Health First Medicare Form

Medical Policy Subject: Baroflex Activation Therapy (BAT) Barostim® Policy Number: MP-0225 Effective Date: October 2023 Applies To: Medicare Advantage Revised: January 2024 Document Page Length: 7 Medical Policy Statement: Implantable carotid sinus baroreflex activation therapy will not be considered medically reasonable and necessary. A review of the current literature shows that the evidence is insufficient to determine that this service is standard medical treatment. There remains an absence of randomized, blinded clinical studies examining benefit and long-term outcomes establishing the value of this service in clinical management. Definitions: The Barostim Neo System Kit - Is a medical device designed to treat CHF. The kit includes an implantable pulse generator (IPG), an implant adapter and implant tool, a carotid sinus lead (CSL), a CSL repair kit, and a wireless programmer system (consisting of a programmer interface, software, and a computer). The IPG is surgically inserted under the collar bone and connected to the carotid artery via a 2 millimeter (mm) electrode. The IPG stimulates the baroreceptors approximately 40 times more frequently than a pacemaker CHF- Congestive Heart Failure Ejection Fraction (EJ) - The volumetric fraction of fluid ejected from the cardiac chamber with each contraction expressed in a percentage. Guideline-Directed Medical Therapy (GDMT) - AHA Clinical practice guidelines of 4 medication drug based therapy for heart failure which include beta blockers, angiotensin-converting enzyme inhibitors (ACEI) / angiotensin receptor blockers (ARB) / Angiotensin receptor-neprilysin inhibitors (ARNI), mineralocorticoid receptor antagonists (MRA) and sodium-glucose cotransporter-2 inhibitors (SGLT2i). Medical Policy Description: Barostim was FDA approved in 2019 as an implanted device for patients with systolic heart failure. The device sends electrical signals to trigger the body’s own natural blood flow regulation system. Unlike a pacemaker, it is not connected to the heart. The device utilizes neuromodulation, the power of the brain and nervous system, to improve the symptoms of patients with systolic heart failure. A person’s body senses changes in blood pressure and other blood flow changes through pressure sensors (baroreceptors) that are found on the carotid artery and in the carotid sinus. These sensors measure and report blood flow to the brain, which compares it to the body’s needs. The Barostim device is implanted under the collarbone and attached with thin leads to the carotid artery. The implanted device communicates with an external device doctors use to noninvasively regulate the activation energy therapy from the device to the leads. The device sends electrical pulses to baroreceptors located in the wall of the carotid artery. Baroreceptors trigger the body’s main cardiovascular reflex called the baroreflex, which in turn triggers an autonomic response to the heart. “Autonomic” means it is part of the body’s systems that are not consciously controlled by the brain. When activated, signals are sent through neural pathways to the brain that responds by telling the: • Arteries to relax, making it easier for blood to flow through the body and reducing cardiac exertion • Heart to slow down, allowing more time for the organ to fill with blood • Kidneys to reduce fluid in the body, lowering both excessive blood pressure and workload on the heart The therapy is designed to restore balance to the autonomic nervous system and reduce the symptoms of heart failure. Clinical Criteria: (Indications/Limitations) Indications – Medical Necessary Criteria I. Prior Authorization is required for any Cardiac Contractility Modulation (CCM) procedures. II. Patient has a diagnosis of systolic heart failure. III. Cardiologist has followed and documented the 2022 AHA Heart Failure Guidelines in member treatment. IV. Member has an ejection fraction of >35% and is symptomatic NYHA Class III. V. Member is on GDMT and is still experiencing significant symptoms VI. Not indicated for Cardiac Resynchronization Therapy or not receiving adequate therapy from existing CRT device Medical Policy • Narrow QRS • Failed CRT attempt • Non responder to CRT VII. Has an existing Implantable cardioverter defibrillator (ICD) device. Limitations: (Not Covered) I. Baroflex Activation Therapy (BAT) is not covered when not considered medically necessary.