Thursday, December 12, 2019

Brief Blog: Consensus Paper on How to Define Clinical Utility in Microbiology Diagnostics

In any part of the diagnostics community - from PET scans to exomes - you can't swing a cat without someone saying that payor standards for clinical utility are too high and too vague.  This blog guides the reader to a new paper on molecular microbiology and clinical utility, Miller et al., 2019.


Frustration between the diagnostics industries and payors becomes productive when it leads stakeholders in diagnostics to come together for consensus papers.  For example, in 2012/2013, CMS was deciding whether it would cover newly-FDA-approved amyloid PET scans for Alzheimer's disease.  Rapidly, the Society for Nuclear Imaging and the Alzheimer Association convened stakeholders to produce a best practices guidance for this new technology (here; Johnson et al., here). 

When FDA issued warning letters about historically valid LDT tests for pharmacogenetics in early 2019, the Association for Molecular Pathology rapidly produced a best-practices statement (here).

Here's a new example.

Hospitals and microbiologist have complained about inadequate coverage and payments for molecular microbiology despite the booming capabilities of this field (see an insightful October article in 360Dx, Ketchum, here).   Stakeholders are now putting pen to paper to write about what standards are appropriate for evidence before payment and adoption for these new categories of tests.

 See the excellent multi-stakeholder review of clinical utility for advanced microbiology testing, Miller et al., published recently in the Journal of Clinical Microbiology - here.   The authors represent  the American Society of Microbiology (ASM) Clinical and Public Health Microbiology Committee and the ASM Corporate Council.  (There's a subscription trade journal article about the Miller publication - see Johnson, at 360Dx, here.)

Miller et al. is a 13-page page publication with 61 up-to-date citations, and it forms a good review of clinical utility (CU) for diagnostics, with a focus on microbiology.   The authors note four different approach to CU in molecular microbiology:  (1) clinical decision making, like revised Rx; (2) improved patient clinical outcomes; (3) improved workflow in the lab (including turnaround time), and (4) reduced costs.  Well worth reading for a great application of general principles poured into a specific topic area.


For a 2016 paper on clinical utility of molecular pathology sponsored by AMP, see Joseph et al. here.  (See also my article, "A quartet of papers on molecular reimbursement," 2018, here.)

For some court cases that grew out of the CMS noncoverage of Amyloid PET scans in Alzheimer's, here.