As of July 1st 2020, Novitas Solutions, Inc (Novitas) and First Coast Services Options, Inc (FCSO) have retired their non-coverage Local Coverage Determination (LCD).
Novitas and FCSO recently retired their long-standing local non-coverage policies for the CardioMEMS™ Heart Failure (HF) System. Novitas is the Medicare Administrative Contractor (MAC) that administers the Medicare claims for Delaware, Maryland, New Jersey, Pennsylvania, District of Columbia, Arkansas, Colorado, Louisiana, Mississippi, New Mexico, Oklahoma, and Texas. FCSO is the MAC for Florida, Puerto Rico, and the Virgin Islands.
Patients in these two Medicare Contractor jurisdictions now have access and implicit coverage to the CardioMEMS HF System based on reasonable and medically necessary guidelines for dates of service on and after July 1st, 2020.
Rx Only
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.
CardioMEMS™ HF System 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.
CardioMEMS™ HF System Contraindications: The CardioMEMS™ HF System is contraindicated for patients with an inability to take dual antiplatelet or anticoagulants for one-month post implant.
CardioMEMS™ HF System 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. Refer to the User’s Manual for detailed indications, contraindications, warnings, precautions and potential adverse events.
MAT-2006849 v1.0
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Unless otherwise specified, all product and service names appearing in this Internet site are trademarks owned by or licensed to Abbott, its subsidiaries or affiliates. No use of any Abbott trademark, trade name, or trade dress in this site may be made without the prior written authorization of Abbott, except to identify the product or services of the company.
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The following pages are intended for medical professionals and provide information on the proper use of products (medical devices, etc.) of Abbott Medical Japan GK.
The information provided here is not intended to provide information to patients and the general public.
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