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… Have an appropriate rationale to seek a non-pharmacologic alternative to warfarin, taking into account the safet… Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. ©2021 Boston Scientific Corporation or its affiliates. WATCHMAN is different from blood thinners not only in how it works, but in how much it costs. At the medical center you and your cardiologist select, a team of trained specialists will implant WATCHMAN in your heart. Medicare beneficiaries account for the overwhelming majority of patients deemed candidates for the WATCHMAN Device. What's covered by Medicare. 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. A Philadelphia cardiologist has written a newspaper column questioning the efficacy and cost of Boston Scientific’s Watchman device for stroke prevention. Medicare beneficiaries account for the overwhelming majority of patients deemed candidates for the Watchman device. The presence of indication(s) for long-term anticoagulation therapy, other than non-valvular atrial​ fibrillation (e.g. This means WATCHMAN can save you money over time. Answer a few short questions to see if you may be a candidate. In 2002, the PLAATO system (ev3 Endovascular) was the first device … All trademarks are property of their respective owners. If you and your cardiologist decide that WATCHMAN is right for you, you may be referred to one of these centers. The CMS' final coverage rule on Boston Scientific's cardiac device the Watchman does not include language requiring … We have information in different languages about What's covered by Medicare. It’s also covered by an increasing number of commercial insurers. Find an implanting watchman facility near you. In April of this year, Boston Scientific submitted a formal request to CMS for a National Coverage … Monday to Friday, 8AM to 5PM Central Time. It may help prepare you for talking to your doctor about your options for reducing stroke risk. 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… They're here to help answer your questions. It’s important to understand that neither WATCHMAN nor blood thinners cure atrial fibrillation (AFib) or its symptoms, like irregular heart rhythm. After getting the WATCHMAN Implant, you’ll continue to see your cardiologist to manage your AFib. The Watchman device is a good example of the double-edged sword that is modern medicine. Of note:​, 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:​ 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. Most studies evaluating the Watchman device have included patients who are eligible for anticoagulation. 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 … 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. device may be associated with increased thrombogenicity and, therefore, anticoagulation is used during the periprocedural period. ©2021 Boston Scientific Corporation or its affiliates. It’s also covered by an increasing number of commercial insurers. WATCHMAN is covered for patients who need an alternative to oral anticoagulants (OACs), including those with an active lifestyle, a physical occupation, trouble maintaining a stable International Normalized Ratio (INR), or problems with treatment compliance. Your cardiologist’s office may be able to help you find out what your coverage is. Electrical Cardioversion – This is a low voltage … Your cardiologist’s office may be able … Patient Ambassadors are a community of people that have received the WATCHMAN implant and have volunteered to share their personal experiences with potential patients. 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. 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. If you don’t have a cardiologist, your primary care physician can refer you to one. Prior to use, please see the complete “Instructions for Use” for more information on Indications, Contraindications, Warnings, Precautions, Adverse Events, and Operator’s Instructions.​, The WATCHMAN Device is indicated to reduce the risk of thromboembolism from the left atrial appendage in patients with non-valvular atrial fibrillation who:​, Implantation of the WATCHMAN Device should only be performed by interventional cardiologists and/or electrophysiologists who are trained in percutaneous and transseptal procedures and who have completed the WATCHMAN Physician Training program.​, In considering the use of the WATCHMAN FLX Device, the rationale for seeking an alternative to long-term anticoagulation therapy and the safety and effectiveness of the device compared to anticoagulation should be taken into account.​, Details regarding the indications, contraindications, warnings, and precautions for oral anticoagulants approved for patients with non-valvular atrial fibrillation are provided in their respective Instructions for Use. Your cardiologist has the special knowledge needed to help you decide if WATCHMAN is right for you. The WATCHMAN procedure is covered for Medicare beneficiaries who meet specific criteria. Stay in touch with WATCHMAN by calling an education specialist, attending a local event, or signing up to hear from us. More than 650 of the nation’s top medical centers implant WATCHMAN. Medicare covers Cardioversion under Part A benefits. *The unspecified code is NOT COVERED under the CMS NCD for LAAC. All trademarks are property of their respective owners. Answer a few short questions to see if you may be a candidate and get a customized guide to help you start a conversation with your doctor. Are at increased risk for stroke and systemic embolism based on CHADS, Are deemed by their physicians to be suitable for anticoagulation therapy; and​. 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. by Nicole Lou, Staff Writer, MedPage Today October 31, 2019 Medicare patients undergoing left atrial appendage (LAA) occlusion with the Watchman device in routine practice tended … Yes, the device helps people but it's also expense and carries potential complications. Medicare Covers Watchman Device, Drops Some Proposed Limits — Agency apparently moved by objections to draft coverage decision How long have WATCHMAN implant procedures been performed? Help with the costs of seeing a doctor, getting medicines and accessing mental health care. 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.​. … The remaining population is represented by private payers. This website is intended to provide patients and caregivers with some information about the WATCHMAN Implant. WATCHMAN is for people with atrial fibrillation not caused by a heart valve problem who need an alternative to blood thinners. … Medicare approves coverage of 'breakthrough' medical devices ... “We believe the Watchman device can be used to safely close the left atrial appendage in high-risk patients,” Bryn … 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.​. The WATCHMAN device is a one-time, ... Is WATCHMAN covered by medical insurance? 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. 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… 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. Have an appropriate rationale to seek a non-pharmacologic alternative to anticoagulation therapy, taking into account the safety and effectiveness of the device compared to anticoagulation therapy. Prior to the CMS final … The left atrial appendage (LAA) is a tubular structure that opens into the left atrium and has been shown to be one … Are at increased risk for stroke and systemic embolism based on CHADS2 or CHA2DS2-VASc scores and are recommended for anticoagulation therapy; 2. WATCHMAN is covered for eligible Medicare patients who meet certain national coverage criteria. In the event of an inconsistency or conflict between the information provided in the Medicare Advantage Coverage … And be sure to ask your cardiologist about the risks and benefits associated with WATCHMAN. Studies highlight complications … 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 … WATCHMAN is different from blood … An increasing number of commercial insurance companies are also beginning to cover … Watchman Medicare coverage missing patient decisionmaking tool. For a list of the criteria, click here. mechanical heart valve, hypercoagulable states, recurrent deep venous thrombosis). Boston Scientific … WATCHMAN is covered for eligible Medicare patients who meet certain national coverage criteria. 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. 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. It is also covered by an increasing number of commercial insurers. 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. Approved a year ago by FDA, the Watchman … Rx only. About 45 days after your procedure, one of the specialists will check your heart to see whether you can stop taking blood thinners. All rights reserved. See Post-Procedure Information section​ (in the IFU) for further detail. 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 indicated to reduce the risk of thromboembolism from the left atrial appendage in patients with non-valvular atrial fibrillation who: 1. The remaining population is represented by private payers. It represents an excellent option for stroke risk reduction in patients with atrial … The WATCHMAN and WATCHMAN FLX Devices are permanent implants designed to close the left atrial appendage in the heart in an effort to reduce the risk of stroke. The … The cost of the Watchman device is covered by Medicare and Medicaid as of February 8, 2016. The device is intended to remain inside a patient’s heart permanently. Cardioversion is an inpatient therapy that comes in a couple of different forms. ​, The safety and effectiveness (and benefit-risk profile) of the WATCHMAN Device has not been established in patients for whom long-term anticoagulation is determined to be contraindicated.​, The LAA is a thin-walled structure. With all medical procedures there are risks associated with the implant procedure and the use of the device. Boston Scientific stock shot up more than 5% in value during Tuesday morning trading after news that the company's Watchman left atrial appendage closure device would be covered by Medicare. WATCHMAN is covered for eligible Medicare patients who meet certain national coverage criteria. If you have atrial fibrillation not caused by a heart valve problem and you’re looking for an alternative to blood thinners, then it’s important to talk to your cardiologist about your options. 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. WATCHMAN Educational Specialists are trained professionals with healthcare experience. Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients globally. Tell your cardiologist about any falls or accidents, unusual bruising, or symptoms of bleeding that you’ve had while on blood thinners. February 19, 2015. 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. 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. Patients with atrial fibrillation (AF), an irregular heartbeat, are at an increased risk of stroke. You likely have more than one doctor that you trust with your health: a primary care physician for your general health needs and a cardiologist for your heart. Are deemed by their physicians to be suitable for warfarin; and 3. In rare cases death can occur. 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