Molecular testing could drive POL market
By Mark Thill
Molecular testing may lead more physician office labs to make the transition from CLIA-waived to moderate complexity, even as the percentage of POLs performing moderate complexity testing has been falling over the past several years.
Government statistics show the trends. The Centers for Medicare & Medicaid Services reports that in 2019, approximately 13% of physician office labs performed moderate and/or high complexity testing procedures. But the percentage has been falling steadily since 2015, when 14.5% performed such tests. During the same timeframe, the number of POLs holding a certificate of waiver steadily increased, from almost 76,000 in 2015 to more than 81,000 in 2019.
More waived options exist today than 10 years ago, and some of those waived options – including BMP and CMP – were previously considered to be moderate complexity, says Jim Poggi, principal, Tested Insights, and the physician office lab columnist for Repertoire. “On the other hand, there’s a cascade effect, where some tests that are high complexity today are likely to transition to moderate complexity in the future.”
Meanwhile, some customers believe the cost of the moderate complexity license exceeds revenues, says Poggi. “There is an upfront investment, but the smart distributor sales rep and their supplier can tailor the right system for the right size customer.” In fact, most moderate complexity test systems have far higher daily throughput than waived platforms, resulting in a better use of labor for larger (5+ doctors) practices, he adds. What’s more:
- POLs can do many more tests of moderate complexity than waived only, such as CBC (with some exceptions); allergy testing; most cardiac markers; Vitamin D; Vitamin B-12; folate; TSH (though some waived tests exist); and PSA.
- Most moderate complexity tests systems are fairly easy to train and run.
- Current moderate complexity labs are ideal settings for menu expansion from hematology to chemistry to immunoassay.
“Moderately complex testing is becoming more of an interest to POLs with the introduction of molecular testing and the patient’s need to have a diagnosis immediately,” says Kathy Mannone, manager, distribution sales, Sysmex America Inc. “There is also a potential revenue opportunity with reimbursements for flu and COVID molecular tests. Once molecular testing is implemented, physicians start to add more testing, like hematology and immunoassay, which gives reps additional opportunities to grow their lab business.”
Susan Densford, director of accreditation for COLA, says that CBCs continue to be the most common moderate complexity tests COLA sees in POLs today. “Basic chemistry tests such as glucose, creatinine, BUN and electrolytes, are also very common in POLs, although some perform these tests via waived methods. Urine microscopic examinations are among the most frequently performed moderate complexity tests that we see in POLs as well. More often than not, the chemical analysis portion of the urinalysis test is performed via a waived method.”
The IDN effect
The acquisition of physician practices by IDNs has affected the market, says Densford. “We have seen many POLs close their moderate complexity laboratories after acquisition by a health system. Testing is consolidated at the laboratory of the ‘parent’ system.”
But that’s not always the case, she adds. “Depending on the location of the POL and the accessibility to laboratory testing, as well as the particular medical specialty of the practice, we have sometimes seen POLs expand testing after being acquired by a health system, [giving them] access to administrative support and capital.” Some IDNs and POLs have formed creative partnerships to provide testing where needed. For example, a urology practice performing a high volume of PSA testing could provide the test for other POLs in the system.
Says Poggi, acquisition of POLs by IDNs is a “mixed bag” insofar as its impact on moderate complexity labs. “Some health systems have allowed their owned practices to continue to have autonomy over tests performed in their office, others have standardized methods while allowing testing to continue as before, and others have pulled higher volume tests into the core lab. Ultimately, it is up to management of the IDN and their physician practices to decide the ‘cost-vs.-convenience’ question.
“I persist in believing a test should be performed in the POL if it can be used to initiate or modify a patient treatment program.”
Regarding the future of moderate complexity testing, Poggi expects drug panels and Vitamin D to decline or remain flat, while the following could grow: CBC, BNP, more sophisticated colorectal cancer tests, and a range of respiratory and other infectious agent tests, including GI infectious agents.
Densford expects to see continued expansion of molecular testing. “The majority of these today are infectious disease molecular tests, but as personalized medicine gains traction, other molecular biomarkers could see growth in the POLs in the next five years.” That said, larger POLs will be more likely to adopt moderate complexity molecular tests than smaller ones, she adds.
COVID-19
The COVID-19 pandemic probably has complicated POLs’ interest in transitioning from CLIA-waived testing to moderate complexity testing, says Dr. David Grenache, chief scientific officer, TriCore Reference Laboratories in Albuquerque, New Mexico, and president of AACC.
“On one hand, COVID-19 has made clear how having rapid access to test results affects clinical care,” he says. “On the other hand, medical practices have experienced revenue shortfalls, as patients have avoided seeking care and procedures have been postponed. Their enthusiasm to invest in the additional tests, personnel and oversight required to operate as a moderately complex lab could be diminished.”
Says Mannone, “More customers are bringing on molecular/IVD COVID testing, which is increasing the interest in moderately complex licensing. I’ve seen increased interest from pediatric and cardiology offices. Some physicians are taking the approach of ‘one stop’ testing and diagnosis to eliminate an additional stop at a lab.”
Poggi believes that following up with patients who have had COVID-19 could increase testing in the physician office. “Knowing whether there is any new, underlying organ damage or a worsening of a preexisting condition is important,” he says. “Organ panels, respiratory assessment (not always by lab tests) and CBC assays should grow as we learn more about the longer-term impact of a COVID-19 infection.” However, he does not see widespread testing for the COVID-19 antigen as a mainstay in the POL, primarily because most such tests are highly complex RT-PCR tests.
Densford says that some practices that had CLIA certificates of waiver have converted to moderate complexity in order to perform COVID-19 diagnostic testing. “Early on in the pandemic, it was difficult for many POLs to obtain instrumentation and supplies for the testing, but that situation has improved, so we do continue to see this trend.
“But more than CLIA-waived laboratories converting to moderate complexity testing, we have seen two other trends. First, new laboratories have started up just to do COVID-19 testing. And second, many high complexity molecular or otherwise specialty laboratories have added diagnostic COVID-19 testing to their test menu.”