More recently, the CHAMPION trial showed a significant reduction in heart failure hospitalizations, shorter length of stay, and improvement in quality of life among patients undergoing ambulatory pulmonary artery (PA) pressure monitoring with the implanted CardioMEMS device (CardioMEMS Inc., Atlanta, GA, USA). Early studies show CardioMEMS cut the re-admission rate by nearly 40%. First, the CHAMPION trial included a minimum 6month, singleblind period (with an average of 18 months) and an additional mean 13month open access period, requiring assumptions about the sustainability of benefits over the long term. A different baseline utility value for patients, such as the 0.55 that another team derived based on an algorithm to convert the Minnesota Living with Heart Failure Questionnaire,29 also had a small influence on the cost/QALY. Finally, sensitivity analyses varied between these 2 models, because the present study tested values as proportion of the CHAMPION trial outcomes, whereas the prior study used alternative inputs from studies with patients who are not indicated for this intervention (ie, use of a population with a large proportion of patients with NYHA class II HF29). 2929 E Camelback Rd Suite 116, Phoenix, AZ 85016. It should be noted that some of the sensitivity analysis results are symmetrical around the base case; others are appropriately not symmetrical. Being able to see this data regularly and spot trends earlier allows physicians to modify treatment plans and medications before symptoms set in. Background The CardioMEMS sensor is a wireless pulmonary artery pressure device used for monitoring symptomatic heart failure (HF). Clinical inputs for the base case, including the rate of implantassociated complications, mortality, and the rate of HFrelated and nonHFrelated hospitalizations appear in Table Table1.1. The CardioMEMS HF System was found to be cost-effective, with an incremental cost-effectiveness ratio of $44,832 per quality-adjusted life year (QALY). CTAFs draft report encourages review and comments from the public, including real world experience from leading clinicians whose experience with the technology has been favorable and supports outcomes realized through the CHAMPION randomized, controlled and comparative clinical trial.". Review our Privacy Policy for more details. 17 The mean estimated cost of each HF readmission within 30 days of hospital discharge was $11,552 in 2014, with a total estimated cost greater than $11 billion. St. Methods. Timothy Malone - Corporate Sales Executive - Abbott | LinkedIn Nieminen MS, Dickstein K, Fonseca C, et al. All rights reserved. The .gov means its official. Sensitivity analysis found the model was sensitive to the device cost and to whether mortality benefits were sustained, although there were no scenarios in which the cost/QALY exceeded $100,000. $71,462 per QALY gained and $48,054 per life-year gained, "excessive" given "insufficient" evidence. Current Role of the CardioMEMS Device for Management of - SpringerLink Abbreviations: HF, heart failure. Fewer inperson outpatient visits could save transportation costs as well as caregiver time and costs, for the patients who are regularly assisted by a caregiver. The following pages are intended for medical professionals and provide information on the proper use of products (medical devices, etc.) The purpose of this study was to develop a Markov simulation model to estimate the costeffectiveness of the CardioMEMS HF System at up to 5 years compared to usual care in the indicated population. . Back in May, St. Jude Medical exercised its option to buy Atlanta-based startup, CardioMEMS, the moment the latter's product won FDA approval. Sensitivity analyses appear in Figure Figure22 and the Supporting Information, Table, in the online version of this article. There are several limitations in this model and analysis that deserve consideration. The information provided here is not intended to provide information to patients and the general public. J Invasive Cardiol. myCardioMEMS on the App Store CardioMEMS HF System Indications and Usage: The CardioMEMS HF System is indicated for wirelessly measuring and monitoring pulmonary artery pressure and heart . Rx Only. The CardioMEMS system from St. Jude Medical consists of a small implant placed in the pulmonary artery to monitor pulmonary artery pressure, widely considered to be an indicator of congestive heart failure. Additionally, CardioMEMS must last over 34 months in order to cost less than $150,000 for every QALY. We encourage future development of the model as other indications are approved, but selectively choosing inputs from nonindicated populations seems speculative and introduces more uncertainty than it resolves. Conclusion: The CardioMems device is cost-effective in populations similar to the CHAMPION trial, with a cost of less than $100,000 per QALY gained, if durability of device effectiveness is sustained. Multivariate and threshold analyses explored additional scenarios to include alternative inputs or to identify input values that would make the cost/QALY meet or exceed various thresholds (Supporting Information, Table, in the online version of this article and Figure Figure22). Patients from CHAMPION trial were those with NYHA class III HF symptoms and a hospitalization in the past year for decompensation. 5. This guide provides a summary of the Medicare Hospital Inpatient Prospective Payment System (IPPS). Federal government websites often end in .gov or .mil. These policies include Highmark, BCBS of NE and Priority Health. This means that Novitas and FCSO will implicitly cover wireless pulmonary artery sensor implants and remote monitoring based on medical appropriateness and the FDA approved indication, and the claims processing edits for denying the aforementioned procedure codes will be removed. Schmier JK, Ong KL and Fonarow GC. Sensitivity analyses explored uncertainty in input parameters. This assumes that at most, health care expenses should grow 1% fasther than the growth of U.S. gross domestic product (GDP). If this device were effective at hospitalizations and further morbidity and mortality, it has the potential to be cost . The CardioMEMS HF System consists of an implantable, battery-free sensor that is implanted into the distal pulmonary artery to continuously measure the heart rate along with systolic, diastolic, and mean pressures. In the absence of a national coverage policy, an item or service may be covered at a local basis. Telemonitoring in patients with heart failure, Effectiveness of remote patient monitoring after discharge of hospitalized patients with heart failure: the Better Effectiveness After TransitionHeart Failure (BEATHF) randomized clinical trial, Racial disparities and the use of technology for selfmanagement in blacks with heart failure: a literature review, Telemonitoring in heart failure: fact, fiction, and controversy, Home monitoring for heart failure management, Effects of home telemonitoring interventions on patients with chronic heart failure: an overview of systematic reviews. A cool $24,950. Philadelphia, [PMC free article] [PubMed] [CrossRef], National Library of Medicine National Correct Coding Initiatives Edits. . ", The authors noted that the device would need to reduce mortality by 4% in order for it to cost less than $100,000 per QALY, but "while this seems likely, it is possible that prevented hospitalizations may be lower risk and mortality may be relatively unaffected.". 90305907 Rev. First, there is a change over time, from enrollment and randomization to the end of the trial's utility observation period. The device allows health care professionals to monitor the condition of their patients remotely. Multivariable sensitivity analysis can address similar concerns, though we believe that individual model users in decisionmaking capacities could best determine their own base case and extreme input values. Positive results have been demonstrated in a clinical trial involving a recently Food and Drug Administration (FDA)approved implantable wireless pulmonary artery pressure monitoring system (CardioMEMS). Sandhu and Borer reported no relevant conflicts of interest. The review showed that patients monitored using the CardioMEMS . A revised version will be posted on October 8 and the CTAF panel will discuss the report at a public meeting on October 29th. FCSO is the MAC for FL, Puerto Rico, and the Virgin Islands. CardioMEMS Implant Device For NYHA Heart Failure Class III - CFR Journal Health economic impact of a pulmonary artery pressure sensor for heart failure telemonitoring: a dynamic simulation, Cost of informal caregiving for patients with heart failure. Heidenreich PA, Albert NM, Allen LA, et al; American Heart Association Advocacy Coordinating Committee; Council on Arteriosclerosis, Thrombosis and Vascular Biology; Council on Cardiovascular Radiology and Intervention; Council on Clinical Cardiology; Council on Epidemiology and Prevention; Stroke Council. At the end of the 60month model time horizon, 49.6% of CardioMEMS patients and 23.8% of SoC patients remained alive. A recently approved implantable wireless pulmonary artery pressure remote monitor, the CardioMEMS HF System, has been shown to be effective in reducing hospitalizations among New York Heart Association (NYHA) class III HF patients. . California. (Low, Intermediate, or High), "Given the available evidence for patients with Class III CHF and a prior hospitalization in the prior 12 months, what is the provisional health system value of incorporating CardioMEMS? The analysis finds that "Results for CardioMEMS indicate that the total budgetary impact at one year is similar to the annual average over five years; this is because nearly all CardioMEMS costs are incurred at the time of implantation . Number 8860726. Gharacholou SM, Hellkamp AS, Hernandez AF, et al. The total number of all-cause hospital admissions prior to device implantation was 61 admissions for all study patients, while the total number for the post-implantation period was 19, correlating with 2.26 + 1.06 admissions/person-year prior to device implantation versus 0.70 + 0.95 admissions/person-year post-implantation (p-value < 0.001). Figure Figure11 illustrates the structure. No use of any Abbott trademark, trade name, or trade dress in this site may be made without the prior written authorization of Abbott, except to identify the product or services of the company. Alternative costs for outpatient care included an estimate less than half of the base case used in the model ($6,93028); using this estimate as a model input resulted in a cost/QALY of $33,040, reflecting that the longerliving treatment patients had lower outpatient expenses over the modeled period. 2022 Medicare Payment and Coding Update Focused on the CardioMEMS HF System. The take-home message for clinicians is that "monitoring pulmonary artery pressure with the CardioMEMS provides clear benefits that justify the costs," Borer agreed. These values were generally consistent across a range of sensitivity analyses. 2227 W Baseline Rd Suite 101, Tempe, AZ 85283. Abraham disclosed receiving consulting fees from CardioMems and St. Jude Medical. An official website of the United States government. Medicare Learning Network (MLN) Matters Articles. CardioMEMS cost $47,768 per QALY in patients with preserved ejection fraction, due to a longer expected survival. Among eligible patients with HF when compared with SoC, the CardioMEMS HF System was found to be costeffective. Indicates a trademark of the Abbott group of companies. Third, this analysis was operationalized as a deterministic model. The new PMC design is here! As values were not collected after 12 months, assumptions were made about how to assign utilities after the end of the observed period to reflect the natural history of HF. Precautions 1. Implantable devices for heart failure monitoring: the CardioMEMS Sandhu AT, et al Cost-effectiveness of implantable pulmonary artery pressure monitoring in chronic heart failureJCHF2016; DOI: 10.1016/j.jchf.2015.12.015. Beside the opportunity presented for managing patients with less time, there are other potential benefits. "This tiny cardiac sensor . Coverage continues to be based on medical necessity. "It is important to assess the cost-effectiveness of new therapies and new monitoring devices because a great deal of that cost will be borne by society through taxation and Medicare and other government sponsored health insurance programs," emphasized Borer, who served on two FDA advisory panels that evaluated the device. Predicting heart failure decompensation using cardiac implantable electronic devices: a review of practices and challenges. A total of 27 patients were followed for 6-18 months. (medical devices, etc.) A Markov cohort model relying on the CHAMPION (CardioMEMS Heart Sensor Allows Monitoring of Pressure to Improve Outcomes in NYHA Class III Heart Failure Patients) clinical trial for mortality and hospitalization data, published sources for cost data, and a mix of CHAMPION data and published sources for utility data, was developed. [Image courtesy of ST. JUDE MEDICAL, INC.]. A systematic review and metaanalysis of the outcomes of structured telephone support or telemonitoring as the primary component of chronic heart failure management in 8323 patients: abridged Cochrane review. 10.1002/clc.22696 One could argue that the changes in population characteristics between the randomized and open access dropout affects our ability to use these data. Which components of heart failure programmes are effective? CardioMEMS procedure allows tiny device to work wonders on heart [prod, crx3, samplecontent, publish, crx3tar], https://vascular.abbott.com/,https://mri.merlin.net/,https://www.thelancet.com/,https://www.ahajournals.org/,https://www.onlinejacc.org/,https://jamanetwork.com/,https://www.sciencedirect.com/,https://onlinelibrary.wiley.com/,https://www.cms.gov/,https://www.novitas-solutions.com/,https://event.on24.com/,https://dx.doi.org/,https://www.myloopaccount.com/,https://www.invasivecardiology.com/,https://manuals.sjm.com/,https://www.cardiovascular.abbott, reasonable and medically necessary guidelines. The The myCardioMEMS app can provide notification of medication adjustments and reminders . References. To contact the HE&R team, please email or call the Reimbursement Hotline at (855) 569-6430. Another assumption that varied across models is the proportion of standard of care patients who received some sort of monitoring with its associated monthly cost. The cost of 30-day readmissions was estimated at $30.7 billion in 2012 and is predicted to be $69.7 billion by 2030. of Abbott Medical Japan GK. Costeffectiveness of left ventricular assist devices in ambulatory patients with advanced heart failure. This device is changing the way doctors and nurses . As these data become available, they should be incorporated to refine or modify these findings. Download the templates using the links below to customize and provide medical justification for consideration of this procedure. Adapted from: "CardioMEMS HF System Clinical Protocol Example, Philip B. Adamson, MD, MSc, FACC, Medical Director at Abbott, and former Director Heart Failure Institute at Oklahoma Heart Hospital, shares his experience with patient management of heart failure . Accessibility Data on File. How much are hospitals paying to buy this clinically novel technology for heart failure patients? It includes information on the Readmission Reductions Program, Value Based Purchasing, and Hospital Inpatient Reimbursement Rates for select cardiovascular DRGs. FCSO is the MAC for FL, Puerto Rico, and the Virgin Islands. Although there are certainly situations that require a stochastic approach, given the little that is known about the distributions for many of the input variables, using such an approach would not increase model accuracy. The Sandhu et al article did not use mortality findings from the CHAMPION trial.29 The authors in that study suggested that the analysis was not powered for mortality; however, recent recognition of the challenges in powering studies for all relevant economic endpoints suggests that it is preferable to use underpowered realworld findings than to make assumptions.42 Similarly, the model by Sandhu and colleagues did not use trial data on patient utilities, but instead elected to convert scores from the conditionspecific qualityoflife measure included in the trial.29 The different source for utilities and the difference in how hospitalrelated decrements were assigned explained the variation in total accrued utilities between these 2 models. This analysis demonstrated that the estimated cost/QALY of CardioMEMS compared to the standard of care (nonPAguided medical management) was $44,832, within the range of what is considered highly costeffective. 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