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Clinical Laboratories and Pathology Groups

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Clinical Laboratories and Pathology Groups

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Yale University’s Mobile Clinical Laboratory Provides Free Medical Tests to Underserved Communities in Connecticut

Clinical laboratories nationwide could follow Yale’s example and enact programs to bring much needed lab services to traditionally underserved communities

Ever since the COVID-19 pandemic drove up demand for telehealth medical services, mobile clinical laboratories have grown in popularity as well, especially among residents of remote and traditionally underserved communities. Now, several divisions of Yale University are getting in on the trend.

In April, Yale Pathology Labs (YPL), the Yale Department of Pathology at Yale School of Medicine (YSM), and Yale School of Public Health (YSPH) unveiled their new Laboratory-in-a-Van program with plans to bring free clinical laboratory services to the public in the communities where they live, a YSPH news release announced. 

“Using a van retrofitted with laboratory-grade diagnostic equipment, the mobile clinic will employ SalivaDirect—a saliva-based COVID-19 PCR test developed at YSPH—to facilitate on-site testing with a turnaround time of two to three hours,” Yale Daily News reported.

Funded by a federal grant, the initial goal was to provide 400 free COVID-19 tests, but the program has exceeded that number. By April 10, the mobile lab had been deployed more than 60 times, appearing at events and pop-up sites throughout various communities in Connecticut, including regular stops at the WHEAT Food Pantry of West Haven.

“[The clinical laboratory-in-a-van] is a brilliant way to reduce the barriers to testing, instead taking the lab to communities who may be less likely—or unable—to access the necessary clinic or labs,” microbiologist Anne Wyllie, PhD, a research scientist who helped develop the PCR test deployed by the mobile lab told Yale Daily News. Wyllie works in the Department of Epidemiology of Microbial Diseases at Yale School of Public Health. “We are actively working with our community partners to identify how we can best serve their communities,” she added. (Photo copyright: Yale School of Medicine.)

Mobile Lab’s Capabilities

Collecting samples, processing, and delivering same-day COVID-19 results was the initial goal but that plan has expanded, Yale School of Medicine noted in a news release

“Same-day onsite delivery of test results is an added benefit for communities and individuals without access to Wi-Fi or the ability to receive private health information electronically,” Yale added. 

The mobile van is staffed with trained clinical laboratory technicians as well as community health navigators who provide both healthcare information and proper follow-up connections as needed for patients who receive positive COVID-19 results. The van runs off power from outdoor electrical outlets at each location and currently serves historically underserved populations in Hartford, Middlesex, Fairfield, New Haven, and New London counties, Yale noted.

“The van allows us to bring our services, as well as healthcare information, directly to communities where they are needed,” said Angelique Levi, MD, Associate Professor, Vice Chair and Director of Pathology Reference Services, and CLIA Laboratory Medical Director in the Department of Pathology at Yale University School of Medicine in a news release.

Launch of a High Complexity Molecular Lab on Wheels

YPL and YSPH collaborated to make the mobile lab a reality. YSPH created the saliva-based COVID-19 test and YPL “provided clinical validation necessary to get the testing method ready for emergency use authorization by the US Food and Drug Administration,” Yale noted.

“YPL recognized the need to be closer to the front lines of patient care and that retrofitting a fully licensed, high complexity molecular laboratory into a consumer-sized van was the right next step,” Chen Liu, MD, PhD, Chair of the Department of Pathology at Yale School of Medicine, noted in a Yale news release. This “gives us options to efficiently deliver accurate diagnostic information when and where it’s needed,” he added.

Throughout the COVID-19 pandemic, the Connecticut Department of Public Health, the City of New Haven, and various community organizations partnered with YPL, YSPH, and the SalivaDirect team to offer free SARS-CoV-2 testing to the public at two different sites in New Haven.

Principal investigators Levi and microbiologist Anne Wyllie, PhD, who helped develop the PCR test deployed by the mobile, lab led the Yale lab-in-a-van research project.

Flambeau Diagnostics, a biomedical company that specializing in mobile lab testing, worked with the Yale team to design and implement the mobile lab van.

“According to Wyllie, the new YSPH and YPL initiative utilizes one of the former Flambeau vans that had been retrofitted for clinical testing,” a Yale news release noted.

Kat Fajardo, Laboratory Manager at Yale University, added custom pieces of equipment to ensure seamless PCR testing. One was a Magnetic Induction Cycler (Mic) measuring only six by six inches. The Mic allowed for measurement of 46 biological specimens, while it’s diminutive size freed up space on the van’s countertop. This allowed lab techs to process specimens concurrently while also providing COVID-19 testing, according to a Yale news release.

Additionally, the van has a Myra portable robotic liquid handler which is “designed to automate the process of moving clinical specimens between vials,” the news release notes.

“What we wanted to do is run high complexity testing in the van, with a reduced timeframe, and then be able to get the results out to the patients as soon as we possibly could,” Fajardo stated.

Exploring the Mobile Laboratory’s Potential

According to a news release, YPL and YSPH consult with community partners to select locations for the mobile lab to visit. These partners include:

Although the van was initially used to provide SalivaDirect COVID-19 testing to vulnerable populations, YPL is working with its partners in those communities to identify other testing needs beyond COVID.

The Yale team is considering additional offerings and support such as the addition of a social worker as well as expanding lung health awareness beyond COVID-19 to other respiratory diseases. Also under consideration:

  • Health screenings such as for glucose levels,
  • Blood pressure checks,
  • Vaccinations including for COVID-19 and Hepatitis B, and
  • Health education and materials for harm reduction and STI prevention, a Yale news release noted. 

Yale’s Laboratory-in-a-Van program is a consumer-facing effort that is bringing much needed clinical lab services to traditionally underserved communities in Connecticut. Clinical laboratories throughout the nation could do the same with remote or homebound patients who cannot reach critical care.

—Kristin Althea O’Connor

Related Information:

High-Tech Mobile Lab-in-a-Van Will Bring Needed Testing to Underserved Communities

Yale Pathology Labs Mobile Lab Provides over 400 Free Tests to Community

Yale Pathology Labs to Serve Vulnerable Populations with New Mobile Testing Van

YSPH and YPL launch Laboratory-in-a-Van program

Pathologists Bill Out-of-Network More Frequently than Other Specialties, According to Health Care Cost Institute Study

Two national studies find pathologists bill out-of-network more frequently than other hospital-based specialties, and one study links that behavior to insurer reimbursement rates

Surprise bills for out-of-network services continue to be an important issue for healthcare consumers. Now comes a recently-released report from the Health Care Cost Institute (HCCI) claiming that pathologists are the specialists that most often bill for out-of-network hospital charges.  

The HCCI study examined the prevalence and frequency of out-of-network billing among six specialties. The sample used for the report included 13.8 million healthcare visits to over 35 thousand hospital-based healthcare providers that occurred in 2017. The types of visits examined for the report were:

  • emergency medicine,
  • pathology,
  • radiology,
  • anesthesiology,
  • behavioral health, and
  • cardiovascular services.

The researchers calculated the percentage of out-of-network claims for both inpatient and outpatient visits to each type of the six specialties.

The study found that, overall, less than half of the specialties billed out-of-network for services obtained at in-network facilities. Providers with at least one out-of-network claim associated with an in-network outpatient visit ranged from 15% for behavioral health to 49% for emergency medicine.

Pathologists’ Out-of-Network Billing

Among the pathologists surveyed, HCCI found 33% had at least one out-of-network claim for an in-network outpatient visit. Providers with at least one out-of-network claim associated with an in-network inpatient visit ranged from 18% for cardiovascular services to 44% for both emergency and pathology services.

HCCI researchers also examined how often individual providers in the six specialties billed out-of-network at least one time and found that the majority billed out of network less than 10% of the time. However, this varied among the specialties with 36% of pathologists who billed out-of-network for inpatient visits, and 20% of pathologists who billed out-of-network for outpatient visits, did so more than 90% of the time.

The graphic  from the latest HCCI report, shows the share of providers who billed out-of-network at least once for inpatient and outpatient visits
The graphic above, taken from the latest HCCI report, shows “the share of providers who billed out-of-network at least once for inpatient and outpatient visits” and illustrates the percentage of out-of-network billings by pathologists compared to other hospital-based healthcare specialties. (Graphic copyright: Health Care Cost Institute.)

Pathologists Top List of Out-of-Network Specialists in Previous HCCI report

Last November, HCCI released a similar report that examined the commonality of out-of-network billing for the same six specialties plus surgical services that took place in 2017. Based on their collected data, they also estimated the amount of surprise bills that patients could expect to receive for those services.

That report found that nationally:

  • 16.5% of visits with emergency room services had an out-of-network claim from an emergency medicine specialist.
  • 12.9% of visits with lab/pathology services had an out-of-network claim from a pathologist.
  • 8.3% of visits with anesthesiology services had an out-of-network claim from an anesthesiologist.
  • 6.7% of visits with behavioral health services had an out-of-network claim from a behavioral health provider.
  • 4.2% of visits with radiology services had an out-of-network claim from a radiologist.
  • 2.1% of visits with surgical services had an out-of-network claim from a surgeon.
  • 2.0% of visits with cardiovascular services had an out-of-network claim from a cardiovascular specialist.

Surgical Services the Most Expensive Out-of-Network Bill

This study also found broad variation in charges between types of services and healthcare settings. The researchers determined that the potential surprise bills for surgical visits due to out-of-network claims were of the greatest magnitude. HCCI estimated that the average potential surprise bill associated with an inpatient surgery was $22,248, while the potential surprise bill associated with an outpatient surgery was $8,493.

Out-of-Network Surprise Billing Varies Widely Depending on Location

The data was further broken down by state. For pathology services, the percentage of visits with out-of-network services in 2017 ranged from 0.3% in Minnesota to 75.3% in Kansas. HCCI researchers estimated the potential surprise bill for out-of-network pathology claims for inpatient services ranged from $14 in Louisiana to $167 in Delaware. The estimated surprise bill for out-of-network outpatient pathology services ranged from $23 in Louisiana to $218 in Wyoming.

Pathologists Also Top Out-of-Network Biller in Yale University Study

A Yale University study into surprise billing released in December and published in the journal Health Affairs found similar results, Modern Healthcare reported. This study examined surprise out-of-network bills incurred by patients who sought care at in-network hospitals for four types of specialists that are not chosen by patients:

  • pathologists,
  • anesthesiologists,
  • radiologists, and
  • assistant surgeons.
Zack Cooper, PhD
Zack Cooper, PhD (above), is an associate professor of public health at the Yale School of Public Health and one of the study’s authors. He noted in Yale News, “When physicians whom patients do not choose and cannot avoid bill out of network, it exposes people to unexpected and expensive medical bills and undercuts the functioning of US healthcare markets,” adding, “Moreover, the ability to bill out of network allows specialists to negotiate inflated in-network rates, which are passed on to consumers in the form of higher insurance premiums.”  (Photo copyright: Yale School of Public Health.)

For the Yale study, the researchers examined employer-sponsored insurance claims from a major commercial insurer for healthcare visits that occurred at in-network hospitals in 2015. They found that 12.3% of cases involving a pathologist were billed out-of-network, which was the highest percentage of the four specialties analyzed. By contrast, 11.8% of anesthesiologists, 11.3% of assistant surgeons, and 5.6% of radiologists billed out-of-network for their services.

The Yale study also found that “the ability of these four specialties to send patients out-of-network bills allowed them to negotiate high in-network payments from insurers, which leads to higher insurance premiums for individuals.”

The Yale study researchers determined that were these specialists unable to bill out-of-network, the particular healthcare plan would save 3.4% of their expenditures or about $40 billion per year, Modern Healthcare reported.

Surprise bills for out-of-network services burden both patients and providers. Insurers want beneficiaries to have access to hospitals and services, but providers in many specialties do not want to contract with those insurers due to low reimbursements.

This disconnect results in providers staying out-of-network and patients receiving surprise bills for out-of-network services even though the hospital was in-network. And pathologists are at the top of the list.

Anatomic pathologists across the country will want to track how government and private payers respond to these findings by amending coverage and reimbursement guidelines in ways that may be unfavorable to the pathology profession.

—JP Schlingman

Related Information:

Pathologists Most Frequent Surprise Billing Offenders, HCCI Finds

How Often Do Providers Bill Out of Network?

How Common is Out-of-Network Billing?

Out-of-Network Billing by Hospital-based Specialists Boosts Spending by $40 Billion

Study Exposes Surprise Billing by Hospital Physicians

Out-of-Network Billing and Negotiated Payments for Hospital-Based Physicians

Clinical Laboratories, Pathology Groups Being Squeezed by ‘Balanced Billing’ Dispute That Puts Providers, Hospitals, and Insurers at Odds