This week, JAMA has two articles discussing a recent "boom" in molecular UTI testing. The articles were highlighted in Genomeweb. Notably, over the past couple years, the MolDx program saw a "boom" in molecular pathogen testing several years ago, and brought out a strictly-limited LCD on the topic, including blocking most molecular testing on routine UTIs.
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- Use of Multiplex Molecular Panels to Diagnose Urinary Tract Infection in Older Adults. JAMA Network Open, Hatfield et al.
- The Proliferation of Multiplex Molecular Testing for Urinary Tract Infections. JAMA Network Open, Fitzpatrick & Morgan [OP ED].
- Also coverage at Genomeweb/360Dx, Andrea Anderson (subscription):
- Study Sees Rise in UTIs Diagnosed With Molecular Panels, Despite Lack of Clinical Evidence for Tests.
- https://www.360dx.com/molecular-diagnostics/study-sees-rise-utis-diagnosed-molecular-panels-despite-lack-clinical
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The JAMA articles are worthwhile reading. Neither Hatfield or Fitzpatrick pick up on another track of the story, which was LCD respones and 180 degree turnarounds in the payment velocity. I believe this would have been most striking in MolDx policy regions. More about MolDx, next.
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MolDx noted an explosion in molecular pathogen codes (including one for "other pathogen" billed in high multiples) several years ago. The responded with a strict LCD, a voluminous billing and coding article, and even a Palmetto website FAQ. These policy activiites led to a marked drop in payments for the now-controlled codes in MolDx regions (28 states).
- Find the FAQ here.
- Find the LCD here.
- Find the billing/coding article here.
- Anticipating requests for coverage based on prior literature, MolDx even published a 9-page PDF of hundreds of molecular UTI articles that "HAVE NOT adequately met the clinical validity and clinical utility criteria for UTI panels." Here.
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While the work of Hatfield et al is important, leading to a JAMA publication with high visibility, I'd also note that much of the data is not secret, but is published annually and openly by CMS, so that anyone in the public could also have tracked the explosive growth in these codes in a matter of an hour or two. (An example from my own work here.) The Hatfield work had a higher level of specificity, by pairing pathogen procedures with UTI ICD-10 codes, which requires researcher-level access. But the take-home lesson which is massive payment growth on uncontrolled codes would be publicly available.
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You can also identify the specific labs that were billing some of these codes, and how much they were paid per year, in a CMS public data source here.