CurrentFidelis CarePolicy CP.MP.160

Implantable Wireless Pulmonary Artery Pressure Monitoring

This policy governs coverage stance for implantable wireless pulmonary artery (PA) pressure monitoring devices (e.g., CardioMEMS) for non‑Medicare Fidelis Care plans and notes that Medicare criteria are in a separate Medicare-specific policy.

Policy Summary

PayerFidelis Care

PolicyImplantable Wireless Pulmonary Artery Pressure Monitoring

Policy CodePolicy CP.MP.160

Change TypeNo material change

Effective Date

Next Review Date

Key ActionSubmit prior authorization with clinical documentation including NYHA class, prior heart failure hospitalization, and device contraindications; expect denial for non‑Medicare plans as investigational.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

CardioMEMS onlyDevice with FDA approval referenced

33289, 93264, C2624Codes referenced in policy

NYHA Class IIIFDA indicated functional class cited

1%Reported complication rate

Coverage Criteria — Implantable Wireless PA Pressure Monitoring

Policy Summary

PayerFidelis Care

PolicyImplantable Wireless Pulmonary Artery Pressure Monitoring

Policy CodePolicy CP.MP.160

Change TypeNo material change

Effective Date

Next Review Date

SourceLink

On This Page

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For non‑Medicare Fidelis Care plans this policy concludes that current evidence is insufficient to support outpatient use of implantable pulmonary artery (PA) pressure measurement devices for heart failure management. Although the CHAMPION trial reported reductions in HF‑related hospitalizations at six months and sustained effects in longer follow‑up, limitations including potential sponsor influence, lack of mortality and baseline quality‑of‑life data, and limited long‑term safety and effectiveness data lead to an investigational/not proven determination for non‑Medicare members.

Accordingly, the long‑term safety and effectiveness of implantable wireless pulmonary artery pressure monitoring has not been proven for any indication for non‑Medicare plans, and the technology is considered investigational for those members; Medicare‑specific criteria are addressed separately in the Medicare policy (MC.CP.MP.160).

Coding and Documentation

Procedure CPTCPT

33289

Transcatheter implantation of wireless pulmonary artery pressure sensor for long- term hemodynamic monitoring, including deployment and calibration of the sensor, right heart catheterization, selective pulmonary catheterization, radiological supervision and interpretation, and pulmonary artery angiography, when performed

Remote monitoring CPTCPT

93264

Remote monitoring of a wireless pulmonary artery pressure sensor for up to 30 days, including at least weekly downloads of pulmonary artery pressure recordings, interpretation(s), trend analysis, and report(s) by a physician or other qualified health care professional

Device HCPCSHCPCS

C2624

Implantable wireless pulmonary artery pressure sensor with delivery catheter, including all system components

Prior heart failure hospitalization — requirement

ThresholdHospitalization for heart failure in the previous year

TimeframeWithin the 12 months prior to consideration of implant

PurposeMatches FDA-labeled population requirement for CardioMEMS NYHA Class III indication

Provider Actions and Billing Expectations

Prior Authorization

Prior Authorization Expected

Prior authorization is expected for non‑Medicare plans. Requests for implantable wireless pulmonary artery pressure monitoring (e.g., CardioMEMS) should be submitted with full clinical documentation; for non‑Medicare members, prior authorization is expected to be denied due to investigational / not proven determination.

Prior authorization expected for non‑Medicare plans
Medicare criteria handled separately

Denial Risk

Investigational / Not Proven

For non‑Medicare health plans affiliated with Centene Corporation®, the long‑term safety and effectiveness of implantable wireless pulmonary artery pressure monitoring has not been proven for any indication, including management of heart failure. The evidence (including the CHAMPION trial) shows reductions in HF‑related hospitalizations at intermediate follow‑up but lacks definitive long‑term safety, mortality, and quality‑of‑life data. Therefore use of this technology is considered investigational / not proven and is expected to be denied for non‑Medicare members.

Investigational / Not proven for all indications in non‑Medicare plans
Evidence limitations: long‑term outcomes, safety, QoL, applicability beyond NYHA Class III

Documentation Required

Required Coding and Clinical Documentation

Specific coding and documentation are required when submitting prior authorization or claim information. Include procedure/device codes and supporting clinical documentation demonstrating medical necessity and prior heart‑failure history as applicable.

CPT 33289 — Transcatheter implantation of wireless pulmonary artery pressure sensor
CPT 93264 — Remote monitoring of a wireless pulmonary artery pressure sensor (up to 30 days)
HCPCS C2624 — Implantable wireless pulmonary artery pressure sensor with delivery catheter
Submit supporting clinical documentation: NYHA class, hospitalization history for HF within prior year, rationale for monitoring, contraindications (e.g., inability to take required antiplatelet/anticoagulation), and all relevant procedural notes and device reports

Background and Rationale

Heart failure (HF) is a common cause of hospitalization and readmission and is categorized by New York Heart Association (NYHA) functional classes to describe symptom burden and functional limitation. Implantable wireless pulmonary artery (PA) pressure monitoring, such as the CardioMEMS HF System, provides daily measurements of systolic, diastolic, and mean PA pressures via a permanently implanted sensor coupled with home monitoring electronics and a secure database.

The intended rationale for implantable PA monitoring is to provide clinicians near‑daily hemodynamic data to guide outpatient medical management with the goal of reducing HF‑related hospitalizations. The CardioMEMS device is FDA‑approved for symptomatic NYHA Class III patients who have had a prior HF hospitalization within the previous year; however, evidence on long‑term benefits, safety, and use in other NYHA classes is limited.

Definitions

CardioMEMS HF System — components

Implanted PA sensorDime-sized pulmonary artery sensor permanently implanted via fluoroscopy-guided right-heart catheterization

Delivery catheterTransvenous catheter delivery system used to place the PA sensor

Home monitoring electronicsPillow antenna and bedside monitoring unit (with cable and remote button) for daily data capture

Secure databaseInternet-accessible secure database for wireless transmission and clinician access to daily PA pressure readings

FDA-labeled population — CardioMEMS indication

FDA-labeled populationNYHA Class III heart failure patients who have been hospitalized for heart failure in the previous year

Measured parametersDaily systolic, diastolic, and mean pulmonary artery pressures and heart rate

Intended useHemodynamic data intended to guide outpatient HF management to reduce HF-related hospitalizations