient’s response to specific medications, be aware that for most medications, the relationship between DNA variations and the medication’s effects has not been established.”

In its coverage of the FDA’s warning, The Dark Report, sister publication to Dark Daily, wrote, “Serious concerns are associated with some pharmacogenetic tests and whether physicians have the training and knowledge needed to use this genetic test data appropriately in patient care.”

Should the FDA Even Be Regulating Clinical Laboratory Tests?

Experts note that it is notoriously difficult in some cases for providers to identify which drug or group of drugs is most likely to help a patient with a psychiatric disorder such as depression. Pharmaceuticals that work well for one individual may actually worsen things for someone else.

Nevertheless, the idea that a genetic test could reveal how a psychiatric patient is likely to react to a particular drug is extremely appealing. It could save years of trial and error, which is often terribly disruptive for the patient.

Thus, several molecular diagnostics companies have come up with laboratory-developed tests (LDTs) for pharmacogenomics that they claim can do exactly that. Genomind and Myriad Genetics, as well as others are all marketing LDTs for pharmacogenomics, including Inova Genomics Laboratory, of Falls Church, Va. However, after receiving its own warning letter from the FDA, Inova discontinued sales of its MediMap genetic tests.

Currently, there’s quite a debate about whether these tests should be available, who should take them, and whether they offer any kind of guidance for providers. There’s even a faction that maintains the FDA should not be regulating clinical laboratory tests at all.

In its coverage of the FDA’s warning, NPR reported that Victoria Pratt, PhD (above), a medical and clinical molecular geneticist who at the time was President of the Association for Molecular Pathology (AMP), said, “Tests conducted in a lab are a medical service, not a medical device that’s shipped like a product. As a medical service, clinical laboratories are already regulated by the Centers for Medicare and Medicaid Services. It would be redundant to have dual regulation by both the FDA and CMS.” (Photo copyright: AMP.)

Does Evidence of Pharmacogenomics Effectiveness Exist?

Studies regarding the effectiveness of genetic tests for psychiatric disorders have had, at best, mixed results. “Genes determine some of our risk for depression and some of our response to treatment,” wrote Bruce Cohen, MD, PhD, and George Zubenko, MD, PhD, in a Harvard Health Blog post, titled, “Gene Testing to Guide Antidepressant Treatment: Has Its Time Arrived?” The authors go on to say that although the genes that are tested in the panels can have an effect on the levels of the drugs in the patient’s blood, they “generally don’t predict clinical response.”

The authors then discussed the results of a dozen studies that looked into the genetic panels. “Most studies were completely unblinded,” they wrote. “Even with that bias, the use of gene results showed no evidence of effectiveness.”

Advocacy Groups, Payors, and Clinicians Support Pharmacogenomics

Nevertheless, even with the FDA’s warning—and tepid study results— pharmacogenetic testing has its supporters. In large part, that is because identifying the most appropriate medication for any given patient can be incredibly difficult.

“Right now, one of our greatest frustrations is that when [patients] comes in with depression, we have very little idea of what the right treatment for them is,” said Amit Etkin, MD, PhD, Founder and CEO of Alto Neuroscience. Etkin is a professor in the Department of Psychiatry and Behavioral Sciences at Stanford and a member of the Wu Tsai Neuroscience Institute. He authored a study published in Nature that investigated measuring patients’ brainwaves to identify the most appropriate treatment. “Essentially, the medications are chosen by trial and error.”

“You use the science that you currently have,” Reyna Taylor, Vice President of Public Policy and Advocacy, National Council for Behavioral Health, told NPR. She says that doctors should be able to use the tests to inform their choice of medication.

Daniel Mueller, MD, PhD, a psychiatrist and clinical scientist, agrees. Mueller is a professor at the University of Toronto and head of the Pharmacogenetic Research Clinic at the Center for Addiction and Mental Health (CAMH) in Toronto. He told NPR that the pharmacogenomic clinical laboratory tests “are not an alternative intervention. It’s additional information.” He suggests that anyone who can afford the test should take it, because it could help them avoid “the cost of depression and weeks of suffering.”

The decision by UnitedHealthcare to cover genetic tests for depression and other psychiatric disorders could be important. “We expect this to be a tipping point,” Shawn Patrick O’Brien, CEO of Genomind, told NPR, adding that he expects other insurance companies to begin covering the cost of the tests, as well, “because they don’t want to be uncompetitive in the marketplace.”

Historically, there have been few clinical laboratory tests for patients with psychiatric disorders, and while these tests may open a new market in the future, for now, caution is warranted. In addition to the warning from the FDA, there will likely be challenges regarding physician education and curbing fraud.

—Dava Stewart

Related Information:

The FDA Warns Against the Use of Many Genetic Tests with Unapproved Claims to Predict Patient Response to Specific Medications: FDA Safety Communication

DNA Tests for Psychiatric Drugs Are Controversial but Some Insurers Are Covering Them

Gene Testing to Guide Antidepressant Treatment: Has Its Time Arrived? 

An Electroencephalographic Signature Predicts Antidepressant Response in Major Depression

Concerns Raised of Pharmaceutical Tests

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

Health Insurers and Hospital Groups Argue Price Transparency Rules on Hospitals, Clinical Laboratories, and Other Providers Will Add Costs and ‘Confuse’ Consumers

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 pushback from hospital and payer lobbies centers on a pair of new federal rules that build on directives in President Trump’s 2017 Executive Order Promoting Healthcare Choice and Competition (13813) and that direct federal agencies to modify their implementation of the Patient Protection and Affordable Care Act.

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.

The second is a Final Rule which goes into effect on Jan.1, 2021, titled, “Medicare and Medicaid Programs: CY 2020 Hospital Outpatient PPS Policy Changes and Payment Rates and Ambulatory Surgical Center Payment System Policy Changes and Payment Rates. Price Transparency Requirements for Hospitals to Make Standard Charges Public” (CMS-1717-F2). The rule requires hospitals to disclose online not only their chargemaster prices but also prices negotiated with payers for 300 “shoppable” healthcare services.

These shoppable services include:

Medical Laboratory and Pathology Services

  • Basic metabolic panel
  • Blood test, comprehensive group of blood chemicals
  • Obstetric blood test panel
  • Blood test, lipids (cholesterol and triglycerides)
  • Kidney function panel test
  • Liver function blood test panel
  • Manual urinalysis test with examination using microscope
  • Automated urinalysis test
  • PSA (prostate-specific antigen)
  • Blood test, thyroid-stimulating hormone (TSH)
  • Complete blood cell count, with differential white blood cells, automated
  • Complete blood count, automated
  • Blood test, clotting time
  • Coagulation assessment blood test

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.

The Alliance of Community Health Plans (ACHP) echoed those views in its own statement, claiming the Trump plan will burden consumers and drive up costs.

“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.

—Andrea Downing Peck

Related Information:

Executive Order Improving Price Quality and Transparency in American Healthcare to Put Patients First

Transparency in Coverage Proposed Rule (CMS-9915-P)

Medicare and Medicaid Programs: CY 2020 Hospital Outpatient PPS Policy Changes and Payment Rates and Ambulatory Surgical Center Payment System Policy Changes and Payment Rates. Price Transparency Requirements for Hospitals to Make Standard Charges Public

Insurers: Price Transparency Rule Puts ‘Staggering,’ Expensive Burden on US

Lawsuit vs Alex M. Azar II, in his official capacity as Secretary of Health and Human Services

Hospital Groups File Lawsuit Over Illegal Rule Mandating Public Disclosure of Individually Negotiated Rates

The Pros and Cons of New Health Care Price Transparency Rule

Azar Price Transparency

Hospital Groups File Lawsuit to Block Trump’s Price Transparency Rule

Walmart Opens Second Health Center Offering Clinical Laboratory Tests and Primary Care Services

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:

  • Primary care physician office visit $40
  • Lipid $10
  • Hemoglobin A1c $10
  • Pregnancy Test $10
  • Flu Test $20
  • Strep Test $20
  • Mono Test $20

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.”

Other Retailers Offering Primary Care Services

Walmart is not the only retailer moving into the outpatient healthcare market. Dark Daily recently reported on CVS Health’s and Walgreens’ strategies in delivering primary care, as well as on the Amazon Care pilot program, which may lead to Amazon becoming a primary care provider as well. (See, “Amazon Care Pilot Program Offers Virtual Primary Care to Seattle Employees; Features Both Telehealth and In-home Care Services That Include Clinical Laboratory Testing,” January 31, 2020.)

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.

—Donna Marie Pocius

Related Information:

Walmart Tests Leap into Healthcare Business by Opening Second Clinic

Calhoun Walmart Remodel Features Opening of New Walmart Health Center

Walmart Takes on CVS, Amazon with Low Price Healthcare Clinics

Walmart Health Center Price List

Walmart Opens Second Primary Care Center

Walmart’s First Healthcare Services Supercenter Opens

Walgreens, CVS Add New Healthcare Services and Technology in Their Retail Locations; is Medical Laboratory Testing Soon to be Included?

Amazon Care Pilot Program Offers Virtual Primary Care to Seattle Employees, Features Bot Telehealth and In-Home Care Services that Include Clinical Laboratory Testing

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