The U.S. Food and Drug Administration (FDA) approved Boston Scientific’s WATCHMAN™ Left Atrial Appendage Closure (LAAC) device on March 13, 2015 for stroke prevention in patients with atrial fibrillation (AF). Indication and contraindication language used by the FDA are listed below.1
The WATCHMAN should only be used in patients who:
- Have AF not related to heart valve disease
- Are at increased risk for a stroke
- Are recommended for blood thinning medicines
- Are suitable for warfarin
- Have an appropriate reason to seek a non-drug alternative to warfarin
The WATCHMAN should not be used in patients who:
- Currently have a blood clot in their heart
- Cannot tolerate blood thinning medicines
However, despite FDA approval, reimbursement has been problematic. This has been driven primarily by non-uniform regional coverage by Medicare (CMS) and other health insurance providers. Medicare has now spoken — and with much greater detail and specificity than the FDA.
In January 2016, CMS released an initial proposed list of covered indications and opened it to public comment for 30 days.2 An abbreviated list of the initial proposal is below:
Percutaneous LAAC therapy is covered for patients with non-valvular atrial fibrillation only, when all of the following conditions 1-7 are met.
- Non-valvular AF.
- High risk of stroke and bleeding:
- a. A high CHADS2 or CHA2DS2-VASc score and
- b. A high HAS-BLED score and
- c. A contraindication to warfarin.
- The procedure is furnished in an interventional lab with fluoroscopy, TEE imaging, anesthesia support, an ICU, and on-site emergency cardiac surgery.
- The procedure is performed by a cardiologist and/or electrophysiologist who has performed ≥25 total (≥10 in past year) interventional cardiac procedures involving a transeptal puncture.
- The primary physician must receive training prescribed by the manufacturer.
- The patient is enrolled in a prospective national registry that consecutively enrolls LAAC patients and tracks the following annual outcomes at the patient data level for a period of at least five years from the time of the LAAC procedure.
- A formal shared decision-making interaction between the patient and provider using an evidence-based decision tool on anticoagulation in patients with NVAF must occur prior to LAAC, must be documented in the medical records, must include a discussion of the benefits and harms, must document an appropriate rationale to seek a non-pharmacologic alternative to anticoagulants, taking into account the safety and effectiveness of the device compared to anticoagulants, and have, after being informed of the reported risks of LAAC and reasonable alternative management strategies, given informed consent.
During the public comment phase, the requirement that received most of the attention was the requirement that patients have a “contraindication” to warfarin. This statement could easily be interpreted as an absolute contraindication, which would have been a nonstarter, because in the clinical trials performed in the United States that led to FDA approval, patients were required to take warfarin for at least six weeks after device implantation and could only discontinue it if imaging demonstrated persistent LAA occlusion six weeks after implantation.
Fortunately, CMS made significant modifications in the final decision3 announced February 8, 2016, but there were tradeoffs. An abbreviated and modified list of the final criteria is below. The criteria have been edited to allow for a more direct comparison of the final indications to the initial proposed criteria, with the main changes underlined. The complete criteria are available online.3
The Centers for Medicare & Medicaid Services (CMS) covers percutaneous left atrial appendage closure (LAAC) for patients who have:
- Non-valvular AF
- A CHADS2 score ≥2 or CHA2DS2-VASc score ≥3.
- A suitability for short-term warfarin but deemed unable to take long-term oral anticoagulation following the conclusion of shared decision making, as LAAC is only covered as a second line therapy to oral anticoagulants. The patient is under the care of a cohesive, multidisciplinary team of medical professionals. The procedure must be furnished in a hospital with an established structural heart disease and/or electrophysiology program.
- The procedure is performed by a cardiologist and/or electrophysiologist who has performed ≥25 total interventional cardiac procedures involving a transeptal puncture, and continues to perform ≥25 interventional cardiac procedures that involve transeptal puncture through an intact septum, of which at least 12 are LAAC, over a two-year period.
- The primary physician must receive the training prescribed by the manufacturer.
- The patient is enrolled in, and the MDT and hospital must participate in a prospective, national, audited registry that: 1) consecutively enrolls LAAC patients and 2) tracks the following annual outcomes for each patient for a period of at least four years from the time of the LAAC.
- A formal shared decision-making interaction with an independent non-interventional physician using an evidence-based decision tool on oral anticoagulation in patients with NVAF prior to LAAC. Additionally, the shared decision-making interaction must be documented in the medical record.
There are several positive changes in the final CMS LAAC decision. One positive is that CMS dropped the specific requirements that the patient must have a “high HAS-BLED score” and a “contraindication to warfarin.” The tradeoff, however, was introduction of a specific cutoff for a CHADS2 score ≥2 or CHA2DS2-VASc score ≥3. It was not surprising that CMS added specificity to the stroke risk scoring systems to provide clarity. However, there are patients with a CHADS2 score <2 who would have been included in the clinical trials and who have a fairly high risk of stroke, particularly patients under age 65, who will not be covered. An example would be a 60-year-old man with longstanding persistent AF, advanced heart failure, and severe left atrial enlargement. This scenario might not occur in Medicare patients over age 65, but the scenario will be common among patients with private insurance companies, which will likely adopt the CMS guidelines. Another positive change in the final CMS decision was the addition of a minimum number of procedures required to maintain procedural competency, by requiring physicians to implant at least 12 WATCHMAN devices every two years.
Perhaps the most notable coverage criteria, however, is the requirement that an independent non-interventional physician must document in the chart that the procedure is indicated. This is unnecessary, and is borderline offensive. For starters, it implies that electrophysiologists do not formally evaluate patients who may be candidates for LAAC in consultation, as if the procedure is somehow scheduled by entering an order in the electronic medical record like an interventional radiology procedure. This is not standard practice. Beyond that, the requirement ignores that electrophysiologists (and interventional cardiologists) are fully trained as internists and cardiologists, and are well qualified to holistically evaluate a patient with atrial fibrillation. It implies that the physician performing the procedure has a conflict of interest that is not in the best interest of the patient.
It is a relief that CMS has finally issued a national coverage determination for the WATCHMAN LAAC device one year after FDA approval. This should greatly help our patients with both Medicare and private health insurance receive appropriate care.
- WATCHMAN LAA Closure Technology – P130013. FDA. Published April 2, 2015. Available online at http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/DeviceApprovalsandClearances/Recently-ApprovedDevices/ucm440621.htm. Accessed February 10, 2016.
- Proposed Decision Memo for Percutaneous Left Atrial Appendage (LAA) Closure Therapy (CAG-00445N). CMS. Published November 10, 2015. Available online at https://www.cms.gov/medicare-coverage-database/details/nca-proposed-decision-memo.aspx?DocID=281&DocType=nca&DocName=Percutaneous+Left+Atrial+Appendage+(LAA)+Closure+Therapy&NCAId=281&bc=AAAAAAAAAAAIAA%3d%3d&. Accessed February 8, 2016.
- Decision Memo for Percutaneous Left Atrial Appendage (LAA) Closure Therapy (CAG-00445N). CMS. Published February 8, 2016. Available online at https://www.cms.gov/medicare-coverage-database/details/nca-decision-memo.aspx?NCAId=281&bc=ACAAAAAAAgAAAA%3d%3d&. Accessed February 8, 2016.