Insertion of Implantable Wireless Pulmonary Artery Pressure Sensor and Monitoring Form

1 Insertion of Implantable Wireless Pulmonary Artery Pressure Sensor and Monitoring (i.e., CardioMEMS) - Medical Policy Updated Revision Effective: June 1, 2025 Policy Number: UM571POL Approval Date: Line(s) of Business: Commercial Medicare Advantage Medicaid (BeHealthy) Description Various cardiac hemodynamic monitoring techniques have been investigated as a means to remotely guide outpatient heart failure (HF) therapy, including implantable wireless pulmonary artery pressure monitoring (e.g., CardioMEMS®). The implanted device measures and monitors daily pulmonary artery (PA) pressure. The data is used by physicians for heart failure management with the goal of reducing heart failure hospitalizations, therefore improving quality of life and reducing morbidity for patients with heart failure. Although other devices that monitor cardiac output through measurements of pressure changes in the pulmonary artery or right ventricular outflow tract are under investigation, (e.g., Chronicle®, ImPressure®), currently, only CardioMEMs has FDA approval. Line of Business Commercial:  Refer to criteria under the Policy section in this medical policy. Medicaid – BeHealthy:
 Refer to criteria under the Policy section in this medical policy. 3/11/2025

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Medicare:

 For Insertion of Implantable Wireless Pulmonary Artery Pressure Sensor, HNE follows CMS coverage criteria found at: NCA - Implantable Pulmonary Artery Pressure Sensors for Heart Failure Management (CAG-00466N)

 For Implantable Wireless Pulmonary Artery Pressure remote monitoring, refer to criteria under policy section in this medical policy. Medicare does not have a National Coverage Determination (NCD) or a Local Coverage Determination (LCD) for this procedure.

Policy

I. Implantable wireless pulmonary artery pressure monitoring (e.g., CardioMEMS®) is considered MEDICALLY NECESSARY for Commercial and Medicaid members when the following criteria are met:

A. Implantable wireless pulmonary artery pressure monitoring, including insertion procedure, device, and sensor, will be covered for up to one year from authorization. There is a limit of one insertion procedure during this one-year period; AND

B. Utilization of implantable wireless pulmonary artery pressure monitoring (e.g., CardioMEMS) as part of treatment for heart failure (Heart Failure with Preserved Ejection Fraction or Reduced Ejection Fraction) may be considered medically necessary when ALL of the criteria listed below are met and documented:

1. Member has been diagnosed with class II, III, or IV heart failure as per standards established by the New York Heart Association (NYHA) for at least 3 months duration; AND,

2. Member has experienced an acute inpatient hospital admission within the past 12 months, with heart failure as a diagnosis contributing to the admission and/or has elevated natriuretic peptides; AND

3. Individual is on maximally tolerated Guideline Directed Medical Therapy (GDMT) or has a documented intolerance to GDMT (e.g., hemodynamic instability); AND

4. Member is not on a waiting list for a heart transplant; AND

5. Member is not receiving and is not scheduled to receive Ventricular Assist Device (VAD) therapy; AND

6. Member has undergone risk-benefit discussion with a cardiologist or his/her team regarding the procedure and periprocedural medication management; AND

7. Member does not have a mechanical right heart valve; AND

8. Given the need for ongoing interaction and management between the clinician and the member, the member must be considered compliant with follow-ups by the practice that would be interpreting the data; AND

9. The member is 18 years of age or older; AND

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10. The member has the capacity to make fully informed decisions and has consented to the procedure after limitations, risks, and complications of the procedure have been discussed; AND

11. Co-morbid medical or mental health disorders are appropriately managed and reasonably controlled.

    II. Remote Monitoring is medically necessary when insertion of a wireless pulmonary artery pressure sensor has been previously approved per criteria noted above.

    III. Implantable wireless pulmonary artery pressure monitoring (e.g., CardioMEMS) for all other indications other than in criteria above including for members with NYHA class I heart failure is considered NOT MEDICALLY NECESSARY.

    Policy Guidelines and Definitions

    Policy Guidelines:

    I. Required Documentation:

    A. Medical documentation that members meet the above criteria.

    Definitions:

    CardioMEMs: Implantable pulmonary artery pressure (PAP) monitor/sensor that is a remote monitoring platform for both HFpEF1 and HFrEF patients.

    HFpEF: Heart Failure with preserved ejection fraction also referred to as diastolic heart failure or diastolic dysfunction. The left ventricle loses its ability to relax normally which impairs cardiac filling and leads to congestion.

    HFrEF: Heart Failure with reduced ejection fraction. The left ventricle loses its ability to contract normally which impairs cardiac output and leads to congestion.

    Ejection Fraction (EF): A measurement, expressed as a percentage of how much blood the left ventricle pumps out with each contraction. (normal EF 50-65%)

    New York Heart Association (NYHA) Heart Failure Classes: See following link: https://www.heart.org/en/health-topics/heart-failure/what-is-heart-failure/classes-of-heart-failure

    Natriuretic peptides: Natriuretic peptides are substances made by the heart. Two main types of these substances are brain natriuretic peptide (BNP) and N-terminal pro b-type natriuretic peptide (NT-proBNP). Normally, only small levels of BNP and NT-proBNP are found in the bloodstream. High levels can mean that the body is retaining fluid (congestion), stretching the wall of the heart. When this happens, it's known as congestive heart failure.

    Coding Guidance

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Code
Description
CPT codes

33289 Transcatheter implantation for long-term hemodynamic monitoring
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. HCPC codes

C2624 Implantable wireless pulmonary artery pressure sensor with delivery catheter, including all system components CPT® Copyright 2025 American Medical Association. All rights reserved. CPT is a registered trademark of the American Medical Association.

Note: CPT/HCPCS codes are included for informational purposes and may not be all inclusive. Inclusion or exclusion of a CPT/HCPCS code(s) does not signify or imply that the service described by the code is a covered or non-covered health service. Benefit coverage for health services is determined by the member’s specific benefit plan document and applicable laws that may require coverage for a specific service. The inclusion of a code does not imply any right to reimbursement or guarantee of payment. Other policies and coverage determination guidelines may apply.

References

1. CardioMEMS Implantable Hemodynamic Monitor (Abbott) for Managing Patients with Heart Failure, Hayes (July 28, 2022)

   CardioMEMS Implantable Hemodynamic Monitor (Abbott) for Managing Patients With Heart Failure

2. CARDIOMEMS HF SYSTEM-for pulmonary artery pressure monitoring, Abbott (N.D.)

   https://www.cardiovascular.abbott/us/en/hcp/products/heart-failure/pulmonary-pressure- monitors/cardiomems/about.html

3. NCA - Implantable Pulmonary Artery Pressure Sensors for Heart Failure Management (January 13, 2025) NCA - Implantable Pulmonary Artery Pressure Sensors for Heart Failure Management (CAG-00466N)

4. MassHealth: Guidelines for Medical Necessity Determination for CardioMEMS, effective date May 13, 2022

   https://www.mass.gov/guides/masshealth-guidelines-for-medical-necessity-determination-for-cardiomems

5. Heidenreich, P, Bozkurt, B, Aguillar, D, et al, 2022 AHA/ACC/HFSA Guideline for the Management of Heart Failure: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines, Journal of the American College of Cardiology (Volume 79 No.17)

   https://www.jacc.org/doi/10.1016/j.jacc.2021.12.012

6. Ayyadurai, P., Alkhawam, H., Saad, M., Al-Sadaw, M.A., Shah, N.N., Kosmas, C.E., Vittorio, T.J. (2019). An update on the CardioMEMS pulmonary artery pressure sensor

   https://dx.doi.org/10.1177%2F1753944719826826

7. Borlaug, B.A., Colucci, W.S.(2019, December 5) Treatment and prognosis of heart failure with preserved ejection fraction

   https://www.uptodate.com

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8. Yancy, C.W., Jessup, M., Biykem, B., Butler, J., Casey, D.E., Colvin, M.M. Drazner, M.H., Fillipatos, G.S., Fanarow, G.C., Givertz, M.M., Hollenberg, S.M., Lindenfield, J., Masoudi, F.A., McBride, P.E., Peterson, P.N., Warner-Stevenson, L., Westlake, C. (2017). 2017 ACC/AHA/HFSA focused update of the 2013 ACFF/AHA guideline for the management of heart failure: A report of the American College of Cardiology/American Heart Association task force on clinical practice guidelines and the Heart Failure Society of America. Journal of American Cardiology, 70(6), 776-803

   https://www.jacc.org/doi/full/10.1016/j.jacc.2017.04.025?_ga=2.101082567.776642292.1614622572- 111830149.161462257

9. 1Heart Failure (MedlinePlus), (Last updated July 22, 2019)

   https://medlineplus.gov/heartfailure.html

10. Types of Heart Failure-Left- sided heart failure

    https://www.heart.org/en/health-topics/heart-failure/what-is-heart-failure/types-of-heart-failure

11. Classes of Heart Failure

    https://www.heart.org/en/health-topics/heart-failure/what-is-heart-failure/classes-of-heart-failure

12. Pulmonary Artery Pressure-Guided Management of Patients With Heart Failure and Reduced Ejection Fraction, Journal of the American College of Cardiology (Vol 70 No. 15)

    Pulmonary Artery Pressure-Guided Management of Patients With Heart Failure and Reduced Ejection Fraction | Journal of the American College of Cardiology (jacc.org)

13. Shavelle MD, D, Desai MD, A, Abraham MD, W, Bourge MD, R, et al. Lower Rates of Heart Failure and All- cause hospitalizations during pulmonary artery pressure-guided therapy for ambulatory heart failure, Circulation Heart Failure, August 2020, page 229-238

    https://www.ahajournals.org/doi/10.1161/CIRCHEARTFAILURE.119.006863

14. Lindenfeld MD, J, Abraham MD, W, Maisel MD, A, Zile MD M, et al, Hemodynamic-GUIDEd management of Heart Failure (GUIDE-HF), American Heart Journal August 2019, page 18-27.

    https://www.sciencedirect.com/science/article/pii/S0002870319301036?via%3Dihub

15. Angermann, C, Assmus, B, Anker, S, Asselbergs, F, et al. Pulmonary artery pressure-guided therapy in ambulatory patients with symptomatic heart failure: the CardioMEMS European Monitoring Study for Heart Failure (MEMS-HF), Eur J Heart Fail, 2020 Oct 22, PMID: 32592227,

    https://onlinelibrary.wiley.com/doi/10.1002/ejhf.1943

16. Abraham MD, J, Bharmi MS, R, Jonsson MD, O, et al, Association of Ambulatory Hemodynamic Monitoring of Heart Failure With Clinical Outcomes in a Concurrent Matched Cohort Analysis, JAMA Cardiology, (May 15, 2019), https://jamanetwork.com/journals/jamacardiology/fullarticle/2732637?utm_campaign=articlePDF&utm_me dium=articlePDFlink&utmsource=articlePDF&utmcontent=jamacardio.2019.1384

17. Desai MD, A, Bhimaraj MD MPH, A, Bharmi, Jermyn MD, R, et al, Ambulatory Hemodynamic Monitoring Reduces Heart Failure Hospitalizations in “Real-World” Clinical Practice, Journal of the American College of Cardiology, (May 16, 2017), PMID: 28330751, https://www.sciencedirect.com/science/article/pii/S0735109717359788?via%3Dihub

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Policy Implementation

Approved by the Medical and Pharmacy Policy Committee

Kate McIntosh MD MBA

Chief Medical Officer

Saad Usmani MD MBA

Medical Director

Date Update 6/2022 Initial Policy Date 8/2023 Moved to new template, no significant changes, changed title from CardioMems 10/2023 Added indications for remote monitoring 1/2024 Added Line of Business Section. References updated. 7/2024 Annual review with no changes. 1/2025 Annual review with the following changes: Updated CMS coverage.
Title updated with additional of “Implantable”. Added to Criteria I: Individual is on maximally tolerated GDMT or has a documented intolerance to GDMT (e.g., hemodynamic instability). References updated.

Medical Criteria Disclaimer

Property of Health New England. All rights reserved. The treating physician or primary care provider must submit to Health New England the clinical evidence that the patient meets the criteria for the treatment, testing or surgical procedure. Without this documentation and information, Health New England will not be able to properly review the request for prior authorization. The clinical review criteria reflect how Health New England determines whether certain services or supplies are medically necessary. Health New England established the clinical review criteria based upon a review of currently available clinical information (including clinical outcome studies in the peer-reviewed published medical literature, regulatory status of the technology, evidence-based guidelines of public health and health research agencies, evidence-based guidelines and positions of leading national health professional organizations, views of physicians practicing in relevant clinical areas, and other relevant factors).
Health New England expressly reserves the right to revise these conclusions as clinical information changes, and welcomes further relevant information. Each benefit program defines which services are covered. The conclusion that a particular service or supply is medically necessary does not constitute a representation or warranty that this service or supply is covered and/or paid for by Health New England, as some programs exclude coverage for services or supplies that Health New England considers medically necessary. If there is a discrepancy between this guideline and a member's benefits program, the benefits program will govern. In addition, coverage may be mandated by applicable legal requirements of a state, the Federal Government or the Centers for Medicare & Medicaid Services (CMS) for Medicare and Medicaid members. All coding and web site links are accurate at the time of publication. Health New England has adopted the herein policy in providing management, administrative and other services to its Health Plan.