CurrentBlue Cross Blue Shield - Rhode IslandPolicy N/A

Baroreflex stimulation (baroreflex activation therapy) devices for heart failure

Policy governs coverage determinations for implanted baroreflex stimulation (baroreflex activation therapy, BAT) devices for treatment-resistant heart failure and related uses for Medicare Advantage and commercial products, including coding guidance for related CPT/HCPCS codes.

Policy Summary

PayerBlue Cross Blue Shield - Rhode Island

PolicyBaroreflex stimulation (baroreflex activation therapy) devices for heart failure

Policy CodePolicy N/A

Change TypeNo material changes

Effective Date

Next Review Date

Key ActionClaims reported with the listed CPT/HCPCS codes for Medicare Advantage and Commercial products are considered not covered/not medically necessary and are subject to denial.

SourceLink

POLICY UPDATE CHANGES

No material changes to clinical evidence or coverage determinations.

All situationsCoverage determination

Multiple listedAffected billing codes

FDA PMA notedRegulatory context

Coverage Summary

Scope: Policy governs coverage determinations for implanted baroreflex stimulation (baroreflex activation therapy, BAT) devices for treatment-resistant heart failure and related uses for Medicare Advantage and commercial products, including coding guidance for related CPT/HCPCS codes.

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Coverage and Medical Necessity Criteria

Medicare Advantage Coverage Determination

Use of baroreflex stimulation therapy with an FDA-approved device is considered not covered in all situations, including but not limited to treatment of heart failure despite maximally tolerated guideline-directed medical and device therapy because evidence is insufficient to show improvement in net health outcome.

ALL of the following

Baroreflex stimulation therapy with an FDA-approved device
Not covered in all situations
Includes treatment of heart failure despite use of maximally tolerated guideline-directed medical and device therapy
Specifically listed as example of not covered situation

Commercial Products Coverage Determination

Use of baroreflex stimulation therapy with an FDA-approved device is considered not medically necessary in all situations, including but not limited to treatment of heart failure despite maximally tolerated guideline-directed medical and device therapy because evidence is insufficient to show improvement in net health outcome.

ALL of the following

Baroreflex stimulation therapy with an FDA-approved device
Considered not medically necessary in all situations
Includes treatment of heart failure despite use of maximally tolerated guideline-directed medical and device therapy
Specifically listed as example of not medically necessary

Not covered / Not medically necessary codes

Not covered / Not medically necessary CPT and HCPCS codes (Medicare Advantage and Commercial)CPTNot Covered

64654	Initial open implantation of baroreflex 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 (ie, total system), and intraoperative interrogation and programming (New Code Effective 1/1/2026)
64655	Revision or replacement of baroreflex activation therapy (BAT) modulation system, with intraoperative interrogation and programming; lead only (New Code Effective 1/1/2026)
64656	Revision or replacement of baroreflex activation therapy (BAT) modulation system, with intraoperative interrogation and programming; pulse generator only (New Code Effective 1/1/2026)
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; without programming (New Code Effective 1/1/2026)
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; with programming, including optimization of tolerated therapeutic level setting (New Code Effective 1/1/2026)
0266T	Implantation or replacement of carotid sinus baroreflex activation device; total system (includes generator placement, unilateral or bilateral lead placement, intra-operative interrogation, programming, and repositioning, when performed) (Code Deleted Effective 12/31/2025)
0267T	Implantation or replacement of carotid sinus baroreflex activation device; lead only, unilateral (includes intra-operative interrogation, programming, and repositioning, when performed) (Code Deleted Effective 12/31/2025)
0268T	Implantation or replacement of carotid sinus baroreflex activation device; pulse generator only (includes intra-operative interrogation, programming, and repositioning, when performed) (Code Deleted Effective 12/31/2025)
0272T	Interrogation device evaluation (in person), carotid sinus baroreflex activation system, including telemetric iterative communication with the implantable device to monitor device diagnostics and programmed therapy values, with interpretation and report (Code Deleted Effective 12/31/2025)
0273T	Interrogation device evaluation (in person), carotid sinus baroreflex activation system, including telemetric iterative communication with the implantable device to monitor device diagnostics and programmed therapy values, with interpretation and report; with programming (Code Deleted Effective 12/31/2025)

Not covered / Not medically necessary HCPCS device codeHCPCSNot Covered

C1825

Generator, neurostimulator (implantable), non-rechargeable with carotid sinus baroreceptor stimulation lead(s)

Background and Evidence Summary

Baroreflex stimulation (also called baroreflex activation therapy) uses an implanted device to electrically stimulate carotid sinus baroreceptors; activation of the baroreflex inhibits sympathetic nervous system output, lowering heart rate and blood pressure. Trials show modest improvements in functional capacity and quality of life (QOL) but have not demonstrated significant reductions in heart failure morbidity or mortality; overall evidence is considered insufficient to establish an improvement in net health outcomes.

Evidence type	Summary
RCTs and meta-analyses	2 RCTs, post hoc subgroup analysis, nonrandomized controlled trial, and meta-analyses with mixed results: short-term improvements in quality of life and 6-minute walk distance but no significant reduction in cardiovascular mortality or heart failure morbidity in extended follow-up
Regulatory approval	Barostim Neo received PMA (P180050) with indication for symptom improvement in specific heart failure populations; indication expanded in 2023

Baroreflex stimulation / Baroreflex activation therapy (BAT): Implanted device-mediated electrical stimulation of carotid sinus baroreceptors to inhibit sympathetic nervous system activity, lowering heart rate and blood pressure.

Revision History

2019regulatory

Barostim Neo received premarket approval (PMA P180050) with indications for improvement of heart failure symptoms (QOL, 6-minute walk, functional status) for specified NYHA class and LVEF criteria.

2023regulatory

Barostim Neo indication expanded to include patients who are NYHA Class III or Class II with recent Class III despite guideline-directed therapies, LVEF ≤35%, and NT-proBNP <1600 pg/ml.

2024evidence_update

Extended phase trial results showed modest, sustained improvements in quality of life, NYHA class, and 6-minute walk distance up to 2 years but no statistically significant reduction in cardiovascular mortality or heart failure morbidity.

2025coding_updateLatest

New CPT codes (64654, 64655, 64656, 93145, 93146) effective 1/1/2026 and deletion of temporary codes (0266T–0268T, 0272T–0273T) effective 12/31/2025; HCPCS device code C1825 listed.

2025coverage_determinationLatest

Use of baroreflex stimulation therapy with an FDA-approved device is considered not covered for Medicare Advantage and not medically necessary for Commercial Products in all situations because evidence is insufficient to show improvement in net health outcome.

OpenPayer