MEDICAL POLICY – 2.02.24 Cardiac Hemodynamic Monitoring for the Management of Heart Failure in the Outpatient Setting BCBSA Ref. Policy: 2.02.24 Effective Date: Aug. 1, 2019 Last Revised: July 1, 2020 Replaces: N/A

RELATED MEDICAL POLICIES: None

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POLICY CRITERIA | CODING | RELATED INFORMATION EVIDENCE REVIEW | REFERENCES | HISTORY

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Introduction

Hemodynamic monitoring measures blood pressure inside the heart, veins, and arteries. It’s often done in a hospital for patients with acute heart failure. Implantable hemodynamic monitoring devices have been developed for outpatient use. The device measures the pressure of the pulmonary artery (which transports blood from the heart to the lungs) and the heart rate. The data is transmitted through a computerized system to the patient’s doctor. The goal of the device is to try to see the early signs of acute heart failure and prevent hospitalizations. In the studies published so far, there is limited data about safety and no demonstration that the devices save more lives. There are also unanswered questions about whether these devices reduce hospitalization. For these reasons, implantable hemodynamic monitoring devices are considered investigational (unproven).

Note: The Introduction section is for your general knowledge and is not to be taken as policy coverage criteria. The rest of the policy uses specific words and concepts familiar to medical professionals. It is intended for providers. A provider can be a person, such as a doctor, nurse, psychologist, or dentist. A provider also can be a place where medical care is given, like a hospital, clinic, or lab. This policy informs them about when a service may be covered.

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Policy Coverage Criteria

Service Investigational Cardiac hemodynamic monitoring

In the ambulatory care and outpatient setting, cardiac hemodynamic monitoring for the management of heart failure using any of the following devices is considered investigational: • Arterial pressure during the Valsalva maneuver • Implantable direct pressure monitoring of the pulmonary artery

(this includes the implantation of the device, eg, CardioMEMS device)

• Inert gas rebreathing • Thoracic bioimpedance

Coding

Code Description CPT 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

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

93799 Unlisted cardiovascular service or procedure

Note: CPT codes, descriptions and materials are copyrighted by the American Medical Association (AMA). HCPCS codes, descriptions and materials are copyrighted by Centers for Medicare Services (CMS).

Related Information

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This policy refers only to the use of stand-alone cardiac output measurement devices designed for use in ambulatory care and outpatient settings. The use of cardiac hemodynamic monitors or intrathoracic fluid monitors that are integrated into other implantable cardiac devices, including implantable cardioverter defibrillators, cardiac resynchronization therapy devices, and cardiac pacing devices are not addressed in this policy.

Evidence Review

Description

A variety of outpatient cardiac hemodynamic monitoring devices are intended to improve quality of life and reduce morbidity for patients with heart failure by decreasing episodes of acute decompensation. Monitors can identify physiologic changes that precede clinical symptoms and thus allow preventive intervention. These devices operate through various mechanisms, including implantable pressure sensors, thoracic bioimpedance measurement, inert gas rebreathing, and estimation of left ventricular end-diastolic pressure by arterial pressure during the Valsalva maneuver.

Background

Chronic Heart Failure

Patients with chronic heart failure are at risk of developing acute decompensated heart failure, often requiring hospital admission. Patients with a history of acute decompensation have the additional risk of future episodes of decompensation and death. Reasons for the transition from a stable, chronic state to an acute, decompensated state include disease progression, as well as acute events such as coronary ischemia and dysrhythmias. While precipitating factors are frequently not identified, the most common preventable cause is noncompliance with medication and dietary regimens.1

Management

Strategies for reducing decompensation, and thus the need for hospitalization, are aimed at early identification of patients at risk for imminent decompensation. Programs for early

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identification of heart failure are characterized by frequent contact with patients to review signs and symptoms with a health care provider, education, and medication adjustments as appropriate. These encounters may occur face-to-face in the office or at home, or via cellular or computed technology.2

Precise measurement of cardiac hemodynamics is often employed in the intensive care setting to carefully manage fluid status in acutely decompensated heart failure. Transthoracic echocardiography, transesophageal echocardiography, and Doppler ultrasound are noninvasive methods for monitoring cardiac output on an intermittent basis for the more stable patient but are not addressed herein. A variety of biomarkers and radiologic techniques may be used for dyspnea when the diagnosis of acute decompensated heart failure is uncertain.

The criterion standard for hemodynamic monitoring is pulmonary artery catheters and central venous pressure catheters. However, they are invasive, inaccurate, and inconsistent in predicting fluid responsiveness. Several studies have demonstrated that catheters fail to improve outcomes in critically ill patients and may be associated with harm. To overcome these limitations, multiple techniques and devices have been developed that use complex imaging technology and computer algorithms to estimate fluid responsiveness, volume status, cardiac output and tissue perfusion. Many are intended for use in outpatient settings but can be used in the emergency department, intensive care unit, and operating room. Four methods are reviewed here: implantable pressure monitoring devices, thoracic bioimpedance, inert gas rebreathing, and arterial waveform during the Valsalva maneuver. Use of the last three is not widespread because of several limitations including use of proprietary technology making it difficult to confirm their validity and lack of large randomized controlled trials (RCTs) to evaluate treatment decisions guided by these hemodynamic monitors.

Summary of Evidence

For individuals who have heart failure in outpatient settings who receive hemodynamic monitoring with an implantable pulmonary artery pressure sensor device, the evidence includes RCTs. The relevant outcomes are overall survival, symptoms, functional outcomes, quality of life, morbid events, hospitalizations, and treatment-related morbidity. One implantable pressure monitor, the CardioMEMS device, has U.S. Food and Drug Administration (FDA) approval. The pivotal CHAMPION RCT reported a statistically significant decrease in heart failure-related hospitalizations in patients implanted with CardioMEMS device compared with usual care. However, trial results were potentially biased in favor of the treatment group due to use of additional nurse communication to enhance protocol compliance with the device. The manufacturer conducted multiple analyses to address potential bias from the nurse

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interventions. Results were reviewed favorably by the FDA. While these analyses demonstrated the consistency of benefit from the CardioMEMS device, all such analyses have methodologic limitations. Early safety data have been suggestive of a higher rate of procedural complications, particularly related to pulmonary artery injury. Given that the intervention is invasive and intended to be used for a highly prevalent condition, in the light of limited safety data, lack of demonstrable mortality benefit, and pending questions related to its benefit in reducing hospitalizations, the net benefit remains uncertain. Many of these concerns may be clarified by an ongoing postmarketing study that proposes to enroll 1200 patients (at least 35% women) is reported. The evidence is insufficient to determine the effects of the technology on health outcomes.

For individuals who have heart failure in outpatient settings who receive hemodynamic monitoring by thoracic impedance, with inert gas rebreathing, or of arterial pressure during the Valsalva maneuver, the evidence includes uncontrolled prospective studies and case series. The relevant outcomes are overall survival, symptoms, functional outcomes, quality of life, morbid events, hospitalizations, and treatment-related morbidity. There is a lack of RCT evidence evaluating whether the use of these technologies improves health outcomes over standard active management of heart failure patient. The case series have reported physiologic measurement-related outcomes and/or associations between monitoring information and heart failure exacerbations, but do not provide definitive evidence on device efficacy. The evidence is insufficient to determine the effects of the technology on health outcomes.

Ongoing and Unpublished Clinical Trials

Some currently unpublished trials that might influence this review are listed in Table 1.

Table 1. Summary of Key Trials

NCT No. Trial Name Planned Enrollment

Completion Date

Ongoing NCT02693691 CardioMEMS European Monitoring Study for Heart Failure 239 Dec 2019

NCT02954341 CardioMEMS HF SystemOUS Post Market Study 800 Dec 2022

NCT03387813 Hemodynamic-GUIDEd Management of Heart Failure 3600 Apr 2023

Unpublished

https://www.clinicaltrials.gov/ct2/show/NCT02693691?term=NCT02693691&rank=1https://www.clinicaltrials.gov/ct2/show/NCT02954341?term=NCT02954341&rank=1https://www.clinicaltrials.gov/ct2/show/NCT03387813?term=NCT03387813&rank=1

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NCT No. Trial Name Planned Enrollment

Completion Date

NCT01121107 Left Atrial Pressure Monitoring to Optimize Heart Failure Therapy Study

486 Apr 2015 (completed)

NCT00409916a Prevention of Heart Failure Events With Impedance Cardiography Testing (PREVENT-HF): Device BioZ Dx

500 Dec 2012 (unknown)

NCT: national clinical trial. a Denotes industry-sponsored or cosponsored trial.

Practice Guidelines and Position Statements

American College of Cardiology et al

The joint guidelines from the American College of Cardiology, American Heart Association, and Heart Failure Society of America (2017) on the management of heart failure offered no recommendations for the use of ambulatory monitoring devices.23

European Society of Cardiology

The European Society of Cardiology guidelines on the diagnosis and treatment of acute and chronic heart failure stated the following: “Monitoring of pulmonary artery pressures using a wireless implantable hemodynamic monitoring system (CardioMEMS) may be considered in symptomatic patients with heart failure with previous heart failure hospitalization in order to reduce the risk of recurrent heart failure hospitalization (Class IIb Level B recommendation).”23

National Institute for Health and Care Excellence

The updated guidance from the National Institute for Health and Care Excellence (2018) on chronic heart failure management did not include outpatient hemodynamic monitoring as a recommendation.24

The Institute (2013) issued guidance on the insertion and use of implantable pulmonary artery pressure monitors in chronic heart failure.25 The recommendations concluded that “Current evidence on the safety and efficacy of the insertion and use of implantable pulmonary artery pressure monitors in chronic heart failure is limited in both quality and quantity.”

https://www.clinicaltrials.gov/ct2/show/NCT01121107?term=NCT01121107&rank=1https://www.clinicaltrials.gov/ct2/show/NCT00409916?term=NCT00409916&rank=1

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Heart Failure Society of America

The Heart Failure Society of America Scientific Statements Committee (2018) published a white paper consensus statement on remote monitoring of patients with heart failure.26

The committee concluded that: "Based on available evidence, routine use of external RPM devices is not recommended. Implanted devices that monitor pulmonary arterial pressure and/or other parameters may be beneficial in selected patients or when used in structured programs, but the value of these devices in routine care requires further study."

Medicare National Coverage

The Centers for Medicare & Medicaid Services (2014) updated its 2006 decision memorandum on thoracic electrical bioimpedance.27 Medicare’s national coverage determination found thoracic bioimpedance to be reasonable and necessary for the following indications:

1. Differentiation of cardiogenic from pulmonary causes of acute dyspnea;

2. Optimization of atrioventricular interval for patients with atrioventricular sequential cardiac pacemakers;

3. Monitoring of continuous inotropic therapy for patients with terminal heart failure;

4. Evaluation for rejection in patients with a heart transplant as a predetermined alternative to myocardial biopsy; and

5. Optimization of fluid management in patients with congestive heart failure.

While Medicare permits coverage of thoracic bioimpedance in these conditions, it has acknowledged that there is a “…general absence of studies evaluating the impact of using thoracic bioimpedance for managing patients with cardiac disease….” Medicare does not cover the use of thoracic bioimpedance in the management of hypertension due to inadequate evidence.

Medicare has also specified that thoracic bioimpedance is not covered for “the management of all forms of hypertension (with the exception of drug-resistant hypertension…).” Further, Medicare specified that:

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[Contractors] have discretion to determine whether the use of TEB [thoracic bioimpedance] for the management of drug-resistant hypertension is reasonable and necessary. Drug resistant hypertension is defined as failure to achieve goal blood pressure in patients who are adhering to full doses of an appropriate 3-drug regimen that includes a diuretic.

There is no Medicare national coverage determination on implantable direct pressure monitoring, inert gas rebreathing, and arterial pressure with Valsalva.

Effective April 7, 2016, Novitas Solutions issued a noncoverage local coverage determination (ID L36419) for outpatient wireless pulmonary artery pressure monitoring for heart failure (CardioMEMS).

Regulatory Status

Noninvasive Left Ventricular End-Diastolic Pressure Measurement Devices

In 2004, the VeriCor® (CVP Diagnostics), a noninvasive left ventricular end-diastolic pressure measurement device, was cleared for marketing by FDA through the 510(k) process. The FDA determined that this device was substantially equivalent to existing devices for the following indication:

The VeriCor is indicated for use in estimating non-invasively, left ventricular end-diastolic pressure (LVEDP). This estimate, when used along with clinical signs and symptoms and other patient test results, including weights on a daily basis, can aid the clinician in the selection of further diagnostic tests in the process of reaching a diagnosis and formulating a therapeutic plan when abnormalities of intravascular volume are suspected. The device has been clinically validated in males only. Use of the device in females has not been investigated.

FDA product code: DXN

Thoracic Bioimpedance Devices

Multiple thoracic impedance measurement devices that do not require invasive placement have been cleared for marketing by the FDA through the 510(k) process. The FDA determined that this device was substantially equivalent to existing devices used for peripheral blood flow monitoring. Table 2 presents an inexhaustive list of representative devices

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FDA product code: DSB

Table 2. Noninvasive Thoracic Impedance Plethysmography Devices

Device Manufacturer Clearance Date BioZ® Thoracic Impedance Plethysmograph SonoSite 2009

Zoe® Fluid Status Monitor Noninvasive Medical Technologies 2004

Cheetah Starling SV Cheetah Medical 2008

PhysioFlow® Signal Morphology-based Impedance Cardiography (SM-ICG™)

Vasocom, now NeuMeDx 2008

ReDSTM Wearable System Sensible Medical Innovations 2015

Also, several manufacturers market thoracic impedance measurement devices integrated into implantable cardiac pacemakers, cardioverter defibrillator devices, and cardiac resynchronization therapy devices.

Inert Gas Rebreathing Devices

In 2006, the Innocor® (Innovision), an inert gas rebreathing device, was cleared for marketing by FDA through the 510(k) process. The FDA determined that this device was substantially equivalent to existing inert gas rebreathing devices for use in computing blood flow. FDA product code: BZG.

Implantable Pulmonary Artery Pressure Sensor Devices

In 2014, the CardioMEMS™ Champion Heart Failure Monitoring System (CardioMEMS, now Abbott) was cleared for marketing by the FDA through the premarket approval process. This device consists of an implantable pulmonary artery (PA) sensor, which is implanted in the distal PA, a transvenous delivery system, and an electronic sensor that processes signals from the implantable PA sensor and transmits PA pressure measurements to a secure database.3 The device originally underwent FDA review in 2011, at which point FDA found no reasonable assurance that the monitoring system would be effective, particularly in certain subpopulations,

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although FDA agreed this monitoring system was safe for use in the indicated patient population.4

Several other devices that monitor cardiac output by measuring pressure changes in the PA or right ventricular outflow tract have been investigated in the research setting but have not received FDA approval. They include the Chronicle® implantable continuous hemodynamic monitoring device (Medtronic), which includes a sensor implanted in the right ventricular outflow tract, and the ImPressure® device (Remon Medical Technologies), which includes a sensor implanted in the PA.

Note: This policy only addresses the use of these technologies in ambulatory care and outpatient settings.

References

1. Opasich C, Rapezzi C, Lucci D, et al. Precipitating factors and decision-making processes of short-term worsening heart failure despite optimal treatment (from the IN-CHF Registry). Am J Cardiol. Aug 15 2001;88(4):382-387. PMID 11545758

2. McAlister FA, Stewart S, Ferrua S, et al. Multidisciplinary strategies for the management of heart failure patients at high risk for admission: a systematic review of randomized trials. J Am Coll Cardiol. Aug 18 2004;44(4):810- 819. PMID 15312864

3. Food and Drug Administration. Summary of Safety and Effectiveness Data (SSED): CardioMEMS HF System. 2014; https://www.accessdata.fda.gov/cdrh_docs/pdf10/P100045b.pdf. Accessed July 2019.

4. Loh JP, Barbash IM, Waksman R. Overview of the 2011 Food and Drug Administration Circulatory System Devices Panel of the Medical Devices Advisory Committee Meeting on the CardioMEMS Champion Heart Failure Monitoring System. J Am Coll Cardiol. Apr 16 2013;61(15):1571-1576. PMID 23352783

5. International Consortium for Health Outcomes Measurement, Inc (ICHOM). Heart Failure version 1.1.4. Oct 2017. Accessed Apr 2, 2019.

6. Zannad, FF, Garcia, AA, Anker, SS, Armstrong, PP, Calvo, GG, Cleland, JJ, Cohn, JJ, Dickstein, KK, Domanski, MM, Ekman, II, Filippatos, GG, Gheorghiade, MM, Hernandez, AA, Jaarsma, TT, Koglin, JJ, Konstam, MM, Kupfer, SS, Maggioni, AA, Mebazaa, AA, Metra, MM, Nowack, CC, Pieske, BB, Piña, II, Pocock, SS, Ponikowski, PP, Rosano, GG, Ruilope, LL, Ruschitzka, FF, Severin, TT, Solomon, SS, Stein, KK, Stockbridge, NN, Stough, WW, Swedberg, KK, Tavazzi, LL, Voors, AA, Wasserman, SS, Woehrle, HH, Zalewski, AA, McMurray, JJ. Clinical outcome endpoints in heart failure trials: a European Society of Cardiology Heart Failure Association consensus document. Eur. J. Heart Fail., 2013 Jun 22;15(10). PMID 23787718

7. CardioMEMSChampionTM Heart Failure Monitoring System: Presentation - CardioMEMS: Oct. 9, 2013. 2013; https://wayback.archive-it.org/7993/20170111163201/http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/MedicalDevicesAdvisoryCommittee/CirculatorySystemDevicesPanel/UCM370951.pdf . Accessed July 2019.

8. CardioMEMS ChampionTM HF Monitoring System: FDA Review of P100045/A004FDA Presentation - CardioMEMS: Oct. 9, 2013. 2013; https://wayback.archive-it.org/7993/20170111163259/http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/MedicalDevicesAdvisoryCommittee/CirculatorySystemDevicesPanel/UCM370955.pdf. Accessed July 2019.

https://www.accessdata.fda.gov/cdrh_docs/pdf10/P100045b.pdfhttps://wayback.archive-it.org/7993/20170111163201/http:/www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/MedicalDevicesAdvisoryCommittee/CirculatorySystemDevicesPanel/UCM370951.pdfhttps://wayback.archive-it.org/7993/20170111163201/http:/www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/MedicalDevicesAdvisoryCommittee/CirculatorySystemDevicesPanel/UCM370951.pdfhttps://wayback.archive-it.org/7993/20170111163201/http:/www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/MedicalDevicesAdvisoryCommittee/CirculatorySystemDevicesPanel/UCM370951.pdfhttps://wayback.archive-it.org/7993/20170111163259/http:/www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/MedicalDevicesAdvisoryCommittee/CirculatorySystemDevicesPanel/UCM370955.pdfhttps://wayback.archive-it.org/7993/20170111163259/http:/www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/MedicalDevicesAdvisoryCommittee/CirculatorySystemDevicesPanel/UCM370955.pdfhttps://wayback.archive-it.org/7993/20170111163259/http:/www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/MedicalDevicesAdvisoryCommittee/CirculatorySystemDevicesPanel/UCM370955.pdf

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9. Adamson PB, Abraham WT, Bourge RC, et al. Wireless pulmonary artery pressure monitoring guides management to reduce decompensation in heart failure with preserved ejection fraction. Circ Heart Fail. Nov 2014;7(6):935-944. PMID 25286913

10. Adamson PB, Abraham WT, Stevenson LW, et al. Pulmonary Artery Pressure-Guided Heart Failure Management Reduces 30-Day Readmissions. Circ Heart Fail. Jun 2016;9(6). PMID 27220593

11. Krahnke JS, Abraham WT, Adamson PB, et al. Heart failure and respiratory hospitalizations are reduced in patients with heart failure and chronic obstructive pulmonary disease with the use of an implantable pulmonary artery pressure monitoring device. J Card Fail. Mar 2015;21(3):240-249. PMID 25541376

12. Abraham WT, Adamson PB, Bourge RC, et al. Wireless pulmonary artery haemodynamic monitoring in chronic heart failure: a randomised controlled trial. Lancet. Feb 19 2011;377(9766):658-666. PMID 21315441

13. Abraham WT, Stevenson LW, Bourge RC, et al. Sustained efficacy of pulmonary artery pressure to guide adjustment of chronic heart failure therapy: complete follow-up results from the CHAMPION randomised trial. Lancet. Jan 30 2016;387(10017):453-461. PMID 26560249

14. Desai AS, Bhimaraj A, Bharmi R, et al. Ambulatory Hemodynamic Monitoring Reduces Heart Failure Hospitalizations in Real-World Clinical Practice. J Am Coll Cardiol. May 16 2017;69(19):2357-2365. PMID 28330751

15. Vaduganathan M, DeFilippis EM, Fonarow GC, et al. ostmarketing adverse events related to the CardioMEMS HF System. JAMA Cardiol. Nov 1 2017;2(11):1277-1279. PMID 28975249

16. Heywood JT, Jermyn R, Shavelle D, et al. Impact of Practice-Based Management of Pulmonary Artery Pressures in 2000 Patients Implanted With the CardioMEMS Sensor. Circulation. Apr 18 2017;135(16):1509-1517. PMID 28219895

17. Kamath SA, Drazner MH, Tasissa G, et al. Correlation of impedance cardiography with invasive hemodynamic measurements in patients with advanced heart failure: the BioImpedance CardioGraphy (BIG) substudy of the Evaluation Study of Congestive Heart Failure and Pulmonary Artery Catheterization Effectiveness (ESCAPE) Trial. Am Heart J. Aug 2009;158(2):217-223. PMID 19619697

18. Anand IS, Greenberg BH, Fogoros RN, et al. Design of the Multi-Sensor Monitoring in Congestive Heart Failure (MUSIC) study: prospective trial to assess the utility of continuous wireless physiologic monitoring in heart failure. J Card Fail. Jan 2011;17(1):11-16. PMID 21187259

19. Anand IS, Tang WH, Greenberg BH, et al. Design and performance of a multisensor heart failure monitoring algorithm: results from the multisensor monitoring in congestive heart failure (MUSIC) study. J Card Fail. Apr 2012;18(4):289-295. PMID 22464769

20. Packer M, Abraham WT, Mehra MR, et al. Utility of impedance cardiography for the identification of short-term risk of clinical decompensation in stable patients with chronic heart failure. J Am Coll Cardiol. Jun 6 2006;47(11):2245-2252. PMID 16750691

21. Amir O, Ben-Gal T, Weinstein JM, et al. Evaluation of remote dielectric sensing (ReDS) technology-guided therapy for decreasing heart failure re-hospitalizations. Int J Cardiol. Aug 1 2017;240:279-284. PMID 28341372

22. Silber HA, Trost JC, Johnston PV, et al. Finger photoplethysmography during the Valsalva maneuver reflects left ventricular filling pressure. Am J Physiol Heart Circ Physiol. May 2012;302(10):H2043-2047. PMID 22389389

23. Yancy CW, Jessup M, Bozkurt B, et al. 2017 ACC/AHA/HFSA Focused Update of the 2013 ACCF/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. J Am Coll Cardiol. Aug 8 2017;70(6):776-803. PMID 28461007

24. National Institute for Health and Care Excellence (NICE). Chronic heart failure in adults: diagnosis and management; NICE guideline NG106. Sep 2018. Accessed Apr 2, 2019.

25. National Institute for Health and Care Excellence (NICE). Insertion and use of implantable pulmonary artery pressure monitors in chronic heart failure [IPG463]. 2013; https://www.nice.org.uk/guidance/ipg463. Accessed July 2019.

26. Dickinson, MM, Allen, LL, Albert, NN, DiSalvo, TT, Ewald, GG, Vest, AA, Whellan, DD, Zile, MM, Givertz, MM. Remote Monitoring of Patients With Heart Failure: A White Paper From the Heart Failure Society of America Scientific Statements Committee. J. Card. Fail., 2018 Oct 12;24(10). PMID 30308242

https://www.nice.org.uk/guidance/ipg463

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27. Centers for Medicare & Medicaid Services (CMS). National coverage decision for cardiac output monitoring by thoracic electrical bioimpedance (TEB) (20.16). 2006; http://www.cms.gov/medicare-coverage-database/details/ncd-details.aspx?NCDId=267&ncdver=3&NCAId=82&NcaName=Electrical+Bioimpedance+for+Cardiac+Output+Monitoring&IsPopup=y&bc=AAAAAAAACAAAAA%3D%3D&. Accessed July 2019.

History

Date Comments 08/01/18 New policy, approved July 10, 2018, effective November 2, 2018. Add to Cardiology

section. This policy was previously archived, but it is now being reinstated. Literature review through March 2018. Policy statement: cardiac hemodynamic monitoring for the management of heart failure in the outpatient setting using any of the stated devices is considered investigational.

01/01/19 Interim Review, approved December 19, 2018. Clarified that implantable direct pressure monitoring of the pulmonary artery includes the implantation of the device as well. Added CPT code 33289 and 93264.

08/01/19 Annual Review, approved July 25, 2019. Policy updated with literature review through April 2019, references added and removed. Policy statement unchanged.

07/02/20 Coding update. Removed CPT 93701.

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አማሪኛ (Amharic): ይህ ማስታወቂያ አስፈላጊ መረጃ ይዟል። ይህ ማስታወቂያ ስለ ማመልከቻዎ ወይም የ Premera Blue Cross ሽፋን አስፈላጊ መረጃ ሊኖረው ይችላል። በዚህ ማስታወቂያ ውስጥ ቁልፍ ቀኖች ሊኖሩ ይችላሉ። የጤናን ሽፋንዎን ለመጠበቅና በአከፋፈል እርዳታ ለማግኘት በተውሰኑ የጊዜ ገደቦች እርምጃ መውሰድ ይገባዎት ይሆናል። ይህን መረጃ እንዲያገኙ እና ያለምንም ክፍያ በቋንቋዎ እርዳታ እንዲያገኙ መብት አለዎት።በስልክ ቁጥር 800-722-1471 (TTY: 800-842-5357) ይደውሉ።

( ةالعربي :(. امةھ ماتولعم اإلشعار ھذا يحوي

خالل من ھاعلي صولحلا تريد لتيا التغطيةلل أو ةصحيلاكطيتتغ لىع اظلحفل نةعيم يخراوت في إجراء خاذتال تحتاج وقد .اإلشعار ھذا في

تكلفة أية بدتك دون بلغتك مساعدةوال تاوملالمع ھذه على ولحصال لك يحق .800-722-1471 (TTY: 800-842-5357)

أو طلبك وصخصب مةمھ ماتوعلم عارشإلا ھذا ويحي قدةمھم يخراوت ھناك تكون قد .Premera Blue Cross

اعدةمس تصلايفكالتال دفع فيبـ

.

Arabic

Oromoo (Cushite): Beeksisni kun odeeffannoo barbaachisaa qaba. Beeksisti kun sagantaa yookan karaa Premera Blue Cross tiin tajaajila keessan ilaalchisee odeeffannoo barbaachisaa qabaachuu danda’a. Guyyaawwan murteessaa ta’an beeksisa kana keessatti ilaalaa. Tarii kaffaltiidhaan deeggaramuuf yookan tajaajila fayyaa keessaniif guyyaa dhumaa irratti wanti raawwattan jiraachuu danda’a. Kaffaltii irraa bilisa haala ta’een afaan keessaniin odeeffannoo argachuu fi deeggarsa argachuuf mirga ni qabaattu. Lakkoofsa bilbilaa 800-722-1471 (TTY: 800-842-5357) tii bilbilaa.

Français (French): Cet avis a d'importantes informations. Cet avis peut avoir d'importantes informations sur votre demande ou la couverture par l'intermédiaire de Premera Blue Cross. Le présent avis peut contenir des dates clés. Vous devrez peut-être prendre des mesures par certains délais pour maintenir votre couverture de santé ou d'aide avec les coûts. Vous avez le droit d'obtenir cette information et de l’aide dans votre langue à aucun coût. Appelez le 800-722-1471 (TTY: 800-842-5357).

Kreyòl ayisyen (Creole): Avi sila a gen Enfòmasyon Enpòtan ladann. Avi sila a kapab genyen enfòmasyon enpòtan konsènan aplikasyon w lan oswa konsènan kouvèti asirans lan atravè Premera Blue Cross. Kapab genyen dat ki enpòtan nan avi sila a. Ou ka gen pou pran kèk aksyon avan sèten dat limit pou ka kenbe kouvèti asirans sante w la oswa pou yo ka ede w avèk depans yo. Se dwa w pou resevwa enfòmasyon sa a ak asistans nan lang ou pale a, san ou pa gen pou peye pou sa. Rele nan 800-722-1471 (TTY: 800-842-5357).

Deutsche (German): Diese Benachrichtigung enthält wichtige Informationen. Diese Benachrichtigung enthält unter Umständen wichtige Informationen bezüglich Ihres Antrags auf Krankenversicherungsschutz durch Premera Blue Cross. Suchen Sie nach eventuellen wichtigen Terminen in dieser Benachrichtigung. Sie könnten bis zu bestimmten Stichtagen handeln müssen, um Ihren Krankenversicherungsschutz oder Hilfe mit den Kosten zu behalten. Sie haben das Recht, kostenlose Hilfe und Informationen in Ihrer Sprache zu erhalten. Rufen Sie an unter 800-722-1471 (TTY: 800-842-5357).

Hmoob (Hmong): Tsab ntawv tshaj xo no muaj cov ntshiab lus tseem ceeb. Tej zaum tsab ntawv tshaj xo no muaj cov ntsiab lus tseem ceeb txog koj daim ntawv thov kev pab los yog koj qhov kev pab cuam los ntawm Premera Blue Cross. Tej zaum muaj cov hnub tseem ceeb uas sau rau hauv daim ntawv no. Tej zaum koj kuj yuav tau ua qee yam uas peb kom koj ua tsis pub dhau cov caij nyoog uas teev tseg rau hauv daim ntawv no mas koj thiaj yuav tau txais kev pab cuam kho mob los yog kev pab them tej nqi kho mob ntawd. Koj muaj cai kom lawv muab cov ntshiab lus no uas tau muab sau ua koj hom lus pub dawb rau koj. Hu rau 800-722-1471 (TTY: 800-842-5357).

Iloko (Ilocano): Daytoy a Pakdaar ket naglaon iti Napateg nga Impormasion. Daytoy a pakdaar mabalin nga adda ket naglaon iti napateg nga impormasion maipanggep iti apliksayonyo wenno coverage babaen iti Premera Blue Cross. Daytoy ket mabalin dagiti importante a petsa iti daytoy a pakdaar. Mabalin nga adda rumbeng nga aramidenyo nga addang sakbay dagiti partikular a naituding nga aldaw tapno mapagtalinaedyo ti coverage ti salun-atyo wenno tulong kadagiti gastos. Adda karbenganyo a mangala iti daytoy nga impormasion ken tulong iti bukodyo a pagsasao nga awan ti bayadanyo. Tumawag iti numero nga 800-722-1471 (TTY: 800-842-5357).

Italiano ( ):Questo avviso contiene informazioni importanti. Questo avviso può contenere informazioni importanti sulla tua domanda o copertura attraverso Premera Blue Cross. Potrebbero esserci date chiave in questo avviso. Potrebbe essere necessario un tuo intervento entro una scadenza determinata per consentirti di mantenere la tua copertura o sovvenzione. Hai il diritto di ottenere queste informazioni e assistenza nella tua lingua gratuitamente. Chiama 800-722-1471 (TTY: 800-842-5357).

Italian

中文 (Chinese):本通知有重要的訊息。本通知可能有關於您透過 Premera Blue Cross 提交的申請或保險的重要訊息。本通知內可能有重要日期。您可能需要在截止日期

之前採取行動，以保留您的健康保險或者費用補貼。您有權利免費以您的母

語得到本訊息和幫助。請撥電話 800-722-1471 (TTY: 800-842-5357)。

037338 (07-2016)

https://www.hhs.gov/ocr/office/file/index.htmlhttps://ocrportal.hhs.gov/ocr/portal/lobby.jsfmailto:AppealsDepartmentInquiries@Premera.com

日本語 (Japanese):この通知には重要な情報が含まれています。この通知には、 Premera Blue Crossの申請または補償範囲に関する重要な情報が含まれている場合があります。この通知に記載されている可能性がある重要な日付をご確認くだ

さい。健康保険や有料サポートを維持するには、特定の期日までに行動を

取らなければならない場合があります。ご希望の言語による情報とサポー

トが無料で提供されます。800-722-1471 (TTY: 800-842-5357)までお電話ください。

한국어 (Korean): 본 통지서에는 중요한 정보가 들어 있습니다 . 즉 이 통지서는 귀하의 신청에 관하여 그리고 Premera Blue Cross 를 통한 커버리지에 관한 정보를 포함하고 있을 수 있습니다 . 본 통지서에는 핵심이 되는 날짜들이 있을 수 있습니다. 귀하는 귀하의 건강 커버리지를 계속 유지하거나 비용을 절감하기 위해서 일정한 마감일까지 조치를 취해야 할 필요가 있을 수 있습니다 . 귀하는 이러한 정보와 도움을 귀하의 언어로 비용 부담없이 얻을 수 있는 권리가 있습니다 . 800-722-1471 (TTY: 800-842-5357) 로 전화하십시오 .

ລາວ (Lao): ແຈ້ງການນີ້ ນສໍ າຄັນ. ແຈ້ງການນີ້ອາດຈະມີ ນສໍ າຄັນກ່ຽວກັບຄໍ າຮ້ອງສະ ກ ຫຼື ຄວາມຄຸ້ມຄອງປະກັນໄພຂອງທ່ານຜ່ານ Premera Blue Cross. ອາດຈະມີ ນທີ າຄັນໃນແຈ້ງການນີ້. ທ່ານອາດຈະຈໍ າເປັ ນຕ້ອງດໍ າເນີ ນການຕາມກໍ ານົດ ເວລາສະເພາະເພື່ອຮັກສາຄວາມຄຸ້ມຄອງປະກັນສຸຂະພາບ ຫຼື ຄວາມຊ່ວຍເຫຼື ອເລື່ອງ າໃຊ້ າຍຂອງທ່ານໄວ້ . ທ່ານມີ ດໄດ້ ບຂໍ້ ນນີ້ ແລະ ຄວາມຊ່ວຍເຫຼື ອເປັ ນພາສາ ຂອງທ່ານໂດຍບ່ໍ ເສຍຄ່າ. ໃຫ້ໂທຫາ 800-722-1471 (TTY: 800-842-5357).

ູຂໍ້

່

ສໍ ັ

ຈ

ໝ

ສິ

ັ

່

ວ

ຄ

ມ

ມູຮັ

ູມີ ມຂໍ້

ភាសាែខមរ ( ): ឹ

រងរបស់

Premera Blue Cross ។ របែហលជាមាន កាលបរ ិ ឆ ំខានេនៅកងេសចក

េសចកតជី ូ

ជាមានព័ ៌ ៉ ងសំ ់អពី ់ ៉ ប់

នដំ ងេនះមានព័ ី

តមានយា ខាន ំ ទរមងែបបបទ ឬការរា

ណ ត៌មានយ៉ា ំ ់ តងសខាន។ េសចក

េចទស ់ ន ុ ត

ណងេនះ។ អ វការបេញញសមតភាព ដលកណតៃថ ចបាស

កតាមរយៈ

ដំ ឹ នករបែហលជារតូ ច ថ ់ ំ ់ ងជាក់ ់

នដ

ន

ី ន

ូ

អ

ូ

ជ

ជ

ំណឹងេនះរបែហល

នានា េដើ ីនងរកសាទុ ៉ បរងស់ ុ ់ ក ឬរបាក់ ំ

អ

មប ឹ កការធានារា ខភាពរបស ជ

ធនកមានសិ ទទលព័ មានេនះ និ ំ យេនៅកុងភាសារបសទិ ួ ត៌ ងជ ននួ

ន

់ កេដាយម

អ

នអ

យេចញៃថល។ ួ

នអស

ន

ិ

លុ ើ ូ ូយេឡយ។ សមទ ទ រស័ព 800-722-1471 (TTY: 800-842-5357)។

Khmer

ਕਵਰਜ ਅਤ ਅਰਜੀ ਬਾਰ ਮਹ ਤਵਪਰਨ ਜਾਣਕਾਰੀ ਹ ਸਕਦੀ ਹ . ਇਸ ਨ ਿਜਸ ਜਵਚ ਖਾਸ

ਤਾਰੀਖਾ ਹ ਸਕਦੀਆ ਹਨ. ਜੇਕਰ ਤਸੀ ਜਸਹਤ ਕਵਰਜ ਿਰਖਣੀ ਹਵ ਜਾ ਓਸ ਦੀ ਲਾਗਤ ਜਿਵਚ ਮਦਦ ਦ ੇਇਛ ੁਕ ਹ ਤਾਂ ਤਹਾਨ ਅ ਤਮ ਤਾਰੀਖ਼ ਤ ਪਿਹਲਾਂ ਕੁ ਝ ਖਾਸ ਕਦਮ ਚ ਕਣ ਦੀ ਲੜ ਹ ਸਕਦੀ ਹ ,ਤਹੁਾਨ ਮਫ਼ਤ ਿਵਚ ਤ ਆਪਣੀ ਭਾਸ਼ਾ ਿਵ ਚ ਜਾਣਕਾਰੀ ਅਤ ਮਦਦ ਪਾਪਤ ਕਰਨ ਦਾ ਅਿਧਕਾਰ ਹ ,ਕਾਲ 800-722-1471 (TTY: 800-842-5357).

ਪ ਜਾਬੀ (Punjabi): ਇਸ ਨ ਿਟਸ ਿਵਚ ਖਾਸ ਜਾਣਕਾਰੀ ਹ. ਇਸ ਨ ਿਟਸ ਿਵਚ Premera Blue Cross ਵਲ ਤੁਹਾਡੀ

ੰ

ੰ

ੇ ੇ ੇ ੱ ੂ ੋ ੈ ੋੋ ਂ ੁ ੇ ੱ ੋ ੇ ੱੱ ੁ ੱ ੂੁ ੱ ੇ ੱ ੇ ੍ਰ ੈ

ੋ ੰ ੂ ੱ ੁ ੋ ੋ ੈ ੰ

ੋ ੈ ੋ

(Farsi): فارسی فرم بارهدر ھمم اطالعات حاوی است ممکن يهمالعا اين. ميباشد ھمم اطالعات یوحا يهمالعا اين

در ھمم ھای خيتار به باشد.پ رایبستاکنممماش زينهھ اختدپر در مککيا تان بيمهوشش حقظ

Premera Blue Cross طريق از ماش مهبيوشش يا و تقاضا ای پ. يدماين جهتو يهمالعا اين

حق شما. يدشاب داشته اجتياح صیاخ کارھای امانج برای صیمشخ ایھ خيتار به تان، انیمدر ھای کسب برای .نماييد دريافت گانيرا ورط به ودخ زبان به را کمک و اطالعات اين که داريد را اين

استم ) 5357-842-800 مارهباش ماست TTY انکاربر(800-722-1471 مارهش با اطالعات .اييدنم برقرار

้

Polskie (Polish): To ogłoszenie może zawierać ważne informacje. To ogłoszenie może

zawierać ważne informacje odnośnie Państwa wniosku lub zakresu świadczeń poprzez Premera Blue Cross. Prosimy zwrócic uwagę na kluczowe daty, które mogą być zawarte w tym ogłoszeniu aby nie przekroczyć terminów w przypadku utrzymania polisy ubezpieczeniowej lub pomocy związanej z kosztami. Macie Państwo prawo do bezpłatnej informacji we własnym języku. Zadzwońcie pod 800-722-1471 (TTY: 800-842-5357).

Português (Portuguese): Este aviso contém informações importantes. Este aviso poderá conter informações importantes a respeito de sua aplicação ou cobertura por meio do Premera Blue Cross. Poderão existir datas importantes neste aviso. Talvez seja necessário que você tome providências dentro de determinados prazos para manter sua cobertura de saúde ou ajuda de custos. Você tem o direito de obter e sta informação e ajuda em seu idioma e sem custos. Ligue para 800-722-1471 (TTY: 800-842-5357).

Română (Romanian): Prezenta notificare conține informații importante. Această notificare poate conține informații importante privind cererea sau acoperirea asigurării dumneavoastre de sănătate prin Premera Blue Cross. Pot exista date cheie în această notificare. Este posibil să fie nevoie să acționați până la anumite termene limită pentru a vă menține acoperirea asigurării de sănătate sau asistența privitoare la costuri. Aveți dreptul de a obține gratuit aceste informații și ajutor în limba dumneavoastră. Sunați la 800-722-1471 (TTY: 800-842-5357).

Pусский (Russian): Настоящее уведомление содержит важную информацию. Это уведомление может содержать важную информацию о вашем заявлении или страховом покрытии через Premera Blue Cross. В настоящем уведомлении могут быть указаны ключевые даты. Вам, возможно, потребуется принять меры к определенным предельным срокам для сохранения страхового покрытия или помощи с расходами. Вы имеете право на бесплатное получение этой информации и помощь на вашем языке. Звоните по телефону 800-722-1471 (TTY: 800-842-5357).

Fa’asamoa (Samoan): Atonu ua iai i lenei fa’asilasilaga ni fa’amatalaga e sili ona taua e tatau ona e malamalama i ai. O lenei fa’asilasilaga o se fesoasoani e fa’amatala atili i ai i le tulaga o le polokalame, Premera Blue Cross, ua e tau fia maua atu i ai. Fa’amolemole, ia e iloilo fa’alelei i aso fa’apitoa olo’o iai i lenei fa’asilasilaga taua. Masalo o le’a iai ni feau e tatau ona e faia ao le’i aulia le aso ua ta’ua i lenei fa’asilasilaga ina ia e iai pea ma maua fesoasoani mai ai i le polokalame a le Malo olo’o e iai i ai. Olo’o iai iate oe le aia tatau e maua atu i lenei fa’asilasilaga ma lenei fa’matalaga i legagana e te malamalama i ai aunoa ma se togiga tupe. Vili atu i le telefoni 800-722-1471 (TTY: 800-842-5357).

Español ( ): Este Aviso contiene información importante. Es posible que este aviso contenga información importante acerca de su solicitud o cobertura a través de Premera Blue Cross. Es posible que haya fechas clave en este

tiene derecho a recibir esta información y ayuda en su idioma sin costo

aviso. Es posible que deba tomar alguna medida antes de determinadas fechas para mantener su cobertura médica o ayuda con los costos. Usted

alguno. Llame al 800-722-1471 (TTY: 800-842-5357).

Spanish

Tagalog (Tagalog): Ang Paunawa na ito ay naglalaman ng mahalagang impormasyon. Ang paunawa na ito ay maaaring naglalaman ng mahalagang impormasyon tungkol sa iyong aplikasyon o pagsakop sa pamamagitan ng Premera Blue Cross. Maaaring may mga mahalagang petsa dito sa paunawa. Maaring mangailangan ka na magsagawa ng hakbang sa ilang mga itinakdang panahon upang mapanatili ang iyong pagsakop sa kalusugan o tulong na walang gastos. May karapatan ka na makakuha ng ganitong impormasyon at tulong sa iyong wika ng walang gastos. Tumawag sa 800-722-1471 (TTY: 800-842-5357).

ไทย (Thai): ประกาศนมขอมลสาคญ ประกาศนอาจมขอมลทสาคญเกยวกบการการสมครหรอขอบเขตประกน สขภาพของคณผาน Premera Blue Cross และอาจมกาหนดการในประกาศน คณอาจจะตอง ดาเนนการภายในกาหนดระยะเวลาทแนนอนเพอจะรกษาการประกนสขภาพของคณหรอการชวยเหลอท มคาใชจาย คณมสทธทจะไดรบขอมลและความชวยเหลอนในภาษาของคณโดยไม่มคาใชจาย โทร 800-722-1471 (TTY: 800-842-5357)

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Український (Ukrainian): Це повідомлення містить важливу інформацію. Це повідомлення може містити важливу інформацію про Ваше звернення щодо страхувального покриття через Premera Blue Cross. Зверніть увагу на ключові дати, які можуть бути вказані у цьому повідомленні. Існує імовірність того, що Вам треба буде здійснити певні кроки у конкретні кінцеві строки для того, щоб зберегти Ваше медичне страхування або отримати фінансову допомогу. У Вас є право на отримання цієї інформації та допомоги безкоштовно на Вашій рідній мові. Дзвоніть за номером телефону 800-722-1471 (TTY: 800-842-5357).

Tiếng Việt (Vietnamese): Thông báo này cung cấp thông tin quan trọng. Thông báo này có thông tin quan trọng về đơn xin tham gia hoặc hợp đồng bảo hiểm của quý vị qua chương trình Premera Blue Cross. Xin xem ngày quan trọng trong thông báo này. Quý vị có thể phải thực hiện theo thông báo đúng trong thời hạn để duy trì bảo hiểm sức khỏe hoặc được trợ giúp thêm về chi phí. Quý vị có quyền được biết thông tin này và được trợ giúp bằng ngôn ngữ của mình miễn phí. Xin gọi số 800-722-1471 (TTY: 800-842-5357).