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A private payor survey by ClearView Healthcare Partners found that medical directors viewed CMS's decision with caution; half had no plans to align commercial plan coverage.

A perspective that hasn't gotten as much attention is that the CMS draft coverage decision could be bad for patients by increasing off-label drug use based on the results of NGS panels.

CureOne also received CMS's approval for 11 quality metrics around biomarker testing that doctors can report for MIPS-related payment. 

Some industry players are accusing CMS of advancing backdoor LDT regulation by proposing to cover NGS tests with FDA approval/clearance, except in a limited setting.

The agency is excluding certain advanced diagnostic lab tests and molecular pathology tests from a billing regulation that created administrative headaches for many labs.

The draft document, which includes recommendations on which molecular tests labs should perform, on what samples, and with what analytical specifications, is available for comment until April 22.

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