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Modifiedblue cross blue shield - louisianaPolicy 00246

Total Artificial Hearts and Implantable Ventricular Assist Devices

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This policy describes Blue Cross Blue Shield of Louisiana coverage criteria for total artificial hearts (TAHs), implantable ventricular assist devices (VADs), and percutaneous VADs, including indications for destination therapy, bridge to transplant, post-cardiotomy/bridge to recovery, and percutaneous devices for cardiogenic shock. It applies to all products administered or underwritten by the Company.

Policy Summary

Payerblue cross blue shield - louisiana

PolicyTotal Artificial Hearts and Implantable Ventricular Assist Devices

Policy CodePolicy 00246

Change TypeAdded FDA-aligned pVAD languageadded Not Medically Necessary sectiondesignated right heart pVADs investigational

Effective DateJul 1, 2026

Next Review DateApr 1, 2027

Key ActionObtain and document medical necessity and device-specific approvals/clearances when requesting coverage or prior authorization.

SourceLink

POLICY UPDATE CHANGES

Added 'left heart pVAD is FDA approved' to the percutaneous ventricular assist devices (pVADs) for the treatment of cardiogenic shock criteria.

Added 'in accordance with FDA approval' to the ventricular assist devices criteria statements.

Added Not Medically Necessary section.

Added statement that use of percutaneous VADs when criteria are not met is not medically necessary.

Added statement that other applications of implantable VADs or total artificial hearts (including TAHs as destination therapy) are not medically necessary.

Removed prior investigational language regarding other indications (replaced with not medically necessary language).

Added investigational designation for right heart percutaneous VADs.

≤14Impella 5.5 label duration (days)

NYHA IV / LVEF ≤25%Medicare NCD criteria noted

HeartMate II & 3FDA recalls noted

≈6.7MHeart failure prevalence (US)

355DanGer Shock trial n

Coverage Criteria for TAHs, Implantable VADs, and pVADs

inv-01: Destination Therapy

Covered when ALL of the following are met:

Destination therapy criteria: Implantable VAD used in accordance with FDA approval; AND adult individual with end-stage heart failure; AND documented NYHA Class III (dyspnea on mild activity) or NYHA Class IV; AND left ventricular ejection fraction ≤ 25%; AND inotrope-dependent OR cardiac index < 2.2 L/min/m2 while not on inotropes AND also meeting one of: on optimal medical management per current guidelines for at least 45 of the last 60 days and failing to respond; OR advanced heart failure ≥14 days and dependent on intra-aortic balloon pump (IABP) ≥7 daysas stated

Per Medicare NCD requirements and policy text.

inv-02: Bridge to Transplantation

Covered when ALL of the following are met:

Adult bridge to transplant: Implantable VAD used in accordance with FDA approval; AND adult individual is currently listed as a heart transplant candidate OR is undergoing evaluation to determine candidacy for heart transplantation AND is not expected to survive until a donor heart can be obtained

Policy Summary

Payerblue cross blue shield - louisiana

PolicyTotal Artificial Hearts and Implantable Ventricular Assist Devices

Policy CodePolicy 00246

Change TypeAdded FDA-aligned pVAD languageadded Not Medically Necessary sectiondesignated right heart pVADs investigational

Effective DateJul 1, 2026

Next Review DateApr 1, 2027

Key ActionObtain and document medical necessity and device-specific approvals/clearances when requesting coverage or prior authorization.

SourceLink

On This Page

inv-04: Percutaneous Ventricular Assist Devices (pVAD) for Cardiogenic Shock

Covered when ALL of the following are met:

pVAD criteria for cardiogenic shock: Left heart pVAD is FDA approved; AND request is for an adult (≥18 years); AND acute myocardial infarction <36 hours duration with either STEMI with new ST‑segment elevation OR new onset ST‑segment depression or new LBBB with emergency angiography demonstrating acute proximal coronary occlusion; AND cardiogenic shock of <24 hours duration confirmed by hypotension and all of: systolic BP <100 mmHg or ongoing vasopressor support; AND end‑organ hypoperfusion with arterial lactate ≥2.5 mmol/L; AND LVEF <45%; AND absence of any exclusion criteria including: comatose after out‑of‑hospital arrest with persistent GCS <8 after ROSC, severe RV failure by echocardiogram, shock duration >24 hours, noncardiogenic shock (e.g., hypovolemia, sepsis, PE, anaphylaxis), mechanical complications of MI (papillary muscle rupture, VSD, free wall rupture), severe aortic valve disease, severe peripheral arterial disease or aortic abnormalities precluding device placement, presence of a mechanical aortic valve prosthesis, LV thrombus, or infective endocarditisas stated

Inclusion/exclusion aligned with DanGer‑SHOCK trial and policy criteria.

inv-06: Coverage rationale by device

Coverage stance and evidence summaries by device type:

Implantable VADs: RCTs, single‑arm trials, and observational studies support improved survival and quality of life as bridge to transplant and as destination therapy in selected patients; evidence sufficient to determine improvement in net health outcome.

See randomized and single‑arm trial evidence summarized in policy.

Total Artificial Heart (TAH): TAH as bridge to transplant: case series suggest benefit for carefully selected patients with end‑stage biventricular failure awaiting transplant when other options are not available; evidence for TAH as destination therapy is limited and insufficient.

Policy finds evidence adequate for bridge‑to‑transplant but insufficient for destination therapy.

pVAD (DanGer‑SHOCK relevant): For infarct‑related cardiogenic shock, the DanGer‑SHOCK trial showed mortality benefit for microaxial pumps in a trial population but with increased serious adverse events; routine pVAD use outside trial‑like populations lacks consistent RCT benefit and has higher complication rates—coverage criteria align with trial inclusion/exclusion and recent guideline recommendations.

Policy references DanGer‑SHOCK and guideline alignment.

pVAD for high‑risk PCI/other uses: Evidence for pVAD use during high‑risk PCI, VT ablation, or other adjunctive settings is limited or mixed; RCTs and observational studies generally have not demonstrated clear net clinical benefit, and evidence is insufficient to support routine coverage for many of these indications.

See policy discussion of high‑risk PCI and VT ablation evidence.

inv-07: Coverage-relevant clinical statements

Guideline- and evidence‑informed statements relevant to coverage decisions:

High-risk PCI / VT ablation: Evidence is insufficient from RCTs to demonstrate clear clinical benefit of pVAD use during high‑risk PCI; nonrandomized studies in VT ablation report reduced time in unstable VT with pVAD but do not demonstrate improved net health outcomes.

Reflects policy synthesis of trials and guideline positions.

Durable LVAD (guidelines & NCD): Durable LVAD therapy is recommended in select patients with advanced HFrEF (NYHA class IV) failing guideline‑directed therapy; Medicare NCD criteria require NYHA class IV, LVEF ≤25%, and inotrope dependence OR cardiac index <2.2 L/min/m2 with additional conditions regarding prior medical therapy or temporary MCS dependence.

Policy references ACC/AHA guidance and Medicare NCD language.

Temporary/acute MCS in cardiogenic shock: Society guidelines (e.g., 2023 ISHLT/HFSA; 2025 ACC/AHA) state temporary MCS, including percutaneous devices and microaxial pumps, are reasonable in hemodynamic compromise or cardiogenic shock as bridge‑to‑recovery or decision, and microaxial pumps may reduce mortality in selected STEMI with shock consistent with DanGer‑SHOCK criteria.

Reflects guideline recommendations cited in policy.

Coding — CPT, HCPCS, ICD-10 and Device Identifiers

Covered CPT CodesCPT

33927
33928
33929
33975
33976
33977
33978
33979
33980
33981

1–10 of 19

1/2

Device PMA / 510(k) / HDE identifiersmixed

P060040	HeartMate II PMA
P170038	CentriMag PMA
P160035	Berlin Heart EXCOR Pediatric VAD PMA
P160054	HeartMate 3 PMA (and supplements)
P030011	SynCardia Temporary Total Artificial PMA/510(k) reference
K110493	TandemHeart 510(k)
P140003	Impella PMA

No specific CPT/HCPCS/ICD-10 codes listed in this sectionmixed

No codes listed

Coding updates — added/removed code system notesmixed

ICD-10	ICD-10 Diagnosis code section added (exact codes not listed in this excerpt)
ICD-9	ICD-9 Procedure/Diagnosis code section removed (exact prior codes not listed in this excerpt)

Coding history entriesmixed

No codes listed

Coding updates notedmixed

No codes listed

Coding updates mentionedmixed

No codes listed

Coding updates noted (ICD-9 removal)mixed

ICD-9

Removal of ICD-9 diagnosis/procedure codes noted (no specific codes listed in these chunks)

Codes referenced for services (CPT guidance)mixed

CPT (see AMA Current Procedural Terminology)

Policy refers to CPT codes and states providers should use the most current CPT listing.

CPT codesCPT

33927
33928
33929
33975
33976
33977
33978
33979
33980
33981

1–10 of 19

1/2

HCPCS codesHCPCS

L8698
Q0477
Q0478
Q0479
Q0480
Q0481
Q0482
Q0483
Q0484
Q0485

1–10 of 33

1/4

ICD-10 Diagnosis codesICD-10

I21.01
I21.02
I21.11
I21.19
I21.21
I21.29
I21.3
I21.4
I21.9
I22.0

1–10 of 14

1/2

Hemodynamic thresholds

Cardiac index< 2.2 L/min/m2 (while not on inotropes)

Left ventricular ejection fraction (LVEF)≤ 25% for destination therapy; <45% noted for pVAD cardiogenic shock criteria

Left atrial / left ventricular filling pressureLeft atrial pressure ~20 mm Hg cited in evidence summaries

pVAD labeled duration

TandemHeart labeled durationTemporary left ventricular bypass ≤6 hours

Impella CP labeled durationTemporary ventricular support for ≤4 days in cardiogenic shock

Impella 5.5 labeled durationTemporary ventricular support for ≤14 days in cardiogenic shock

Left ventricular ejection fraction (LVEF) threshold

LVEF threshold for destination therapyLeft ventricular ejection fraction less than or equal to 25%

LVEF in pVAD cardiogenic shock criteriaLeft ventricle ejection fraction <45% (pVAD shock criteria)

Guideline contextDurable LVAD recommended for refractory NYHA III–IV when guideline-directed therapy fails (supports LVEF thresholds)

Cardiac index threshold

Cardiac index threshold< 2.2 L/min/m2 (while not on inotropes)

Alternate study thresholdsSome studies reference <2.0 L/min/m2 in trial contexts

Use caseRequired physiologic criterion for destination therapy when not inotrope-dependent

Optimal medical management duration requirement

Required duration of optimal medical managementAt least 45 of the last 60 days on guideline-directed medical therapy

PurposeDemonstrates failure of medical therapy before considering destination VAD

Documentation noteProviders should document duration per policy's required clinical documentation

IABP or temporary MCS dependence duration thresholds

IABP / temporary MCS dependenceDependent on intra-aortic balloon pump or similar temporary MCS ≥7 days with advanced heart failure ≥14 days

ContextAlternative pathway to destination therapy when cardiac index criterion met or inotrope dependent

Facility requirementManagement by an explicitly identified multidisciplinary VAD team per Medicare NCD language

ICD coding change

ICD coding updateICD-10 diagnosis codes section added to policy; ICD-9 procedure/diagnosis codes removed

Historical noteICD-9 sections removed from policy as of prior coding updates (policy history)

ImpactProviders should use ICD-10 diagnosis coding for documentation and claims

CPT reference

CPT examples listedPolicy lists multiple CPT codes associated with TAH/VAD services (e.g., 33927, 33928, 33929, 33975, etc.)

GuidanceProviders should reference the AMA CPT for complete and current code descriptors

Provider Actions, Prior Authorization, and Documentation

Prior Authorization

Medical necessity required for coverage

Coverage for implantable VADs, total artificial hearts (TAHs), and percutaneous VADs (pVADs) is contingent on meeting the medical necessity criteria listed for each indication (e.g., destination therapy, bridge to transplant, post‑cardiotomy, or pVADs for cardiogenic shock).

Prior Authorization

Device-specific prior authorization

Prior authorization requests should reference device-specific FDA approvals/clearances (manufacturer and PMA/510(k)/HDE identifiers) and the device's labeled indication (e.g., bridge to transplant, destination therapy, or temporary support durations).

Document PMA/510(k)/HDE numbers listed for the device (e.g., P060040, P160054, P160035, K110493, P140003).
Include the device's labeled indication when requesting authorization (bridge to transplant, destination therapy, temporary support duration).

Prior Authorization

Demonstrate NCD criteria for VADs

When Medicare NCD criteria apply for VADs, prior authorization should include documentation that the patient meets NYHA class and physiologic thresholds (NYHA class IV or specified cardiac index/LVEF criteria) and facility/team qualifications per the NCD.

Demonstrate NYHA class and LVEF thresholds (e.g., LVEF ≤25%).
Document cardiac index <2.2 L/min/m2 while not on inotropes when applicable.
Confirm facility credentialing and multidisciplinary team composition per CMS requirements.

Prior Authorization

Prior authorization — not specified in these chunks

This excerpt does not specify procedural steps or a defined prior authorization process for these services; the policy text in the provided chunks identifies coverage criteria and effective dates but does not list an authorization workflow or affected billing codes.

Prior Authorization

Prior authorization

The provided excerpt does not include explicit prior authorization requirements; coverage is governed by the policy criteria but prior authorization instructions are not stated in these chunks.

Prior Authorization

Prior authorization not specified in excerpt

The excerpt does not state explicit prior authorization requirements for implantation of total artificial hearts or VADs; authorization details are not present in these sections.

Prior Authorization

Prior authorization

No explicit prior authorization procedures are stated in the extracted section; content is limited to coding and revision history rather than authorization requirements.

Prior Authorization

Prior authorization not described in these chunks

Prior authorization requirements are not described in these chunks; the text documents committee reviews, coding updates, and added FDA information but does not specify authorization processes.

Note

Coverage eligibility and coding updates

Confirm coverage eligibility and review coding updates in the policy prior to requesting authorization; distinctions between pVADs and implantable VADs/TAHs and recent policy changes affect eligibility for coverage with criteria.

Check whether pVADs are eligible for coverage with criteria (policy changed from investigational to eligible with criteria).
Verify any coding updates referenced in the policy before submission.

Billing Rule

Codes potentially affected

Services associated with TAHs and VADs are identified by listed CPT and HCPCS codes in the policy; plans may require prior authorization per their rules, so include relevant procedure and HCPCS codes when requesting authorization.

Use the CPT/HCPCS codes listed in the policy coding sections when preparing authorization requests.
Confirm plan-specific prior authorization requirements for the cited codes.

Step Therapy

Prior optimization required before destination therapy

Destination therapy requires prior optimization of guideline-directed medical management (e.g., on optimal medical management for at least 45 of the last 60 days) before VAD destination therapy is considered; document this optimization in authorization requests.

Document at least 45 of the last 60 days of guideline-directed medical therapy, if applicable.
If dependent on temporary MCS or IABP, document duration thresholds (e.g., advanced heart failure ≥14 days and IABP dependence ≥7 days).

Step Therapy

Step therapy not specified

No explicit step therapy sequences are provided in the policy excerpt; the document does not specify staged medication or device therapy steps beyond required prior optimization for destination therapy.

Step Therapy

Step therapy

The excerpt does not specify additional step therapy requirements beyond prior optimization of medical management described for destination therapy.

Step Therapy

Step therapy

No further step therapy instructions are present in these extracted chunks.

Step Therapy

Step therapy

No step therapy requirements are described in the provided excerpt; policy focuses on coverage criteria and documentation rather than step-wise therapy protocols.

Documentation Required

VAD program team requirements

Facility must have an explicitly identified, cohesive multidisciplinary VAD team based at the facility; team members must include at minimum a cardiothoracic surgeon with experience implanting at least 10 durable intracorporeal LVADs in the prior 36 months, a cardiologist trained in advanced heart failure, a VAD program coordinator, a social worker, and a palliative care specialist.

Documentation Required

Device approval/indication documentation

Document device-specific FDA approval/clearance details for the device selected, including manufacturer, approval/clearance date, and PMA/510(k)/HDE number, and include the device's labeled indication to support coverage decisions.

Include PMA/510(k)/HDE identifier (e.g., P060040, P160054, P160035, K110493, P140003).
State the labeled indication (bridge to transplant, destination therapy, temporary support duration).

Documentation Required

Required clinical documentation

Authorization requests should include clinical documentation demonstrating NYHA class, left ventricular ejection fraction, inotrope dependence or cardiac index measurements, duration of prior optimal medical therapy, and evidence of multidisciplinary team management and facility credentialing where applicable.

Record NYHA class (III with dyspnea on mild activity or IV) and LVEF (≤25% for destination therapy).
Provide cardiac index measurements (e.g., <2.2 L/min/m2) and inotrope dependence status.
Document duration of prior optimal medical therapy (e.g., ≥45 of last 60 days) or temporary MCS/IABP dependence durations.

Documentation Required

References for supporting documentation

FDA summary documents and clinical trial reports cited in the policy (e.g., FDA summaries of safety and clinical trial publications) may be provided to support device safety and benefit claims when requesting coverage.

Billing Rule

Coding/documentation note

Policy notes include coding updates such as the addition of an ICD‑10 diagnosis code section and removal of ICD‑9 codes; ensure authorization and billing use current ICD‑10 and CPT guidance.

Refer to the policy coding section and the most current CPT listing when submitting claims.

Denial Risk

Denial risk — unmet pVAD criteria

Use of percutaneous VADs when the policy criteria are not met is considered not medically necessary and may be denied; ensure all inclusion/exclusion criteria in the pVAD cardiogenic shock section are met before submission.

Verify adherence to trial-aligned inclusion/exclusion criteria for pVAD coverage (e.g., timing, hemodynamics, absence of listed exclusions).

Denial Risk

Short-term external device use — documentation and setting

Devices with most system components external to the body are intended for short‑term use (6 hours to 14 days) because of infection risk and require careful in‑hospital monitoring; use beyond labeled short‑term durations or outside inpatient settings may lead to noncoverage or denial.

Document intended duration of use consistent with device labeling (e.g., TandemHeart ≤6 hours; Impella CP ≤4 days; Impella 5.5 ≤14 days).

Definitions

Implantable ventricular assist device (VAD) definition

Implantable VAD definitionA surgically implanted mechanical pump attached to the native heart and vessels to augment cardiac output; may be internal or external, electrically or pneumatically powered, and pulsatile or continuous-flow

Intentions of useUsed as bridge to transplant, destination therapy, or bridge to recovery in reversible conditions

Anatomic notesInflow attached to ventricular apex with outflow to corresponding great artery; size of patient is an important consideration

Total artificial heart (TAH) definition

Total Artificial Heart (TAH) definitionA biventricular device that completely replaces the function of the diseased heart; native heart is removed and the device is attached to the pulmonary artery and aorta

Power/port notesOften requires an internal battery with external recharging; may use percutaneous power line or transcutaneous power-transfer coil

Current US deviceSyncardia Temporary Total Artificial Heart is the only TAH currently available in the US (P030011)

Ventricular Assist Device (VAD) summary definition

VAD (summary)Mechanical support attached to the native heart and vessels to augment cardiac output; may be implantable or external and used as bridge to transplant, destination therapy, or bridge to recovery

Flow typesDevices may be pulsatile or continuous-flow (rotary or axial pumps)

PlacementPump may be implanted in thorax or abdomen or remain external; inflow/outflow attachments described

Total Artificial Heart (TAH) — biventricular device description

TAH — biventricular device descriptionReplaces both ventricles; native heart removed; device failure is synonymous with cardiac death; used primarily as bridge to transplant

Contraindications referencedPolicy lists contraindications for TAH (chronic irreversible hepatic/renal/respiratory failure; active systemic infection; coagulation disorders/inability to tolerate anticoagulation)

Use caseTAH considered when no other reasonable medical or surgical options exist and patient is transplant candidate or under evaluation

Percutaneous VAD (pVAD) definition and examples

Percutaneous VAD (pVAD) definitionCirculatory assist devices placed percutaneously (not implanted), e.g., TandemHeart (transseptal left atrial to arterial bypass) and Impella (microaxial pump across aortic valve)

ExamplesTandemHeart (K110493), Impella CP and Impella 5.5 (P140003) are cited in policy tables

Short-term natureSystems with most components external to the body intended for short-term use (6 hours to 14 days) due to infection risk

Nondurable MCS definition per AHA guidance

Nondurable MCS definition (AHA)Defined as IABPs, extracorporeal membrane oxygenation, extracorporeal VADs, and pVADs per AHA guidance

Intended useTypically temporary support for hemodynamic compromise, bridge-to-recovery or bridge-to-decision

Infection risk noteDevices with external components for short-term use require in-hospital monitoring

Durable MCS / LVAD indications — summary

Durable MCS / LVAD indications (summary)Durable LVAD therapy recommended for select patients with advanced HFrEF (NYHA class IV) failing guideline-directed therapy; Medicare NCD criteria include NYHA class IV, LVEF ≤25%, and inotrope dependence OR CI <2.2 L/min/m2 with additional duration/therapy requirements

Clinical benefitDurable LVAD can improve functional status, quality of life, and survival in select patients

Program requirementsPatients receiving VADs for destination therapy must be managed by a multidisciplinary team and facilities credentialed per CMS

Percutaneous mechanical circulatory support / pVAD — examples and trial citations

pVAD examples and trial citationsPolicy cites Impella studies, IMPELLA-STIC, PROTECT II, DanGer-SHOCK / Møller et al. (2024), and meta-analyses regarding percutaneous mechanical circulatory support in cardiogenic shock

Device examplesImpella CP, Impella 5.5, TandemHeart listed in Table 3 with PMA/510(k) references

Evidence noteDanGer-SHOCK and other RCTs/meta-analyses are referenced to align coverage criteria with trial inclusion/exclusion

Total artificial heart — SynCardia example and use

Total Artificial Heart — SynCardia exampleSynCardia Temporary Total Artificial Heart (SynCardia Systems) is listed as the currently available TAH in the US (P030011) and used as bridge to transplant

Other historical devicesAbioCor was previously approved under HDE but is no longer marketed

Clinical referencesReferences include longer-term SynCardia outcomes and FDA summaries to support TAH use as bridge to transplant

BERLIN heart EXCOR (pediatric) — pediatric approval referenced

BERLIN heart EXCOR (pediatric) approvalBERLIN heart EXCOR pediatric VAD is referenced as approved for pediatric patients aged 0–16; policy amended to reflect this approval

Pediatric evidenceReferences cited include Almond et al. (2013) and subsequent pediatric VAD outcome studies

Policy changeCoverage statement on children amended from age 5–16 to 0–16 to reflect device approval

BERLIN heart EXCOR — notes on pediatric age range

BERLIN heart EXCOR — pediatric age range notePolicy amended to change pediatric coverage age range to 0–16 years to reflect BERLIN heart EXCOR approval

Coverage statement historyMultiple committee reviews documented the age-range change and related coverage language

Supporting referencesPediatric VAD trial publications are cited in policy references

Coverage clause (transplant evaluation)

Coverage clause — transplant evaluation includedPolicy coverage for TAHs and implantable VADs includes patients who are undergoing evaluation to determine candidacy for heart transplantation

Bridge-to-transplant criteriaTAH coverage requires patient to be listed or undergoing evaluation and not expected to survive until donor heart available

Documentation implicationProviders should document transplant listing status or evaluation and imminence of death risk

Percutaneous VAD (pVAD) — left heart pVADs noted as FDA-approved

Left heart pVAD FDA statusPolicy explicitly notes left heart percutaneous VAD is FDA approved and added to pVAD cardiogenic shock criteria

ExamplesImpella devices (CP, 5.5) and TandemHeart are listed with PMA/510(k) identifiers in policy tables

ImplicationCoverage criteria require use in accordance with FDA approval and trial-aligned inclusion/exclusion

Total Artificial Heart (TAH) — policy criteria when used as bridge to transplant

TAH — bridge to transplant policy criteriaTAH considered eligible as bridge to transplant when used in accordance with FDA approval and absence of listed contraindications (hepatic/renal/respiratory failure, active infection, coagulation disorders)

Destination therapy notePolicy states evidence for TAH as destination therapy is insufficient and other applications may be NMN

Device listingSynCardia Temporary Total Artificial Heart (P030011) listed as available TAH in US

Medically Necessary definition

Medically Necessary definitionHealth care services that a Provider, exercising prudent clinical judgment, would provide that are in accordance with nationally accepted standards, clinically appropriate, and not primarily for comfort or convenience

ComponentsMust be clinically appropriate in type, frequency, extent, site and duration, and considered effective for the patient's condition

Cost/benefit clauseNot primarily for personal comfort and not more costly than alternatives likely to produce equivalent results

Investigational definition

Investigational definitionA medical treatment, procedure, drug, device, or biological product is Investigational if effectiveness has not been clearly tested and it has not been incorporated into standard medical practice; determinations consider FDA approval status and need for further studies

Evidence considerationsDeterminations based on ability to be lawfully marketed, need for further studies, credible peer-reviewed evidence, and reference to federal regulations

Policy implicationDevices or indications lacking clear evidence or FDA marketing authorization may be designated investigational and not covered

Revision History and Policy Changes

2026-04-16policy_revisionLatest

Added statements: left heart pVAD is FDA approved; added 'in accordance with FDA approval' to VAD criteria; added Not Medically Necessary section and explicit statements that pVADs outside criteria and TAH as destination therapy are not medically necessary; designated right heart pVADs investigational.

2020-12-11coding_update

Coding update recorded (12/11/2020) reflecting revisions to code sections noted in policy history.

2021-11-04coding_update

Coding update recorded (11/04/2021) as part of ongoing coding revisions and committee reviews.

2017-01-01coding_update

Coding update: removal of ICD-9 diagnosis codes effective 01/01/2017.

2026-07-01effective_date

Current policy effective date recorded as 07/01/2026; CPT/HCPCS/ICD-10 coding tables included in policy (see coding section).

Total Artificial Hearts and Implantable Ventricular Assist Devices

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Coverage Criteria for TAHs, Implantable VADs, and pVADs

Coding — CPT, HCPCS, ICD-10 and Device Identifiers

Provider Actions, Prior Authorization, and Documentation

Background and Rationale

Definitions

Revision History and Policy Changes