Baroreflex stimulation device (baroreflex activation therapy) coverage criteria
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Defines HUSKY Health prior authorization and medical necessity guidelines for implantation, interrogation, evaluation, revision, and removal of baroreflex stimulation devices for Connecticut Medicaid (HUSKY) members.
No material clinical or coverage changes in this revision.
Coverage determination and scope
Not medically necessary — investigational
Covered when ALL of the following are met:
This is the definitive coverage criterion in the document.
HUSKY Health considers baroreflex stimulation devices investigational and therefore not medically necessary for any indication. This determination applies to the device itself as well as any associated interrogation and evaluation services because the available peer‑reviewed literature does not provide sufficient evidence of clinical efficacy or improved health outcomes.
Implantation, revision, removal, interrogation, and evaluation services related to baroreflex stimulation systems are not covered. These procedures and services are included in the policy determination that baroreflex stimulation therapy is investigational and not medically necessary for any indication.
Procedure and interrogation codes
| 64654 | Initial implantation of baroflex activation therapy (BAT) modulation system, including lead placement onto the carotid sinus, lead tunnelling, connection to a pulse generator placed in a distant subcutaneous pocket (i.e., total system), and intraoperative interrogation and programming. |
| 64655 | Revision or replacement of baroflex activation (BAT) modulation therapy system with intraoperative interrogation and programming; lead only. |
| 64656 | Revision or replacement of baroreflex activation therapy (BAT) modulation system, with intraoperative interrogation and programming; pulse generator only. |
| 64657 | Removal of baroreflex activation therapy (BAT) modulation system; total system, including lead and pulse generator. |
| 64658 | Removal of baroreflex activation therapy (BAT) modulation system; lead only. |
| 64659 | Removal of baroreflex activation therapy (BAT) modulation system; pulse generator only. |
| 93145 | Interrogation device evaluation (in person), carotid sinus baroreflex activation therapy (BAT) modulation system including telemetric iterative communication with the implantable device to monitor device diagnostics and programmed therapy values, with interpretation and report (e.g., battery status, lead impedance, pulse amplitude, pulse width, therapy frequency, pathway mode, burst mode, therapy start/stop times each day); without programming. |
| 93146 | Interrogation device evaluation (in person), carotid sinus baroreflex activation therapy (BAT) modulation system including telemetric iterative communication with the implantable device to monitor device diagnostics and programmed therapy values, with interpretation and report (e.g., battery status, lead impedance, pulse amplitude, pulse width, therapy frequency, pathway mode, burst mode, therapy start/stop times each day); with programming, including optimization of tolerated therapeutic level setting. |
Prior authorization, documentation, and provider guidance
Prior authorization required for implantation, revision, removal, and interrogation
Prior authorization is required for implantation, revision, removal, and interrogation/evaluation services for baroreflex stimulation devices; these requests will be reviewed per surgical procedure review processes.
- Applies to CPT codes 64654–64659, 93145–93146
No step therapy specified; FDA approval (BaroStim Neo) noted but limited
No step therapy pathway is specified in this policy. The document notes that one commercially available system (BaroStim Neo) has FDA approval for a narrow heart‑failure indication, but the policy nevertheless deems the technology investigational for any indication.
Submit case‑specific clinical information; surgical procedure review
Prior authorization requests will be reviewed in accordance with procedures for surgical procedures and require submission of case‑specific clinical information to demonstrate medical necessity at the time of the request.
- Authorization is based on medical necessity at the time authorization is issued and is not a guarantee of payment.
- Coverage determinations will be based upon review of requested and/or submitted case‑specific information.
Denial risk — device considered investigational for all indications
Requests for baroreflex stimulation devices (including implantation, revision, removal, interrogation, and evaluation services) will be denied as not medically necessary for any indication because the device is considered investigational due to insufficient evidence of clinical efficacy and improved health outcomes.
Clinical background
Baroreflex stimulation (also called baroreflex activation therapy) uses an implanted system to electrically stimulate carotid sinus baroreceptors with the intended physiologic effect of modulating autonomic outflow to reduce heart rate and blood pressure. The policy notes that, despite proposed uses (for example in certain heart failure or resistant hypertension contexts), the evidence base is insufficient to demonstrate meaningful clinical benefit.
Key definitions and terms
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