CMS Seeking Comment on CLIA Rule Allowing Remote Access to Digital Laboratory Data
The Centers for Medicare & Medicaid Services is seeking comment on a proposed rule to amend regulations from the Clinical Laboratory Improvement...
The College of American Pathologists (CAP) submitted comments in response to a request for information on the Centers for Medicare & Medicaid Services (CMS) Comprehensive Regulations to Uncover Suspicious Healthcare (CRUSH) initiative.
In the March 30 letter, CAP expressed concern that this initiative would fail to differentiate between fraudulent and compliant laboratories, writing “increased utilization or spending alone does not establish systemic fraud.” CAP stressed the importance of “regulatory responses [that] do not unintentionally conflate specific bad actors with compliant laboratories operating within coverage policies and clinical guidelines.” CAP also recommended policy guidelines that better distinguish between bad actors and compliant laboratories, without adding undue administrative burdens on the latter and while effectively targeting the former.
CAP also urged CMS to reevaluate its use of the Molecular Diagnostic Services program, explaining “any expansion of the program would represent a significant structural shift in Medicare coverage administration,” ultimately hindering patient access to innovative diagnostics. Instead, CAP recommends a more targeted approach that would leverage existing antifraud mechanisms.
Source:
https://documents.cap.org/documents/FINAL-CRUSH-RFI-Comment-v.5.pdf
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