The Centers for Medicare and Medicaid Services (CMS) finalized its decision to cover percutaneous left atrial appendage closure (LAAC) services on Feb. 8. This is a significant step forward for patients who are unable to take long-term oral anticoagulation. It also eliminates uncertainty about whether and how this service will be covered and paid, allowing facilities and providers to make informed decisions about both individual patient care and program planning. The national coverage determination (NCD) took effect immediately. Additional information for Medicare Administrative Contractors (MACs) and providers will be issued in the coming months.

The ACC worked closely with the Society of Cardiovascular Angiography and Interventions and the Heart Rhythm Society to submit joint comments to CMS on the proposed NCD last year. Many of the changes recommended in the letter were made. This is another of many recent instances where the societies have collaborated to secure positive coverage and payment policies for services provided to patients by members. The societies relied heavily on the societal overview and institutional and operator requirements documents for guidance. Each of those collaborative efforts were key to obtaining a positive outcome.

CMS covers LAAC for non-valvular atrial fibrillation (NVAF) as a second line therapy to oral anticoagulants when performed with a device that is approved by the U.S. Food and Drug Administration (FDA) for that indication under coverage with evidence development (CED). CED is used to collect additional clinical data on services likely to benefit Medicare beneficiaries for which CMS determines available evidence does not exist to provide coverage under the traditional “reasonable and necessary” standard. Patients, facilities, and operators must meet certain requirements to qualify for CED:

• The patient has a CHADS2 score ≥ 2 or a CHA2DS2-VASc score ≥ 3.
• The patient can tolerate short-term warfarin but has been deemed unable to take long-term oral anticoagulation through a shared decision making process.
• A formal shared decision making interaction with an independent non-interventional physician, such as a clinical cardiologist or neurologist, using an evidence-based decision tool precedes the decision to proceed and is documented in the medical record.
• The patient is under the care of a multidisciplinary team of medical professionals at a facility with an established structural heart disease and/or electrophysiology program.
• The procedure is performed by interventional cardiologist(s), electrophysiologist(s) or cardiovascular surgeon(s) who have been trained by manufacturer and have performed ≥ 25 transeptal puncture procedures through an intact septum who continue to perform ≥ 25 procedures, with at least 12 LAAC procedures, over a two-year period.
• The patient, multidisciplinary team, and facility participate in a qualifying national registry that consecutively enrolls LAAC patients and tracks certain outcomes. The NCDR is already completing an application for the LAAO Registry to be an approved registry.
• LAAC will also be covered when performed in an FDA-approved randomized controlled trial that meets CMS requirements and has been reviewed and approved by CMS.

ACC Advocacy will continue to keep members updated on the status of the LAAO Registry as an approved registry.

Keywords: Angiography, Anticoagulants, Atrial Appendage, Centers for Medicare and Medicaid Services, U.S., Electrophysiology, Medicaid, Medical Records, Medicare, Patient Care, Patient Care Team, Registries, United States Food and Drug Administration, Warfarin

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