Aetna Left Atrial Appendage Occlusion Devices coverage criteria

What this means for the claim

The covered path, the next step to get it approved, and the specific way it denies — built only from this policy.

Coverage criteria

• Percutaneous left atrial appendage closure (LAAC) devices are considered medically necessary for non-valvular atrial fibrillation (NVAF) when the device has received FDA Premarket Approval (PMA) and ALL of the following conditions are met (criteria A through H below).
• Stroke risk qualification (ONE of): CHADS2 score >=2 (congestive heart failure, hypertension, age >75, diabetes, stroke/TIA/thromboembolism) OR CHA2DS2-VASc score >=2 (CHF, hypertension, age >=65, diabetes, stroke/TIA/thromboembolism, vascular disease, sex category).
• Shared decision making: a formal shared decision making interaction with an independent non-interventional physician using an evidence-based decision tool on oral anticoagulation, documented in the medical record.
• Anticoagulation unsuitability: member is deemed unable to take long-term oral anticoagulation for ONE OR MORE of the following: (1) member has thromboembolism while on an oral anticoagulant (i.e., while INR is in therapeutic range); (2) member has major bleed (intracranial bleed, significant gastrointestinal bleeding [not just guaiac positive stools]) while on an oral anticoagulant (i.e., while INR is in therapeutic range); (3) member has elevated risk of bleeding on oral anticoagulant with a HAS-BLED score of 3 or more; (4) member has other absolute contraindication to long-term anticoagulation.
• Short-term anticoagulation/antiplatelet requirement: member is suitable for short-term dual antiplatelet therapy or warfarin for 45 days AND long-term aspirin.
• Multidisciplinary team care: member (preoperatively and postoperatively) is under the care of a cohesive multidisciplinary team (MDT) of medical professionals.
• Facility requirement: the procedure is furnished in a hospital with an established structural heart disease (SHD) and/or electrophysiology (EP) program.
• Operator qualifications: the interventional cardiologist(s), electrophysiologist(s), or cardiovascular surgeon(s) must meet ALL of: (1) has received training prescribed by the manufacturer on the safe and effective use of the device prior to performing LAAC; (2) has performed >=25 interventional cardiac procedures that involve transeptal puncture through an intact septum; (3) continues to perform >=25 interventional cardiac procedures that involve transeptal puncture through an intact septum, of which at least 12 are LAAC, over a two-year period.
• Registry participation: the candidate is enrolled in a prospective, national, audited registry; the MDT and the hospital must participate; the registry must consecutively enroll LAAC candidates and track annual outcomes for at least 4 years, including operator-specific complications, device-specific complications including thrombosis, stroke (adjudicated, by type), TIA, systemic embolism, death, and major bleeding (by site/severity).
• Surgical ligation of the left atrial appendage (LAA) is considered medically necessary for individuals with atrial fibrillation AND CHADS score >=2 OR CHA2DS2-VASc score >=2 who are undergoing open heart surgery AND will continue long-term anticoagulation after surgery.
• Aetna considers percutaneous left atrial appendage closure to be an outpatient procedure.

Covered codes

Codes listed in this Aetna policy. Check each one's prior-authorization verdict and Medicare rate:

• 33340·PA verdict·Rate

Documentation required

• Shared decision making interaction must be documented in the medical record (demonstrating discussion of oral anticoagulation alternatives using an evidence-based decision tool with an independent non-interventional physician).
• Medical record evidence of a qualifying stroke risk score: CHADS2 >=2 or CHA2DS2-VASc >=2.
• Documentation of one or more reasons for unsuitability for long-term oral anticoagulation (thromboembolism while on an anticoagulant, major bleed while on an anticoagulant, HAS-BLED score >=3, or other absolute contraindication to long-term anticoagulation).
• Documentation of multidisciplinary team (MDT) involvement preoperatively and postoperatively, and confirmation of hospital SHD and/or EP program status.
• Operator credentials documentation: manufacturer-prescribed training completion, >=25 prior interventional cardiac procedures involving transeptal puncture, and ongoing procedure volume (>=25 transeptal procedures of which >=12 are LAAC over a two-year period).
• Confirmation of enrollment in the prospective, national, audited registry.

Frequently asked questions

When does Aetna cover Left Atrial Appendage Occlusion Devices (CPT 33340), and what gets it denied?

Aetna covers percutaneous left atrial appendage closure (LAAC) with an FDA-PMA-approved device (Watchman or Amplatzer Amulet) for non-valvular atrial fibrillation only when all gating conditions are met: a qualifying stroke-risk score (CHADS2 or CHA2DS2-VASc >=2), documented shared decision making, unsuitability for long-term oral anticoagulation, suitability for short-term antiplatelet/warfarin plus long-term aspirin, multidisciplinary-team care, a qualified operator and SHD/EP-program hospital, and registry enrollment. Surgical LAA ligation during open heart surgery is covered for AF patients with a qualifying score who will continue long-term anticoagulation, while other LAA exclusion devices/indications and percutaneous use of non-approved devices are deemed experimental/investigational. Coverage criteria include: Percutaneous left atrial appendage closure (LAAC) devices are considered medically necessary for non-valvular atrial fibrillation (NVAF) when the device has received FDA Premarket Approval (PMA) and ALL of the following conditions are met (criteria A through H below).; Stroke risk qualification (ONE of): CHADS2 score >=2 (congestive heart failure, hypertension, age >75, diabetes, stroke/TIA/thromboembolism) OR CHA2DS2-VASc score >=2 (CHF, hypertension, age >=65, diabetes, stroke/TIA/thromboembolism, vascular disease, sex category).; Shared decision making: a formal shared decision making interaction with an independent non-interventional physician using an evidence-based decision tool on oral anticoagulation, documented in the medical record.; Anticoagulation unsuitability: member is deemed unable to take long-term oral anticoagulation for ONE OR MORE of the following: (1) member has thromboembolism while on an oral anticoagulant (i.e., while INR is in therapeutic range); (2) member has major bleed (intracranial bleed, significant gastrointestinal bleeding [not just guaiac positive stools]) while on an oral anticoagulant (i.e., while INR is in therapeutic range); (3) member has elevated risk of bleeding on oral anticoagulant with a HAS-BLED score of 3 or more; (4) member has other absolute contraindication to long-term anticoagulation.; Short-term anticoagulation/antiplatelet requirement: member is suitable for short-term dual antiplatelet therapy or warfarin for 45 days AND long-term aspirin.; Multidisciplinary team care: member (preoperatively and postoperatively) is under the care of a cohesive multidisciplinary team (MDT) of medical professionals.; Facility requirement: the procedure is furnished in a hospital with an established structural heart disease (SHD) and/or electrophysiology (EP) program.; Operator qualifications: the interventional cardiologist(s), electrophysiologist(s), or cardiovascular surgeon(s) must meet ALL of: (1) has received training prescribed by the manufacturer on the safe and effective use of the device prior to performing LAAC; (2) has performed >=25 interventional cardiac procedures that involve transeptal puncture through an intact septum; (3) continues to perform >=25 interventional cardiac procedures that involve transeptal puncture through an intact septum, of which at least 12 are LAAC, over a two-year period.; Registry participation: the candidate is enrolled in a prospective, national, audited registry; the MDT and the hospital must participate; the registry must consecutively enroll LAAC candidates and track annual outcomes for at least 4 years, including operator-specific complications, device-specific complications including thrombosis, stroke (adjudicated, by type), TIA, systemic embolism, death, and major bleeding (by site/severity).; Surgical ligation of the left atrial appendage (LAA) is considered medically necessary for individuals with atrial fibrillation AND CHADS score >=2 OR CHA2DS2-VASc score >=2 who are undergoing open heart surgery AND will continue long-term anticoagulation after surgery.; Aetna considers percutaneous left atrial appendage closure to be an outpatient procedure.. Applies to 1 code: 33340. Confirm prior-authorization status with Aetna before scheduling — it is code- and plan-specific, and this policy is not an exact authorization source. Documentation: Shared decision making interaction must be documented in the medical record (demonstrating discussion of oral anticoagulation alternatives using an evidence-based decision tool with an independent non-interventional physician).; Medical record evidence of a qualifying stroke risk score: CHADS2 >=2 or CHA2DS2-VASc >=2.; Documentation of one or more reasons for unsuitability for long-term oral anticoagulation (thromboembolism while on an anticoagulant, major bleed while on an anticoagulant, HAS-BLED score >=3, or other absolute contraindication to long-term anticoagulation).; Documentation of multidisciplinary team (MDT) involvement preoperatively and postoperatively, and confirmation of hospital SHD and/or EP program status.; Operator credentials documentation: manufacturer-prescribed training completion, >=25 prior interventional cardiac procedures involving transeptal puncture, and ongoing procedure volume (>=25 transeptal procedures of which >=12 are LAAC over a two-year period).; Confirmation of enrollment in the prospective, national, audited registry. Policy exclusions and limitations: Aetna considers cardiac devices for occlusion of the left atrial appendage experimental, investigational, or unproven for all other indications (i.e., other than those that meet the medically necessary criteria).; Exclusion of the LAA (e.g., clip, excision, isolation via stapling, ligation, over-sewing, and plication) alone during open heart surgeries in members without atrial fibrillation, or who have atrial fibrillation but are not expected to be on anticoagulation after the open heart surgery, is considered experimental, investigational, or unproven.; Percutaneous LAA closure using any device other than the Amplatzer Amulet Left Atrial Appendage Occluder and the Watchman device (e.g., Amplatzer Cardiac Plug, AtriClip, and Lariat Suture Delivery Device) is considered experimental, investigational, or unproven.; The use of surgical left atrial appendage occlusion devices, including the AtriClip device, for stroke prevention in individuals with atrial fibrillation (AF) undergoing open or thoracoscopic cardiac procedures is considered experimental, investigational, or unproven.; The use of surgical left atrial appendage occlusion devices, including the AtriClip device, for stroke prevention as a stand-alone procedure for stroke prevention in individuals with AF is considered experimental, investigational, or unproven.; Aetna will not reimburse a transesophageal echocardiogram for the same provider that places the Watchman. Claims may be denied when the requested service falls under these.

Does Aetna require prior authorization for Left Atrial Appendage Occlusion Devices?

Confirm prior-authorization status with Aetna before scheduling — it is code- and plan-specific, and this policy is not an exact authorization source. Documentation: Shared decision making interaction must be documented in the medical record (demonstrating discussion of oral anticoagulation alternatives using an evidence-based decision tool with an independent non-interventional physician).; Medical record evidence of a qualifying stroke risk score: CHADS2 >=2 or CHA2DS2-VASc >=2.; Documentation of one or more reasons for unsuitability for long-term oral anticoagulation (thromboembolism while on an anticoagulant, major bleed while on an anticoagulant, HAS-BLED score >=3, or other absolute contraindication to long-term anticoagulation).; Documentation of multidisciplinary team (MDT) involvement preoperatively and postoperatively, and confirmation of hospital SHD and/or EP program status.; Operator credentials documentation: manufacturer-prescribed training completion, >=25 prior interventional cardiac procedures involving transeptal puncture, and ongoing procedure volume (>=25 transeptal procedures of which >=12 are LAAC over a two-year period).; Confirmation of enrollment in the prospective, national, audited registry.

What does Aetna exclude for Left Atrial Appendage Occlusion Devices?

Policy exclusions and limitations: Aetna considers cardiac devices for occlusion of the left atrial appendage experimental, investigational, or unproven for all other indications (i.e., other than those that meet the medically necessary criteria).; Exclusion of the LAA (e.g., clip, excision, isolation via stapling, ligation, over-sewing, and plication) alone during open heart surgeries in members without atrial fibrillation, or who have atrial fibrillation but are not expected to be on anticoagulation after the open heart surgery, is considered experimental, investigational, or unproven.; Percutaneous LAA closure using any device other than the Amplatzer Amulet Left Atrial Appendage Occluder and the Watchman device (e.g., Amplatzer Cardiac Plug, AtriClip, and Lariat Suture Delivery Device) is considered experimental, investigational, or unproven.; The use of surgical left atrial appendage occlusion devices, including the AtriClip device, for stroke prevention in individuals with atrial fibrillation (AF) undergoing open or thoracoscopic cardiac procedures is considered experimental, investigational, or unproven.; The use of surgical left atrial appendage occlusion devices, including the AtriClip device, for stroke prevention as a stand-alone procedure for stroke prevention in individuals with AF is considered experimental, investigational, or unproven.; Aetna will not reimburse a transesophageal echocardiogram for the same provider that places the Watchman. Claims may be denied when the requested service falls under these.

Source

Related

• All Aetna coverage policies
• Aetna prior-authorization requirements — which codes need PA, by CPT