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. Focusing on coverage, billing, and payment rules for specific provider types, these articles explain national Medicare policy in an easy-to-understand format. Patients were free from device- or system-related complications. In the absence of a national coverage policy, an item or service may be covered at a local basis. The medical device that Korte had threaded into her pulmonary artery in 2020 is called CardioMEMS and was developed by Abbott. A prior independent analysis by the nonprofit Institute for Clinical and Economic Review had estimated a cost per QALY of about $58,000 for the device, which it called "excessive" given "insufficient" evidencefor overall patient outcome improvement. As these data become available, they should be incorporated to refine or modify these findings. Request Appointment. Table Table22 presents costs used in the model and their corresponding sources. Costeffectiveness of left ventricular assist devices in ambulatory patients with advanced heart failure. KolominskyRabas PL, Kriza C, Djanatliev A, et al. Learn more With the substantial societal and economic impact of HF, technologies that can help minimize the likelihood for readmission and cost of care associated with HF may provide significant benefits to the healthcare system. ATLANTA, June 2, 2014 /PRNewswire/ -- Arcapita Ventures announced today that CardioMEMS, Inc. has been acquired by St. Jude Medical, Inc. (NYSE: STJ) a . 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. Utilities are represented as a single value to adjust for the patient's lifeyears. The implant is delivered using a matching vascular catheter and readings from the implant are gathered by a bedside electronics . CardioMEMS' 11-year payoff worth the wait for Boston Millennia Partners July 31, 2014 By Brian Johnson The CardioMEMS story didn't end when St. Jude Medical (NYSE: STJ) acquired the. For this reason, we determined that using open access period data was reasonable, because sensitivity analyses also explored carrying forward data from the randomized period. The device allows health care professionals to monitor the condition of their patients remotely. A revised version will be posted on October 8 and the CTAF panel will discuss the report at a public meeting on October 29th. It should be noted that some of the sensitivity analysis results are symmetrical around the base case; others are appropriately not symmetrical. This document delivers a current list of reimbursement Healthcare Procedural Coding System (HCPCS) Device Category C-codes, Frequently Used CPTCodes for Cardiac Device Monitoring Services. Number 8860726. The CardioMEMS HF System was found to be costeffective, with an incremental costeffectiveness ratio of $44,832 per qualityadjusted life year (QALY). Other authors have also reported higher QALYs and cost-effectiveness when CardioMEMS is compared to standard therapy (20,21). There are several limitations in this model and analysis that deserve consideration. These payments recognized the CardioMEMS HF System as a substantial clinical improvement over previous standard of care. 3,4,5 The presymptomatic data provided by the CardioMEMS HF System allow for proactive changes in medical therapy before . Among eligible patients with HF when compared with SoC, the CardioMEMS HF System was found to be costeffective. Informa PLC's registered office is 5 Howick Place, London SW1P 1WG. Number 8860726. There are not yet time and motion studies comparing staff time on monitoring and responding to data from the CardioMEMS HF System compared to other technologies, but it seems plausible that the time required would be less than gathering a full report from the patient during a telephone call. It is always important to check with the payers coverage policy and prior authorize for services. Department of Health Sciences Exponent, about navigating our updated article layout. Prior to use, reference the Instructions for Use, inside the product carton (when available) or online for more detailed information on Indications, Contraindications, Warnings, Precautions and Adverse Events. Nieminen MS, Dickstein K, Fonseca C, et al. ", 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.". Novitas is the Medicare Administrative Contractor (MAC) that administers the Medicare claims for DE, MD, NJ, PA, DC, AR, CO, LA, MS, NM, OK and TX. The implantable sensor is a completely sealed . 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 . Heart failure (HF) currently affects 5.7 million adults in the United States, with the prevalence projected to increase.1, 2 There is a decrement in healthrelated quality of life, likely related to disease progression and frequency of hospitalization,3 as well as psychological and financial burdens on caregivers of HF patients.4 The economic burden of HF is also substantial and estimated at more than $30 billion annually in 2012.3 As an important cost driver is hospital readmissions for patients following decompensation,5 technologies and advances that minimize likelihood for readmission could minimize costs and the associated patient and caregiver burden. To assist CXR interpretation, we "pre-deployed" an artificial intelligence (AI) model to assess (1) accuracies in LLIED-type (and consequently safety-level) identification, (2) safety implications of LLIED nondetections or misidentifications, (3 . The alternatives, explored in sensitivity analyses, include having the values increase or decrease incrementally over time, reflecting how utility values may increase with the duration of time since the most recent hospitalization or may decrease over time as the patient ages.23 These 3 optionsincrease, decrease, or remain the samecover all possibilities. Patients, hospitals, and insurance companies must bear the . Of approximately 5500 CardioMEMS HF System implants, 155 cumulative adverse events (2.8%), 28 PA injury or hemoptysis (0.5%), and 22 deaths (0.4%) were reported in the MAUDE database related to the CardioMEMS HF System since US Food and Drug Administration (FDA) approval. "The reduction in hospitalizations with the CardioMEMS device ultimately should lead to cost reductions relative to the benefits of using the device. Before The ultimate responsibility for coding and obtaining payment/reimbursement remains with the customer. Unless otherwise specified, all product names appearing in this Internet site are trademarks owned by or licensed to Abbott, its subsidiaries or affiliates. Abbott. CRT is designed to provide access to the worlds leading clinicians and the latest research in order to improve practice and treatment outcomes for a variety of health care professionals. With positive clinical evidence behind the CardioMEMS HF System remote pulmonary artery pressure monitoring device, this study sought to evaluate the costeffectiveness of the device. Martinson M, Bharmi R, Dalal N, Abraham WT, Adamson PB. To contact the HE&R team, please email or call the Reimbursement Hotline at (855) 569-6430. Federal government websites often end in .gov or .mil. Choi H, Schoeni RF, Langa KM, Heisler MM. 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. Beyond ICER's evaluation of the technology's body of evidence, the authors go on to note that the $17,750 list price for CardioMEMS is too high, based on cost-effectiveness thresholds and impact on the health care system budget. In the case of CardioMEMS, "which is FDA approved and now shown to be cost-effective, should be strongly considered for indicated patients -- those with NYHA Class III heart failure, regardless of ejection fraction, and a history of at least one heart failure hospitalization in the past 12 months," concluded Abraham, who was a principal investigator of the CHAMPION trial. Given that the SoC cohort was receiving more intense, although not PApressureguided, care than a typical population by nature of their study participation, it is likely that the trial design inherently minimized the effect of the intervention. The time associated with remote monitoring using less technologically advanced systems might create a greater time burden on clinical staff. Rogers JG, Bostic RR, Tong KB, Adamson R, Russo M, Slaughter MS. Costeffectiveness analysis of continuousflow left ventricular assist devices as destination therapy. of Abbott Medical Japan GK. The sensor measures 3.5 mm in width, 2 mm in thickness, and . The review showed that patients monitored using the CardioMEMS . Download a sample letter template that provides suggestions to assist in writing a Letter of Medical Necessity or prior authorization request for CardioMEMS implant. The group suggests the device, which costs $17,750, has a "value-based price benchmark" of merely $7,622 for treating CHF. CardioMEMS HF System Indications and Usage: The CardioMEMS HF System is indicated for wirelessly measuring and monitoring pulmonary artery pressure and heart rate in NYHA . The CardioMEMS HF System Workflow Research. (Low, Intermediate, or High)", Allowed HTML tags:

. St. Caro JJ, Briggs AH, Siebert U, Kuntz KM; Force ISMGRPT. Shavelle D, Jermyn R. The CardioMEMS heart failure sensor: a procedural guide for implanting physicians. CardioMEMS cost $47,768 per QALY in patients with preserved ejection fraction, due to a longer expected survival. Heywood JT, Jermyn R, Shavelle D, et al. 602-698-5820. 7. The use of CardioMEMS was associated with a reduction of hospitalizations of HF patients, but the acquisition cost could be high in low-and-middle income countries. Our findings are also specific to the CardioMEMS HF System and should not be taken to be reflective of all remote monitoring systems due to potential differences in clinical effectiveness, utilities, and cost. The new PMC design is here! The output is the incremental costeffectiveness ratio (ICER), that is, the difference in costs divided by the difference in utilities, of CardioMEMS vs usual care. CostEffectiveness of Remote Cardiac Monitoring With the CardioMEMS Heart Failure System, Clinical Cardiology National Correct Coding Initiatives Edits. The technology was evaluated in the CHAMPION trial before FDA approval in May 2014. Baras Shreibati J, GoldhaberFiebert JD, Banerjee D, Owens DK, Hlatky MA. CMS also established hospital outpatient and office-based reimbursement of ongoing remote monitoring. Analysts have written about some experts' concerns about the cost of the device and set up expenses for implementing the technology. CardioMEMS, a graduate of Georgia Tech's ATDC startup accelerator, is a rising star in the medical device industry. The device relates pressure and heart rate information to health providers, who access it through a database. 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. Remote monitoring after recent hospital discharge in patients with heart failure: a systematic review and network metaanalysis. 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. This finding puts CardioMEMS in the hightointermediate value according to the American College of Cardiology/American Heart Association27 and other organizations.30, 31 Findings were consistent across a range of sensitivity analyses. St. Jude Fires Back on CardioMEMS Cost Criticism St. Jude Medical's medical director defended the nearly $18,000 price tag on the CardioMEMS heart failure monitoring system and accused payers of trying to hinder adoption and drive down the cost. FOIA CardioMEMS is an FDA-approved device that has been shown to significantly reduce heart failure hospital admission and improve the quality of life in New York Heart Association (NYHA) class III patients [3] by remote monitoring of pulmonary artery pressures, an indirect measurement of left ventricle volume load. Several commercial payers now have positive coverage policies supporting the CardioMEMS HF System. The approval makes the core technology - pulmonary artery pressure measurement - which is very well known and regarded in clinical circles - available to monitor congestive heart failure patients at home, which many consider a clinical breakthrough. Projections suggest that, by 2030, the total cost of HF will increase by almost 130% to $70 billion USD annually . Bertini M, Marcantoni L, Toselli T, Ferrari R. Remote monitoring of implantable devices: Should we continue to ignore it? Pulmonary artery pressureguided heart failure management: US costeffectiveness analyses using the results of the CHAMPION clinical trial [published online September 19, 2016]. The cost of 30-day readmissions was estimated at $30.7 billion in 2012 and is predicted to be $69.7 billion by 2030. 17 Device-based monitoring tools are classified into PAP monitor, RV monitor (the Chronicle; . PurposeChest X-ray (CXR) use in pre-MRI safety screening, such as for lead-less implanted electronic device (LLIED) recognition, is common. 2929 E Camelback Rd Suite 116, Phoenix, AZ 85016. The site is secure. Physicians should customize the letter based on the patient's medical history and diagnosis and to be consistent with any specific prior authorization requirements from the health plan. 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. In addition, data analyses presented at the Heart Rhythm Society annual meeting in May 2015 pointed to CardioMEMS as a cost-effective technology that offers a 43% reduction in hospitalizations due to heart failure and a 53% reduction in death among Class III heart failure patients with cardiac resynchronization or ICD therapy. It includes updates to the Comprehensive APC Policy, Site Neutral Payments, Device Intensive Procedures, the Transitional Pass-Through Payment Policy, and Hospital Outpatient Reimbursement Rates for select cardiovascular APCs. Cost-effectiveness would exceed $100 000 per QALY gained if the benefits of CardioMEMS persist for 4.6 years or less, or if device cost doubled. Patients who have a hospitalization also have a different rate of accrual of utilities in the immediate posthospitalization cycle. Private payors typically follow the lead of CMS when it comes to reimbursing new technologies and it will be interesting to see whether the pattern will continue. Developed by CMS, the initiative promotes correct coding methodologies to control improper coding leading to inappropriate payment. Sandhu AT, et al Cost-effectiveness of implantable pulmonary artery pressure monitoring in chronic heart failureJCHF2016; DOI: 10.1016/j.jchf.2015.12.015. Based on the model's base case, half (50.4%) the original CardioMEMS patients were dead at 60 months; in the SoC group, mortality exceeded 50% earlier (at 40 months). Across both groups, the baseline utility score was 0.711. Providers should continue to document medical necessity of CardioMEMS for their patients. This posthospitalization state is not represented as a separate health state in this visual representation of the model. Web page addresses and e-mail addresses turn into links automatically. Sandhu, MD, of California's VA Palo Alto Health Care System, and colleagues. The .gov means its official. Use and predictors of heart failure disease management referral in patients hospitalized with heart failure: insights from the Get With the Guidelines Program. These assumptions are detailed in the Supporting Information, Appendix, in the online version of this article. There are 2 ways in which utilities are used in the model. A Markov model was developed to estimate costeffectiveness of the CardioMEMS HF System compared with usual care over a 5year period. 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. Adamson PB, Bharmi R, Bauman J, Dalal N, Martinson M, Abraham WT. 8600 Rockville Pike Data on File. Abbott. In either cohort, patients may remain stable and not incur hospitalizations, or they may require a hospital admission. (Yes or No), "Given the available evidence for patients with Class III CHF and a prior hospitalization in the prior 12 months, what is the care value of CardioMEMS vs. usual care? Device cost, even when it was increased to $20,759, still resulted in a cost/QALY<$50,000, remaining in the highvalue space, using the guidelines sponsored by the American College of Cardiology and American Heart Association.27 Even doubling the device price resulted in a cost/QALY of<$76,000, well within the intermediatevalue space. 1 See an animation of the CardioMEMS PA sensor being implanted into the pulmonary artery.View indications, safety and warnings: https://www.cardiovascular.abbo. A Medtronic executive in the past has raised the notion that having an implantable system is perhaps a much too expensive answer to managing congestive heart failure patients. 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. It is not provided or authorized for marketing use. The dime-sized device is actually a small pressure sensor and is part of the Cardiomems heart failure management system. Model Number Description; CM1100: Patient Electronics System: CM1170: Fabric Cover: CM1050: Orientation Ball: . Illustrations are artist's representations only and should not be considered as engineering drawings or photographs. In the conference call, Daniel Starks, CEO of St. Jude Medical, highlighted the fact that CMS will reimburse the device. May 2017. Sensitivity analyses explored uncertainty in input parameters. MD+DI Online is part of the Informa Markets Division of Informa PLC. The mean cost for one hospital stay is $15,000, and many patients are in . The This includes the responsibility for accuracy and veracity of all coding and claims submitted to third-party payers. Rx Only. Patients with HF enter the model. The authors write that they give the CardioMEMS body of evidence an "insufficient" rating because they see many unanswered questions such as mortality impact, usefulness of the technology without vigilant nurse communication, lack of comparison to a strict, rigorous heart failure management regimen, and examination of the technology with only one 550-patient trial. Letter of Prior Authorization and Medical Necessity. Methods. Exponent received a grant from St. Jude Medical to evaluate the costeffectiveness of its implantable remote monitoring system. References. Abbreviations: CHAMPION, CardioMEMS Heart Sensor Allows Monitoring of Pressure to Improve Outcomes in NYHA Class III Heart Failure Patients clinical trial; HF, heart failure; LOCF, last observation carried forward. This week Heart Care Centers of Illinois physicians and nurses implanted a new, state of the art device for the management of congestive heart failure. Beside the opportunity presented for managing patients with less time, there are other potential benefits. Woo CY, Strandberg EJ, Schmiegelow MD, et al. Abbreviations: QALY, qualityadjusted life year. These values were generally consistent across a range of sensitivity analyses. Medicare Local Coverage Determinations (LCDs). 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 . It is not intended to increase or maximize payment by any payer. Ziaeian B, Sharma PP, Yu TC, Johnson KW, Fonarow GC. This site uses cookies. All rights reserved. Our reimbursement resources provide information about coverage, coding and payment, denied claims and supporting documentation for the CardioMEMS HF System. The GUIDE-HF trial shows that Abbott's CardioMEMS device has a role in both," said Philip B. Adamson, M.D., chief medical officer of Abbott's heart failure business. Establish and maintain relationships with key decision-makers and influencers within assigned IDNs and hospital systems. 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. Oct 07, 2015 Jamie Hartford Pandor A, Gomersall T, Stevens JW, et al. We queried all available adverse event reports from May 28, 2014 (date of FDA premarket approval), to May 28, 2017, using search limits by product class ("system, hemodynamic, implant"), model number ("CM1000," "CM1010 . 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