Clinical Policy Title: Wireless pulmonary artery pressure monitoring devices for heart failure

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1 Clinical Policy Title: Wireless pulmonary artery pressure monitoring devices for heart failure Clinical Policy Number: Effective Date: January 1, 2017 Initial Review Date: September 21, 2016 Most Recent Review Date: September 21, 2016 Next Review Date: September 2017 Policy contains: CardioMEMS TM. Chronic Heart Failure. Pulmonary artery pressure monitoring. Related policies: CP# CP# CP# CP# CP# Real-time outpatient cardiac monitoring Ambulatory blood pressure monitoring Implantable cardiac loop recorder Wearable cardioverter-defibrillator External counterpulsation (ECP) therapy ABOUT THIS POLICY: AmeriHealth Caritas Pennsylvania has developed clinical policies to assist with making coverage determinations. AmeriHealth Caritas Pennsylvania s clinical policies are based on guidelines from established industry sources, such as the Centers for Medicare & Medicaid Services (CMS), state regulatory agencies, the American Medical Association (AMA), medical specialty professional societies, and peer-reviewed professional literature. These clinical policies along with other sources, such as plan benefits and state and federal laws and regulatory requirements, including any state- or plan-specific definition of medically necessary, and the specific facts of the particular situation are considered by AmeriHealth Caritas Pennsylvania when making coverage determinations. In the event of conflict between this clinical policy and plan benefits and/or state or federal laws and/or regulatory requirements, the plan benefits and/or state and federal laws and/or regulatory requirements shall control. AmeriHealth Caritas Pennsylvania s clinical policies are for informational purposes only and not intended as medical advice or to direct treatment. Physicians and other health care providers are solely responsible for the treatment decisions for their patients. AmeriHealth Caritas Pennsylvania s clinical policies are reflective of evidence-based medicine at the time of review. As medical science evolves, AmeriHealth Caritas Pennsylvania will update its clinical policies as necessary. AmeriHealth Caritas Pennsylvania s clinical policies are not guarantees of payment. Coverage policy AmeriHealth Caritas Pennsylvania considers the use of wireless pulmonary artery pressure monitoring devices for heart failure monitoring to be investigational, and, therefore, not medically necessary. Limitations: Note: The following CPT/HCPCS codes are not listed in the Pennsylvania Medicaid fee schedule: C Implantable wireless pulmonary artery pressure sensor with delivery catheter, including all system components 1

2 C Right heart catheterization with implantation of wireless pressure Sensor in the pulmonary artery, including any type of measurement, angiography, imaging supervision, interpretation and report Alternative covered services: Self-contained pacemaker monitors Chronicle implantable hemodynamic monitors Background Heart failure occurs when the heart is unable to pump enough blood and oxygen to the body s organs. About 5.7 million Americans have chronic heart failure; about half of those who develop the condition die within five years of diagnosis (U.S. Centers for Disease Control and Prevention, 2016). Persons with chronic heart failure are more likely to develop decompensated heart failure (a worsening of the condition that can result in acute respiratory distress) which typically results in a hospital admission and sometimes death. Perhaps the most preventable cause of decompensation is lack of compliance with appropriate diet or prescribed medications. To avoid decompensation in persons with heart failure, it is critical that pulmonary artery pressure be monitored. Traditionally, monitoring did not occur until the onset of symptoms and the patient s encounter with the provider. Just over a decade ago, researchers created a new wireless pressure sensor for use in the pulmonary artery, implanted during a right heart catheterization procedure in heart failure patients, to monitor pulmonary artery pressure. As monitoring is done for patients in their homes, this method offered the potential to reduce avoidable admissions, as well as improved survival. Readings could be transmitted to the provider s external monitor to help in clinical decision making while the patient remains at home. The U.S. Food and Drug Administration (FDA) approved permanent implantation of wireless sensors in Champion CardioMEMS TM is a heart failure monitoring system that uses a sensor that communicates wirelessly to share information in the body. (MEMS is an abbreviation for microelectromechanical systems). The sensor is small (15 mm x 3 mm) and is implanted into the pulmonary artery to monitor cardiac output and pulmonary artery pressure. Implanting the sensor is done through the femoral vein using a Swan-Ganz catheter based system that delivers the device into the pulmonary artery. After discharge, the patient takes 20 second readings from the device. Any pressure changes are picked up by an external antenna wand and data is transmitted to a web site for provider use. The FDA approved the CardioMEMS TM system (St. Jude Medical, St. Paul, MN) on May 28, 2014 (U.S. Food and Drug Administration, 2014). The FDA ruled that the device is approved for patients hospitalized in the past year for New York Heart Association (NYHA) Class III heart failure patients. Other 2

3 devices that monitor pulmonary artery pressure changes have not received FDA approval. These include the Chronicle implantable continuous hemodynamic monitoring device (Medtronic Inc., Minneapolis, MN) and the ImPressure device (Remon Medical Technologies, Caesara, Israel), which the FDA rejected in Searches AmeriHealth Caritas Pennsylvania searched PubMed and the databases of: UK National Health Services Centre for Reviews and Dissemination. Agency for Healthcare Research and Quality s National Guideline Clearinghouse and other evidence-based practice centers. The Centers for Medicare & Medicaid Services (CMS). We conducted searches on August 1, Search term was: wireless pulmonary artery pressure monitor. We included: Systematic reviews, which pool results from multiple studies to achieve larger sample sizes and greater precision of effect estimation than in smaller primary studies. Systematic reviews use predetermined transparent methods to minimize bias, effectively treating the review as a scientific endeavor, and are thus rated highest in evidence-grading hierarchies. Guidelines based on systematic reviews. Economic analyses, such as cost-effectiveness, and benefit or utility studies (but not simple cost studies), reporting both costs and outcomes sometimes referred to as efficiency studies which also rank near the top of evidence hierarchies. Findings One study published soon after the 2005 FDA approval of wireless sensors determined that CardioMEMS TM Champion TM was equally accurate in monitoring pulmonary artery pressure as was Swan- Ganz catheterization and echocardiography in ambulatory heart failure patients (Verdejo, 2007). Another controlled study documented a 36% reduction in hospitalization rate, no pressure-sensor failures, and 3% system-related complications for heart failure Class III or IV patients whose providers were given information from the Chronicle system (Bourge, 2008). To date, the largest-scale study of the efficacy (and safety) of wireless sensors for heart failure has been the prospective, single-blind, randomized controlled trial (RCT) CHAMPION study of the CardioMEMS TM system, conducted at 64 U.S. medical centers. A total of 550 subjects were included: those who had at least one previous hospitalization for heart failure in the past 12 months and were classified as having NYHA Class III heart failure for at least three months. The treatment group included 270 subjects for 3

4 which pulmonary artery pressure data from the sensor was used, and 280 subjects with no such data used. Between September 6, 2007 and October 7, 2009, patients were randomly assigned to the treatment or control group. Of these, 347 completed the randomized access period in August 2010, and also transitioned to the open access period, which ended April 30, 2012 (Abraham, 2016). An FDA summary of the initial six months of the trial showed that outcomes for the treatment group consistently exceeded those of the control group (U.S. Food and Drug Administration, 2011). Table 1 summarizes these findings, a number of which were later published in peer-reviewed journals. Table 1 Patient Outcomes, CardioMEMS TM Champion TM Heart Failure Monitoring System Six Months After Initiation of Trial Outcome Measure Treatment Group (n=270) Control Group (n=280) Heart failure-related hospitalizations Percent of subjects hospitalized Hospitalization rates/patient-year, ejection fraction change <40% Hospitalization rates/patient-year, ejection fraction change >40% Average days hospitalized Deaths per 100 subjects Survival (average days alive) Mean pulmonary artery pressure change, in mmhg days Percent Subjects with serious adverse events Improvement in quality of life score, using Minnesota Living with Heart Failure Q naire In the treatment group, hospitalization rates were consistently lower, regardless of the ejection fraction change. Average length of stay was also lower. Pulmonary artery pressure change was reduced by mmhg days in the treatment group, and increased by 33.1 for the control group. The serious adverse event rate is lower for the treatment group, and quality of life score declined more sharply (preferable). All differences achieved statistical significance. The only measure for which there was no difference between the two groups was average days of survival (176.6 and days), although the death rate was lower for the treatment group (5.6% vs. 7.1%), based on 15 and 20 deaths, respectively. Of the 550 subjects, there were 15 adverse events, including 8 which were device-related and 7 which were procedure-related. (Abraham, 2011). 4

5 The findings are encouraging. However, there are no meta-analyses or systematic reviews on efficacy of wireless devices, and the number of controlled trials is limited. Thus, the strength of evidence is relatively weak and more studies are needed before an evidence-based rationale exists on whether to cover wireless pulmonary artery pressure monitors (Hayes, 2015). Subsequent reports upheld the reduced number of hospital admissions over a longer period of time (Adamson, 2014). One study of 245 Medicare patients from the CHAMPION group found that 30 day readmissions were 49% lower and 58% lower for the treatment groups for heart failure and for all causes, respectively (Adamson, 2016). In addition, providers made more changes in the diuretic and vasodilator therapies to subjects in the treatment group due to increased information (Adamson, 2014). Another study found subjects in the active monitoring group experienced a greater number of medication adjustments; significant increases of diuretics, vasodilators, and neurohormonal antagonists; targeted intensification of diuretics and vasodilators in patients with higher pulmonary artery pressures; and preservation of renal function despite diuretic intensification (Costanzo, 2016). Other reports used CHAMPION data to analyze risk of 314 patients who had Stage II (World Health Organization) pulmonary hypertension (PH), whose mortality rate was more than double that of 236 subjects without the condition. In patients with and without PH, knowledge of hemodynamic data meant a reduction of 38% in hospitalizations (Benza, 2015). Another study documented 48.8% of patients with Right Heart Catheterization (RHC) exhibited PH, suggesting PH may be significantly underdiagnosed in the RHC population (Raina, 2015). Another recent review found that in CHAMPION patients with Chronic Obstructive Pulmonary Disease, intervention with CardioMEMS TM resulted in a 41% and 62% reduction in hospitalizations for heart failure and respiratory disorders, respectively (Krahnke, 2015). A recent report estimated cost savings in Germany from use of the wireless pulmonary artery monitor in the CHAMPION study, based on 37% fewer hospitalizations. The calculation of 114,000 fewer admissions from means a savings of 522 euros, or $575 million (Kolominsky-Rabas, 2016). A team from Stanford University showed that despite CardioMEMS TM decreasing lifetime hospitalizations among heart failure patients (2.18 vs in patients with no CardioMEMS TM ) average quality-adjusted lifeyears actually increased (2.74 vs. 2.46) as did average costs from $156,569 to $176,648 (Sahndu, 2016)). Policy updates: None. Summary of clinical evidence: Citation Kolominsky-Rabas (2016) Content, Methods, Recommendations Key points: 5

6 Citation Economic benefits of reduced hospitalizations from pressure monitoring devices for heart failure Abraham (2016) Updated results of pressure monitoring devices for heart failure from six months to 3-5 years Adamson (2016) Impact of pulmonary artery pressure-guided heart failure on 30-day readmits Benza (2015) Hospitalization rate changes in patients with heart failure and pulmonary hypertension via wireless monitoring Abraham (2011) Content, Methods, Recommendations Used 37% reduction in hospitalizations from CHAMPION study. Extrapolation calculated at 114,000 fewer admissions from Savings in Germany estimated at 522 euros, or $575 million, from Key points: 347 of 550 original patients in CHAMPION study followed for an additional 18 months. 177 subjects in treatment group, 170 in control group. Heart failure admission rate 33% lower for treatment group overall. Heart failure admission rate 48% lower for treatment group after pulmonary artery pressure information made available. Key points: Key points: 245 Medicare patients from CHAMPION study. In treatment group, 30 day readmits 49% lower for heart failure, 58% lower all causes. 314 of 550 CHAMPION patients have pulmonary hypertension (PH). PH patients have more than double the hospitalization rate than non-ph patients. Pressure monitoring devices reduced hospitalization rates for both those with and without PH (-36% and -40%). Key points: Test if implantable hemodynamic monitoring systems reduce rates of hospitalization in heart failure patients 550 NY Heart Assn. Class III heart failure patients (270 treatment, 280 control). Subjects tracked for six months after enrollment. Hospitalization rate for heart failure 39% less after 15 months for study group. 2.7% (8 of 270) treatment patients had device-related complications. Glossary CardioMEMS TM A wireless heart failure monitoring system that uses a sensor that communicates information in the body to providers (MEMS stands for microelectromechanical systems). CHAMPION study A study of 550 heart failure patients at 64 U.S. medical centers, comparing patients with and without a CardioMEMS TM to manage patients based on assessment of pulmonary artery pressure Chronic Heart Failure A syndrome marked by signs and symptoms that suggest the heart is impaired and cannot pump adequate amounts of blood through the body. Pulmonary artery pressure Increased pressure in the pulmonary arteries (which carry blood from the heart to the lungs), marked by shortness of breath, fatigue, chest pain, and racing heartbeat. 6

7 References Professional society guidelines/other: Hauptman, PJ, Rich MW, Heidenreich PA, et al. The Heart Failure clinic: A consensus statement of the Heart Failure Society of America. J Card Fail. 2008;14(10): National Institute of Health Care and Excellence. August 2013 NICE interventional procedure guidance [IPG463]: Insertion and use of implantable pulmonary artery pressure monitors in chronic heart failure. Available at Accessed August 5, Ollendorf DA, Sandhu AT, Chapman R, et al. Institute for Clinical and Economic Review (ICER). CardioMEMS TM HF System (St. Jude Medical) and Sacubitril/Valsartan (Entresto, Novartis) for Management of Congestive Heart Failure: Effectiveness, Value, and Value-Based Price Benchmarks. Draft Report. San Francisco, CA: California Technology Assessment Forum (CTAF). Announcement December 1, Accessed August 2, Yancy, CW, Jessup, M, Bozkurt, B, et al ACCF/AHA guideline for the management of heart failure: a report of the American College of Cardiology Foundation/American Heart Association Task Force on practice guidelines. Circulation. 2013;128:e Peer-reviewed references: Abraham WT, Adamson PB, Bourge RC, et al. Wireless pulmonary artery haemodynamic monitoring in chronic heart failure: a randomized controlled trial. Lancet. 2011;377(9766): Abraham WT, Adamson PB, Hasan A, et al. Safety and accuracy of a wireless pulmonary artery pressure monitoring system in patients with heart failure. Amer Heart J. 2011;161(3): Abraham WT. Disease management: Remote monitoring in heart failure patients with implantable defibrillators, resynchronization devices, and haemodynamic monitors. Europace. 2013;15 Suppl 1:i40 i46. Abraham WT, Stough WG, Pina IL, et al. Trials of implantable monitoring devices in heart failure: Which design is optimal? Nat Rev Cardiol. 2014;11(10): 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 randomized trial. Lancet. 2016;387(10017):

8 Adamson PB, Abraham WT, Aaron M, et al. CHAMPION trial rationale and design: the long-term safety and clinical efficacy of a wireless pulmonary artery pressure monitoring system. J Card Fail. 2011;17(1):3 10. 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. 2014;7(6): Adamson PB, Abraham WT, Stevenson LW, et al. Pulmonary artery pressure-guided heart failure management reduces 30-day readmissions. Circ Heart Fail. 2016;9(6): doi: /CIRCHEARTFAILURE Benza RL, Raina A, Abraham WT, et al. Pulmonary hypertension related to left heart disease: Insight from a wireless implantable hemodynamic monitor. J Heart Lung Transplant. 2015;34(3): Bourge RC, Abraham WT, Adamson PB, et al. Randomized controlled trial of an implantable continuous hemodynamic monitor in patients with advanced heart failure: the COMPASS-HF study. J Am Coll Cardiol. 2008;51(11): Castro PF, Concepcion R, Bourge RC, et al. A wireless pressure sensor for monitoring pulmonary artery pressure in advanced heart failure: initial experience. J Heart Lung Transplant. 2007;26(1): Costanzo MR, Stevenson LW, Adamson PB, et al. Interventions linked to decreased heart failure hospitalizations during ambulatory pulmonary artery pressure monitoring. JACC Heart Fail. 2016;4(5): Hayes Health Technology Brief. Wireless Pulmonary Artery Pressure Monitoring With CardioMEMS TM HF System (St. Jude Medical Inc.) for Management of Chronic Heart Failure. November 24, earch_type%3dall%24icd%3d%24keywords%3dwireless%2cpulmonary%2cartery%2cpressure%2cmoni tor%24status%3dall%24page%3d1%24from_date%3d%24to_date%3d%24report_type_options%3d%2 4technology_type_options%3D%24organ_system_options%3D%24specialty_options%3D%24order%3Da searchrelevance. Accessed August 4, Kolominsky-Rabas PL, Kriza C, Djanatliev A, et al. Health economic impact of a pulmonary artery pressure sensor for heart failure telemonitoring: a dynamic simulation. Telemed J E Health June 10 (Epub ahead of print) 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. 2015;21(3):

9 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 TM Champion Heart Failure Monitoring System. J Am Coll Cardiol. 2013;61(15): Raina A, Abraham W, Adamson P, et al. Limitations of right heart catheterization in the diagnosis and risk stratification of patients with pulmonary hypertension related to left heart disease: insights from a wireless pulmonary artery pressure monitoring system. J Heart Lung Transplant. 2015;34(3): Sandhu AT, Goldhaber-Fiebert JD, Owens DK, Turakhia MP, Kaiser DW, Heidenreich PA. Costeffectiveness of implantable pulmonary artery pressure monitoring in chronic heart failure. JACC Heart Fail. 2016;4(5): U.S. Centers for Disease Control and Prevention. Heart Failure Fact Sheet Accessed August 1, U.S. Food and Drug Administration. FDA Executive Summary: CardioMEMS TM Champion TM HF Monitoring System. Silver Spring MD: U.S. Food and Drug Administration. December 8, edicaldevicesadvisorycommittee/circulatorysystemdevicespanel/ucm pdf. Accessed August 3, U.S. Food and Drug Administration (FDA). FDA approves first implantable wireless device with remote monitoring to measure pulmonary artery pressure in certain heart failure patients. FDA News Release. Silver Spring, MD: FDA; May 28, Accessed August 2, Verdejo HE, Castro PF, Concepción R, et al. Comparison of a radiofrequency-based wireless pressure sensor to Swan-Ganz catheter and echocardiography for ambulatory assessment of pulmonary artery pressure in heart failure. J Am Coll Cardiol. 2007;50(25): Clinical trials: Searched clinicaltrials.gov on August 4, 2016, using terms wireless pulmonary artery pressure monitoring and CardioMEMS TM. Five (5) Open Studies, two relevant. St. Jude Medical. CardioMEMS TM HF System Post Approval Study. ClinicalTrials.gov website. Last updated February 20, Accessed August 4, St. Jude Medical. CardioMEMS TM European Monitoring Study for Heart Failure (MEMS-HF). Clinicaltrials.gov website. 9

10 Last updated June 2, Accessed August 4, CMS National Coverage Determinations (NCDs): No NCDs identified as of the writing of this policy. Local Coverage Determinations (LCDs): L36419 Outpatient Wireless Pulmonary Artery Pressure Monitoring for Heart Failure. CMS website. KeyWord=wireless+pulmonary+artery+pressure+monitor&KeyWordLookUp=Title&KeyWordSearchType =And&bc=gAAAACAAAAAAAA%3d%3d&. Accessed August 4, Commonly submitted codes Below are the most commonly submitted codes for the service(s)/item(s) subject to this policy. This is not an exhaustive list of codes. Providers are expected to consult the appropriate coding manuals and bill accordingly. CPT Code N/A Description ICD-10 Code Description I50.20 Unspecified systolic (congestive) heart failure I50.22 Chronic systolic (congestive) heart failure I50.23 Acute on chronic systolic (congestive) heart failure I50.30 Unspecified diastolic (congestive) heart failure I50.32 Chronic diastolic (congestive) heart failure I50.40 Unspecified combined systolic (congestive) and diastolic (congestive) heart failure I50.42 Chronic combined systolic (congestive) and diastolic (congestive) heart failure I50.43 Acute on chronic combined systolic (congestive) and diastolic (congestive) heart failure I50.9 Heart failure, unspecified HCPCS Level II Code C2624 C9741 Description Implantable wireless pulmonary artery pressure sensor with delivery catheter, including all system components Right heart catheterization with implantation of wireless pressure Sensor in the pulmonary artery, including any type of measurement, angiography, imaging supervision, interpretation and report 10