The Watchman procedure reduces the risk of stroke for patients with non-valvular atrial fibrillation (Afib). Afib causes an irregular heartbeat, leading to blood pooling and clot formation primarily within the left atrial appendage (LAA). The Watchman device is a permanent implant that seals off the LAA, preventing clots from escaping and causing a stroke. It offers an alternative for individuals who cannot tolerate long-term blood-thinning medications. Medicare coverage for this procedure is governed by federal policies.
The General Rule for Medicare Coverage
The Centers for Medicare & Medicaid Services (CMS) has determined that the Watchman procedure is a covered benefit for eligible beneficiaries. This determination is established through a National Coverage Determination (NCD), a federal policy that specifies whether a medical service is considered reasonable and necessary. The NCD ensures uniform coverage across all Medicare administrative contractors and sets the foundational requirements for approval.
The policy specifically targets percutaneous left atrial appendage closure (LAAC) devices, which includes the Watchman implant. For the procedure to be covered, it must be performed to address stroke risk in patients with non-valvular Afib. The NCD mandates that specific, strict criteria must be met by both the patient and the facility performing the procedure. This policy confirms the procedure’s medical benefit for a narrowly defined population.
Specific Requirements for Patient Eligibility
To qualify for Medicare coverage, a patient must meet several clinical criteria. The primary requirement is a diagnosis of non-valvular atrial fibrillation, meaning the irregular heartbeat is not caused by a heart valve problem. Furthermore, the patient must be assessed as having a high risk for stroke, typically demonstrated by a CHA2DS2-VASc score of three or greater, or a CHADS2 score of two or greater. These scoring systems quantify stroke risk using factors like age, sex, and medical history.
The patient must be deemed unsuitable for long-term oral anticoagulation (OAC) therapy due to a high risk of bleeding. However, they must still be suitable for short-term OAC use, which is required post-procedure. The patient must also participate in a formal shared decision-making interaction with an independent, non-interventional physician. This consultation uses an evidence-based tool to ensure the patient fully understands the risks and benefits compared to other treatment options.
Facility and Physician Requirements
The facility and physician performing the implant must satisfy experience and volume requirements set by the NCD.
- The procedure must be done at a hospital with an established structural heart disease or electrophysiology program.
- Physicians must have specific training and experience with complex cardiac procedures involving transeptal puncture.
- The patient and facility are required to enroll in a prospective, national, audited registry.
- The registry must track annual outcomes for at least four years to contribute to long-term data collection.
Understanding Financial Responsibility
Even when eligible, patients retain financial responsibility for a portion of the total cost. The procedure is generally billed under Medicare Part A if the patient is admitted as an inpatient, covering the hospital stay and the device itself. If the service is provided in an outpatient setting, coverage falls under Medicare Part B.
For Part A services, the patient is responsible for the inpatient deductible, which is a set amount for each benefit period (e.g., $1,676 in 2025). If covered under Part B, the patient must first satisfy the annual deductible (e.g., $257 in 2025). After meeting the Part B deductible, the patient is typically responsible for a 20% co-insurance of the Medicare-approved amount for physician services and outpatient care, including follow-up appointments.
Patients enrolled in a Medicare Advantage (Part C) plan have coverage managed through a private insurer. These plans must cover all services offered by Original Medicare but may have different cost-sharing structures, such as co-pays or different deductibles. Individuals with a Medigap (Supplemental) plan may have some or all of their out-of-pocket costs covered.