Currentblue cross blue shield - louisianaPolicy MA-210

Total Artificial Hearts and Percutaneous Ventricular Assist Devices

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Medical policy governing coverage criteria for total artificial hearts (TAHs) and percutaneous ventricular assist devices (pVADs) for members of Blue Cross Blue Shield - Louisiana across applicable products when benefits and medical necessity criteria are met.

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Currentblue cross blue shield - louisianaPolicy MA-210

Total Artificial Hearts and Percutaneous Ventricular Assist Devices

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Policy Summary

PayerBlue Cross Blue Shield - Louisiana

PolicyTotal Artificial Hearts and Percutaneous Ventricular Assist Devices

Policy CodePolicy MA-210

Change TypeNo material changes

Effective DateJul 1, 2026

Last ReviewApr 21, 2026

Next Review DateApr 21, 2026

Key ActionObtain prior authorization and include clinical documentation demonstrating device FDA status and that the patient meets the medical necessity criteria (e.g., transplant candidacy for TAH or DanGer-SHOCK–like criteria for pVAD).

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

Bridge to transplantTAH stance

Cardiogenic shockpVAD stance

FDA-clearedDevices listed

ExcludedInvestigational uses

n=355 analyzedDanGer-SHOCK RCT

Prior auth requiredAuth requirement

Coverage criteria — TAH and pVAD

inv-01: Total Artificial Heart (TAH) — Bridge to Transplant

Covered when ALL of the following are met

TAH coverage criteria: TAH is used in accordance with FDA approval; AND individual has biventricular heart failure; AND there are no other reasonable medical or surgical treatment options; AND ineligible for other univentricular or biventricular support devices; AND currently listed as a heart transplantation candidate OR undergoing evaluation to determine candidacy for heart transplantation AND is not expected to survive until a donor heart can be obtained; AND absence of any contraindications (chronic irreversible hepatic, renal, or respiratory failure; active systemic infection; coagulation disorders or inability to tolerate anticoagulation).

Follow FDA-approved indications (Syncardia Temporary TAH bridge-to-transplant).

inv-02: Percutaneous Ventricular Assist Device (pVAD) — Infarct-related Cardiogenic Shock

Covered when ALL of the following are met

pVAD coverage criteria: pVAD is FDA approved; AND request is for an adult individual (>= 18 years); AND acute myocardial infarction of <36 hours duration with either (a) STEMI with new ST-elevation OR (b) new ST-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 blood pressure <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 conditions (resuscitated out-of-hospital cardiac arrest with persistent coma GCS <8 on arrival to cath lab; severe RV failure; shock duration >24 hours; other causes of shock such as hypovolemia, sepsis, pulmonary embolism, anaphylaxis; mechanical MI complications including papillary muscle rupture, VSD, or free wall rupture; severe aortic valve disease; severe peripheral arterial disease or aortic abnormalities precluding placement; presence of mechanical aortic valve prosthesis; LV thrombus; infective endocarditis).See listed physiologic thresholds (SBP <100 mmHg; lactate >=2.5 mmol/L; LVEF <45%).

Device-specific duration limits and FDA labeling apply; cardiac arrest in ambulance or after hospital arrival is NOT an exclusion.

inv-03: Total Artificial Heart (TAH) — TAH coverage summary

TAH coverage summary

TAH as bridge to transplant: TAH is considered to likely improve outcomes for carefully selected patients with end-stage biventricular heart failure awaiting transplant who are not appropriate candidates for a left VAD.

Evidence from case series supports bridge-to-transplant use; sufficient to determine improvement in net health outcome.

inv-04: TAH — Destination Therapy — TAH destination therapy summary (often not covered)

TAH destination therapy summary

TAH as destination therapy: Evidence is insufficient to determine that TAH as destination therapy improves net health outcome.

Based on limited case series; routine destination therapy use not supported by current evidence.

inv-05: pVAD — STEMI-related cardiogenic shock — DanGer-SHOCK–based criteria

pVAD for STEMI-related cardiogenic shock (DanGer-SHOCK–based criteria)

Eligibility for microaxial flow pump per DanGer-SHOCK: Patient has STEMI-related cardiogenic shock with physiologic and clinical features consistent with the DanGer-SHOCK trial (elevated arterial lactate—trial median 4.5 mmol/L; noncomatose after cardiac arrest; suitable peripheral vasculature for large-bore access; meets SCAI shock stage C, D, or E); AND meets trial systolic blood pressure and LVEF characteristics as applicable.See DanGer-SHOCK trial thresholds (median lactate 4.5 mmol/L; trial primary endpoint assessed at 180 days).

DanGer-SHOCK demonstrated reduced 180-day mortality (HR 0.74) but increased serious adverse events; selection should mirror trial inclusion/exclusion and guideline recommendations.

inv-06: pVAD — Other cardiogenic shock indications

pVAD for other cardiogenic shock indications

pVAD for general cardiogenic shock or refractory to IABP: Evidence is insufficient to determine net health outcome improvement for pVADs in cardiogenic shock outside DanGer-SHOCK criteria; randomized trials versus IABP did not show mortality benefit and reported higher complication rates. Case series of pVAD after IABP failure report hemodynamic improvement but do not demonstrate mortality benefit.

Use outside trial-like STEMI cardiogenic shock populations carries higher risk of denial due to limited evidence.

inv-07: pVAD — High-risk PCI and VT ablation

pVAD for high-risk PCI and VT ablation

pVAD for high-risk PCI: Use of pVAD as ancillary hemodynamic support for high-risk percutaneous coronary intervention has mixed evidence: PROTECT II supported FDA temporary approval for selected high-risk PCI populations; subsequent observational and PMA studies (PROTECT III) provide additional safety/efficacy data but randomized evidence of clear clinical outcome benefit is limited. Coverage considerations should reference trial inclusion characteristics (e.g., unprotected left main or last patent vessel with reduced LVEF, complex PCI) and FDA labeling.PROTECT II/PROTECT III inclusion characteristics (e.g., LVEF thresholds per trials).

Observational Restore EF suggests LVEF improvement but lacks comparator; PROTECT IV is ongoing.

pVAD for VT ablation: Nonrandomized studies demonstrate reduced time in unstable VT with pVAD support versus no support, but evidence is insufficient to conclude clinical outcome benefit; routine coverage is not supported by current evidence.

Insufficient evidence for routine coverage of pVAD for VT ablation.

inv-08: Medicare NCD-aligned indications — criteria summarized from Medicare NCD

Covered when ALL of the following Medicare NCD criteria are met (as summarized in policy):

Primary criteria: Patient has NYHA Class IV heart failure AND LVEF ≤25% AND is inotrope dependent.LVEF ≤25%

From Medicare NCD summary in policy.

Alternate hemodynamic pathway (OR): Cardiac index <2.2 L/min/m2 while not on inotropes, AND one of: (a) on optimal medical management based on current guidelines for at least 45 of the last 60 days and failing to respond; OR (b) advanced heart failure ≥14 days and dependent on IABP or similar temporary MCS for ≥7 days.CI <2.2 L/min/m2

From Medicare NCD summary in policy.

Facility/team requirements: For destination therapy, patient must be managed by an explicitly identified cohesive multidisciplinary team at the facility and facilities must be credentialed by an organization approved by CMS.

inv-09: General Coverage Framework — use of medical necessity, InterQual®, and NCD/LCD guidance

Coverage decisions follow medical necessity definitions and may reference InterQual® and Medicare NCD/LCD guidance.

Policy-level requirements: Coverage determinations must adhere to the policy's medical necessity definition, applicable Medicare NCDs/LCDs for Medicare Advantage members, and utilize InterQual® as a first-level screening tool.

InterQual® is used as first-level screening; if criteria are not met the case is referred to medical director.

The policy classifies certain applications of total artificial hearts (TAHs) and percutaneous ventricular assist devices (pVADs) as investigational when available evidence is insufficient to establish improved net health outcomes. Specifically, the Health Plan considers the use of TAHs as destination therapy and the use of non–FDA-approved or uncleared TAHs to be investigational. Likewise, pVADs for indications not explicitly listed in this policy are considered investigational and therefore not covered.

TAH: Evidence from case series supports use of TAH as a bridge-to-transplant in carefully selected patients with end-stage biventricular heart failure who are not appropriate candidates for a left ventricular assist device; the policy considers this use likely to improve outcomes. By contrast, the body of evidence for TAH as destination therapy is limited (two case series) and is judged insufficient to demonstrate improved net health outcome.

pVAD: For infarct-related (STEMI-related) cardiogenic shock, the policy aligns coverage criteria with trial-based selection (DanGer-SHOCK–like criteria) and with FDA-approved device indications for adult patients meeting physiologic thresholds. For broader cardiogenic shock populations or other indications, randomized trials have not shown consistent mortality benefit and have reported higher complication rates; therefore routine coverage is not supported outside the specified trial-aligned criteria.

The policy notes that effective December 1, 2020, Artificial Hearts were removed from the Medicare NCD Manual and that subsequent coverage determinations for artificial hearts and related devices are made by Medicare Administrative Contractors. This change in the NCD manual is cited to clarify that Local Coverage determinations and contractor decisions may apply for Medicare members.

Federal and State law, as well as the member's contract language and specific contract provisions or exclusions, take precedence over this Medical Policy. Where contract definitions or statutory requirements differ from the policy, those legal or contractual terms must be applied to determine coverage.

pVADs used for indications not explicitly listed in this policy are considered investigational and therefore not covered. The policy explicitly states that percutaneous VADs for "all other indications" beyond the specified, labeled, or trial-aligned uses are investigational.

The policy cautions against routine use of pVADs in populations where randomized evidence did not show a mortality benefit and where higher complication rates were observed (for example, pVAD versus IABP in general cardiogenic shock trials). Such uses lack support for improved net health outcomes and carry increased procedural risks.

The policy defines investigational as a treatment, procedure, device, drug, or biological product for which effectiveness has not been clearly tested and which has not been incorporated into standard medical practice. Determinations consider FDA marketing status and whether further studies are needed to establish safety and effectiveness.

Items or services designated investigational under the policy do not meet the Health Plan's definition of medical necessity and therefore are not eligible for coverage.

Codes, thresholds, and device identifiers

Device regulatory identifiers mentionedmixed

P030011	SynCardia Temporary Total Artificial Heart, PMA No.
K110493	TandemHeart, 510(k)
P140003	Impella CP and Impella 5.5, PMA No.

Covered CPT Codesmixed

No codes listed

Covered CPT Codes (listed in policy)CPT

33927
33928
33929
33990
33991
33992
33993
33995
33997

HCPCS Codes (listed in policy)HCPCS

L8698
Q0477
Q0478
Q0479

ICD-10 Diagnosis Codes (listed in policy)ICD-10

I21.01-I21.02
I21.11-I21.19
I21.21-I21.29
I21.3
I21.4
I21.9
I22.0-I22.9
R57.0
T81.11XA-T81.11XS

Covered CPT Codes (listed)CPT

33927
33928
33929
33990
33991
33992
33993
33995
33997

HCPCS Codes (listed)HCPCS

L8698
Q0477
Q0478
Q0479

ICD-10 Diagnosis Codes (listed)ICD-10

No codes listed

Arterial lactate threshold referenced

Arterial lactate threshold>= 2.5 mmol/L

Context of useRequired sign of end-organ hypoperfusion in pVAD infarct-related cardiogenic shock criteria

DanGer‑SHOCK median for referenceMedian arterial lactate in DanGer‑SHOCK = 4.5 mmol/L (trial population)

Systolic blood pressure threshold referenced

Systolic blood pressure threshold< 100 mmHg or ongoing vasopressor support

Prior authorization, documentation, and operational requirements

Prior Authorization

Prior authorization required — demonstrate benefits eligibility and medical necessity

Prior authorization is required and requests must demonstrate that the member has benefits for the service and that medical necessity criteria are met (TAH: FDA‑approved bridge‑to‑transplant indications including biventricular failure and transplant candidacy; pVAD: FDA‑cleared device use in adult STEMI‑related cardiogenic shock meeting the policy physiologic thresholds).

TAH requests must document FDA‑approved use, biventricular heart failure, no reasonable alternative therapies, and transplant candidacy or evaluation status.
pVAD requests must document FDA clearance/approval, adult age (≥18), STEMI‑related cardiogenic shock with required hemodynamics and lactate thresholds, and absence of listed exclusions.

Prior Authorization

Prior authorization must verify stated indication

Prior authorization must verify the clinical indication specified in the policy — for TAH whether use is bridge‑to‑transplant (destination therapy considered investigational), and for pVAD whether the indication is STEMI‑related cardiogenic shock meeting the DanGer‑SHOCK–like criteria (timing and physiologic thresholds).

Background and context

Heart failure prevalence is increasing and donor hearts are scarce, prompting use of mechanical circulatory support. TAHs replace both ventricles and are used primarily as a temporary bridge-to-transplant for selected patients with end-stage biventricular failure when other medical or surgical options are not viable. pVADs are catheter-delivered temporary pumps intended to provide short-term circulatory support in settings such as infarct-related cardiogenic shock or as adjuncts during high-risk cardiac procedures. The policy recognizes procedural risks (including bleeding and other device-related complications) and emphasizes selection criteria based on FDA labeling and pivotal trial inclusion/exclusion to maximize likelihood of benefit.

Key definitions

Total artificial heart (TAH) definition

DefinitionA biventricular device that completely replaces the function of the diseased heart; native heart is removed and device failure is synonymous with cardiac death

Example deviceSynCardia Temporary Total Artificial Heart is the currently available TAH in the U.S.

Power/systems noteInternal battery with external recharging; some systems use transcutaneous power‑transfer coils to avoid percutaneous lines

Percutaneous ventricular assist device (pVAD) definition

DefinitionCatheter‑delivered circulatory assist device placed percutaneously (examples: Impella, TandemHeart); provides temporary ventricular support

Typical durationShort‑term use (hours to days) due to external components and infection risk

Policy revision history and review dates

2026-07-01policy_effectiveLatest

Policy MA-210 became effective (current effective date).

2026-04-21review_approved

Utilization Management Committee reviewed and approved the policy (new policy).

2020-12-01ncd_change

Policy Summary

PayerBlue Cross Blue Shield - Louisiana

PolicyTotal Artificial Hearts and Percutaneous Ventricular Assist Devices

Policy CodePolicy MA-210

Change TypeNo material changes

Effective DateJul 1, 2026

Last ReviewApr 21, 2026

Next Review DateApr 21, 2026

SourceLink

On This Page

Quoted from Medicare NCD language in policy.

Example vasopressorsDopamine, norepinephrine, or epinephrine (as cited)

Role in criteriaPart of hypotension definition confirming cardiogenic shock <24 hours duration

Left ventricle ejection fraction (LVEF) threshold referenced

LVEF threshold for pVAD eligibility< 45%

Median LVEF in DanGer‑SHOCK trial (for context)Median LV EF = 25%

Also used in documentation requirementsLVEF should be documented to match trial/selection criteria

Age eligibility

Age eligibility for pVAD>= 18 years (adult)

TAH candidatesNo age explicit in TAH bridge‑to‑transplant criteria; transplant candidacy assessed clinically

Device labeling sourcesAge statements referenced from pVAD coverage criteria and device tables

Duration limits (device-specific)

TandemHeart duration limit<= 6 hours

Impella CP duration limit<= 4 days

Impella 5.5 duration limit<= 14 days

DanGer-SHOCK median arterial lactate (trial detail)

DanGer‑SHOCK median arterial lactate4.5 mmol/L

Trial population contextMedian arterial lactate reported for randomized DanGer‑SHOCK patients

Use in policyCited to justify selecting a higher‑severity STEMI shock population

DanGer-SHOCK primary endpoint time

Primary endpoint time in DanGer‑SHOCK180 days

Primary endpoint definitionDeath from any cause at 180 days (6 months)

Outcome reportedMortality benefit (HR 0.74) assessed at 180 days

LVEF threshold aligned with Medicare NCD

Medicare NCD LVEF thresholdLVEF ≤25%

Associated requirementNYHA Class IV and inotrope dependence (primary pathway) per NCD summary

Alternate hemodynamic pathwayCardiac index <2.2 L/min/m2 as alternate NCD criterion

Cardiac index threshold

Cardiac index threshold<2.2 L/min/m2

ApplicationAlternate hemodynamic pathway for Medicare NCD‑aligned destination therapy indications

Conditioning criteriaCI <2.2 while not on inotropes AND additional duration/management requirements (see NCD language)

TAH: confirm bridge‑to‑transplant indication and that destination therapy is investigational per policy.
pVAD: confirm infarct‑related STEMI <36 hours and cardiogenic shock <24 hours with required BP, lactate, and LVEF criteria.

Prior Authorization

Reference CPT/HCPCS codes in prior authorization requests

Include the relevant CPT and HCPCS procedure/device codes listed in the policy with the prior authorization request; requests should include supporting clinical criteria and facility/team credentialing evidence.

Submit one or more of the CPT codes: 33927, 33928, 33929, 33990, 33991, 33992, 33993, 33995, 33997 when applicable.
Submit HCPCS codes when applicable: L8698, Q0477, Q0478, Q0479.

Prior Authorization

All listed codes require prior authorization

All procedure and device codes enumerated in the policy require prior authorization; failure to obtain authorization may result in denial or nonpayment.

The policy lists CPT codes 33927–33997 (selected) and HCPCS L8698, Q0477–Q0479 — each requires prior authorization.
Authorization ensures appropriate utilization and alignment with clinical guidelines.

Step Therapy

Step requirement — document lack of reasonable alternatives for TAH

For TAH candidates, prior authorization must show that no other reasonable medical or surgical treatment options exist and that the patient is ineligible for alternative univentricular or biventricular support devices.

Document prior therapies attempted and rationale why alternatives (including VADs) are not appropriate.
Confirm absence of contraindications listed in the policy (e.g., irreversible hepatic/renal/respiratory failure, active systemic infection, inability to tolerate anticoagulation).

Step Therapy

Step‑up from IABP — document refractory shock if used after IABP

If pVAD is being used after failure of an intra‑aortic balloon pump (IABP), prior authorization may require documentation that shock was refractory to IABP therapy.

Provide documentation of IABP use and objective evidence of refractory shock despite IABP support.

Note

Action not specified

Not specified in this portion of the policy.

Prior Authorization

InterQual® screening used for first‑level authorization review

InterQual® criteria are used as a first‑level screening tool; utilization review staff apply InterQual® and refer cases that do not meet criteria to the medical director for further review.

If InterQual® criteria are met, the case is typically approved at first‑level screening.
If InterQual® criteria are not met, expect referral to the medical director for case review.

Documentation Required

Required clinical documentation — device status and core clinical data

Prior authorization requests must include required clinical documentation: device FDA approval/clearance status, evidence of biventricular failure and transplant candidacy for TAH, or adult STEMI‑related cardiogenic shock meeting the policy physiologic thresholds for pVAD.

For TAH: FDA approval statement, evidence of biventricular failure, transplant listing or evaluation documentation, and absence of listed contraindications.
For pVAD: device regulatory status, timing of STEMI and shock duration, systolic BP, arterial lactate (≥2.5 mmol/L), and LVEF (<45%).

Documentation Required

Match clinical documentation to pivotal trial criteria when applicable

When prior authorization cites benefit from a pivotal trial (e.g., DanGer‑SHOCK), clinical documentation should support that the patient matches the trial inclusion/exclusion criteria used in the policy (e.g., STEMI‑related shock, arterial lactate elevation, noncomatose status, suitable peripheral access).

Provide arterial lactate, systolic BP, LV EF, shock staging, and details on cardiac arrest status to align with DanGer‑SHOCK criteria.
Document peripheral vascular suitability for large‑bore access when applicable.

Documentation Required

Required clinical and facility/team documentation

Authorization requests for TAH or pVAD should include facility and team information and clinical measures: NYHA class, LVEF, inotrope dependence or cardiac index, duration and optimization of medical therapy, prior MCS use, and evidence of facility credentialing and an identified multidisciplinary team when applicable.

For destination‑therapy considerations and facility credentialing references, include documentation of multidisciplinary team composition and facility CMS‑approved credentialing if applicable.
Include objective hemodynamic data (LVEF, cardiac index), duration of symptoms/therapy, and inotrope dependence.

Documentation Required

Transition authorization documentation for 90‑day continuity

When a member is transitioning from a prior plan, documentation of the previous plan's prior authorization may be required to continue an ongoing course of treatment under a 90‑day transition policy.

Provide the prior plan's authorization documentation and show that the services are covered under the new plan for continuity.

Denial Risk

Verify benefits and avoid investigational indications

Confirm that the member’s contract includes benefits for the requested service and that the use is not investigational or non‑FDA‑approved; investigational uses (including TAH as destination therapy and non‑FDA‑approved TAHs, and pVADs for other unlisted indications) are excluded and may be denied.

Verify member benefit coverage before submitting an authorization request.
Do not request coverage for investigational indications listed in the policy; such uses are considered not covered.

Denial Risk

Denial risk — unsupported pVAD indications

Use of pVADs for indications without demonstrated net health benefit (for example, general cardiogenic shock populations outside the DanGer‑SHOCK criteria) is considered unsupported by evidence and carries higher risk of claim denial.

pVAD use outside the policy's specified indications (e.g., non‑STEMI cardiogenic shock without trial criteria) may be investigational or not medically necessary.

Denial Risk

Denial risk — missing Medicare NCD clinical or facility/team documentation

Failure to document that the patient meets Medicare NCD‑aligned clinical criteria (e.g., NYHA Class IV, LVEF ≤25%, inotrope dependence or cardiac index <2.2 L/min/m2 with supporting conditions) or to provide facility credentialing/multidisciplinary team evidence may result in noncoverage or denial.

Include objective evidence for NYHA class, LVEF, cardiac index, and duration/optimization of medical therapy as applicable.
Provide documentation that the facility and team meet CMS‑approved credentialing requirements when relevant.

Prior Authorization

Prior authorization requirement — obtain authorization or risk denial

All services and codes listed in this policy require prior authorization; failure to obtain authorization prior to service may result in denial or nonpayment.

Authorization is required for listed CPT and HCPCS codes to ensure appropriate utilization.
Confirm authorization before scheduling procedures.

Common risksAccess‑site bleeding, vascular injury, myocardial perforation, stroke, arrhythmia

Nondurable mechanical circulatory support (MCS) definition

DefinitionIncludes nondurable devices such as intra‑aortic balloon pumps (IABP), extracorporeal membrane oxygenation (ECMO), extracorporeal VADs, and percutaneous VADs used for short‑term support

Typical intentBridge to recovery or bridge to decision in acute settings

Duration noteOften external components limit use to hours‑to‑14 days depending on device

DanGer-SHOCK–like population definition

DanGer‑SHOCK–like population—core featuresSTEMI‑related cardiogenic shock with elevated arterial lactate, noncomatose, SCAI shock stages C–E, and adequate peripheral vasculature for large‑bore access

Trial enrollment specificsDanGer‑SHOCK required elevated arterial lactate and excluded patients who remained comatose after out‑of‑hospital cardiac arrest

Guideline alignmentACC/AHA guidance endorses microaxial pump use in patients matching DanGer‑SHOCK inclusion features

Acute MCS definition

DefinitionMechanical circulatory support initiated for patients with cardiogenic shock who fail to stabilize or continue to deteriorate despite initial interventions

Recommended timingShould be initiated as soon as possible when patients fail to stabilize (per ISHLT/HFSA guidance)

PurposeUsed as bridge to recovery, bridge to decision, or to allow optimization before durable MCS or transplant

Destination therapy (DT) definition

DefinitionLong‑term mechanical circulatory support for patients not eligible for transplant; managed by an identified multidisciplinary team at a credentialed facility

Medicare NCD requirementsTeam must include members experienced before and after VAD placement; facility credentialing by CMS‑approved organization required

TAH distinctionTAH bridge‑to‑transplant is an accepted indication; TAH as destination therapy lacks sufficient evidence per policy

Medically Necessary (Medical Necessity) definition

DefinitionServices provided to prevent, evaluate, diagnose, or treat illness that are in accordance with nationally accepted standards of medical practice and are clinically appropriate

Key requirementsAppropriate in type, frequency, extent, level of care, site and duration; not primarily for convenience and not more costly than alternatives offering equivalent results

Evidence baseBased on credible scientific evidence, specialty society recommendations, and physician consensus

Investigational — definition used in policy

Investigational definitionA 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

DeterminantsConsiders FDA marketing status, need for further studies, consensus of expert opinion, consultation with technology evaluation centers, and credible peer‑reviewed evidence

Policy consequenceItems deemed investigational do not meet medical necessity for coverage purposes

Artificial Hearts was removed from the Medicare NCD Manual; Medicare Administrative Contractors make coverage determinations for artificial hearts and related devices thereafter.