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Clinical Laboratories and Pathology Groups

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Clinical Laboratories and Pathology Groups

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CMS’ Latest Value-Based Care Reimbursement Model Explores Geographic Direct Contracting for Medicare, Focuses on Costs and Quality

Physicians engaged with CMS in value-based care are asking clinical laboratories to help them close gaps in patient care through testing  

Clinical laboratories know that any change to how the federal Centers for Medicare and Medicaid Services (CMS) reimburses healthcare providers could also affect how labs are reimbursed for services they provide. Thus, lab leaders will want to take note of the latest value-based reimbursement model being tested by the Center for Medicare and Medicaid Innovation at CMS.

Called the Geographic Direct Contracting Model (GEO), CMS’ new “voluntary payment model” aims at giving providers of Medicare Part A and Part B services “a direct incentive to improve care across entire geographic regions,” according to a CMS press release.

“The Geographic Direct Contracting Model is part of the Innovation Center’s suite of Direct Contracting models and is one of the Center’s largest bets to date on value-based care,” Brad Smith, Deputy Administrator and Director of the Center for Medicare and Medicaid Innovation (CMMI), told RevCycleIntelligence. Smith is also the former CEO and co-founder of Aspire Health.

According to a CMS Fact Sheet, the GEO model “will test whether a geographic-based approach to value-based care can improve quality of care and reduce costs for Medicare beneficiaries across an entire geographic region.”

“This model allows participating entities to build integrated relationships with healthcare providers and invest in population health in a region to better coordinate care, improve quality, and lower the cost of care for Medicare beneficiaries in a community, said CMS Administrator Seema Verma in the CMS press release. Clinical laboratories may find opportunities as well, to collaborate with physicians in the clinical decision-making process. (Photo copyright: Business Insider.)

CMS Continues to Move Away from Fee-for-Service

Years ago in “CMS Seeks ‘New Direction’ for its Innovation Center as the Agency Evaluates Current Value-Based Payment Models for Medicare Services, including Medical Laboratory Testing,” Dark Daily alerted readers that CMS was planning to offer different models of value-based care and that medical laboratory revenues could be affected as the federal agency aims to move reimbursement for healthcare—including clinical laboratory testing—away from the fee-for-service payment model.

“Leveraging best practices and lessons learned from prior Innovation Center models, Geo will enable Direct Contracting Entities (DCEs) to build integrated relationships with healthcare providers and community organizations in a region to better coordinate care and address the clinical and social needs of Medicare beneficiaries,” the CMS Fact Sheet states.

“If we’re successful, we’ll move value-based care from something that might be 10 or 20% of somebody’s revenue to something that’s 80 or hopefully 100% of somebody’s revenue (in five to 10 years),” Smith told MedPage Today.

Healthcare providers and health plans that participate in the Geographic Direct Contracting model must be covered entities under the Health Insurance and Portability Accountability Act (HIPAA) and submit applications by April 2, 2021, the CMS fact sheet states.

 The first performance period starts Jan. 1, 2022, and participation is voluntary. Direct contracting entities take “100% shared savings and shared losses for Medicare Part A and B services for aligned Medicare fee for service beneficiaries in a defined region,” the CMS fact sheet explained.

CMS is considering implementing the GEO model in Atlanta, Dallas, Denver, Detroit, Houston, Los Angeles, Miami, Minneapolis, Orlando, Phoenix, Philadelphia, Pittsburgh, Riverside, San Diego, and Tampa.

“By initially testing the model in a small number of geographies, we will be able to thoughtfully learn how these flexibilities are able to impact quality and costs,” Smith told RevCycleIntelligence.

How Will Value-Based Care Programs Affect Clinical Laboratories?

Value-based payment arrangements require doctors to accept changes to how they are reimbursed for their services. In kind, doctors are examining how clinical laboratories can take on an enhanced role in clinical decision making.

“Physicians and hospitals in a value-based environment need a different level of service and professional consultation from the lab and pathology group because they are being incented to detect disease earlier and be active in managing patients with chronic conditions to keep them healthy and out of the hospital,” said Robert Michel, Publisher and Editor-in-Chief of Dark Daily and its sister publication The Dark Report.

Michel explained that value-based care providers are calling on labs to go beyond reporting accurate test results within allotted turnaround times. “They want collaboration in identifying at-risk patients and in finding and closing gaps in care by using laboratory test results.”

Medical laboratory leaders may want to reach out to healthcare providers participating in value-based care models to explore areas of interest relating to patient population, chronic conditions, and severity of illness. 

As Dark Daily reported in “Repositioning the Clinical Laboratory as a Strategic Pillar of the Value-Based Healthcare Organization, Consistent with Clinical Lab 2.0,” labs need to be effective and efficient performers in integrated delivery networks and play a critical role in coordinating care.

Clinical laboratories that offer testing and reporting and additionally collaborate with healthcare providers and health plans in ways that contribute to improved patient outcomes and lowered costs, may be in a position to earn any financial rewards from these and other new value-based arrangements.

—Donna Marie Pocius

Related Information:

CMS Announces New Model to Advance Regional Value-Based Care in Medicare

CMS Announces a New Value-Based Direct Contracting Model

CMMI Expanding Direct Contracting, Advancing Other New Models

Facts: Geographic Direct Contracting Model “Geo”

Changes Coming to Bundled Payments and Direct Contracting, CMMI Chief Says

CMS Seeks New Direction for Its Innovation Center as the Agency Evaluates Current Value-Based Payment Models for Medicare Services Including Medical Laboratory Testing

Repositioning the Clinical Laboratory as a Strategic Pillar of the Value-Based Healthcare Organization Consistent with Clinical Lab 2.0

University of Kansas Health System Laboratory Shares Lessons from Assessing Pooled Testing for COVID-19 Patients

Available funds and disease prevalence affect whether pooled testing is feasible and desirable, notes University of Kansas Health System microbiology laboratory director

Pooled testing for the SARS-CoV-2 coronavirus has its supporters and its critics. There is no one-size-fits-all when it comes to pooling multiple patients’ biological samples into a single COVID-19 test in the hopes that the result will be all negative. Several factors must be in place for COVID-19 pooled testing to be viable at individual clinical laboratories. The experience of medical labs that considered doing pooled testing are informative.

For example, when Rachael Liesman, PhD, Director of Microbiology in Pathology and Laboratory Medicine at the University of Kansas Health System in Kansas City, researched developing a plan for pooled testing of COVID-19 patients for her health system, she found the strategy less than ideal for two reasons:

  • First was the rate of infection in the population being tested. If the rate was too high, pooled testing produced too many positive results, making the process impractical.
  • Second was the need for expensive automated equipment in the microbiology laboratory, the funding to buy that equipment, and the room to accommodate it.

Last summer, as Liesman and her microbiology lab staff were evaluating pooled testing, she spoke with Dark Daily’s sister publication The Dark Report. “We were trying to decide whether pooled testing really would save us anything,” she said in the exclusive interview. “We were looking at the barriers and trying to understand what we’d gain and what we’d lose.”

Deciding Against Pooled Testing at University of Kansas Health System

After careful consideration, the lab staff stopped considering pooled testing due to increased prevalence in the community, Liesman said in December. “Our positivity rate is double what we were seeing in the summer,” she noted.

“Of course, the biggest challenge with pooling specimens is you have to have a patient population that has a low enough virus prevalence to make it worth your time,” she noted. “For us, there may be some patient populations that have a low enough level of prevalence, but not enough to make pooling feasible.”

University of Kansas Health System’s microbiology laboratory has been running 800 to 1,000 COVID-19 molecular tests 24 hours a day, seven days a week, although the lab runs fewer tests on the weekends. On Jan. 8, the number of new coronavirus cases in Kansas was at 1,780 per million, according to the COVID Tracking Project (CTP). That was about the highest rate since the pandemic began early in the year.

Rachael Liesman, PhD smiling headshot
“Pooling makes a lot of sense for massive high-volume reference labs. I don’t have the capacity to run 6,000 specimens a day through my lab,” noted Rachael Liesman, PhD (above), Director of Microbiology in Pathology and Laboratory Medicine at the University of Kansas Health System, in an exclusive interview with The Dark Report. Not all clinical laboratories can or should consider pooled testing, which Dark Daily noted in previous e-briefings. (Photo copyright: Twitter.)

“One of the challenges in any lab is when you get specimens arriving in volume of say 100 or 200 specimens every few hours,” Liesman explained. “When that happens, you have to determine rapidly which of those specimens you would want to pool and which of them you wouldn’t pool. Or, if you had the right circumstances, you could pool all of them.

“You might have asymptomatic patients in one group and symptomatic patients in another group. So, then you could put all samples from one group into a pool. But if you’re not set up that way, just figuring that part out could be really time consuming,” she noted.

“Another challenge,” Liesman added, “is if your laboratory doesn’t have liquid handlers, which are the instruments that do the pooling for you.”

Manual versus Automated Pooling

In a clinical laboratory without liquid handlers, the task of pooling is not automated and instead requires staff to do the work manually—one specimen and one pool at a time.

Without the right equipment, Liesman noted, somebody in the lab must physically take five tubes and combine them in into one tube. And that one person has to ensure the test tube of pooled specimens is appropriately stickered. Then, once that is completed, the information must be input into the laboratory information system (LIS).

“We have a liquid handler because we purchased one from Hamilton specifically for COVID testing. But getting all that information into the computer system can take a lot of time,” she said. “A lot of labs don’t have access to this type of instrumentation, which means the process becomes very hands-on.

“We already see repetitive-use injuries, and if many of your staff are spending their eight-hour shifts doing pipetting motions, then they’re at greater risk for repetitive-use injury,” she added.

In addition, having humans doing repetitive motions in a clinical laboratory increases the risk of specimen-handling errors such as tubes being mislabeled or misplaced. “Those mistakes are very hard to find,” Liesman noted. “For us, we’ve been asking if we have the resources to do pooling successfully. And, if we put all these resources into it, what do we gain? That’s the big question for us.”

As Dark Daily reported in “University of Vermont Microbiology Laboratory Identifies Inefficiencies When Performing Pooled Testing for COVID-19,” the microbiology laboratory at the University of Kansas is not the only lab to have considered pooled testing and found it not desirable.

For a clinical laboratory to successfully initiate and maintain an effective program for pooled testing of the SARS-CoV-2 coronavirus, it must have specific equipment available to reduce manual touches of the specimens and automate as many work processes as possible. The lab’s manager must also consider the staffing required to handle pooled testing. Even then, if disease prevalence climbs above a certain level, pooled testing will not be a viable solution.

These are the reasons why many medical laboratories have considered a pooled testing arrangement but decided it would not be appropriate for their organization. Meanwhile, at other clinical labs pooled SARS-CoV-2 testing has been a major success, partly because it enables the labs to test many more patients using the same quantity of test kits and related supplies.

—Joseph Burns

Related Information:

University of Vermont Microbiology Laboratory Identifies Inefficiencies When Performing Pooled Testing for COVID-19

Memphis Path Lab Pivots to COVID, Pooled Testing

NY Hospital Lab Succeeds with Pooled COVID-19 Testing

Is COVID-19 Pooled Testing Good for Labs, Bad for IVDs?

Officials Differ on Value of COVID-19 Pooled Testing

University of Vermont Microbiology Laboratory Identifies Inefficiencies When Performing Pooled Testing for COVID-19

The key to success with pooled testing, says the lab’s director, is having the right personnel and equipment, and an LIS that supports the added steps

Experts believe pooled testing for COVID-19 could reduce the number of standard tests for SARS-CoV-2 by conserving testing resources and cutting lab spending on tests and testing supplies. However, some clinical laboratories have found pooled testing causes inefficiencies due to the lab’s lack of staff, limitations of existing equipment, and biosafety hood space, as well as not having a laboratory information system (LIS) that can manage the large volume of specimens and retesting involved in pooled testing.

One such example is the microbiology lab at 562-bed University of Vermont Medical Center (UVMC) in Burlington, Vt. After evaluating the pooled-testing method, Christina M. Wojewoda, MD, pathologist, Director of Clinical Microbiology at UVMC and an Associate Professor at the Larner College of Medicine at University of Vermont, decided last summer not to do pooled testing, due to the manual steps that the process requires.

The manual steps include having clinical laboratory scientists work under protective hoods to limit the virus’ spread, and both hood space and med techs are in short supply at UVMC, she explained during an exclusive interview with The Dark Report, Dark Daily’s sister publication.

“Our evaluation then is the same as it is now,” she commented. “The barriers to pooling still hold true. Instead of pooling, we keep up with the volume of COVID-19 samples by balancing in-house SARS-CoV-2 testing and send-out testing.”

Low Viral Load a Problem in Pooled Testing for SARS-CoV-2

Another problem, Wojewoda added, is when one patient’s sample in a pool of specimens has a low viral load of SARS-CoV-2. Clinical labs in some states have found that when the prevalence of the novel coronavirus in the population is below 5%, then pooled testing could be an effective testing strategy. However, although Vermont has a relatively low presence of the COVID-19 virus in the population, Wojewoda remains concerned about the viral load in a pooled sample.

“For us, it is less of an issue with prevalence in the population than an issue with low viral load in one patient sample, and that can happen with any prevalence level,” she said. “If there is a low level of virus in one sample, and that sample is combined with samples from four other patients to create the pool, you could dilute the virus below the assay’s level of detection. That means you could miss low-level positive patients.

“When we first considered pooling, we worried about missing those patients, but since then we’ve learned more about the SARS-CoV-2 virus,” she continued. “Now, we now know that patients start producing high levels of virus quickly and that low virus levels often occur toward the end of their infection, after they’ve probably been tested or identified.

“That means we’re less concerned with low levels of virus now than we were initially, at least when pooling five specimens in one tube. But it’s still something to watch for,” she noted.

What About Too Much Virus?

The opposite of this problem also is a concern. If the incidence of infection is too high in a population, then pooled testing could produce too many positive results. The required retesting then makes the process inefficient.

Wojewoda has heard similar concerns from her colleagues at other medical laboratories. They said they were not doing pooled SARS-CoV-2 testing for some of the same reasons.

“When we looked into pooled testing, a number of complications made it impractical,” she said. “Instead, we have been testing each patient individually.”

Since the spring, UVMC’s microbiology lab has run 200 to 500 molecular COVID-19 tests per day on two Hologic Panther instruments and has run a laboratory-developed test (LDT) from the federal Centers for Disease Control and Prevention (CDC) on the ABI 7500 from Applied Biosystems of Waltham, Mass., a Thermo Fisher Scientific (NYSE:TMO) company.

When patient COVID-19 samples exceed 500 in a day, UVMC sends those specimens to the Broad Institute in Cambridge, Mass., for testing.

During the summer, the rate of COVID-19 infections in Vermont was at about 1%, Wojewoda noted. In the last week of December, the Vermont Department of Health reported the seven-day average percentage of positive tests was 2.2%.

Laboratory Information System Challenges When Doing Pooled Testing

In addition to her concerns about the level of detection, UVMC’s laboratory information system (LIS) was another worry. “Clinical laboratories are designed to test one sample and get one result, and that one result goes into one patient’s chart,” she explained. “But when the lab makes a pool of, say, five patients’ samples, those five results need to go into five patients’ charts.

Wojewoda estimates that manual data entry for each of those results takes a solid minute per sample. “That’s not a lot, but it adds up over time, and it’s not something we do normally.”

Normally, lab test results get filed automatically into the patient’s chart, and then those results are available to patients online, she noted.

“There may be multiple fixes for this problem of accurately and efficiently getting pooled test results into the LIS, then reported to each individual patient, but for us the current state of our computer system requires that we enter each result into each patient’s chart manually. We try not to do that as much as possible because of the potential for errors from manual entry,” she said.

When Automation Falls Short

In addition, Wojewoda said that pooled testing cannot be automated the way most standard clinical laboratory tests are run.

“With routine testing, we put a sample on the instrument and let the test run,” she explained. “When we get the result, it goes into the patient’s chart. But, for pooled testing, we have to collect five samples and then pause to manually put a little bit of each of those five samples into one tube. Then, we put that tube on the instrument.

“After we get the results, we manually report the negative results into each patient’s chart,” she continued. “But if they’re positive, then lab staff must find the five tubes and test each one individually. Therefore, we’re doubling the time it normally takes to produce and report a positive result for SARS-CoV-2.”

Any positive results in a pooled sample, she explained, are held up at the instrument so that the lab staff can pull those five samples from the pool and test each one individually. “Then those individual results go into each patient’s chart, because potentially only one of the five might be positive. We don’t want all five of those patients to be labeled as positive if only one is positive,” she added.

UVMC lab Director Christina M. Wojewoda, MD
Pooled testing for COVID-19 adds a layer of complexity that the UVMC lab does not normally do, noted the lab’s Director Christina M. Wojewoda, MD (above), a pathologist and Director of Clinical Microbiology at the University of Vermont Medical Center (UVMC) in Burlington, in an interview with The Dark Report. She added that the lab’s staff is already stretched thin and doing as much as possible. “In all these ways, pooled testing is different from how we usually run clinical lab tests. It’s clear that the idea behind pooled testing is to improve efficiency, and yet the need for manual data entry and pulling pooled samples apart create inefficiencies,” she commented. (Photo copyright: University of Vermont.)

Shortage of Lab Techs and Hood Space Compound Inefficiencies of Pooled Testing

Another problem is the requirement to pipette each specimen, she noted. “All infectious samples require hood space and a lab technician to do the work under the hood. But both hood space and lab techs are in short supply.”

Wojewoda explained that some tests being run at the UVMC lab are not being tested from the primary tube.

“There’s often a step where we take some of the primary sample and put it into a tube or cartridge for the test. Then, we put multiple samples together, and we have to pipette each one into the tube without cross contaminating the other samples,” she explained.

“At the same time, we have to track the five patient samples so that we can find the original specimen for testing if we need to do so later. All those steps take more staff time.

“So, while pooled testing saves reagents, it also takes more staff time for pipetting and data entry and the need to record which samples are in which tubes,” she noted. “That might require a spreadsheet or other electronic means to track which samples come from which patients.

“An automated way to do the pipetting would be helpful and would increase staff safety,” she added. “I worry when we’re working with something as infectious as SARS-CoV-2, because the lab techs must dig swabs out of liquid media before discarding them, while being careful not to contaminate anything around them.”

Pooled testing for COVID-19 clearly has potential. But, as Wojewoda explained, it brings complications that can cause inefficiencies. Clinical laboratory managers will want to evaluate existing instrumentation, automation, staffing, and laboratory informatics capabilities to determine if and how their labs would experience similar inefficiencies before a final decision to begin a program of pooled testing for COVID-19.

—Joe Burns

Related Information:

Is COVID-19 Pooled Testing Good for Labs, Bad for IVDs?

Officials Differ on Value of COVID-19 Pooled Testing

Memphis Path Lab Pivots to COVID, Pooled Testing

NY Hospital Lab Succeeds with Pooled COVID-19 Testing