The WATCHMAN procedure, technically Left Atrial Appendage Occlusion (LAAO), treats non-valvular atrial fibrillation in individuals who cannot safely take long-term oral blood thinners. The procedure implants a device to close the left atrial appendage, a small heart pouch where most stroke-causing blood clots form. Medicare generally covers the WATCHMAN procedure. However, this coverage is not automatic and is strictly limited to patients who meet specific clinical and procedural conditions mandated by national and local Medicare rules.
Clinical Requirements for Coverage
The Centers for Medicare & Medicaid Services (CMS) governs coverage through the National Coverage Determination (NCD) 20.34, which defines when the procedure is deemed medically necessary. Coverage is extended only to patients with non-valvular Atrial Fibrillation (AFib) who face a significant risk of stroke.
Patient risk must be quantified using established clinical tools to confirm the procedure’s necessity. Patients must be at high risk for stroke, typically demonstrated by a calculated CHA2DS2-VASc score of 3 or higher if female or 2 or higher if male, or a similar score like a CHADS2 score of 2 or higher. This score confirms the significant need for stroke prophylaxis.
Crucially, coverage requires a formal contraindication to long-term oral anticoagulation (OAC) therapy, meaning the patient cannot safely take blood thinners indefinitely due to conditions like a high bleeding risk. The patient must still be suitable for short-term OAC use for approximately 45 days following the procedure, which is required while the implant site heals.
The decision to proceed must be made by a multidisciplinary team of physicians, including a cardiologist and a stroke specialist. This team must document that the patient is a suitable candidate for the device based on anatomical measurements and overall health status, ensuring the patient selection meets the high standards required for coverage under the NCD.
How Medicare Parts A and B Apply
The part of Original Medicare that covers the procedure depends entirely on the setting of care, specifically whether the patient is formally admitted to the hospital. The procedure’s classification dictates whether Medicare Part A or Part B is responsible for the facility charges associated with the stay.
Part A covers the facility costs, including the operating room, room, board, and nursing services, if the patient is formally admitted as an inpatient. This admission is often required for procedures like LAAO to allow for an overnight hospital stay for observation to monitor for immediate post-procedure complications, such as pericardial effusion.
Part B covers physician fees and the facility costs if the procedure is performed on an outpatient basis, meaning the patient is not formally admitted for an overnight stay. This coverage also includes necessary supplies and durable medical equipment used during the procedure.
Institutional Requirements
CMS requires both the facility and the physician to meet specific institutional standards.
- The hospital must participate in a national, CMS-approved registry to track long-term outcomes and safety data for the LAAO device.
- The facility must perform at least 25 LAAO procedures annually.
- The physician must have a minimum of 25 lifetime procedures to maintain proficiency.
Beneficiary Out of Pocket Expenses
Even when the WATCHMAN procedure is covered by Medicare, the beneficiary is responsible for cost-sharing obligations, which vary significantly depending on whether Part A or Part B covered the facility portion. These costs represent the standard deductibles and coinsurance required under Original Medicare.
If Part A covers the stay as an inpatient, the beneficiary is responsible for the Part A deductible per benefit period. No coinsurance is typically required for the first 60 days of an inpatient stay, which is sufficient time for the LAAO procedure.
If Part B covers the services as an outpatient, the annual Part B deductible must first be met. After the deductible is satisfied, the beneficiary generally owes a 20% coinsurance of the Medicare-approved amount for the procedure and physician services.
The 20% Part B coinsurance can represent a significant financial responsibility for the patient because the cost of the procedure is substantial. Supplemental insurance, commonly known as Medigap policies, can significantly reduce or eliminate the Part B coinsurance. Medicare Advantage (Part C) plans must cover the WATCHMAN procedure if it is medically necessary. These plans have their own cost-sharing structures, usually involving copayments and an annual maximum out-of-pocket limit.
Navigating Coverage Denial
Initial coverage denial can occur if the patient’s medical documentation fails to strictly meet the National Coverage Determination criteria. Denial can also result if the facility or the operating physician does not meet the required procedure volume or registry participation standards mandated by CMS.
Beneficiaries have the right to appeal any coverage denial, starting with a request for reconsideration by a Qualified Independent Contractor. If the denial is upheld, the case may proceed to a hearing before an Administrative Law Judge and potentially higher levels of review.
It is advisable to work closely with the cardiologist’s office and the hospital billing department to ensure comprehensive pre-authorization is obtained before the procedure takes place. Meticulous documentation of the patient’s medical history and stroke risk factors must be submitted to minimize the chance of a claim denial.