Flagging a Louisiana Blue ‘Investigational‘ Determination for LAAC

研报英文原文证据摘录

Flagging a Louisiana Blue ‘Investigational‘ Determination for LAAC

USA | Medical Supplies & Devices EquityJulyResearch16, 2026

Flagging a Louisiana Blue 'Investigational'

Determination for LAAC

Louisiana Blue (LAB) has published a non-coverage (“investigational”)

determination for left atrial appendage closure (LAAC), effective 8/01/2026,

reversing a prior favorable coverage decision. Although we think the

commercial importance of this is low, we thought it worth flagging. HRS

appears to be mobilizing support, and we note that CMS has coverage in place

for both standalone and concomitant procedures, and that most LAAC patients

are Medicare-age.

This decision applies to commercially insured patients in that jurisdiction, with small

commercial importance as ~88% of standalone LAAC recipients and likely 70%+ concomitant

recipients are covered by Medicare (FFS or Medicare Advantage), with their care defined by

favorable NCDs for both standalone LAAC or concomitant LAAC. The Heart Rhythm Society,

perhaps among others, is mobilizing support to resist this planned coverage change. In our view,

LAB's stance is interesting because it considers the compendium of recent LAAC data, inclusive

of the PRAGUE 17, OPTION, CHAMPION, and CLOSURE-AF trials.

The intent of the re-evaluation was to assess the importance of new clinical trial data in the

context of the original standalone LAAC indication with the benefit of being able to compare

LAAC to direct oral anticoagulants (DOACs) (as opposed to warfarin). The net clinical benefit

that the analysts were trying to assess was among elderly patients at high risk for both stroke and

bleeding with a contraindication for OAC.

The clinical analysis was not oriented towards the legitimacy of the OPTION indication (not