There have been a few attempts at "Enhanced CLIA" legislation, and there's a new kid in town: H.R. 8890.
It's introduced by Congr. Dunn of Florida, who recently introduced an "Improve LCDs" bill (here).
The legislative language of H.R. 8890 is NOT posted yet but will appear here.
(See page pdf 74 of Congressional Record here.)
See early coverage at Genomeweb here. See an article by Alex Dickinson at LinkedIn here.
See Congr. Dunn press here. And see a generally supportive comment by ACLA, here.
I'll reserve more detailed comment for when the actual legislative language is public. In the meantime, here are the five bullets used in the Dunn press release.
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The Enhancing CLIA Act would:
- Direct CMS to establish a transparent and publicly accessible database with key information regarding laboratory developed testing services (LDTs), including summaries of performance specifications and validation information
- Reaffirm that LDTs are professional services regulated by CMS under CLIA
- Clarify that LDTs include innovative analyses of digital laboratory information, such as genomic data derived from previously-sequenced patient samples
- Leverage existing review and oversight mechanisms to allow laboratories to voluntarily obtain confirmation from a recognized third party that an LDT is analytically and clinically valid
- Establish centralized error reporting and bolster CMS oversight authority if credible information indicates an LDT lacks analytical or clinical validity
