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In 2002, the PLAATO system (ev3 Endovascular) was the first device … The CMS' final coverage rule on Boston Scientific's cardiac device the Watchman does not include language requiring … Air embolism, Airway trauma, Allergic reaction to contrast media, anesthetic, WATCHMAN Implant material, or medications, Altered mental status, Anemia requiring transfusion, Anesthesia risks, Angina, Anoxic encephalopathy, Arrhythmias, Atrial septal defect, Bruising, hematoma or seroma near the catheter insertion site, Cardiac perforation, Chest pain/discomfort, Confusion post procedure, Congestive heart failure, Contrast related nephropathy, Cranial bleed, Death, Decreased hemoglobin, Deep vein thrombosis, Device embolism, Device fracture, Device thrombosis, Edema, Embolism, Excessive bleeding, Fever, Fistula, Groin pain, Groin puncture bleed, Hematuria, Hemoptysis, Hypotension, Hypoxia, Improper wound healing, Inability to reposition, recapture, or retrieve the device, Infection/pneumonia, Interatrial septum thrombus, Intratracheal bleeding, Major bleeding requiring transfusion, Misplacement of the device/improper seal of the appendage/movement of device from appendage wall, Myocardial erosion, Nausea, Oral bleeding, Pericardial effusion/tamponade, Pleural effusion, Prolonged bleeding from a laceration, Pseudoaneurysm, Pulmonary edema, Renal failure, Respiratory insufficiency/failure, Stroke – Hemorrhagic, Stroke – Ischemic, Surgical removal of the device, TEE complications (e.g., throat pain, bleeding, esophageal trauma), Thrombocytopenia, Thrombosis, Transient ischemic attack (TIA), Valvular or vascular damage, Vasovagal reactions​, There may be other potential adverse events that are unforeseen at this time.​. WATCHMAN is covered for eligible Medicare patients who meet certain national coverage criteria. The left atrial appendage (LAA) is a tubular structure that opens into the left atrium and has been shown to be one … WATCHMAN is different from blood … How long have WATCHMAN implant procedures been performed? We have information in different languages about What's covered by Medicare. Find an implanting watchman facility near you. WATCHMAN is a device that blocks a portion of the heart known as the left atrial appendage to prevent blood clots from forming there, where they can exit the heart and cause strokes. The WATCHMAN device is a one-time, ... Is WATCHMAN covered by medical insurance? It’s also covered by an increasing number of commercial insurers. All rights reserved. In this article I will discuss the watchman procedure for patients with atrial fibrillation, and discuss who would be ideal an candidates for this procedure. Left Atrial Appendage Closure devices are covered when the device has received Food and Drug Administration (FDA) Premarket Approval (PMA) for that device’s FDA-approved indication and meet all of the conditions spe… Approved a year ago by FDA, the Watchman … Coverage for Closure or Occlusion of the Left Atrial Appendage (LAA) There have been a number of studies related to cardiac devices for the occlusion of the left atrial appendage (e.g., Amplatzer cardiac plug, Amulet, AtriClip device, Lariat Snare device, Watchman device… See Table 45 (in the IFU).​, The patient has a known hypersensitivity to any portion of the device material or the individual components (see Device Description section in the IFU) such that the use of the WATCHMAN device is contraindicated.​, Any of the customary contraindications for other percutaneous catheterization procedures (e.g., patient size too small to accommodate TEE probe or required catheters) or conditions (e.g., active infection, bleeding disorder) are present.​, There are contraindications to the use of anticoagulation therapy, aspirin, or P2Y, This device has not been studied in pregnant or breastfeeding women. It’s important to understand that neither WATCHMAN nor blood thinners cure atrial fibrillation (AFib) or its symptoms, like irregular heart rhythm. An increasing number of commercial insurance companies are also beginning to cover … It may help prepare you for talking to your doctor about your options for reducing stroke risk. The remaining population is represented by private payers. The risks include but are not limited to accidental heart puncture, air embolism, allergic reaction, anemia, anesthesia risks, arrhythmias, AV (Arteriovenous) fistula, bleeding or throat pain from the TEE (Trans Esophageal Echo) probe, blood clot or air bubbles in the lungs or other organs, bruising at the catheter insertion site, clot formation on the device, cranial bleed, excessive bleeding, gastrointestinal bleeding, groin puncture bleed, hypotension, infection/pneumonia, pneumothorax, pulmonary edema, pulmonary vein obstruction, renal failure, stroke, thrombosis and transient ischemic attack. Are deemed by their physicians to be suitable for warfarin; and 3. … Prior to the CMS final … All trademarks are property of their respective owners. It’s also covered by an increasing number of commercial insurers. Use caution when accessing the LAA and deploying the Closure​ Device, Use caution when introducing a WATCHMAN Access System to prevent damage to cardiac structures.​, Use caution when introducing the Delivery System to prevent damage to cardiac structures.​, To prevent damage to the Delivery Catheter or Closure Device, do not allow the WATCHMAN Device to protrude beyond the distal tip of the Delivery Catheter when inserting the Delivery System into the Access Sheath.​, If using a power injector, the maximum pressure should not exceed 100 psi.​. WATCHMAN is covered nationally for a broad range of patients by Centers for Medicare & Medicaid Services (CMS) and an ever-increasing number of commercial insurers. Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients globally. WATCHMAN is different from blood thinners not only in how it works, but in how much it costs. It is also covered by an increasing number of commercial insurers. The appearance of a health service (e.g., test, drug, device or procedure) in the Coverage Summary Update Bulletin does not imply that UnitedHealthcare provides coverage for the health service. While blood thinners must be taken every day for life and represents an ongoing cost, WATCHMAN is a one-time procedure and one-time cost. February 19, 2015. This means WATCHMAN can save you money over time. Your cardiologist has the special knowledge needed to help you decide if WATCHMAN is right for you. Your cardiologist’s office may be able to help you find out what your coverage is. Following pressure from medical societies, Centers for Medicare & Medicaid Services (CMS) eased some of the proposed restrictions for its final national coverage determination (NCD) on left atrial appendage (LAA) closure devices -- namely Boston Scientific's Watchman … CHADS2 score ≥ 2 or a CHA2DS2-VASc score ≥ 3, But deemed unable to take long-term oral anticoagulation, Documented evidence of a formal interaction between the patient and an independent non-interventional physician using an OAC evidence-based decision tool, ~120 million patients covered through Medicare and commercial insurers, CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician. Medicare beneficiaries account for the overwhelming majority of patients deemed candidates for the WATCHMAN Device. The WATCHMAN procedure is covered for Medicare beneficiaries who meet specific criteria. Help with the costs of seeing a doctor, getting medicines and accessing mental health care. … Electrical Cardioversion – This is a low voltage … All rights reserved. Boston Scientific … It represents an excellent option for stroke risk reduction in patients with atrial … Medicare beneficiaries account for the overwhelming majority of patients deemed candidates for the Watchman device. The Watchman device has been FDA approved since 2015, and has been implanted in over 50,000 patients worldwide. The worst-case Medicare reimbursement scenario for Boston Scientific‘s (NYSE:BSX) Watchman anti-stroke device is unlikely to play out, according to a pair of analysts. At the medical center you and your cardiologist select, a team of trained specialists will implant WATCHMAN in your heart. Stay in touch with WATCHMAN by calling an education specialist, attending a local event, or signing up to hear from us. Studies highlight complications … Medicare beneficiaries account for the overwhelming majority of patients deemed candidates for the WATCHMAN Device. WATCHMAN Educational Specialists are trained professionals with healthcare experience. Some private payers have included this ICD-10 code in their coverage policy Item 24B designates place of service (POS) 21 for inpatient hospital as required by Medicare… Careful consideration should be given to use of the Closure Device in pregnant and/or breastfeeding women due to the risk of significant exposure to x-rays and the use of anticoagulation medicine.​, Device selection should be based on accurate LAA measurements obtained using echocardiographic imaging guidance (TEE recommended in multiple angles [e.g., 0º, 45º, 90º, 135º]) to avoid improper Closure Device sizing.​, Do not release (i.e., unscrew) the WATCHMAN Device from the core wire unless all release criteria are satisfied to avoid suboptimal results.​, Potential for Closure Device embolization exists with cardioversion <30 days following Closure Device​ implantation; verify Closure Device position post-cardioversion during this period.​, Appropriate post-procedure drug therapy should be followed. WATCHMAN is covered for eligible Medicare patients who meet certain national coverage criteria. Monday to Friday, 8AM to 5PM Central Time. Are at increased risk for stroke and systemic embolism based on CHADS2 or CHA2DS2-VASc scores and are recommended for anticoagulation therapy; 2. About 45 days after your procedure, one of the specialists will check your heart to see whether you can stop taking blood thinners. A Philadelphia cardiologist has written a newspaper column questioning the efficacy and cost of Boston Scientific’s Watchman device for stroke prevention. Rx only. And be sure to ask your cardiologist about the risks and benefits associated with WATCHMAN. WATCHMAN is covered for eligible Medicare patients who meet certain national coverage criteria. If you're an eligible Medicare patient who meets certain criteria, WATCHMAN will most likely be covered. Speak to one of our Education Specialists to learn more. The remaining population is represented by private payers. Be sure to talk with your doctor so that you thoroughly understand all of the risks and benefits associated with the implantation of the device. Answer a few short questions to see if you may be a candidate. The Centers for Medicare & Medicaid Services (CMS) covers percutaneous left atrial appendage closure (LAAC) for non-valvular atrial fibrillation (NVAF) through Coverage with Evidence Development (CED) under 1862(a)(1)(E) of the Social Security Act with the following conditions:A. The safety and effectiveness (and benefit-risk profile) of the WATCHMAN FLX Device has not been established in patients for whom long-term anticoagulation is determined to be contraindicated.​, Overall medical status, including conditions which might preclude the safety of a percutaneous, transcatheter procedure.​, Suitability for percutaneous, transseptal procedures, including considerations of:​, Cardiac anatomy relating to the LAA size and shape.​, Vascular access anatomy (e.g., femoral vein size, thrombus, or tortuosity).​, Ability of the patient to tolerate general or local anesthesia.​, Ability of the patient to undergo required imaging.​, Ability to comply with the recommended post-WATCHMAN FLX Device implant pharmacologic regimen (see Post-Procedure Information section in the eIFU) especially for patients at high risk for bleeding.​, Potential adverse events (in alphabetical order) which may be associated with the use of a left atrial appendage closure device or implantation procedure include but are not limited to:​, Contact a Boston Scientific Representative. An atrial septal defect repair or closure device or a patent foramen ovale repair or closure device is​ present.​, The LAA anatomy will not accommodate a device. After getting the WATCHMAN Implant, you’ll continue to see your cardiologist to manage your AFib. Patients with atrial fibrillation (AF), an irregular heartbeat, are at an increased risk of stroke. In rare cases death can occur. Nationally Covered Indications The Centers for Medicare & Medicaid Services (CMS) covers percutaneous LAAC for non-valvular atrial fibrillation (NVAF) through Coverage with Evidence Development (CED) with the following conditions: A. LAAC devices are covered when the device … Medical center you and your cardiologist has the special knowledge needed to you. Ongoing cost, WATCHMAN is covered for Medicare beneficiaries who meet certain national criteria... Therapy, other than non-valvular atrial​ fibrillation ( e.g the event of an inconsistency or conflict the! 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