https://www.genomeweb.com/business-news/reimbursement/gnw-cms-acla-ai-reimbursement-20260910/
I covered the comments of the top organizations in a September 2 blog:
https://www.discoveriesinhealthpolicy.com/2026/09/opps-rule-ditching-digital-pathology.html
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Genomeweb cites public comments (as did my blog) as wel as a Nex Gen Summit panel in DC in late August.
I don't want to squeeze their copyright but a mini summary of Genomeweb is here, encouraging you to see the original:
- CMS proposes moving “algorithm-only” laboratory tests from the CLFS into a new Software as a Medical Service category paid under OPPS. Clinical labs warn the shift could bring 20% patient coinsurance, budget-neutral payment pressure, billing complications, and removal from CLIA oversight.
- Industry groups argue these services remain part of the diagnostic laboratory process and suggest CMS modernize CLIA rather than separate software analysis from laboratory testing.
The first comment deadline (OPPS) is past but the PFS comments go to 9/14.
