Patients caught in squabbles over infectious disease testing
(Published March 11, 2026, on LinkedIn)
Clinical diagnostic testing has always been one of the most complex areas of healthcare, but while there are instances of fraud, even conscientious lab operators are stuck with a coding system that is both awkward and prone to abuse, often leaving patients without access to tests that are essential to their health.
Ashley Zarling, director of business development and marketing at Doc Lab Inc., told me in an interview that the COVID-19 pandemic gave rise to rapid growth in the number of clinical labs that might not have otherwise found a foothold. Many of these new labs purchased polymerase chain reaction (PCR) equipment that is essential to timely testing for infectious diseases, and a few of these labs have fallen into the practice of billing for tests that are not seen as reasonable and necessary services under Medicare and other payer policies.
Zarling said much of the tension between labs and payers is the result of misalignment of payment codes and legitimate clinical needs. Some of the claims filed with payers might not constitute outright fraud but may nonetheless be reasonably seen as abuse of payer policies. The issues in communicable disease testing are emblematic of problems in the world of cancer testing, but there are similar problems at play in the areas of testing for epilepsy and pharmacogenomics as well.
PCR’s advantages include avoidance of ABR
One of the problems in PCR for infectious disease testing is that the current standard of care would suggest that a lab be limited to filing a claim that reimburses less than $20 when evaluating a cultured sample via microscopy. Zarling said this approach entails a drawn-out process that can consume a week, making it impractical for many patients. PCR, in contrast, can yield results in between four and 24 hours, but PCR is also a much more useful technology when it comes to polymicrobial testing. Some labs were capturing reimbursements of $700 or more for PCR infectious disease testing by adding codes for pathogens that are unlikely to be responsible for the patient’s symptoms, a dilemma to which payers understandably react poorly.
The problem for patients with wound infections is that they are at risk of amputation, which calls for the quick turn-around times that PCR can provide. Zarling added, however, that PCR is also perfect for helping physicians sidestep the antibiotic resistance (ABR) problem. “There are good patient outcomes that arise from this testing, but there’s the right target audience for it,” she stated, adding that payers may at times be inclined to restrict coverage of PCR solely for clinically complex patients when it comes to infectious disease testing.
There is, however, an evidentiary problem for PCR regarding infectious disease testing. This technology hasn’t been particularly well explored in double-blinded, prospective clinical studies to check performance against culture and microscopy. “Labs all over the nation have been billing billions of dollars on these PCR infectious disease tests without doing the scientific investigation first,” Zarling said. While these tests do not lack demonstrations of analytical validity, evidence of clinical validity is often absent, a problem that does little but aggravate payers.
The abuse is conspicuous for respiratory pathogen panels (RRPs), which have been validated for detection of infectious diseases, but Medicare typically won’t pay for tests directed toward more than five organisms. Labs are nonetheless conducting large-panel tests, sometimes for as many as 20 pathogens, and Medicare has no easy way to determine that a claim represents a large RPP panel.
Tests for urinary tract infections (UTIs) are another sore spot in that at least one payer states it will not pay for PCR performed for wound infections or UTI, but providers have been billing and payers have been paying for these tests for several years. There are instances in which labs have added codes to claims for PCR tests that have nothing to do with the test that was performed, Zarling said, which may illegitimately add as much as $400 to the value of the filed claim.
Rate of CPT code issuance another source of drag
The foregoing obviously resurrects the pay-and-chase problem for payers, but Zarling said makers of in-vitro diagnostics also must struggle through the CPT coding process, a dynamic with which makers of other medical device types are all too familiar. Zarling said the American Medical Association’s CPT coding committee recently published a new code for in-joint bone infection, so the committee is not completely stuck in CPT code quicksand. Still, payers and test developers alike may wonder whether the CPT committee has the bandwidth to keep pace with the demand for new codes.
Zarling said most claims forms provide a text box in which providers could add information that would answer a lot of a payer’s questions. “All payers would have to do is agree that the sample type should be listed there,” she said, adding that payers could also meet with labs periodically to go over some of the claims that raised that payer’s eyebrows. One payer has reacted, however, by subjecting each infectious disease PCR claim to an audit, “and labs have been struggling because of this,” Zarling said.
This is not a new problem, but the problem grows exponentially for legitimate operators in the lab business when payers follow up with an audit a few years later, followed by a claw-back of payments they deemed inappropriate long after the claim was filed and paid. More than one Medicare administrative contractor has engaged in this same kind of late-stage claw-back as well, thus amplifying a practice that has forced several labs out of business.
Zarling said the problem may require intervention by the Centers for Medicare & Medicaid Services, which may or may not reasonably conclude that some formal policy statement would be helpful. At the very least, she said, “they need to get the MACs in a room and have a conversation” because of the sheer volume of PCR testing for various purposes, including infectious disease testing.
Congress is somewhat aware of the problem, Zarling said, adding that she has discussed the situation with more than one member of the House and Senate. While Congress could direct CMS to put more effort into cleaning up these PCR testing controversies, Zarling said the problem hasn’t gained much traction on Capitol Hill to date. The net effect of all this is to suggest that the problem with PCR testing, CPT codes and infectious disease claims are likely to persist for the foreseeable future to the detriment of patients and clinical labs alike.
