Novitas and First Coast are currently reviewing their Local Coverage Determination (LCD) policies for outpatient wireless pulmonary artery pressure monitoring for the management of Heart Failure. Both Medicare Administrative Contractors (MACs) currently have non-coverage policies for the CardioMEMS™ HF System which severely limits Medicare access for patients in the Novitas and First Coast areas access to this technology outside of an approved clinical trial.
This review is a positive first step that may lead to reconsideration of the policy. The information below is intended to help you advocate for your patients to have access to the CardioMEMS HF System.
Novitas and First Coast are convening a Contractor Advisory Committee (CAC) meeting on April 7, 2020 via teleconference from 6 pm to 8 pm ET for outpatient implantable wireless pulmonary artery pressure monitoring for the management of Heart Failure (CardioMEMS HF System). The purpose of a CAC meeting is to review and discuss the evidentiary requirements for a procedure and technology to determine if it warrants additional consideration for changes and updates in the local coverage determination (LCD) policy.
Public registration for the CAC meeting can be found on your contractor’s website and is open 2 weeks prior to the scheduled date of the meeting. The public can only participate in “listen-only” mode. There will be a greater opportunity for public comments when the Medicare contractors post the proposed LCD and engage in an OPEN meeting for stakeholders, physicians, hospitals and the clinical community to weigh in. For further information about the CAC meeting, please visit your MAC website below:
Abbott will have better visibility after the CAC meeting to determine next steps to keep you involved in the process. As a result of the 21st Century Cures Legislation, the MACs have changed the LCD deliberation process to provide greater transparency and stakeholder engagement.
The new process could take 9 months to 1 year to complete. We will provide you better visibility to the key dates and milestones as we approach each phase so please bookmark this page to keep abreast of the latest developments on CardioMEMS.
The information contained herein is for general information purposes only and is not intended, and does not constitute legal, reimbursement, business, or other advice. Furthermore, it does not constitute a representation or guarantee of cost-effectiveness, and it is not intended to increase or maximize payment by any payer. Nothing in this communication should be construed as a guarantee by Abbott regarding cost effectiveness, expenditure reduction, reimbursement or payment amounts, or that reimbursement or other payment will be received. The ultimate responsibility for determining cost-effectiveness and obtaining payment/reimbursement remains with the customer. This includes the responsibility for accuracy and veracity of all claims submitted to third-party payers. Also note that actual costs for products and services and any related expenditures vary, and that the information presented herein is based on the assumptions, variables, and data presented. In addition, the customer should note that laws, regulations, and coverage policies are complex and are updated frequently, and, therefore, the customer should check with its local Medicare Administrative Contractor often and should consult with legal counsel or a financial or reimbursement specialist for any questions related to cost-effectiveness, expenditure reduction, billing, reimbursement or any related issue. This information does not guarantee coverage or payment at any specific level, and Abbott does not advocate or warrant the appropriateness of the use of any particular code. This update reproduces information for reference purposes only. It is not provided or authorized for marketing use.
Brief Summary: Prior to using these devices, please review the Instructions for Use for a complete listing of indications, contraindications, warnings, precautions, potential adverse events and directions for use.
Indications and Usage: The CardioMEMS™ HF System is indicated for wirelessly measuring and monitoring pulmonary artery (PA) pressure and heart rate in New York Heart Association (NYHA) Class III heart failure patients who have been hospitalized for heart failure in the previous year. The hemodynamic data are used by physicians for heart failure management and with the goal of reducing heart failure hospitalizations.
Contraindications: The CardioMEMS HF System is contraindicated for patients with an inability to take dual antiplatelet or anticoagulants for one month post implant.
Potential Adverse Events: Potential adverse events associated with the implantation procedure include, but are not limited to, the following: Infection, Arrhythmias, Bleeding, Hematoma, Thrombus, Myocardial infarction, Transient ischemic attack, Stroke, Death, and Device embolization.
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