CARDIOMEMS HF SYSTEM

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CARDIOMEMS HF SYSTEM

HS-304

Clinical Coverage Guideline page 1 Original Effective Date: 10/1/2015 - Revised: 12/3/2015, 10/6/2016, 8/7/2017, 8/24/2018

Easy Choice Health Plan Missouri Care

‘Ohana Health Plan, a plan offered by WellCare Health Insurance of Arizona

OneCare (Care1st Health Plan Arizona, Inc.) Staywell of Florida

WellCare (Arizona, Arkansas, Connecticut, Florida, Georgia, Illinois, Kentucky, Louisiana, Mississippi, Nebraska, New Jersey, New York, South Carolina, Tennessee, Texas) WellCare Prescription Insurance

WellCare Texan Plus (Medicare – Dallas & Houston markets)

CardioMEMS HF System

Policy Number: HS-304 Original Effective Date: 10/1/2015

Revised Date(s): 12/3/2015; 10/6/2016;

8/3/2017, 8/24/2018

APPLICATION STATEMENT

The application of the Clinical Coverage Guideline is subject to the benefit determinations set forth by the Centers for Medicare and Medicaid Services (CMS) National and Local Coverage Determinations and state-specific Medicaid mandates, if any.

DISCLAIMER

The Clinical Coverage Guideline (CCG) is intended to supplement certain standard WellCare benefit plans and aid in administering benefits. Federal and state law, contract language, etc. take precedence over the CCG (e.g., Centers for Medicare and Medicaid Services [CMS] National Coverage Determinations [NCDs], Local Coverage Determinations [LCDs] or other published documents). The terms of a member’s particular Benefit Plan, Evidence of Coverage, Certificate of Coverage, etc., may differ significantly from this Coverage Position. For example, a member’s benefit plan may contain specific exclusions related to the topic addressed in this CCG. Additionally, CCGs relate exclusively to the administration of health benefit plans and are NOT recommendations for treatment, nor should they be used as treatment guidelines. Providers are responsible for the treatment and recommendations provided to the member. The application of the CCG is subject to the benefit determinations set forth by the Centers for Medicare and Medicaid Services (CMS) National and Local Coverage Determinations, and any state-specific Medicaid mandates. Links are current at time of approval by the Medical Policy Committee (MPC) and are subject to change. Lines of business are also subject to change without notice and are noted on www.wellcare.com. Guidelines are also available on the site by selecting the Provider tab, then “Tools” and “Clinical Guidelines”.

BACKGROUND

The CardioMEMS™ HF System is the first and only FDA-approved heart failure (HF) monitor proven to significantly reduce heart failure hospital admissions and improve quality of life in New York Heart Association (NYHA) class III patients. The CardioMEMS HF System provides direct pulmonary artery (PA) pressure monitoring using the sensor, patient electronics system and the CardioMEMS HF System website to manage patient data. Patient-initiated sensor readings are wirelessly transmitted to an electronics unit and stored in a secure website for clinicians to access and review. The reliable radiopaque sensor is implanted in the pulmonary artery using a delivery system via a safe and proven right-heart catheterization procedure. The sensor endothelializes, occupying on average ~10% of cross-sectional lumen for low risk of infection, thrombus or occlusion. The sensor is calibrated during manufacturing and the mean pressure baseline is matched to the pulmonary artery catheter mean pressure during the implant procedure. The sensor does not contain a battery or other components which would limit its usable life.¹

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CARDIOMEMS HF SYSTEM

HS-304

Indications for the CardioMEMS HF System is indicated for wirelessly measuring and monitoring pulmonary artery (PA) pressure and heart rate in NYHA Class III heart failure patients who have been hospitalized for heart failure in the previous year. The hemodynamic data are used by physicians for heart failure management and with the goal of reducing heart failure hospitalizations.

The CardioMEMS™ HF System is contraindicated for patients with an inability to take dual antiplatelet or anticoagulants for one month post implant...”

In May 2014, the FDA cleared the CardioMEMS Heart Failure System for use in monitoring the heart rates and pulmonary arterial pressures of individuals with NYHA Class III heart failure who have been placed in the hospital for heart failure within the previous 12 months.²

POSITION STATEMENT Applicable To:

Medicaid Medicare

Implantable wireless pulmonary artery pressure monitors (CardioMems) is considered medically necessary and a covered benefit for the treatment of heart failure and all other indications.

CODING

Covered CPT Codes

93297 Interrogation device evaluation(s), (remote) up to 30 days; implantable cardiovascular monitor system, including analysis of 1 or more recorded physiologic cardiovascular data elements from all internal and external sensors, analysis, review(s) and report(s) by a physician or other qualified health care

professional

93299 Interrogation device evaluation(s), (remote) up to 30 days; implantable cardiovascular monitor system or implantable loop recorder system, remote data acquisition(s), receipt of transmissions and technician review, technical support and distribution of results

93451 Right heart catheterization including measurement(s) of oxygen saturation and cardiac output, when performed +93568 Injection procedure during cardiac catheterization including imaging supervision, interpretation, and report;

for pulmonary angiography (List separately in addition to code for primary procedure) 93799 Unlisted cardiovascular service or procedure

Covered HCPCS Codes

C2624 Implantable wireless pulmonary artery pressure sensor with delivery catheter, including all system components C9741 Right heart catheterization with implantation of wireless pressure sensor in the pulmonary artery, including any type of measurement, angiography, imaging supervision, interpretation, and report

Covered ICD-10-CM Codes

I50.1 - I50.9 Heart failure , I50.1 (Left ventricular failure) - unspecified (I50.9)

*And all other indications Covered ICD-10-PCS Codes

02HQ30Z Insertion of Pressure Sensor Monitoring Device, Right Pulmonary Artery, monitoring device with pressure sensor 02HR30Z Insertion of Pressure Sensor Monitoring Device, Left Pulmonary Artery,monitoring device with pressure sensor Coding information is provided for informational purposes only. The inclusion or omission of a CPT, HCPCS, or ICD-10 code does not imply member coverage or provider reimbursement. Consult the member's benefits that are in place at time of service to determine coverage (or non- coverage) as well as applicable federal / state laws.

REFERENCES

1. Wireless pulmonary artery pressure monitoring with CardioMEMS HF system (St. Jude Medical Inc.) for management of chronic heart failure. Hayes Directory Web site https://www.hayesinc.com. Published November 22, 2016 (reviewed December 11, 2018). Accessed August 21, 2018.

2. FDA approves first implantable wireless device with remote monitoring to measure pulmonary artery pressure in certain heart failure

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CARDIOMEMS HF SYSTEM

HS-304

patients. U.S. Food and Drug Administration (FDA) Web site https://wayback.archive-

it.org/7993/20161023125525/http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm399024.htm. FDA News Release.

Silver Spring, MD: FDA; May 28, 2014. Accessed August 21, 2018.

MEDICAL POLICY COMMITTEE HISTORY AND REVISIONS

Date Action

8/24/2018, 8/3/2017, 10/6/2016  Approved by MPC. No changes.

12/3/2015  Approved by MPC. Previously E/I; now a covered benefit.

10/1/2015  Approved by MPC. New.