Implanted Pulmonary Artery Pressure Sensor for Heart Failure Management

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On behalf of the American Heart Association (AHA), including the American Stroke Association (ASA) and 40 million volunteers and supporters, we appreciate the opportunity to comment on the Centers for Medicare and Medicaid Services (CMS) national coverage analysis (NCA) for use of implantable pulmonary artery (PA) pressure sensors for heart failure (HF) management.

CMS opened the coverage analysis after receiving a request to develop a national coverage policy for remote implantable hemodynamic monitoring for New York Heart Association (NYHA) II or III HF patients who either have been hospitalized for HF in the previous year and/or have elevated natriuretic peptides.

• NYHA Class II or III HF symptoms predominantly present over the previous 30 days despite maximally tolerated guideline-directed medical and device therapies regardless of left ventricular ejection fraction;
• Patients able to tolerate dual antiplatelet or anticoagulation therapy for one-month post implant;
• Patients should be within the anatomical considerations per the manufacturer’s IFU for appropriateness of sensor functionality (e.g., body mass index (BMI), chest circumference);
• At least one HF-related hospitalization within the past 12 months OR an elevated B-type natriuretic peptide (BNP) or N-terminal (NT)-pro hormone BNP (NT-proBNP).

The request for coverage is for patients with elevated BNP and/or those patients with previous HF hospitalization, consistent with the current FDA indications for the implantable PA pressure sensor. AHA supports the inclusion of NYHA Class II or III HF patients who either have been hospitalized for HF in the previous year and/or have elevated BNP. When considering the use of implantable PA pressure sensors in patients with NYHA Class II HF with elevated BNP and without a HF hospitalization in the previous 12 months, it will be important for clinicians to rule out non-HF related causes of elevated BNP and consider the severity of HF symptoms.

Additionally, if the patient is obese and/or has a large chest circumference, obtaining a signal and getting a measurement can be difficult. AHA supports exclusion criteria around increased BMI as an important consideration, due to decreased transmission capability of the device/receiver, and issues with interpretation of the data.

Outcomes To Be Examined
CMS has stated it will consider outcomes as part of the NCA including, but are not limited to, decreased mortality, reduced emergency room or hospital admissions, lowered readmission rate, improved function, and quality of life. We agree that mortality, hospital admissions, and at least one patient outcome (quality of life) are appropriate outcomes to examine.

Equity Concerns
Lack of coverage for implantable PA pressure sensors can lead to inequities in access. There is the potential for inequities to persist, even with a determination by CMS to provide coverage of implantable PA pressure sensors. Disadvantaged populations in rural or low socioeconomic status communities may require additional resources to successfully implement such an intervention. For example, disparities exist in access to internet service for certain marginalized populations and those in rural communities. If a patient does not have internet access or cell service (unable to afford; in a geographic location that limits this access) data transmission can be an issue, limiting the utility of the device. In addition to internet access, patients must be willing to comply with regular downloads to ensure data is properly transmitted. As part of a coverage policy, we urge CMS to ensure that the PA pressure sensors be implanted only in patients who have reliable internet access and will comply with regular downloads.

Further, the trial population, to-date, has not been very diverse. It is important that CMS examine how implantable PA pressure sensors’ utility extends to various groups of patients. The AHA is strongly committed to promoting health equity, including improving diversity in trial participants, and recommends this issue be addressed in future research.

Conclusion
We believe that it would be reasonable for CMS to provide Medicare coverage of implantable PA pressure sensors for NYHA Class II and Class III HF patients who either have been hospitalized for HF in the previous year and/or have elevated natriuretic peptides. For patients with NYHA Class II HF with elevated BNP and without a HF hospitalization in prior year, it will be important for clinicians to rule out non-HF related causes of elevated BNP and consider the severity of HF symptoms.

The AHA thanks you for the opportunity to submit comments on this NCA. If you have any questions or require any additional information, please contact Maryellen Guinan at (202) 785-7948 or Maryellen.Guinan@heart.org.

Sincerely,
Joseph C. Wu, MD, PhD, FAHA
President, American Heart Association

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Pulmonary artery pressure (PAP) monitoring is indeed a crucial tool in managing heart failure. I have seen its direct impact on our patients. The ability to proactively capture early signs of heart failure exacerbations leads to decrease hospitalization, symptom improvement (naturally enhancing quality of life), and confidence in their care team.

Probably one of the most impactful aspects of the PAP monitoring is how it results in patient engagement and empowerment. Engaging patients in their own care by involving them in the monitoring process can lead to better health outcomes. When patients understand their condition and see the direct impact of their actions and treatments on their health metrics, they are more likely to adhere to their treatment plans and make positive lifestyle changes. This active participation fosters a sense of control and responsibility, which has been linked to improved health outcomes and higher quality of life.

In summary, pulmonary artery pressure monitoring is a vital component of heart failure management that not only prevents hospitalizations and improves symptoms but also enhances the overall quality of life by empowering patients to take an active role in their care.

This should be considered high on the list of priorities for future treatment guidelines.

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Cardiomems has been the most important medical device in managing heart failure patients. I think it is the perfect tool for communities such as ours, which represents the majority of communities in the USA. We have a medium sized hospital placed in a mix of the rural and small sized metropolitan areas covering 3 counties with varying income levels.

As other communities we are plagues by the epidemic of heart failure and the readmissions it produces. As everyone knows the financial burden of 30-day readmissions weighs heavily on community hospitals and ours was not an exception.
Starting a heart failure management program in a small to medium sized community hospitals could be a daunting task. But the introduction of this device to our healthcare system has provided a breakthrough in managing those patients. We were able to take the initiative in managing heart failure and be proactive with our patients without having to add additional resources to our clinic structure. We have maintained below national average rates for 30-readmission over the past 2 years. Those with Cardiomems in our system rarely get admitted with volume overload because they know they have a direct line to our clinic by the benefit of having the device which was a very pleasant unintended consequence.

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The implantable PA pressure monitoring system had been utilized to make a substantial difference for our heart failure patients. We have over 100 patients that have been screened, implanted and managed by our advanced heart failure clinic. We have been able to reduce HF admissions 70-80% and all cause admissions 50-55%. The use of CardioMEMS has allowed some patients to fully enjoy their lives again instead of spending more time in the hospital than at home. One particular patient was able to go on a multi month vacation, something they had not been able to do for more than 5 years. They described it as "life changing" with being able to identify changes in fluid status much earlier and avoiding hospitalization.

Many commercial insurance companies and Medicaid deem "investigational, experimental and not medically necessary" which is depriving the patients of tailor prompt treatment of their heart failure. Even with evidence of need it continues to be denied upon appeal.
All patients should be given the optimal treatment and care regardless of insurance.

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May 30, 2024

Tamara Syrek Jensen, JD
Director, Coverage & Analysis Group
Centers for Medicare & Medicaid Services
7500 Security Blvd.
Baltimore, MD 21244

RE: CAG-00466N Implanted Pulmonary Artery Pressure Sensor for Heart Failure Management

Dear Ms. Syrek Jensen:

Abbott welcomes the opportunity to comment on the National Coverage Analysis (NCA) for implanted PA pressure sensor for heart failure management, CAG-00466N, opened on April 30, 2024. Abbott’s CardioMEMSTM Heart Failure (HF) System received FDA approval ten years ago, on May 28, 2014, and over the course of the last ten years, the data have continued to show the device is safe, effective, and leads to improved patient outcomes. Abbott therefore believes establishing a national coverage policy for remote implantable hemodynamic monitoring with the CardioMEMS HF System will ensure long-term, predictable, and consistent coverage for all Medicare beneficiaries.

HF is one of the top five health conditions affecting Medicare beneficiaries, with approximately 80% of HF patients being >65 years of age.(1, 2) It is also the leading cause of hospitalization among older adults; and Medicare beneficiaries with HF have the highest readmission rate of any condition.(1) Much of the financial burden falls to Medicare, as an estimated three-quarters of emergency department visits and hospitalizations with primary or comorbid HF were among Medicare beneficiaries.(3) The magnitude of unmet need warrants access to meaningful interventions.

The CardioMEMS HF System measures PA pressures to guide HF patient management, using a paperclip-sized permanently implantable wireless sensor, a patient electronics system, and a secured patient database for clinician review. Trended hemodynamic data enables physicians to remotely adjust medications as a meaningful component of medical care.

Abbott has worked collaboratively with CMS to best define the evidentiary requirements to support an NCD for remote hemodynamic monitoring for HF with the CardioMEMS HF System.

In the NCA, CMS mentioned it would examine the clinical literature to determine if there were “characteristics or comorbidities that make patients more or less likely to benefit from the device” and if there were treatment conditions required so that all patients could achieve the published outcomes. CMS also stated they wanted to learn more about decreased mortality, decreased frequency of exacerbations requiring emergency room or hospital admission, increased time to hospital re-admission for HF complications, improved function, and quality of life. In addition, CMS requested to hear specifically about peer-reviewed evidence regarding implantable PA pressure sensors and their use in managing HF, as well as health disparities and health equity issues that should be considered in the analysis.(4)

Abbott included a detailed summary of the peer-reviewed literature related to CardioMEMS in the formal request for an NCD submitted November 3, 2022. Abbott also discussed the disparate impact on specific populations including HF with preserved ejection fraction (HFpEF), women, and African Americans.

Since then, more research has been published. CardioMEMS continues to be one of the most comprehensively studied medical technologies across all disease states, and the data consistently tell the same story: PA pressure monitoring reduces HF hospitalizations and leads to improved outcomes. The most recent research highlights further benefits in quality of life and improved survival. Below, we summarize studies and analyses evaluating CardioMEMS that were published following submission of our NCD request.

MONITOR-HF Randomized Controlled Trial
The Remote hemodynamic monitoring of pulmonary artery pressures in patients with chronic HF (MONITOR-HF) trial was a prospective, randomized, open-label, multi-center trial conducted in the Netherlands and recently published in 2023.(5) The trial enrolled NYHA Class III HF patients with a prior HF hospitalization and compared heart failure management using the CardioMEMS device to standard of care over a follow-up period of at least 12 months. A total of 348 patients were randomized with a mean follow-up period of 1.8 years. The primary endpoint was the mean difference in quality of life as measured by the KCCQ. The results of the trial are summarized by outcome measure in sections below.

Quality of Life: The primary endpoint was met, with a mean difference in KCCQ scores between CardioMEMS and standard of care groups of 7.13 -points (p=0.013) resulting from a 7.05-point improvement (p=0.014) in KCCQ overall summary score in the CardioMEMS group at 12 months and no improvement observed for the standard care group (-0.08 points, p=0.97). Importantly, a responder analysis indicated a greater proportion of patients with a clinically meaningful improvement in KCCQ score of 5 points or more in the CardioMEMS-HF group compared to standard of care (47.7% and 38.1% respectively, p=0.046).
HF Hospitalizations: A significant reduction in HF hospitalizations was observed, with 44% fewer HF hospitalizations in the CardioMEMS-HF group compared to the Standard Care group (p=0.0053).

Reduction in PA Pressures: The CardioMEMS-HF group demonstrated a significant reduction in PA pressures from the baseline mean of 33.3 mmHg to 24.9mmHg at 12 months, reflected by an area under the pressure-time curve (AUC) of 1623.8 mmHg-days over the follow-up period (p<0.0001).
Safety: The MONITOR-HF trial had 97.7% (168/172) freedom from device or system-related complications, further demonstrating the strong safety profile of the device and implantation procedure in alignment with prior trials.

Cost-Effectiveness: Cost-effectiveness analyses were conducted for the MONITOR-HF trial to evaluate the value of remote hemodynamic monitoring in a European healthcare system.(6) The quality adjusted life years per patient was 4.07 for hemodynamic-guided therapy and 3.48 for standard of care, reflecting a gain of 0.58 quality adjusted life years from hemodynamic monitoring. The resulting cost-effectiveness ratio was below the Dutch willingness-to-pay threshold and suggests that hemodynamic-guided management is cost-effective for HF patients in the Netherlands.

Patient-Level Meta-Analysis of Hemodynamic Monitors
A patient-level meta-analysis of hemodynamic monitors was published in 2024 including pooled randomized data from the GUIDE-HF, CHAMPION, and LAPTOP-HF trials.(7) The population included a total of 1350 patients with HF with reduced ejection fraction. Each trial demonstrated a significant reduction in HF hospitalizations at 12 months between treatment and control which, when pooled, demonstrated a 36% reduction in HF hospitalizations overall for hemodynamic monitoring compared to control groups at 12 months (p<0.0001). In addition, this meta-analysis showed a mortality benefit for the pooled population, with a 25% reduction in mortality at 24 months for hemodynamic monitoring compared to control (p=0.043), demonstrating that hemodynamic monitoring with implantable devices including the CardioMEMS HF System improves survival in heart failure patients.

GUIDE-HF Analysis of Hemodynamic-Guided Management Across the Spectrum of Ejection Fraction
An analysis of the GUIDE-HF Randomized Arm data across the range of left ventricular ejection fractions was published in 2022.(8) The analysis demonstrated the consistent decrease in both the primary endpoint composed of HF hospitalizations, urgent HF visits, and mortality and in HF hospitalizations along across different ejection fraction groups. When ejection fraction was used as a continuous predictor of outcomes, the hazard ratios remained consistently below one and demonstrating benefit of hemodynamic-guided management in not only HF patients with reduced ejection fraction but also those with preserved ejection fraction. The linear relationship observed for the hazard ration highlights that the utility and benefit observed from hemodynamic-guided management with CardioMEMS is not limited to a particular ejection fraction range.

Additional Analyses in Sub-populations of Prior CardioMEMS Trials

The GUIDE-HF population was evaluated according to the enrollment criteria of elevated natriuretic peptides of a prior HF hospitalization and the results were published in 2023.(9) The outcomes demonstrated consistency across enrollment groups, with reductions in both the HF hospitalizations and in the composite primary endpoint also including death and urgent HF visits together with HF hospitalizations. The results of the sub-analysis highlight the benefit of hemodynamic monitoring not just in patients with congestion severe enough to warrant a prior hospital admission but also in those with biomarkers indicating sufficient risk for future HF events.

A sub-analysis of the US Post Approval Study demonstrated that hemodynamic-guided care was effective regardless of renal function, demonstrating lower hospitalization rates across eGFR quartiles and stages of chronic kidney disease.(10) Similarly, a sub-analysis from the MEMS-HF study demonstrated reductions in HF hospitalizations and improvements in both quality of life and NYHA class regardless of the presence or absence of pulmonary hypertension at baseline.(11)

Additional Meta-Analyses of Implantable Hemodynamic Monitoring

Three meta-analyses focused on implantable hemodynamic monitoring have recently been published. Clephas et al.(12) completed a meta-analysis combining the outcomes of CHAMPION, GUIDE-HF, and MONITOR-HF. The results indicated that PA pressure-guided management using the CardioMEMS HF System reduced the number of HF hospitalizations by 30%. Curtain et al.(13) completed a meta-analysis including CHAMPION and GUIDE-HF data but also included data from the COMPASS-HF, REDUCE-HF, and LAPTOP-HF trials for other implantable hemodynamic monitoring devices. HF hospitalizations were reduced by 26% in the implantable hemodynamic management arm compared to control groups within the studies. In a similar methodology, Iaconelli et al.(14) performed a meta-analysis including CHAMPION, GUIDE-HF, COMPASS-HF, and REDUCE-HF data. The outcomes demonstrated a 25% reduction in HF hospitalizations associated with hemodynamic monitoring relative to control.

CHAMPION Trial Analysis of Inclusion
The demographics of the CHAMPION study and of the first 10,631 Medicare beneficiaries receiving an implantable pulmonary artery pressure sensor were recently compared to demographics from Medicare patients hospitalized for HF in an effort to assess inclusion within the trial.(15) The CHAMPION trial was found to have adequately represented African Americans, Hispanic Americans, and Asian Americans, and the demographics of the CHAMPION trial cohort were similar to the first patients who received pulmonary artery sensors. The study authors also concluded that the demographics of Medicare beneficiaries hospitalized with HF vary regionally and by age, which should be considered when defining "adequate" representation in clinical studies, and enrollment diversity in clinical trials may affect who receives early application of recently approved innovations.

There are two studies that are ongoing, evaluating CardioMEMS:
The PASSPORT-HF trial is a German prospective, randomized, open, multicenter trial evaluating the effects of a hemodynamic-guided, HF nurse-led care approach using the CardioMEMS™ HF-System on clinical end points, safety, and quality of life. The target population consists of heart failure (HF) patients who have been predominantly in New York Heart Association (NYHA) Stage III for the past 30 days and were admitted to the hospital at least once in the past 12 months for HF. More information can be found at: https://clinicaltrials.gov/ct2/show/NCT04398654

The CardioMEMS HF System Real-World Evidence (RWE) Post-Approval Study (PAS) is a study intended to evaluate the long-term safety and effectiveness of the CardioMEMS™ HF System using RWE methods. The population includes subjects identified in Abbott's Merlin.net remote monitoring database and linked to Medicare fee-for-service (FFS) claims data to longitudinally track outcomes over a 36 month period. More information can be found at: https://clinicaltrials.gov/ct2/show/NCT06306573

In summary, we believe the presentation of the evidence to date strongly supports an NCD that establishes coverage for remote hemodynamic monitoring in appropriate Medicare beneficiaries. In particular, recent peer-reviewed publications continue to demonstrate what the earlier literature found: CardioMEMS is safe, effective, and leads to improved patient outcomes. In addition, they highlight improvements in quality of life and improved survival. Rather than showing there are specific characteristics making patients more or less likely to benefit from the device, the evidence to date has repeatedly demonstrated consistency in the treatment effects across multiple patient subgroups, including comorbidities, ejection fraction, and renal function, among other characteristics. Finally, while there are no studies focused specifically on CardioMEMS and its ability to increase health equity, by its very nature, as a remote monitoring device, CardioMEMS facilitates care where it might otherwise not occur. Patients in rural areas and those for whom transportation is an issue can have challenges accessing care; CardioMEMS addresses this barrier for them, by providing remote monitoring and facilitating remote medical care. Consistent access to care is also blocked by the coverage issues patients have encountered, where the 51% of Medicare beneficiaries covered by Medicare Advantage are being denied access because of the various Commercial plan coverage inconsistencies they must face due to the lack of an NCD.(16) An NCD would, at the very least, enable Medicare beneficiaries consistent access to this safe, effective technology that can lead to improved outcomes and decreased mortality.

Thank you for your consideration of our comments.

Sincerely,

James Hasegawa
Senior Director, Health Economics and Reimbursement
Abbott Medical Devices

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Tamara Syrek Jensen, J.D.
Director, Coverage and Analysis Group
Centers for Medicare & Medicaid Services
7500 Security Boulevard
Baltimore, MD 21244

RE: National Coverage Analysis (NCA) for Implanted Pulmonary Artery Pressure Sensor for Heart Failure Management (CAG-00466N)

Dear Ms. Syrek Jensen,

Endotronix, a digital health and medical device manufacturer of the Cordella Pulmonary Artery (PA) Sensor and Heart Failure (HF) System, is dedicated to improving care for people living with heart failure. The Cordella Sensor is an implantable PA pressure sensor that directly measures the leading indicator of congestion, allowing early, targeted therapy. The Cordella HF System is a patient health management platform, which combines comprehensive vital sign data from non-invasive devices to support patient-clinician engagement and care decisions for guideline-based treatment of HF patients at risk of congestive events (NYHA class II or III). Endotronix has submitted the Cordella Sensor for FDA PMA approval for NYHA class III HF patients. Additionally, the company is conducting the PROACTIVE-HF-2 clinical trial to investigate the Sensor's effectiveness for NYHA class II patients and self-management for NYHA class III patients.

Endotronix thanks CMS for the opportunity to comment on the National Coverage Analysis (NCA) for Implanted Pulmonary Artery Pressure Sensor for Heart Failure Management (CAG-00466N). This letter provides a summary of the current scientific evidence for pulmonary artery pressure (PAP) Sensors for Heart Failure Management and recommendations based on this evidence. Endotronix appreciates CMS’ commitment to ensuring patient access to this important therapy for HF patients.

Heart Failure Management

Heart failure (HF) is a complex and life-threatening syndrome characterized by significant morbidity and mortality, poor functional capacity and quality of life, and enormous cost.(1) HF prevalence is expected to increase with an aging population while HF morbidity and mortality remain unacceptably high, with rates equivalent to common forms of cancer.(2) Survival rates are dismal with one recent meta-analysis showing 1, 5, and 10 years rates to be 86.5% (95% confidence interval 85.4 – 87.6), 56.7% (54.0-59.4), and 34.9% (24.0-46.8), respectively, and a recent cohort study highlighted a reversal of the declining HF mortality trends from 1999-2012, specifically, HF mortality rates are now worse than they were in 1999.(3,4) Moreover, the number of HF hospitalizations (HFH) has been shown to be a strong predictor of all-cause death, with the median survival after the first, second, third and fourth hospitalizations to be 2.4, 1.4, 1.0, and 0.6 years, respectively.(5) A recent research letter highlighted reductions in HFH were associated with greater reductions in mortality risk for NYHA class III and IV, suggesting that HFH is a predictor of either all cause or cardiovascular mortality.(6) Additionally, the economic burden of HF, on both patients and the healthcare system is substantial, with 1%-2% of the total healthcare budget in the US allocated to HF and inpatient admissions accounting for >50% of this expenditure.(7)

Despite well-established guidelines and innovations in both pharmacological and device-based HF management over the past 20 years, HF remains a leading cause of hospital admissions in the United States with HF admissions accounting for approximately 6.5 million hospital days annually.(8)

PAP-guided HF management is currently included in the aforementioned April 2022 guidelines, listed with a Level IIb recommendation. Subsequent to the publication of these guidelines, three major studies were published: (i) MONITOR-HF demonstrated favorable KCCQ and HFH results in a prospective RCT in NYHA class III (9), (ii) a patient-level pooled meta-analysis of three randomized studies demonstrated favorable mortality and HFH results in NYHA class III patients (10), and (iii) PROACTIVE-HF that also demonstrated favorable results in a prospective trial in NYHA class III patients.(11) We anticipate the consideration of these studies may result in future changes to the guidelines, upgrading the indication from Level IIb.

Clinical Evidence Summary

There is significant evidence of benefit of PAP-guided HF management in NYHA class III across numerous randomized controlled trials and single arm trials with the CardioMEMS HF System [MONITOR-HF (N=348),(9) GUIDE-HF (N=1000),(12) CHAMPION-HF (N=550),(13) CardioMEMS Post Approval Study (N=1200),(14) MEMS-HF (N=234)(15)] and now with Cordella System in PROACTIVE-HF (N=528),(11) demonstrating a class effect of PAP sensors.

The CHAMPION-HF study met its primary endpoints with additional long term follow up data supporting the primary conclusions and the GUIDE-HF study met its primary endpoints in the pre-COVID follow-up period.(12,13) Subsequently, the MONITOR-HF randomized trial also met its primary and secondary endpoints reinforcing the similar HFH reduction seen in CHAMPION-HF and GUIDE-HF.(9) The prospective single arm Post Approval Study and MEMS-HF study further support the favorable results in NYHA III patients.(14,15)

Most recently, the results of PROACTIVE-HF further support the favorable results in NYHA III patients with the study meeting its primary endpoints, and were further supported by favorable evidence from the randomized phase of this study.(11) As numerous prospective trials with PAP sensors have generated evidence supporting a reduction of HFH events for NYHA class III patients, evidence was also recently presented by Zile at the 2024 Technology and Heart Failure Therapeutics conference strengthening the relationship between high PAP and mortality risk and the reduction of PAP to lower mortality risk.(16)

The recent publication of PROACTIVE-HF trial results reinforces the benefits of remote PAP guided HF management, with the trial surpassing primary and secondary safety and effectiveness endpoints. The trial reported rates of freedom from device-related complications and freedom from pressure sensor failure, at 99.2% and 99.8%, respectively. There were low HF hospitalization and mortality rates with the six-month incidence of HFH and mortality of 0.1549 [95% CI: 0.1225, 0.1957] events per patient. There was a statistically significant improvements in quality of life (p<0.0001), functional class (p<0.0001), and six-minute walk test (p=0.001) through six months. Subjects with mean PAP (mPAP) above target range (seated mPAP > 20 mmHg) at baseline saw a significant reduction in mPAP (2.4 mmHg, p=0.0006). Systolic blood pressure, whether measured in-office or at home, was also significantly lowered over six months. There was high compliance in both subject transmission of daily data and clinician acknowledgement of those transmissions.(11)

In NYHA III patients at risk of congestive events, the Cordella PA Sensor and HF System was safe, improved quality of life, functional class, functional capacity and enabled both a significant reduction in PAP in congested subjects and significant reduction in systolic blood pressure overall. The markedly low event rates may relate to high subject and clinician compliance, high rates of GDMT at baseline, and integration of daily vital signs with seated mPAP, which may be more relevant for monitoring of ambulatory HF patients.

Prior to the PROACTIVE-HF trial, Cordella was also investigated in Europe in the SIRONA 2 trial (n=70 NYHA III subjects, average age 71), where the primary and secondary safety and efficacy endpoints were met.(17) The SIRONA 2 trial demonstrated a 98.6% freedom from device-related complications, no sensor failures, accurate PAP measurements, and high adherence (94% at 3 months and 95% at 12 months).(17,18) Overall, there were low rates of HFH or death, with only five deaths (7.1%) at 12 months and a 12-month cumulative hazard rate for HFH was 0.27.(18) Furthermore, there was a significant reduction of 78.6% of HFH in the 12-months following implant compared to the 12-months prior to implant.(18)

PAP-guided HF management has also been demonstrated to be beneficial within the Medicare beneficiary population. Studies of the CardioMEMS device enrolled a significant proportion of patients older than 65 years, approximately 40% for CHAMPION and 75% for GUIDE-HF.(12) Similarly, PROACTIVE-HF enrolled NYHA III patients where the average age was 64 (± 13) and the proportion of subjects > 65 years of age was 46%.(11)

Health equity was also a notable aspect of the PROACTIVE-HF trial, as evidenced by its successful inclusion of a diverse patient demographic, representing the largest cohort of women and minorities among similar studies 39.4% (180/456) and 23.9% (109/456), respectively.(11) This approach facilitated broad access to innovative care strategies across traditionally underserved groups, potentially reducing disparities in HF management outcomes. Specifically, the sub-group analysis for women and non-white participants demonstrated similarly low event rates to the overall population.(11) PROACTIVE-HF, similar to other large PAP clinical studies, enrolled subjects across more than 70 sites, with a mix of urban, rural, academic, and community hospital settings.(12,13) This suggests that the use of PAP to remotely manage heart failure is similarly effective in women and minorities and across geographies and therefore applicable to the broader Medicare beneficiaries who have been diagnosed with NYHA class III HF.

Endotronix, the manufacturer of the Cordella Sensor, is also in the early stages of enrollment in a subsequent clinical trial, PROACTIVE-HF-2, which aims to establish evidence of the benefit of PAP-guided HF management where patients have access to their daily PA pressures for patients at risk of congestive events, regardless of NYHA functional class II or III. A total of 1,650 patients will be included in the study at up to 120 sites in the United States and Europe. The trial design consists of two component arms intended to examine complementary hypotheses. The randomized arm, enrolling 1,150 patients, is designed to test the hypothesis that PAP-guided HF management in NYHA class II patients who have access to their daily PA pressure will improve mortality and reduce HFH when compared to telehealth in the active control arm over two years. The design of the observational single-arm of PROACTIVE-HF-2, enrolling 500 patients, is twofold: (1) to test the hypothesis that PAP-guided HF management with patient access to daily PA pressures is similarly effective to standard PAP-guided HF management in NYHA class III HF patients at 12 months, as previous PA sensor trials did not allow patients access to their PA pressure readings; and (2) to inform future prospective study designs in patient self-management.

PAP-guided HF management is shown to be cost effective from a US payer perspective. Three economic models with varying assumptions and methods found PAP guided HF management to be a cost-effective means of increasing quality of life and reducing hospitalizations for HF patients.(19,20,21) All models demonstrated PAP was either cost effective or highly cost effective with cost per QALY estimates ranging from $12,262 to $71,462. Interestingly, the model with the highest estimate was most sensitive to the effect of the device on mortality noting a 4% reduction in mortality was needed to reduce cost <$100,000 per QALY gained.(21) This model was published in 2016 and US economic models have not been updated to include recent meta-analysis results showing up to a 25% reduction in mortality two-years after PAP Sensor implantation.(10)

NCD Considerations

We concur with CMS that the scope of this NCA is appropriate for implanted PA pressure sensors for HF management. CardioMEMS and Cordella have both demonstrated safety and efficacy for patients with NYHA class III symptoms at risk for congestive events (with a recent HFH or elevated NT-proBNP). HF treatment based on the PA pressure data notably improved patients' quality of life, functional class and exercise capacity, while reducing event rates. We believe, based on the totality of the evidence of PAP-guided HF management described above, that ensuring broad access to appropriately indicated Medicare beneficiaries is critical for patients to receive the best possible HF care and live more full and active lives.

As noted in the NCD request letter, the FDA label for the CardioMEMS HF System was recently expanded to include NYHA class II patients at risk of congestive events (with a recent HFH or elevated NT-proBNP). Understanding that additional clinical data collection will continue to occur for both NYHA class II and III patients, we encourage CAG to continue to define and provide coverage for PAP sensor systems based on the available evidence which shows PAP-guided HF management is effective for patients at risk of congestive events with a recent HFH and/or elevated NT-proBNP.

Endotronix is grateful to CMS for considering the above clinical evidence and recommendations for the proposed NCD.

Sincerely,
Harry Rowland
CEO, Endotronix

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UnitedHealthcare (UHC) is responding to the National Coverage Analysis request for comments regarding the Implanted Pulmonary Artery Pressure Sensor for Heart Failure Management System (CardioMEMS™). The request for a National Coverage Decision (NCD) for this device was submitted by Abbott in a letter to the Centers for Medicare & Medicaid Services (CMS) on November 11, 2022. For the reasons stated below, we do not believe an NCD is appropriate at this time due to the lack of evidence regarding the efficacy of the device and the availability of other treatment approaches.

Inconsistencies in Clinical Trial Reporting

CardioMEMS™ was approved for use by the Food and Drug Administration (FDA) in 2014 on the basis of the Champion trial. Concerns with the results of this study have been raised by provider professional societies. For example, the recent Heart Failure Guidelines from American College of Cardiology (ACC)/American Heart Association (AHA)/ Heart Failure Society of America (HFSA) stated the following:

"However, CHAMPION was a nonblinded trial, and there was differential contact of study personnel with patients in the treatment arm, raising methodological concerns about the opportunity for bias to have influenced its results. In the recent GUIDE-HF (Haemodynamic-GUIDEed management of Heart Failure) study, hemodynamic-guided management of patients with NYHA class II to IV heart failure did not significantly reduce the composite endpoint rate of mortality and total HF events. The usefulness of noninvasive telemonitoring or remote monitoring of physiological parameters (eg, patient activity, thoracic impedance, heart rate) via implanted electrical devices (ICDs or CRT-Ds) to improve clinical outcomes remains uncertain. Further study of these approaches is needed before they can be recommended for routine clinical care." (2022 AHA/ACC/HFSA Guideline for the Management of Heart Failure: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines | Circulation (ahajournals.org), Section 4.6 Wearables and Remote Monitoring (Including Telemonitoring and Device Monitoring).

These guidelines formed the basis for insurance coverage decisions over the past decade as not demonstrating hard endpoint outcomes generally referenced as demonstrating a “lack of long-term efficacy and safety.”

In 2022, the FDA issued an additional approval for CardioMEMS™ based on the GUIDE-HF trial, referenced in ClinicalTrials.gov as NCT03387813. The Abbott letter states that it was terminated in 2020/2021, yet ClinicalTrials.gov shows that the trial has ended on 5/17/23, as shown on their website. The Lancet publication which revied that trial purports to demonstrate the definitive outcomes of this trial but only represents one selected portion of the trial.

The FDA continued to have concerns even after the publication of the GUIDE-HF trial and requested a Post Approval Study in 2022 with the mandate to “collect additional evidence of continued safety and effectiveness” and to answer unresolved issues. (found at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P100045S056). The study required the following:

• Sufficient New York Heart Association (NYHA) Class II patients, including a mortality analysis.
• Sufficient women enrolled so that an analysis by sex can be pre-specified.
• A pre-specified analysis for patients with and without a CRT
• An enrollment strategy to promote a balance in patients across ejection fraction and sex.
• To consider modification of the protocol response to pulmonary artery (PA) pressures in HFpEF and HFrEF, since now there are at least two drugs approved for HFpEF and use of SGLT2i is expected to expand.

This study will not complete until 2029 and has the pre-specified endpoints:

"The primary endpoint is survival for all-cause mortality in the Primary Cohort (NYHA Class II subjects) at 2 years. The analysis will evaluate survival for the Primary Cohort compared to a pre-specified performance goal of 71.7% survival at 2 years, established based on data from the literature. The secondary endpoint is survival for all-cause mortality in the Full Cohort (NYHA Class II and Class III subjects) at 2 years. The analysis will evaluate survival for the Full Cohort compared to a pre-specified performance goal of 69.6% survival at 2 years, established based on data from the literature. " (https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma_pas.cfm?t_id=739325&c_id=7113 , Appendix V. Performance Criteria). We believe any results on the ongoing GUIDE-HF study and FDA follow-up should be provided as part of this analysis.

In summary, four clinical trials over a 20-year period with various study designs covering almost 8,000 patients have failed to demonstrate any meaningful impact on survival in heart failure patients using CardioMEMS. The surrogate endpoints do not meet a Standards of Medical Practice definition commonly used throughout medicine. UHC cannot support the implication that coverage of the implant meets the effectiveness standards by which all other devices are measured as we cannot have different standards of effectiveness for different devices, or different manufacturers of the same or similar devices. Without completion of the mandatory FDA approved safety and efficacy studies, there exists no mandate for coverage.

Other Available Devices for Heart Failure Monitoring

Approximately one-half of all heart failure patients have systolic dysfunction. With an ejection fraction of less than 30-35%, it is a Class I recommendation from the American Heart Association that a defibrillator be implanted in these patients to prevent sudden cardiac death. A significant number of those patients have a bi-ventricular device. Another smaller minority of patients will have pacemaker implants, including bi-ventricular pacemakers implanted. Each of these devices have FDA approved pulmonary fluid monitoring capabilities marketed under trademarks such as OptiVol, HeartInsight and CorVue. This reporting capability is far more robust than that provided by CardioMEMS™.

Implanted pacemakers and implanted cardiac devices have Bluetooth/wireless automatic reporting capabilities. CardioMEMS™ not an actively reporting device. It is a Radio Frequency Identification Device (RFID) passive implant that requires patient compliance to set up and use an external transmitter. In addition, for patients with a Body Mass Index (BMI) greater than 40, the transmitter cannot physically “reach” the CardioMEMS™ device, rendering it unreadable. We believe there there is no additional benefit (and incremental risk) to patients with existing fluid monitoring devices to have a second device implanted.

Contraindications for Use of the Device

Abbott has indicated that the following patients may not be appropriate of implantation of the CardioMEMS™ HF System:

• Patients with an active infection.
• Patients with a history of recurrent (> 1) pulmonary embolism or deep vein thrombosis
• Patients unable to tolerate a right heart catheterization.
• Patients with a Glomerular Filtration Rate (GFR) <25 ml/min who are non-responsive to diuretic therapy or who are on chronic renal dialysis.
• Patients with congenital heart disease or mechanical right heart valve(s)
• Patients with known coagulation disorders.
• Patients with a hypersensitivity or allergy to aspirin, and/or clopidogrel.
• Patients who have undergone implantation of a Cardiac Resynchronization Device (CRT) within the past 3 months.
• If the patient’s BMI is greater than 35, measure the patient’s chest circumference at the axillary level. If the chest circumference is > 165cm, sensor implantation should not occur.

We cannot, in the context of medical necessity, support the implantation of devices for which written contraindications have been issued.

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Our organization has implanted two CardioMEMS and each one provided significant benefits to each patient. For the first patient, the cardioMEMS was able to steer physicians in a different direction when the patient had one additional admission because the MEMS provided data that showed she was not in heart failure overload. The secondary diagnosis for the patient was metastatic cancer - which had been overlooked due to her history of CHF and the presumption with each admission it was volume overload.

The second patient was an elderly man who had been admitted 5 times in six months, once the CardioMEMS was inserted the patient did not have another admission for 8 months as we were able to better monitor his status and adjust medications to keep him out of symptomatic heart failure. During the eight months he regained his strength, previously he was able to walk only short distances with maximum assistance; however, he was able to walk independently with assistance of a cane because of better HF management with the information from the CardioMEMS.

A third patient that was considered but was unable to receive the MEMS device was a patient with cognitive impairment with severe heart failure. Her mother cared for her at home and her sick husband, based on the cognitive impairment there were challenges with the patient being compliant with diet and fluid intake. Had the patient been able to receive the MEMS device we would have the opportunity to manage the patient's HF; as of now we will be challenged because the patient is unable to verbalize changes in her symptoms.

This is a tool that could help so many patients better manage a chronic disease that already poses so many challenges with dietary changes and fluid challenges each day, and to be able to eliminate the overall stress and strain on the heart earlier will allow patients to live longer fuller lives.

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I have been actively engaged in managing patients using the CardioMEMS system for the past 10 years. Without reservation, I can clearly state that the CardioMEMS system, used in the right patient population, provides remarkable advantages and outcome benefits that are not achievable through usual standard of care.

The clearest and strongest data for the use of the CardioMEMS system is in the reduction in hospitalizations for congestive heart failure. Much of the data since the initial Champion HF trial have replicated the reduction in rehospitalization for congestive heart failure afforded by the pulmonary artery pressure monitoring data from the CardioMEMS system. The connection between heart failure hospitalization and mortality is irrefutable.

More recently, there has been a series of randomized and meta-analysis data demonstrating either trend toward, or strong statistical inference of mortality benefit using the CardioMEMS system.

With the relatively low upfront cost of the implantation, and the remarkable safety data, not to mention the reliability, I find it difficult to make an argument not to implant the device in a patient with refractory congestive heart failure. In addition to having a more objective assessment of heart failure status, helping to shape changes in medical management, patients also receive biofeedback through the use of the system, which actually improves their own ability to navigate management of their heart failure at home. There are many ancillary advantages to having this system in place, not to mention the fact that the patient is interacting with the healthcare system on a daily basis, which undoubtedly plays a role in medication/lifestyle compliance.

From my clinical anecdotal experience, there is no doubt that I have provided patients with outcome benefits, and improved quality of life, through my ability to navigate their pulmonary pressures to make clinical decisions.

I continue to struggle to understand why this technology and monitoring system is not more widely supported. I look forward to a positive National Coverage decision on the CardioMEMS system.

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I am in Advanced heart failure, Cardiologist and I’ve had multiple patients who have benefited from CardioMems implantation. Those who receive CardioMems implants are rarely if ever admitted to the hospital. I’ve also had several patients who were denied who would have likely benefited who were subsequently admitted to the hospital several times.

Cardio helps significantly in the follow up, and management of our heart failure patience. It has been shown in multiple studies to reduce admissions and cross our Multi hospital system, it has shown the same.

At this point, it would be against the standard of care to deny a heart failure patient Cardiomems.

Sunil

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As the director of a highly successful CardioMEMS program, which currently manages over 100 patients, I have witnessed firsthand the significant benefits of the implanted pulmonary artery pressure sensor for heart failure management. Our program has demonstrated a remarkable reduction in hospitalizations, ranging between 70-80%, showcasing the profound impact this technology has on patient outcomes.

When an insurance denial for CardioMEMS is received, it effectively mandates that I must treat my heart failure patients with a standard of care that falls below what I consider the gold standard. This not only undermines the advancements we have achieved in managing heart failure but also jeopardizes the well-being of patients who could otherwise experience improved quality of life and reduced hospital admissions.

I strongly urge the approval of coverage for the implanted pulmonary artery pressure sensor, as it is an essential tool in providing optimal care for heart failure patients.

Thank you for considering this important matter.

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I've been involved with cardiomems implantation and management since the original cardiomems registry as far back as 2014. I can think of no greater benefit to heart failure patients, on top of guideline directed medical therapy, than pulmonary pressure monitoring. The patients that receive this therapy go from being admitted frequently to the hospital (a “frequent flyer”) to having virtually no admissions. Not only that, but by enlarge these patiens live better lives free of clinical congestion. With a pulmonary artery pressure sensor (Cardiomems) we have a window into the patients failing heart that gives us day-to-day updates and significantly helps management as the clinical exam can be difficult in assessment of fluid status.

The greatest benefit of this therapy is best told through the stories not of those fortunate patients who are actually implanted with devices but of those who are not implanted. Every single patient who has been denied this therapy continues to suffer with clinical congestion, admission after admission to the hospital and an overall much rockier course over the life of their disease. More importantly, many of these patients succumb to their heart failure ultimately dying much more quickly. This is largely because the risk of being admitted to the hospital and chronically congesting and recongesting has been repeatedly shown to increase patients risk of death.

Despite having performed numerous appeals for patients to allow devices to be implanted we are repeatedly denied. Both time and energy of our staff and physicians is wasted on trying to help patients live lives free of morbidity and mortality related to heart failure. It is demoralizing as a provider to see one subset thriving and another failing despite knowing we have a tool to help. It is a travesty to see this in an almost daily basis in our clinics for patients who are denied the best care. Yes, the therapy is expensive but it pales in comparison to the cost of even a short stay in the hospital. I can confidently say that patients that have been implanted with this life saving, life prolonging, and life improving therapy have spent many more days out of the hospital than they would have without the device.

Please consider expanding coverage for this therapy to patients in need. I could not think of a greater benefit to the heart failure population.

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May 29, 2024

Tamara Syrek Jensen, JD
Director, Coverage & Analysis Group
Centers for Medicare & Medicaid Services
7500 Security Blvd.
Baltimore, MD 21244

RE: CAG-00466N Implanted Pulmonary Artery Pressure Sensor for Heart Failure Management

The American College of Cardiology (ACC) and the Heart Failure Society of America (HFSA) appreciate the opportunity to provide comment on the National Coverage Analysis (NCA) for Implanted Pulmonary Artery (PA) Pressure Sensor for Heart Failure (HF) Management. The societies are supportive of the development of a National Coverage Determination (NCD) for implanted PA sensors for HF Management. An NCD would rectify inconsistent coverage for Medicare beneficiaries across the country and ensure eligible patients have equitable access to this valuable technology. We recommend that the Centers for Medicare & Medicaid Services (CMS) cover Implanted PA Pressure Sensors for HF management in Medicare beneficiaries who meet the Food & Drug Administration’s (FDA) approved indication of NYHA Class II or Class III heart failure with either a prior heart failure hospitalization in the past 12 months and/or elevated natriuretic peptide levels.

HF is a complex clinical syndrome with symptoms and signs that result from any structural or functional impairment of ventricular filling or ejection of blood. According to data from CMS, the prevalence of HF among people enrolled in Medicare was 12% in 2022. HF is the leading cause of hospitalization among older adults, and Medicare enrollees with heart failure have the highest readmission rate of any condition.(1,2) The incorporation of implantable hemodynamic monitoring (IHM) services into the management of HF could bring about significant improvements in Medicare patient outcomes. The device is deployed through the pulmonary artery to monitor vascular pressure and to guide targeted HF treatment. The innovative technology allows for real-time monitoring of key physiological parameters, enabling healthcare providers to make timely and informed decisions about treatment adjustments. By facilitating early intervention at the onset of symptom exacerbation, the technology has the potential to drastically reduce the rate of hospital readmission, a common and costly occurrence in the HF patient population. Furthermore, the technology empowers patients, giving them an active role in managing their condition and improving their quality of life (QOL).

There are a number of studies that serve as evidence to demonstrate improved outcomes when the appropriate patients are monitored and managed with an implantable pulmonary artery pressure sensor, including the CHAMPION pivotal, randomized control trial (RCT),(3) U.S. Post-Approval Study (PAS),(4) the MEMS-HF study,(5) the CardioMEMS HF Post-Market Study (COAST)(6) and the GUIDE-HF RCT.(7) Additionally, the GUIDE-HF single arm study, which was presented at the Heart Failure Society of America’s Conference in October 2023 and is anticipated to be published soon, showed comparable results to the primary trial, indicating a functional benefit even in patients with elevated NT-pro BNP levels without prior hospitalization.

Since the submission of the NCD request, notable data has been published to further underscore the benefit of PA pressure sensor monitoring in select patients. MONITOR-HF was an open-label, randomized clinical trial conducted across 25 centers in the Netherlands with QOL as the primary endpoint. Patients with moderate-to-severe heart failure who received hemodynamic monitoring experienced significant improvements in QOL and a reduction in heart failure hospitalizations, following guideline-directed medical therapy (GDMT). The overall summary score mean improvement in the Kansas City Cardiomyopathy Questionnaire was 7.05 in the treatment group compared to -0.08 for the standard care group at 12 months (p=0.013). An improvement =10 points was seen in 41.7% in the monitored arm vs 30.6% in the standard care (OR 1.85, p 0.020). These results align with other randomized studies demonstrating improvement in QOL cited in the NCD request. Also notable was the benefit of reducing HF hospitalizations from 0.678 in control group to 0.38 per patient-year in the CardioMEMS-monitored group (HR 0.56, CI 0.38-0.84, p=0.0053).(8)

We would also like to highlight a recent meta-analysis, which concluded that the use of an implantable hemodynamic monitor improves survival rates in patients with HF with reduced Ejection Fraction (HFrEF). The HF management guided by hemodynamic monitoring significantly reduced overall mortality with an HR of 0.75 (95% CI: 0.57-0.99); P = 0.043. Furthermore, HF hospitalizations were significantly reduced with an HR of 0.64 (95% CI: 0.55-0.76); P < 0.0001. The analysis showed an evident decrease in HF hospitalization within the first year of monitoring and the benefits in terms of reduced mortality become apparent after the first year.(9)

Currently, Abbott’s CardioMEMS HF System is the only FDA approved device for remote hemodynamic monitoring for HF patients. There are several IHM services currently under development for HF management, including the Cordella System by Endotronix. The Cordella System PROACTIVE-HF Trial enrolled 456 patients at 75 hospitals in the U.S., Belgium, and Ireland with Class III symptoms, prior HF hospitalization or urgent visit and/or elevated NT-proBNP level > 1500pg/ml with LVEF = 0.50 or =800 for HF> 0.50, corrected for BMI. Participants were initially randomized followed by conversion to an open label trial after discussions with the FDA regarding clarification of current approved clinical indications for Class III HF. Primary effectiveness endpoint was a performance goal of 0.43 event/patient 6 months established prospectively with FDA, achieved 0.15 (CI 0.12-0.20, lower than performance goal, p<0.0001) and also (p=0.03) compared to the 0.28 rate for 72 patients implanted in the formal control arm prior to conversion to single arm at or before 6 months. This study was recently accepted for publication by JACC Heart Failure.(10)

The societies recommend that the developed NCD apply to all future hemodynamic devices that are approved by the FDA and indicated for wirelessly measuring and monitoring pulmonary artery pressure and heart rate in NYHA Class III or II heart failure patients who either have been hospitalized for heart failure in the previous year and/or have elevated natriuretic peptides. This approach ensures that the NCD remains relevant and applicable as new technologies emerge, supporting ongoing advancements in HF management.

Clinical Indications For Use Of Implantable PA Pressure Sensors For HF Management Among Medicare Beneficiaries

Data supports the benefits of ambulatory hemodynamic monitoring in the Medicare population to reduce HF hospitalization. A retrospective cohort study used U.S. Medicare claims data from patients undergoing a PA pressure sensor implantation between June 2014 to December 2015, and the rates of HF hospitalization during predefined periods before and after implementation were compared. The results showed that among 1,114 patient receiving the implants, there were 1,020 HF hospitalizations in the 6 months prior compared with 381 HF hospitalizations, 139 deaths, and 17 ventricular assist device implantations and/or transplants in the 6 months after implantation (HR=0.55 p<0.001) with estimated cost-saving $7433/patient. These benefits align with those demonstrated in the trials and were sustained to 1 year, supporting the “real world” effectiveness of an implanted PA pressure sensor to manage HF.(11)

Treatment efficacy is consistent across the spectrum of FDA indications; however, individuals at a higher risk experience greater absolute benefit as long as they have not become refractory to diuretic therapy. Overall, the higher absolute clinical benefit of reduced hospitalization is most pronounced in patients with higher absolute risk, which are those patients classified with Class III and Class II HF with prior hospitalization. The relative benefit is parallel in Class III and Class II HF patients without hospitalization and with elevated BNP or NT-proBNP. All patients were required to have elevated BNP or NT-proBNP levels for enrollment in trials.(12 )

The benefit of remote monitoring using PA pressure sensors has been shown across all EF ranges, including HFrEF and HF with preserved EF (HFpEF). In fact, the benefit is equal, if not higher, in patients with HFpEF.(13,14) Additionally, the hospitalization criterion is particularly relevant in patients with whom BNP or NT-proBNP levels are lower, such as patients with obesity. The data shows lack in apparent variants across subgroups, and that subgroups consistently benefit from utilization of the technology. Real-world experience demonstrates a larger representation of subgroups, including minorities. The data indicates there is no significant difference among subgroups, and all subgroups consistently benefit from the technology.(15)

The societies endorse a patient selection criteria that aligns with the GUIDE-HF trial. As outlined in the NCD request, patients must present with the following conditions:

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As the world’s largest peer to peer heart patient support organization, Mended Hearts sees first-hand the positive impact implantable hemodynamic monitoring devices have made on patients. These devices have reduced hospitalizations in heart failure patients. In addition, it has improved these patients’ quality of life through real-time insights of their medical condition by their medical team. This is especially significant for our rural population where receiving timely care is geographically challenging.

Thus, we ask CMS to provide coverage for the CardioMEMS HF System.

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I have been in practice for 41 years and have extensive experience in taking care of patients with congestive heart failure.
The CardioMems device (Pulmonary Artery Pressure Sensor) has been essential in keeping numerous of my patients out of the hospital. Patients who routinely were being admitted four to five times per year for CHF, are now staying home with almost no readmissions. Unfortunately, access to this technology is being limited by various insurances who label this "experimental" despite extensive support in the literature (eg GuideHF study) thus depriving those who need it the most.
Please approve this technology for general usage so that my patients can stay home and lead productive lives.

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We started implanting CardioMEMS sensors in 2008. Initially, it was part of the original CHAMPION HF Trial. With increasing aging of the U.S. population, the rate of HF hospitalizations and associated economic burden to insurance companies will continue to rise in the future. We witnessed a significant reduction in admission rates in our heart failure patients implanted with CardioMEMS.

I would like to emphasize the clinical significance of fluid overload in HF patients and the role of this implantable pulmonary artery pressure sensor to monitor hemodynamics in ambulatory setting to reduce HF re-admission rate. Early recognition of changes in patients’ hemodynamics using CardioMEMS led to earlier interventions before patients became fluid overloaded and admitted to hospital. Congestion is the primary cause of heart failure hospital admissions, predicts readmissions, and is often difficult to recognize, delaying appropriate treatment.

We have sufficient evidence from clinical trials and meta-analysis demonstrating the clinical benefit of remote pulmonary artery pressure monitoring. Therefore, it is time for insurance companies to cover pulmonary artery pressure monitoring to reduce healthcare costs by decreasing HF hospitalizations in the US.

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Cardiomems has helped me manage my patients heart failure tremendously. I have been able to keep my patients out to the hospital with this device. My patients are happier with this device because they can stay home and live their life out of the hospital.

It also helps delineate why patients are short of breath. Many times patients are admitted with heart failure when they have COPD or pneumonia and are given diuretics inappropriately and to their detriment; sometimes even putting them into renal failure.

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As a physician deeply involved in the care of patients with heart failure, I strongly support expanding insurance coverage and indications for the CardioMEMS device. This advanced technology has proven to significantly improve patient outcomes by allowing for continuous monitoring of pulmonary artery pressures, thereby enabling timely interventions that can prevent hospitalizations and deterioration of patient health.

In my experience, the use of CardioMEMS has facilitated more precise management of heart failure, allowing for adjustments in treatment before symptoms worsen. This preemptive approach not only enhances the quality of life for patients but also reduces the overall healthcare costs associated with frequent hospital admissions and acute care.

Expanding coverage to include a broader patient population will ensure that more individuals benefit from this life-saving technology. It will also support ongoing efforts to optimize heart failure management through innovative and evidence-based practices.

Thank you for considering these crucial updates to insurance coverage and indications for CardioMEMS. Your support will make a substantial difference in the lives of many patients and their families.

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The Cardiomem’s device has been instrumental in keeping our patients at corewell health west out of acute heart failure. More important than the significant reduction in admissions to the hospital, is the prevention of acute heart failure ( a very significant event associated with increased mortality) in our patients
Asymptomatic PA pressure monitoring adds a component of monitoring that is superior to other forms of monitoring. We decongest the patient before weight changes , vital changes and symptoms ( all late manifestations). The success of our program relies on the system we have set up to make adjustments when a patient has elevated PA pressures. We have a cohesive team and have created a platform to significantly improve the care of our patients. I would recommend that payers require evidence of a comprehensive monitoring program with minimal requirements prior to approving the device being implanted. The devices success is directly correlated to this monitoring platform. For example we have a set team of PAs and nurses making phone calls with standards for medication changes based on abnormal hemodynamics. We have a monthly multi-D meeting to discuss high risk patients. With such a system set in place using the information from the Cardiomem’s device ( it is key to understand this info can only come from measurement of PA pressures ).

In summary cardioMems is a fantastic device that should become more standard of care, with a set platform for monitoring in place.

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hello

I am a cardiologist and a heart failure specialist in Austin Texas and have taken care of thousands of patient's during my 17 years of practice. cardioMEMS has bene a novel tool that I've used now for 10 years to help manage patients more intelligently and offer better care. After over 300 patients, I have a very firm understanding of the strength of this device. My patient's have avoided being hospitalized and as such have enjoyed a better quality of life. there can be a significant anxiety component to having heart failure and having symptoms that may resemble an exacerbation of it. However, with cardioMEMs, we've been able to reassure many patients that they DIDN'T have a heart failure epsiode and that an urgent ER visit for CHF was not needed. This has calmed a lot of nerves (pts and providers alike).

During the peak of the COVID pandemic, we were able to offer "intelligent telemedicine" to our cardioMEMs population as we were able to get a sense of the patient's clinical status WITHOUT EVEN PHYISICALLY SEEING THEM and still offering them top notch care, despite the shortcomings of telemedicine

CardioMEMs has allowed me to care better for my patients. It is a shame that it is not available to all patients who may benefit despite robust data from 3 well conducted clinical trials.

I ask that you strongly consider supporting coverage and a national coverage decision for this tool. Within its indication, CardioMEMs should be considered standard of care and with it, it will positively impact the at risk and vunerable population that I see

thank you for your time

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As a heart failure and transplant physician, I have had the privilege of witnessing the transformative impact of implanted PA sensors on patients grappling with heart failure. These sensors are indispensable, enabling precise monitoring and optimization of heart failure therapies. Large clinical trials have demonstrated the benefits of the sensors, including improved quality of life, fewer hospitalizations, and decreased cardiovascular mortality. These advantages have persisted even as the technology has become more widely available commercially. It is astonishing that broader insurance coverage has lagged, given how well these benefits align with national healthcare goals, such as optimizing heart failure management and reducing hospitalizations. The benefits of the PA sensor are long term and are beneficial for patients near the beginning of their heart failure diagnosis when their symptoms start to worsening through the progression to end-stage heart failure. Treating heart failure is far more complex than merely adjusting medications, and the ability to monitor pulmonary artery pressure closely has revolutionized our practice, allowing us to deliver the right care at the right time.

Here are just a few examples of how implanted PA pressure sensors have made a significant difference:

A 62-year-old female with heart failure and preserved ejection fraction who previously required 2-3 hospitalizations annually has not been admitted to the hospital for over five years since her PA sensor was implanted.
A 55-year-old male with a history of a massive myocardial infarction was monitored with a PA sensor for four years. When his pulmonary artery pressures worsened, the sensor's data indicated he needed a heart transplant, which he successfully received.
A 68-year-old female with long standing heart failure due to familial cardiomyopathy requiring hospital admissions every 4 weeks for acute heart failure until she was able to receive a PA sensor and was managed at home until she eventually underwent Left Ventricular Assist Device implantation with ongoing PA sensor monitoring
An active elderly male, initially told he had no options and advised to say goodbye to his family, has lived for over five years thanks to the PA sensor. This device has allowed his medical team to gradually optimize his heart failure therapy while closely monitoring his fluid status, enabling him to continue enjoying life, including riding his motorcycle.

Many other patients could benefit from this remarkable tool, but access remains limited due to inadequate insurance coverage. The next step to further enhance patient care will hopefully be the ability to provide data on cardiac output.

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Implantable pulmonary artery sensors are an integral tool in the management of patients with congestive heart failure. There have been multiple observational and randomized trials that have shown a consistent outcome: pulmonary artery sensor monitors reduce heart failure hospitalizations in symptomatic patients regardless of ejection fraction. Furthermore, a recent meta-analysis of three randomized trials shows that implantable monitors decrease mortality in patients with reduced ejection fraction over a two-year period.

We currently follow >100 patients with the CardioMEMS device, and the ability to target congestion using pulmonary artery pressures has enhanced our ability to not only keep patients out of the hospital but also allowed us to optimize our implementation of guideline directed medical therapy. In addition, this technology has helped us to manage patients who may have limited access to health care due to distance, social determinants of health, age, etc.

Unfortunately, many insurance plans have denied coverage for implantable pulmonary artery sensors. As the prevalence of heart failure continues to grow, it is imperative that we need every tool to help combat this disease process. Based on the multitude of published trials and my team’s experience with the CardioMEMS device, I strongly urge that a national coverage decision is made for implantable pulmonary artery sensors monitors.

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The CardioMEMs device has been an extremely valuable tool in our patient cohort, allowing us to closely monitor the volume status of our relatively sick heart failure population that has a tendency to have multiple admissions per year. In the patients that have had CardioMEMs implantation, heart failure readmission has decreased substantially. Within the New York Presbyterian system, we have been able to reduce heart failure readmissions in patients with a CardioMEMs by 82% and all cause readmissions by 55%. I am one of 3 heart failure cardiologists that works with our central monitoring program, and our amazing team has been able to utilize the CardioMEMs in a way that has greatly improved our patient outcomes and quality of life.

As an anecdote, I have an elderly patient with end stage cardiac amyloidosis who had a cardioMEMs implanted in 2021. With the assistance of the CardioMEMs device, we have been able to greatly reduce his rehospitalization rate and provide sufficient control of his HF symptoms that he was able to travel to Jamaica and visit family he had not seen in over 2 decades.

A major frustration has been that several insurance providers reject approval for CardioMEMs implant, describing it as an experimental device, despite several published studies showing benefit in HF management.

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Cardiomems has been an instrumental advancement in how we an provide accurate care for the patients, and decrease hospitalization and now with meta analysis showing survival benefit, I have worked in the private sector for 8 years and continued at VA recently and my patients have benefited on both sides with this device. the outcomes have been better than what the studies reported for my institution

Biggest barrier has been inconsistency in how these approvals come through,
Studies have shown benefit across NYHA class, reduced clinic visits, travel burden.
All of this was magnified as we managed complex patients during COVID without having to risk the patients

The financial and clinical evidence both are robust for a device around for a decade with multiple RCT and registry to support it
It is time to make this more accessible to patients considering there is more evidence to a cardiomems managed appropriately helping decrease hospitalization then a provider provider routine phone call and encouragement or weight guided management

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The implantable PA pressure monitoring system, with the appropriate infrastructure in place that assures regular monitoring, response to alarms - have shown decreased HF hospitalization, improved patient quality of life, with some hints at survival benefit.

The device provides the platform for monitoring. But it is what follows, that makes the difference. I firmly believe that no one should be allowed to implant this device if monitoring and management services us/are not available post-op. As a corollary to that, patient contact, whether by tele or video visits to optimize medication regimen should be legitimate billable services.

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CardioMEMS (PA hemodynamic monitor) has been used at institution for over 2 yrs now. The procedure has been simple without complications. We follow patients in our virtual heart failure clinic with the assistance of nurse navigator, pharmacist, ADHF-TC MD, and HF trained NPs. We have close follow up on trends and triggers. Our patients have benefited tremendously. Review our own internal data, our HF readmissions mirror the clinical trial data.

I believe this is a valuable population health tool that can be used in multidisciplinary clinic to improve patients' quality of life and HF readmissions.

There are substantial amount of insurers that continue to denial this PA hemodynamic monitor quoting that it is still investigational. So we are not able to offer this to all of those patients.

Please consider a comprehensive review of the data and expanding the availability of this proven device to a wider population of pts and insurers

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We have implanted several hundred CardioMems at Scripps starting with the Champion trial and continuing after the device was approved. The device allows us to manage people more intelligently in the home and maintain euvolemia. Heart failure is often accompanied by elevated PA pressures and we are able to see these decline as we add therapy for both low and normal EF heart failure. We are also able to eliminate or reduce diuretics as they become euvolemic. Many of our patients have never been hospitalized again following the implant.

In my experience the device is extremely useful in the management of heart failure and results in significant patient benefit.

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I am writing to express my support for the national coverage of CardioMEMS™, an innovative technology that has demonstrated significant efficacy in managing heart failure patients. As a Heart Failure Nurse Practitioner and Coordinator of the Heart Failure Program at PENN Medicine Lancaster General Health, I have personally witnessed the positive impact that CardioMEMS™ has had on patient outcomes.
Heart failure is a significant public health concern, affecting millions of individuals in the United States and placing a substantial burden on healthcare systems. The annual cost of heart failure in the United States amounts to an estimated $32 billion, with a staggering 80% attributed to hospitalizations. Despite advancements in treatment modalities, managing heart failure patients can be challenging due to the dynamic nature of the disease and the need for timely intervention to prevent exacerbations and hospitalizations. This underscores the need for a strong partnership between patients and their care providers to reduce symptom burden and promote optimal patient outcomes.
The primary cause of HF hospitalization is congestion from elevated pulmonary artery pressures, which manifests as patient-reported dyspnea and edema. Timely recognition of new or worsening heart failure symptoms is paramount in managing the condition and preventing hospitalization. However, heart failure symptoms can be nebulous and challenging for patients to discern and intervene to prevent worsening congestion. Some patients have a tendency to minimize symptoms or adjust their level of activity to reduce their symptoms. In addition, 50% of patients hospitalized with worsening heart failure gain less than 2 pounds weight prior to hospitalization. This creates a significant challenge for patients to effectively monitor their condition. Therapies that can aide patients with self-care and reduce hospitalizations would have significant positive impact on patient quality of life, clinical outcomes and cost of illness.
CardioMEMS™ offers a unique solution by providing real-time hemodynamic monitoring of patients with heart failure. By implanting a small sensor in the pulmonary artery, CardioMEMS™ enables continuous remote monitoring of pulmonary artery pressure, allowing clinicians to proactively adjust treatment regimens based on individual patient data. This personalized approach has been shown to reduce heart failure-related hospitalizations and improve overall outcomes. Numerous clinical trials and real-world studies have demonstrated the efficacy and safety of CardioMEMS™ in reducing hospitalizations and improving quality of life. As HF program coordinator, I have personally analyzed the outcomes of our HF patients utilizing this technology and have observed a significant reduction in HF hospitalizations. The ability to respond promptly to changing hemodynamics not only facilitates adjustments to therapies but also offers valuable feedback to patients. It is not uncommon to see increases in pulmonary artery pressures due to patients skipping doses of their diuretics, taking over-the-counter medications such as NSAIDS or increased dietary sodium intake. Real-time knowledge of pulmonary artery pressure readings allows for timely feedback and education to the patient regarding the impact of medication and dietary non-adherence on their hemodynamics. This was confirmed in clinical trial where patients reported improved knowledge of their disease and impact of their lifestyle choices with CardioMEMS™ sensor data.
The evidence supporting the benefits of this technology is compelling, and its inclusion in national coverage would ensure equitable access for all eligible patients, regardless of geographic location or socioeconomic status. Furthermore, investing in the widespread adoption of CardioMEMS™ has the potential to generate substantial cost savings for healthcare systems by reducing hospital admissions and emergency department visits. By shifting towards a proactive, data-driven approach to heart failure management, we can improve patient outcomes while simultaneously alleviating the economic burden associated with this chronic condition.
In conclusion, I urge you to consider the compelling evidence supporting the national coverage of CardioMEMS™ and to advocate for its inclusion in reimbursement policies. By utilizing innovative technologies like CardioMEMS™, we can transform the landscape of heart failure management and improve the lives of HF patients across the United States.
Thank you for your attention to this important matter. I look forward to the positive impact that national coverage for CardioMEMS™ will have on heart failure patients and the healthcare system as a whole.

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As a cardiology clinic nurse, I have seen first hand how this device improves patient’s lives. With knowledge of increased pulmonary pressures, cardiologists are able to change patients diuretics before they even become symptomatic from fluid overload. Many of our patients have had an improved quality of life due to faster symptom recognition. This device also provides reassurance to teaching and instructions. With knowledge of their pressures, patients begin to have a better understanding of disease process management.

Overall our patient population is getting sicker and more and more people are ending up with recurrent hospital stays. A cardiomem is a HUGE asset to our HF patients in preventing recurrent visits due to enhanced knowledge. Knowledge is in fact power. Patients have reassurance that they are being closely monitored in their home. This prevents them from rushing to the hospital at the first sign of increased shortness of breath. APPROVE THE CARDIOMEMS. This device will change the way we manage HF for the better!

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The CHAMPION trial was done pre-COVID pandemic and was selective in evaluating patients with NYHA functional class III heart failure who had heart failure hospitalization in the previous 12 months. CardioMEMS resulted in a significant 28% reduction in heart failure hospitalization regardless of LVEF. The trial was not powered to evaluate mortality. Recently, the GUIDE-HF trial evaluated patients NYHA II-IV with a primary composite endpoint of mortality and heart failure events. The trial did not result in a lower primary endpoint rate in the overall study analysis. However, the trial did show a benefit in a pre- COVID-19 impact analysis (19% reduction in primary endpoint) driven mainly by a significant 24% reduction in heart failure events. This benefit disappeared during the COVID-19 pandemic. CardioMEMS may still have a key role in reducing heart failure hospitalizations in patients with NYHA functional class III. It is unlikely to benefit patients with NYHA class II or class IV. Further, it is not associated with survival benefit. Another analysis in 3-5 years may be helpful to determine if the benefit in heart failure events in patients with NYHA III class is sustained, and if the procedure is cost-effective in these patients.

Thank you,
Mohamad Yamani, MD, Division Chair-CV Circulatory Failure

Referenced articles:
William T Abraham, Philip B Adamson, Robert C Bourge, et al. Wireless pulmonary artery haemodynamic monitoring in chronic heart failure: a randomised controlled trial, Lancet 2011; 377: 658–66. DOI:10.1016/S0140-6736(11)60101-3

Jasper J. Brugts, Sumant P. Radhoe, Dilan Aydin, et al. Clinical Update of the Latest Evidence for CardioMEMS Pulmonary Artery Pressure Monitoring in Patients with Chronic Heart Failure: A Promising System for Remote Heart Failure Care, Sensors 2021, 21, 2335. https://doi.org/10.3390/s21072335

JoAnn Lindenfeld, Michael R Zile, Akshay S Desai, et al. Haemodynamic-guided management of heart failure (GUIDE-HF): a randomised controlled trial, Lancet 2021; 398: 991–1001. https://doi.org/10.1016/S0140-6736(21)01754-2

Puvanalingam Ayyadurai, Hassan Alkhawam, Muhammad Saad, et al. An update on the CardioMEMS pulmonary artery pressure sensor, Ther Adv Cardiovasc Dis 2019, Vol. 13: 1–11. DOI: 10.1177/1753944719826826

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The CardioMEMS system has made a substantial leap forward in the management of heart failure patients and improved overall access to care for patients with this disease process that results in repeat hospitalizations, poor quality of life and early mortality. Unfortunately, the potential of the system and management of the patients has been impeded by insurance companies who have been swayed by the pharmaceutical industry and evidence-based articles related to mortality. However, more data has been developed since the initial CHAMPION trial with the most recent evidence stemming from the MONITOR-HF trial that continues to show substantial benefit beyond current guideline directed medical therapy. Additionally meta-analysis have shown mortality benefit 2 years of monitoring.

The coverage decision is essential for numerous reasons. It will help move the field forward as bioinformatics will reduce time for appropriate intervention and help sustain appropriate medical therapy. The system will also bridge the gap as there will not be enough heart failure clinicians to provide the necessary care for the increasing number of heart failure patient's. Moreover it will provide insight into continued development of technology that would result in better outcomes and care while helping reduce costs for patients with heart failure.

I encourage you to support a decision to provide coverage for this device so that all patients, regardless of insurance, may benefit as it undoubtedly provides outstanding outcome for patients with heart failure.

Thank you for your consideration.

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Lack of reliable coverage has prevented us from providing CardioMEMS monitoring to our patients. I recall caring for a patient who could have greatly benefitted from this monitoring and we submitted her information to her insurance company. Despite probably a half dozen insurance pre-authorization attempts we could not get it authorized. I personally spoke with the peer to peer reviewer who flat out said its experimental and refused to authorize it. He was not even a cardiologist and had no interest in reviewing the randomized control trials supporting utilizing CardioMEMS. As a direct result of this, the patient has had dozens of heart failure exacerbations and many admissions. Our experience has been similar with other patients. Also the downstream monitoring needs to be financially viable option for practices to be able to invest FTE resources in providing the monitoring needed for checking readings and then contacting patients for medication titration.

NCD coverage of this device would prevent unnecessary HF admits by alerting physicians early about impending HF hospitalizations saving the health systems, the patients and the insurance carriers precious health care dollars. This investment is a win-win for all parties involved. More than a decade of data exists to support use of CardioMEMS as a safe and effective tool to prevent HF hospitalizations and leading to also better medication titration.

We conducted an analysis of the publicly available MAUDE data base and have not identified worsening complications in recent years despite a wider approved indication for use. Data is being submitted for publication. Data supporting value of this device is extensive and out of scope of discussion here.

It’s time to make this monitoring main stream in properly selected patients and encourage practices to invest in it to improve lives of our patients.

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As a VAD coordinator working with many types of Heartmate 3 patient profiles, the remote implantable monitoring of PAD has been extremely beneficial for those folks that have it implanted prior to Heartmate 3 in reducing Heart failure progression and hospital admission. It is also shown to improve patient's QOL to remotely monitor versus having a patient return to clinic/hospital setting for assessment and diuretic management.

Due to the success we have seen in that patient population, we have attempted to get coverage for the device for those post operatively implanted with a Heartmate 3 Device. The attempts remain very difficult, as each insurance requires a different definition of necessity. With a standardization, our teams would know how to approach this therapy with our own patients and potentially improve their quality of life.

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I oversee clinical operations for a large Cardiovascular Medical Practice that now implants CardioMEMS devices in our ASC. We appreciate CMS approving this procedure to be done in the place of service of an ASC as this opens the door to more cost effective, convenient care for many patients who can benefit from this device. The national healthcare quadruple aim is to improve access, improve quality, improve cost effective care, and improve patient satisfaction. Allowing this procedure to be done in the ASC setting will enable greater access to this implanted monitoring device that will provide early detection of heart failure episodes, modification of treatment plans, and reduction of hospital admissions and critical patient events. A coverage determination plan that supports this procedure and allows this procedure to be done in the ASC setting would greatly benefit patients with heart failure.

Thank you
Angela Szczublewski, CMPE, MES, B.Ed
Chief Operating Officer
Tri-City Cardiology Consultants, PC

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Heart failure is a chronic and often fatal disease that is often associated with a high hospital admission events. Not only does each hospitalization increase risk of mortality but also the healthcare cost to the patient and society. Cardiomems is a VERY USEFUL tool in the management of heart failure patients- regardless of whether HF is from diastolic/ systolic disfunction or in Pulmonary Hypertension pts w/ Right sided heart failure. . In the majority of patients we have implanted the Cardiomems, device we have found that hospital readmissions have declined with an improvement in quality of life in our patients with better management. Often this immediate feedback on fluid overload status helps the patient identify dietary indiscretions easier and therefore can change diet behaviors. This results in less need for diuretics and less renal failure.

Thank you in advance for your consideration in allowing use of this device in patients with heart failure.

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Dear CMS,

I am writing to share with you my thoughts about the important role that CardioMems currently pays and possibly in the future if it was made easy for physicians to implant in the right patient population:

1) This device has obviously been shown to be reliable in tracking pressures in the lung and left side of the heart telling physicians REMOTELY that patient are in heart failure BEFORE these patients get to the hospital. We all know that admission to the hospital with CHF is the number one diagnosis for Medicare admission and costs our healthcare millions of Dollars. So, it behooves all of us to work together to figure out how best to use this device, not only to tell us who is in CHF, but more importantly who is a risk for going into CHF, by monitoring their pressure on a daily basis and be able to call patient and adjust their meds while still at home to avoid hospitalization.

2) Call patient and advise them on salt intake and salty food when we see that their pressure if going up before they are bad and need hospital admission

3) Use this device in patient with ESRD to help decide on their volume status during dialysis to avoid drying them up too much or keeping them fluid overloaded

4) Even in patients admitted with CHF, and for some reasons were not following up and downloading their data, be able to monitor them objectively and titrating diuresis so we can get them out of the hospital ASAP

I hope you find these statements useful for your consideration. Please feel free to email me if you want to engage in more discussion regarding this device.

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Implanted pulmonary artery sensors play a vital role in managing patients with heart failure. Several studies have shown that a rise in pulmonary artery pressures precede traditional measures like weight gain when trying to identify early heart failure decompensation. Early intervention reduces hospitalization and decreases health care expenditures. Medicare coverage of this important technology is vital to promote its continued use.

Our own experience with pulmonary artery sensors has been very positive. Patients appreciate the attention to their disease management and over time gain a better understanding of how their behaviors affect they pressures and heart failure.

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As the managing provider of our CardioMEMs program, I have first hand knowledge of the benefit of CardioMEMs devices. We have been able to prevent many hospitalizations and harm to patients by the use of this device. So many of our patients are symptomatic from their lung disease and it is very difficult to assess many patients due to their body habitus. The CardioMEMs device removes the guess work and thereby decreases harm and prevents hospitalizations.

I 100% support CardioMEMs devices in this high risk group of patients for which the device is recommended.

Lisa Armstrong, DNP, APRN-CNP

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Symptomatic heart failure continues to be associated with very high rates of hospitalization and high rates if health care utilization. Our institution was a part if the CHAMPION and GUIDE-HF studies along with PROACTIVE -HF study using implantable hemodynamic monitors for heart failure management. Beyond the data published based in clinical trials, our internal use data showed significant decrease in HF hospitalization as well as decrease in need for repetitive clinic visits foe these patients.

In patients with symptomatic class II and class III HF, we believe that IHM guided management should be an available option for all patients.

The current lack of national and universal coverage for implantable pulmonary artery monitors has been a very big impediment in our ability to use this very powerful tool to take care of these patients. We would urge CMS the make this available by making a positive decision on National Coverage.

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I commend CMS for considering to perform a NSA on implanted pulmonary artery pressure sensors. This move is a positive step forward, setting the stage for more groundbreaking advancements in healthcare technology within the CHF space.

Despite the undeniable benefits of current monitoring technologies, their invasive nature, significant costs, and the complex requirements for usage represent notable drawbacks. Fortunately, we are on the cusp of a major breakthrough. By 2025, a new, non-invasive, cost-efficient remote patient self monitoring device using bioimpedance spectroscopy will be introduced to the market, transforming how we monitor body fluid levels—from a cumbersome, invasive process to a quick, simple measurement that enhances patient comfort and compliance.

Clinical trials have repeatedly shown the efficacy of remote monitoring in reducing hospitalizations and improving treatment for heart failure patients. However, to truly revolutionize heart failure management and make it accessible to all, we need technologies that are not just effective but also broadly accessible, to the point that every single person diagnosed with CHF has access. Only such a solution can promise to extend these benefits across diverse populations, including those typically underserved by current healthcare models.

Looking ahead, the potential to integrate automated diuretic dosing devices, similar to those used in diabetes care, could radically alter heart failure treatment, making it more responsive and tailored to individual needs, while at the same time lowering system costs.

The proposed NCA will pave the way towards better patient outcomes. It's imperative that we continue to push the boundaries of what's possible in medical technology. By supporting innovation and reducing barriers to access, we can ensure that advancements in heart failure management are not only possible but are within reach for every patient who stands to benefit.

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To whom it may concern,

Heart failure is the leading cause of death in patients with congenital heart disease. Patients with ACHD at particularly high risk for HF are those with two ventricles and a systemic right ventricle (sRV), including complete dextro-transposition of the great arteries (TGA) after atrial switch (D-TGA/AS) and congenitally corrected TGA (ccTGA), and in patients with single ventricle Fontan circulation. We have found the CardioMEMS HF system useful in patients with sRV and Fontan circulation in ways that can potentially decrease the costs of patient care.

As we published recently (Heart, 2023, https://heart.bmj.com/content/110/7/491), pulmonary hypertension (PH) is a common complication in patients with sRV and can limit the ability to provide life-saving heart transplant if it is present. Furthermore, in this population with sRVs, echocardiography is a poor screening tool for PH. Therefore we have used the CardioMEMS system to monitor patients at high risk for PH to prevent the development of transplant-limiting PH. The CardioMEMS system allows for serial monitoring of pulmonary artery pressures without repeat catheterizations to help identify the optimal time for heart transplant referral. This improves the patient experience by decreasing serial catheterizations (sometimes as often as every 6 months) and decreases the costs of care as 1 catheterization with CardioMEMS placement may prevent multiple follow up catheterizations over the next few years. In addition, we have used it for medical therapy titration and medical management after ventricular assist device, all reducing invasive cardiac catheterizations.

The trajectory of heart failure is different in patients with sRV, and some may not ever have a heart failure hospitalization but have PH already. Therefore, use of this device BEFORE a heart failure hospitalization can be helpful, but is often not covered by the patient's insurance. Furthermore, we have had patients with classic indications for CardioMEMS (heart failure hospitalization, elevated BNP) who have not been approved, therefore increasing coverage for the use of this device would be helpful for not only the health care team but also the patients, potentially preventing multiple invasive procedures in the future.

Another population where we have found the device to be useful is in patients with single ventricle Fontan circulation, which is a variable form of complex congenital heart disease, at high risk of heart failure and with accompanying liver disease which develops in direct relation to the degree of pressure elevation in the venous system. In these patients, we have found that pressures by the cardioMEMS HF system may better represent real-life conditions compared with catheterization pressures, as they were associated with long-term mortality (JAHA, 2023. https://www.ahajournals.org/doi/full/10.1161/JAHA.123.031836). Furthermore, the pressures by the CardioMEMS device were also better associated with the degree of future liver disease than catheterization pressures. Therefore, this is another unique patient population with high incidence of heart failure in which the CardioMEMS device has prognostic significance and can reduce the number of invasive procedures the patient may have in their life.

We thank you for your attention.

William H. Marshall V, MD

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Heart failure is exceedingly common among Medicare beneficiaries and management of heart failure represents one of the largest cost categories for Medicare. The great majority of that cost is due to hospitalizations for decompensated heart failure. Heart failure admissions are almost universally due to volume overload and pulmonary congestion. For many years the mantra for prevention of heart failure admissions has been close interaction with patients by phone or in person to monitor for symptom and weight changes. A long series of randomized trials however show that disease management programs focused on daily weights and symptoms do not decrease the frequency of hospital admissions. At least 30-40% of heart failure admissions are not preceded by any weight gain at all. Three prospective sham controlled randomized trials of remote hemodynamic pressure monitoring have each demonstrated a reduction in heart failure admissions by 30-40%. The recent meta-analysis by Lindenfeld et al makes that conclusion unassailable and in fact showed a significant mortality benefit. Based on the trial database and our anecdotal experience with many patients in our heart failure program we strongly believe that this strategy improves symptoms and quality of life for these patients. We strongly urge creation of a NCD creating a positive coverage for remote monitoring of hemodynamic pressures.

Thanks sincerely,
R. Douglas Ensley, MD
Medical Director, Heart Failure Program
Chairman, CV Sciences Department
Saint Francis Hospital
Tulsa, Oklahoma

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I work as the Advanced Heart Failure Coordinator RN for a university hospital in central Arkansas. In our clinic we frequently see patients who note a decreased quality of life due to daily symptoms resulting from their heart failure diagnosis, with many of these patients experiencing frequent hospital admissions due to heart failure exacerbations. We have several patients whom we have implanted with the CardioMEMS device, allowing our providers to closely monitor patients PA pressures and titrate medications accordingly prior to patient symptoms. Our clinic has tracked these CardioMEMS patients hospitalizations both pre and post implant, noting a significant decrease post implant in both ER visits and hospital admissions relating to heart failure exacerbations. This decrease in hospital admissions not only assist in improving our patients quality of life, but also helps to relieve the financial strain that readmissions have on our institution as a whole.

A large portion of our patients are low-income patients receiving government insurance. Medicaid does not cover for patients to receive CardioMEMS and other insurance companies such as United Health Care, Blue Crose Blue Shield, and Medicare Advantage plans, frequently deny initial request and require peer to peer review. After peer to peer reviews are completed, a large portion of our CardioMEMS prior authorizations are still denied. These denials prevent our patients from receiving a higher level of monitoring and care for their heart failure.

In addition to allowing our providers to closely monitor patients PA pressures to assess fluid status, the CardioMEMS device has assisted our team in identifying when a patient has an abnormal rhythm like a-fib, allowing our providers to further investigate with ICD device interrogations or EKG’s to confirm rhythms and treat accordingly.

Many of our CardioMEMS patients voiced having a sense of comfort knowing that their pressures are being monitored daily while they are home by their cardiologist. This device has allowed us to better care for our patients resulting in improved quality of life, as well as decreasing the strain of readmissions on our facility. In order to make a greater impact on the area we serve, we need CardioMEMS to be approved by a wider selection of insurance companies.

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With the implementation of CardioMEMS we have seen a drastic decrease in hospitalizations in this patient population of Heart Failure patients.

CardioMEMS gives us the ability to track patients daily for Pulmonary Artery pressure to ensure we have a good trend on their fluid status. CardioMEMS data allows us to remotely treat and modify patient diuretics to match what their body is doing in near real-time and to prevent worsening heart failure and costly readmissions.

CardioMEMS is the only product that we have seen that can help us predict worsening condition of heart failure up to 30 days before a readmission may occur. This early detection helps Heart Failure patients to live a longer more active and healthier life. It is well documented that for every heart failure readmission a patient decreases their probability of death. https://bmccardiovascdisord.biomedcentral.com/articles/10.1186/s12872-022-03020-x#:~:text=The%20adjusted%20mortality%20HR%20for,CI%2C%202.00%E2%80%932.45).

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As the device clinic RN, I manage the ICD, pacemaker and ILR patients. Most ICDs and some pacemakers have heart failure diagnostics, some are better than others in the detailed information to be able to gauge a patients heart failure status, but nothing compares to the Cardiomems sensor. The PA sensor helps our team to be able to manage our patients heart failure on a day to day basis to keep them out of the ER and hospital. Patients with PA sensors are more engaged in their heart failure management and it enables providers to have real time data to manage their heart failure accurately. This sensor has significantly increased our capabilities of taking care of our patients and managing their symptoms.

We are a centralized University hospital in Little Rock and we have a high percentage of low income patients. Many patients require the assistance of state benefits such as Medicaid services. Most patients with heart failure are in need resources such as nutrition and medication counselling and this patient demographic is in need of extra attention due to their risks of decreased resources available to them in their direct community which creates a domino effect and they end up being treated in the hospital rather than from an outpatient standpoint. One of the current problems our team is facing is patients with Medicaid insurance are not provided with the same resources as patients with private insurance. If this PA sensor was available to our Medicaid population, we would see a decrease in ER visits and we would be able to manage them remotely. As an organization, we are already doing everything we can to optimize these patients care by providing scales, etc but this has shown not to be enough. We are in need of other real time data to help reduce hospitalizations and manage our patients to the best of our ability!

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As a registered nurse specializing in heart failure care, I strongly advocate for the national coverage approval of CardioMEMS implanted pulmonary artery pressure sensor. This innovative technology offers a transformative approach to managing heart failure by providing real-time, remote monitoring of pulmonary artery pressures. By implanting a small sensor in the pulmonary artery, CardioMEMS enables healthcare providers to closely track changes in a patient's condition, allowing for timely interventions and adjustments to their treatment regimen. I am our organization's CardioMEMS coordinator and have personally arranged for over 70 implantations thus far. Due to the limitations we face in terms of insurance barriers, my patients are prevented from accessing this life-saving technology. This immediate denial of coverage puts them at a significant disadvantage. Traditional monitoring of heart failure can pose significant challenges for patients with difficult-to-manage heart failure. Here's why:

1. Delayed Detection of Decompensation: Heart failure is characterized by fluid overload and impaired cardiac function, which can worsen rapidly. Without continuous monitoring provided by CardioMEMS, subtle changes in pulmonary artery pressures that indicate worsening heart failure may go unnoticed until symptoms become severe. This delay in detection can lead to delayed interventions and increased risk of hospitalization or even life-threatening complications.

2. Limited Treatment Optimization: CardioMEMS enables healthcare providers to make timely adjustments to medication regimens based on real-time data. Without this technology, treatment optimization relies heavily on periodic clinic visits and subjective symptom reporting from patients. As a result, there's a higher likelihood of suboptimal medication dosing or delays in modifying therapy, which can impede symptom management and disease progression.

3. Increased Healthcare Utilization: Heart failure exacerbations often necessitate emergency room visits and hospital admissions, which not only disrupt patients' lives but also impose substantial healthcare costs. Without CardioMEMS, patients are at higher risk of experiencing sudden decompensations that require acute medical attention, leading to a greater reliance on costly healthcare resources and potentially preventable hospitalizations.

4. Limited Patient Engagement: CardioMEMS empowers patients to actively participate in their care by providing them with regular feedback on their health status. This engagement fosters a sense of responsibility and accountability, motivating patients to adhere to treatment plans and make lifestyle modifications. Without access to CardioMEMS, patients may feel disempowered and disconnected from their healthcare, potentially leading to poorer self-management and adherence to medical recommendations.

5. Long-term Health Outcomes: Studies have shown that CardioMEMS-guided therapy is associated with reduced heart failure-related hospitalizations, improved quality of life, and prolonged survival. Denying patients access to this evidence-based technology due to insurance limitations not only compromises their immediate well-being but also undermines their long-term health outcomes and quality of life.

Heart failure is a complex and chronic condition that requires diligent management to prevent exacerbations and improve patient outcomes. However, traditional methods of monitoring, such as routine clinic visits and symptom assessment, often fail to capture subtle changes in a patient's condition until they escalate into serious complications. CardioMEMS offers a proactive solution by continuously monitoring pulmonary artery pressures, which are sensitive indicators of fluid status and cardiac function. This proactive approach empowers healthcare providers to intervene early, optimize medication therapy, and prevent hospitalizations.

Furthermore, CardioMEMS has demonstrated significant clinical benefits in numerous studies, including reduced heart failure-related hospitalizations, improved quality of life, and prolonged survival. By expanding access to this life-saving technology through national coverage approval, we can enhance the standard of care for heart failure patients across the country. It not only improves patient outcomes but also reduces the burden on healthcare resources by minimizing hospital admissions and emergency room visits.

In conclusion, from the perspective of an RN working directly with CardioMEMS patients, I have seen firsthand the transformative impact this technology has on their lives. By enabling proactive monitoring, fostering patient engagement, and facilitating personalized care, CardioMEMS plays a vital role in improving outcomes and enhancing the quality of life for individuals living with heart failure. As a nurse dedicated to providing the highest quality of care to heart failure patients, I believe that the approval of CardioMEMS for national coverage is imperative. It represents a critical advancement in heart failure management, offering a proactive approach to monitoring and intervention that can significantly improve patient outcomes and reduce healthcare costs in the long term. I ask, with no small amount of pleading, that the national coverage decision for this device be approved. I am sincerely grateful for your time and attention regarding this very important matter.

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Dear CMS,

I want to express my strong support for the national coverage decision to include pulmonary arterial pressure (PAP) monitoring as a standard care option for patients with heart failure. As an advanced heart failure cardiologist, I have witnessed firsthand the challenges faced by individuals struggling with heart failure and believe that PAP monitoring represents a significant advancement in our ability to manage this debilitating condition effectively.

Heart failure affects millions of individuals in US, imposing a substantial burden on both patients and healthcare systems. Traditional management approaches have often fallen short in preventing hospitalizations and improving long-term outcomes. PAP monitoring technology offers a proactive approach, enabling continuous, real-time assessment of a patient’s cardiac status. This allows for timely interventions before symptoms worsen, potentially averting critical exacerbations and reducing the frequency of hospital admissions. Notably, heart failure related mortality is on the rise and this affects disproportionately rural communities with difficulties to access health care (https://jamanetwork.com/journals/jamacardiology/article-abstract/2817830). This is exactly where remote monitoring is most helpful.

Evidence from clinical trials and real-world studies has consistently demonstrated that PAP monitoring leads to a significant reduction in hospital readmissions for heart failure patients. For instance, the landmark CHAMPION trial revealed that this technology reduced heart failure hospitalizations by ~30% over a six-month period. Such outcomes not only enhance patient quality of life but are also cost-effective, reducing the economic impact on our health services. To date, the cumulative body of evidence strongly supports hemodynamic monitoring as an effective strategy to reduce not only hospitalization rates but also mortality related to heart failure (https://www.sciencedirect.com/science/article/abs/pii/S0735109723082578?via%3Dihub) (https://www.sciencedirect.com/science/article/abs/pii/S0735109723082050?via%3Dihub).

Incorporating PAP monitoring into the national coverage would ensure that all eligible patients, regardless of their geographical location or economic status, have access to this innovative and lifesaving technology. It is a step forward in personalizing heart failure management, aligning treatment protocols more closely with individual patient conditions, thereby optimizing therapeutic outcomes.

I urge you to consider the substantial clinical benefits and cost-effectiveness of PAP monitoring for heart failure management. National coverage is a crucial step in ensuring that healthcare providers can offer the best possible care, utilizing all available tools to improve patient outcomes and quality of life.

Thank you for considering this important matter.

Marat Fudim, MD, MHS
Duke University Medical Center
Durham, NC, USA

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I am a Cardiomems implanting physician. This device in my opinion is a "game changer" for the management of CHF patients, with both systolic and diastolic heart failure.

It is fairly easy to implant, the risks are minimal, and the most important fact is that it improves the quality of life of the patients and has been shown over and over again TO KEEP PATIENTS OUT OT THE HOSPITAL!!

It should be approved as a standard in the armamentarium of treatment options for patients with congestive heart failure.

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Implanted pulmonary artery pressure monitoring is a great way to manage symptoms and allow for a better quality of life for individuals. Our heart failure population struggles every day with symptoms that change their quality of life. This progressive disease leads to death and increased disability. Using real time monitoring helps people to live a better life with the time that they have left making them happier overall. Pulmonary artery pressure monitoring also allows to reduce hospitalizations in heart failure patients leading for more resources for other individuals who need them. Hospitalization of heart failure patients leads to a higher mortality rate. Reducing exacerbation of heart failure reduces the damage that is done to the heart of the individual again giving them a better quality of life. Please approve pulmonary artery monitoring devices for all people who need them to improve their overall wellbeing.

thanks
Melody Sonnenberg

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I am writing in strong support for national coverage for ambulatory pulmonary artery monitors in chronic heart failure management. I have followed the data and progress of this technology since I presented the results of the Champion trial in 2011. I am now the medical director for heart failure in Ascension Texas and guide the care and management of heart failure patients throughout our network of multiple hospitals and cardiologists.

We have incorporated this technology into our network as part of a multifaceted disease management of heart failure patients. I have seen that it has allowed for coordination of care within a large system with multiple providers and hospitals and allows for early identification of patients failing medical therapy and improves quality of life. We have overall made great gains in our readmission metrics locally in our hospital in part to this technology. Technology such as this also promotes equity in healthcare outcomes allowing monitoring of patients with heart failure and close follow-up even if they reside hours away from an advanced heart failure hospital. The data supports these efforts and I look forward to a national decision to continue to support our program.

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Thank you for considering pulmonary artery pressure (PAP) monitoring for a National Coverage Determination. I am writing in strong support of this NCD for several reasons:

1. Clinical trial data (GUIDE-HF and CHAMPION studies) demonstrates that PAP guided HF management results in lower PA pressures and fewer hospitalizations in patients with heart failure. The control arm of both trials utilized routine telephone monitoring, proving the scientific concept that PAP-informed management is more effective than our usual methods of telephone monitoring (asking about weights, symptoms, etc).

2. Furthermore, routine telephone monitoring of patients with heart failure is not even done in routine clinical practice. Real world studies actually show much more dramatic decrease in PAP than seen in clinical trials, providing evidence for even greater benefit in a broader patient population. Additionally, the MONITOR-HF study used a real world control group (no implant) with greater reductions in HF events and improvements in quality of life compared against PAP monitoring.

3. In the GUIDE-HF study, the subgroups that demonstrated the most dramatic benefit were WOMEN and BLACK patients. The mechanism for this benefit has not been fully explained, but based on my clinical/research experience, use of symptoms alone to adjudicate severity of heart failure results in inequity due to (1) symptom-hemodynamic mismatch (2) the observation that women may describe their heart failure symptoms in affective terms (depression, feeling tired, feeling anxious) rather than typical physical symptoms (shortness of breath) and (3) underreporting of symptoms based on cultural or other reasons. The poor concordance between symptoms/functional class and hemodynamics is further demonstrated by the finding that patients with NYHA Class II and NYHA Class III symptoms were not hemodynamically distinguishable in the GUIDE-HF study. PAP sensor allows for objective treatment of heart failure, decreasing bias in the care of patients.

4. Currently, there is inequity in coverage for PAP sensor implantation. In most regions, Medicare fee for service (FFS) patients have access to this therapy, while most other patients do not. Most of the time, patients cannot determine their own insurance destiny (cannot decide to be covered by Medicare FFS). This is also a bias against younger patients who do not quality for Medicare.

5. As a result, we are often spending extraordinary amounts of administrative time to try to provide PAP sensor implantation/monitoring through insurance authorizations, appeals, etc. An NCD would allow our focus to be back on the patient.

6. I have managed patients with PAP sensors in multiple regions (formerly the South, currently the Pacific Northwest) and the consistency of benefit is remarkable.

Thank you for your consideration and please feel free to contact me with any question.

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I am writing to advocate for the expansion of coverage under the National Coverage Determination (NCD) for CardioMEMS, an innovative and life-saving technology for managing heart failure patients.

As a cardiologist, I have witnessed firsthand the transformative impact of CardioMEMS in improving patient outcomes and reducing healthcare utilization among individuals living with heart failure. CardioMEMS is a wireless pulmonary artery pressure monitoring system that allows for proactive management of heart failure by providing clinicians with real-time data on patients' hemodynamic status.

Numerous clinical trials and real-world studies have demonstrated the efficacy and cost-effectiveness of CardioMEMS in reducing heart failure hospitalizations, improving quality of life, and prolonging survival for heart failure patients. By enabling early detection of worsening heart failure symptoms and facilitating timely intervention, CardioMEMS empowers both patients and healthcare providers to optimize treatment strategies and prevent disease progression.

However, despite the overwhelming evidence supporting the clinical benefits of CardioMEMS, access to this life-saving technology remains limited due to existing coverage restrictions under the NCD. Expanding coverage for CardioMEMS would ensure equitable access to this proven intervention for all eligible heart failure patients, thereby reducing disparities in care and improving health outcomes across diverse populations.

I urge you to consider the compelling evidence supporting the efficacy and value of CardioMEMS and to support its inclusion in the NCD for broader coverage. By expanding access to CardioMEMS, we can enhance the quality of care for heart failure patients, reduce healthcare costs associated with heart failure exacerbations, and ultimately save lives.

Thank you for your attention to this important matter. I am available to provide any additional information or support needed to facilitate the expansion of coverage for CardioMEMS under the NCD.

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The CardioMEMS device is a FDA approved lifesaving remote monitoring system for heart failure patients which allows for in depth understanding and knowledge of a heart failure patient's volume status which can indicate acute volume overload at least 2 weeks before there may be outward symptoms which would bring a patient to the ER. Heart failure (HF) is a chronic, progressive syndrome that is characterized by congestion, fluid retention, as well as inadequate cardiac output. Without proper management, HF worsens and develops into acute decompensated heart failure (ADHF), a condition associated with increased hospitalization and mortality rates.

The CardioMEMS HF System is FDA approved for wirelessly measuring and monitoring pulmonary artery pressure in New York Heart Association (NYHA) Class II or III heart failure patients with a prior hospitalization for heart failure the previous year and/or an elevated natriuretic peptides.
The hemodynamic data are used by physicians for HF management and with the goal of controlling PA pressure and reducing HF hospitalizations. CardioMEMS will allow us to more closely monitor pulmonary pressures and volume status, which are indications that allow for actionable interventions with diuretics and other HF medications.

Ongoing monitoring of PA pressure, used in conjunction with clinical signs and symptoms, can provide a rational basis for the selection of medication dosagesii-iv and can reduce HF hospitalizations and improve patient outcomes. Based on measures collected remotely via the patient home electronics unit, the CardioMEMS system pairs with a securely designed data platform that automatically generates easy-to-read reports for physicians. This gives physicians the ability to make time-sensitive and potentially critical treatment decisions for patients with heart failure.

There are multiple studies which prove the utility of this device for our heart failure patient population. It is often time consuming to have this device covered by insurance payors which limits the timely use of this device. This device has been statistically proven to improve and reduce hospitalizations due to heart failure.

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This technology has a tremendous amount of benefit versus risk. We have a very active CardioMEMS program and manage patients on a daily basis. We have been able to accurately manage their diuretics while they are remotely from home and intervene 2 weeks BEFORE they have symptoms of shortness of breath or weight gain because the pulmonary pressures will rise first. The data also supports it decreases hospitalizations and mortality. Unfortunately, the insurance companies have not been educating themselves on this and we have had several denied appeals with them claiming it is 'investigational'. It is NOT investigational; it is in the Heart Failure guidelines and has been FDA approved for several years. We have also been able to detect recurrent atrial fibrillation (since you also trend the heart rates) and pushed off hemodialysis by avoiding overdiuresis.

For ALL these reasons, please take it into consideration because it is worth its cost when you can improve the patient's quality of life and keep them out of the hospital.

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Dear CMS Decision Makers,

I am writing to express my strong support for the inclusion of CardioMEMS in the National Coverage Determination (NCD) by CMS. CardioMEMS represents a significant advancement in the management of heart failure patients, offering a novel approach to monitoring and managing this chronic condition.

The CardioMEMS device provides real-time hemodynamic data, enabling early detection of worsening heart failure symptoms before they escalate into critical events that often result in hospitalization. By allowing clinicians to intervene proactively, CardioMEMS has the potential to reduce hospital readmissions, improve patient outcomes, and ultimately lower healthcare costs.

Furthermore, numerous clinical studies have demonstrated the efficacy and safety of CardioMEMS in reducing heart failure-related hospitalizations and improving quality of life for patients. This evidence underscores the importance of ensuring access to this life-saving technology for Medicare beneficiaries.

Incorporating CardioMEMS into the NCD would not only benefit patients by providing access to innovative care but also align with CMS's goal of promoting value-based healthcare delivery. By investing in preventive measures and technologies like CardioMEMS, CMS can support a healthcare system that prioritizes proactive management, patient-centered care, and improved outcomes.

I urge CMS to recognize the significant clinical benefits of CardioMEMS and include it in the NCD, ensuring equitable access for Medicare beneficiaries nationwide. Thank you for your attention to this matter and for your ongoing commitment to advancing healthcare for all Americans.

Sincerely,
Shivanshu Madan

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I have personally seen extremely touching stories of patients who have reached a point of hopelessness with heart disease. Some do not have family near to care for them, which is just the tip of the ice burg. Many others are frequenting our hospital which is also risky for such frail individuals. The care and oversight our providers provide patients who have been carefully selected for cardiomems implant have had incredible success and we've seen their readmission reduced by > 90%! What a tremendous way to care for patients. Sadly many insurances have prevented patients we've carefully selected. Our nurse monitors patients and watches over them and their tendencies to determine who would be compliant and do well with the implant. It's been a flawless model!

Thank you for considering this a covered portion of CMS's national coverage.

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As the Medical Director of our enterprise-wide remote heart failure management program, I am writing CMS to approve for PA Pressure monitoring devices for symptomatic heart failure patients (NYHA II/III) and the follow up. I have real world clinical experience using these devices for the past 7 years and our enterprise-wide HF program has cared for over 600 patients with these devices. Our internal data shows consistent reduction in heart failure and all cause hospitalizations at 82% and 55% (using patients as their own control) since we started using these devices in 2016. We have also seen improvement in quality of life using these devices not only related to hospitalization reduction where patients have reported 4.7 out of 5 stars satisfaction with how they are better able to understand their health, feel involved in the decisions about their care and they would recommend this management to their friends/family. These devices are safe with <1% risk. The clinical trial data shows consistent drop-in heart failure hospitalization rates from 24-62%, recent data with improvement in quality of life by KCCQ-12 score of 7 points higher in patients managed using PA pressure monitors. The key to success is implementation and having a team approach to using this data as patients do require many more touch points for medication titration both up and down (on average 9 changes over first 3 months and then 1-2 monthly thereafter). Also, this device works across the spectrum of heart failure patients with similar outcomes in patients with preserved ejection fraction and reduced ejection fraction and midrange ejection fraction. Finally, the FDA even worked with clinical trialists on the PROACTIVE-HF trial for the Cordella Pulmonary Artery sensor and deemed it unethical to include a control arm in the trial given the vast amount of data on how PA Pressure based management helps reduce heart failure hospitalization and that safety and non-inferiority to prior clinical trials data was considered enough in the trial design to open a PMA application.

This monitoring technology when used to MANAGE patients can help greatly reduce heart failure hospitalizations. I urge CMS to approval a national coverage decision for this technology not only based on the data but also our clinical experience.

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The results and efficacy of the CardioMEMs device within Advocate Aurora Health as well as at our institution (Illinois Masonic Medical Center) alone has been tremendous. At IMMC, our data has shown a 71% reduction in heart failure hospitalizations for patients at 6/12 months utilizing this device.

A retrospective analysis (Valika, et al.) conducted at Advocate Aurora Health (AAH) looked at 30 and 90-day readmission rates after HFH in patients with ambulatory pulmonary artery pressure (PAP) monitoring guidance. Patients in this analysis were included regardless of their left ventricular ejection fraction. Of importance, the mean ejection fraction of the study cohort was 40.3 ± 17.3%. Of the 459 patients, 48% had an ejection fraction > 40%. This study demonstrated that post-PAP sensor implantation within AAH led to a reduction in all-cause 90-day readmission rates from an index HFH event and this benefit was consistent across all patient subgroups.

Additionally, in the randomized CHAMPION trial, HF treatment guided by PAP sensor data reduced HFH compared with standard of care. These benefits were consistent across patients with both preserved and reduced ejection fraction.

This is only a fraction of the data that demonstrates that CardioMEMs works for patients, keeps our patients out of the hospital, and can improve morbidity/mortality as it relates to heart failure. From anecdotal experience, a patient I follow with closely (HFpEF - EF 55%) had 4 admissions for acute decompensated heart failure prior to CardioMEMs implant in November 2022. She has not had any admissions since implant.

The use of this device has truly changed the lives of our patients as well as the way we practice as providers. With the CardioMEMs device in place, it removes the guess work from physical exam alone regarding whether or not a patient is retaining. Additionally, patient's do not have to become symptomatic in order to know if they are retaining fluid; we are able to tell this by the filling pressures/hemodynamics. This overall, leads to fewer blood draws (for BMP, NTproBNP, etc.) and fewer clinic visits because of the remote monitoring that takes place.

The CHF Clinic's goal for implantations of CardioMEMs devices in the 2024 year is 24 implants. Widespread insurance coverage for CMEMs is imperative for our patients to continue to benefit from this device and to reduce heart-failure hospitalizations.

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Implantable hemodynamic monitoring devices have significantly helped me manage my heart failure patients. With utilization of these devices, we have seen a significant reduction in heart failure hospitalizations in this patient population following implantation. These devices also help with initiation and optimization of guideline directed medical therapy in the heart failure population as well, which has been shown to reduced hospitalizations and improve survival. The patient population that I take care of are often of limited resources and may have difficulty with transportation and getting on optimal GDMT due to cost. Having a device that can help better monitor and manage their care despite possibly other limited resources would be a huge benefit to their quality of life.

Unfortunately, many insurance companies do not cover this device despite numerous randomized, clinical trials showing reduction in heart failure hospitalizations as well as improvement in quality of life when ambulatory hemodynamics are utilized to guide management. Reasons that I'm often given by the companies during peer-to-peer are that this technology is "experimental" or that it will only be covered as part of an IDE. With this technology being approved by the FDA for over a decade at this time, these reasons seem absolutely ludicrous and a way for companies to take care of their bottom line more than take care of their patients.

I urge the committee to help the practicing community have improved access to this very helpful technology and pass the NCD.

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In the management of our sickest HF patients, we have implemented usage of Pulmonary artery sensor (cardiomems) implantation and regular monitoring to reduce their hospitalization and guide management of medical therapy. We have established a HF clinic in the practice where we cohort these patients and the device has been invaluable in identifying high risk patients and seeing them in the office to titrate their medications more aggressively to improve their quality of life and prevent readmission to the hospital.

I believe that this technology, if used appropriately can impact management of these high risk cardiovascular patients .

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I am writing to express strong support for a NCD covering PA pressure sensors. While these require a procedure to implant, the use of these sensors in appropriately selected patients can be invaluable, and they provide information that unfortunately cannot be obtained by other means. Within our hospital system, patients managed in our centralized HF program using PA Pressure have experienced a relative reduction in heart failure hospitalizations by 82% and all cause hospitalizations by 55%.

In light of these observations, I do feel that not only patients will benefit, but these sensors have significant cost-saving advantages (if we factor in the avoidance of hospitalizations).

Thanks for your consideration.

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I am an interventional cardiologist working in the Texas Medical Center.
I work for an HMO.
When it comes to our patients my group focuses on quality and value of care above everything else.
Unfortunately the cost of care for cardiac patients has increased drastically over the last decade.
There is a strong need for technology that can mitigate the burden to our health care system.
One such solution that I strongly advocate for is Abbott CardioMEMS.
This device is proven to significantly decrease hospital admissions and lower the overall cost of healthcare. CardioMEMS continuously monitor key cardiac parameters remotely, allowing for early detection of cardiac issues and timely intervention without the need for hospitalization. By providing real-time data to healthcare providers, this device empowers proactive management of cardiovascular conditions, ultimately leading to better outcomes for patients and reduced healthcare costs. Hospital admissions for cardiac-related issues are a significant driver of healthcare expenditure, and by implementing this device on a larger scale, we can substantially mitigate these costs while improving patient care.

We must address the existing insurance hurdles that can impede the widespread adoption of such groundbreaking solutions. Insurance reimbursement policies often lag behind advancements in medical technology, creating barriers for patients and healthcare providers seeking to utilize these cost-effective and beneficial tools. I strongly urge you to alleviate these insurance hurdles that we face on a daily basis so that our patients can benefit from improved outcomes and our health care system can benefit from reduced cost of care for cardiac patients.

Sincerely,
Javid Alakbarli

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The CardioMEMS HF system has been byFAR the MOST widely studied device in heart failure. It has shown consistent reductions in heart failure hospitalizations more than any other device or medications to date. Post-marketing studies and real world experience point to a CONSISTENT over 50% reduction in heart failure hospitalizations in at least the first year after implantation.

Because of the lack of an NCD and commercial insurer's continuing to label the device as "investigational", tens of thousands if not hundreds of thousands of patients are being denied access to this ground breaking technology. Management of heart failure up until now has been akin to managing hypertension without a sphygmomanometer, diabetes without a glucometer or asthma without a peak flow meter If you can't measure it - you can't manage it.

The FDA and CMS have granted coverage for medications and devices with far weaker data than support wireless pressure monitoring, i.e. Entresto for HFpEF.

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I am part of the Heart Failure Team caring for 60+ patients with CardioMEMs. As a former ICU nurse, the amazing benefit of having PA pressures uploaded from the patients home for assessment is unmatched when discussing gold standard for patient care.
The innovative realm of home monitoring is outstanding! This device is also accessible when patients have to be admitted to the hospital (for multiple reasons) thus preventing a possible HF readmission.

CardioMEMs should be standard of care, covered and utilized to improve patient care, outcomes and overall mortality. Insurance needs to "SEE" that overall cost would be LESS if preventative care measures are taken, like CardioMEMs.

The process for insurance approval is the BIGGEST barrier when caring for patients.
Lets do what is right for patient care!

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Three randomized trials have demonstrated that heart failure (HF) management with an implantable pulmonary artery pressure (PAP) sensor reduces the risk of HF hospitalization in a broad range of HF patients (NYHA class II-IV)^1-3 across the continuum of ejection fraction⁴. A recent meta-analysis of 3 trials of implantable hemodynamic sensors found a significant reduction in all-cause mortality and HF hospitalizations in patients with HFREF⁵. The reduction in all-cause mortality in this meta-analysis is strikingly consistent with the benefit associated with PAP sensor implant in a concurrent matched cohort analysis⁶.

Real-world studies have confirmed the clinical and hemodynamic benefits of PAP monitoring.^7-9 We published our single center experience highlighting that PAP-management lead to more intensive diuretic management, lower pulmonary artery pressure, and fewer hospitalizations¹⁰.

Based on our center experience, PAP monitoring has become an important component of HF management that enhances health equity for patients, including those living in rural areas, the elderly, or those with limited transportation. Unfortunately, the benefits of hemodynamic-guided HF management are not fully realized, in part due to variation in insurance coverage.¹¹

In view of the totality of the published literature — supported by my own clinical experience as a practicing advanced HF cardiologist — I urge CMS to provide a national coverage determination for implantable PA pressure sensors.

Jacob Abraham, MD
Section Head, Advanced Heart Failure
Providence Heart Institute
Portland, Oregon

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I have been a nurse since 2001. Seeing the advances in both medications and devices for patient's with heart failure has been a game changer. When working on the cardiology unit in the hospital we had many patients with HF in which we called "frequent fliers." These patient's were so sick and I felt as a nurse that this was the end of life for these patients. Then they came out with protocols and algorithms that helped prevent some hospitalizations. Well that was helpful and still is. However, the best approach to thriving instead of surviving is the device such as CardioMems.

I now work with a group of providers for heart failure and our patients are thriving with these sensors, We are very selective in whom we implant a sensor. We now have a large data base of patient's that we monitor with these sensors. There are many instances when the sensors have an early detection of fluid building up before the patient is even noticing the symptoms. The sensors not only prevent many hospitalizations for our patient's but they also allow us to see trends and know when the patient feels their best within a "goal" we set for them. The continuity of care allows us to manage their HF and give them their best life!

I would urge the NCA to please put forth an effort to truly understand the importance in not just the maintenance of these devices, but also the best quality of life for our patients. We are all working together to keep these patient's out of the hospital and the best way to do that is to allow more coverage to those in need. Thank you for your time.

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To whom it may concern,

I work in a high-volume heart failure clinic in South Carolina. We currently monitor about 120 patients implanted with a CardioMEMS pulmonary artery sensor and are also part of a research study evaluating the effectiveness of a competitor PA sensor that will likely come to market called the Cordella system, made by Endotronix (we monitor about 50 patients implanted with this PA sensor). We have found implanting pulmonary artery sensors to be very effective at keeping our heart failure patients out of the hospital and have seen how the early detection of impending heart failure exacerbation with such technology can improve a patient's quality of life. We think this technology should be available to all heart failure patients struggling with heart failure exacerbation or showing signs of worsening heart failure (via an elevated BNP or ProBNP labwork). Currently, we've found that patients must have Medicare A + B + supplemental insurance to get this procedure and the monthly monitoring that comes thereafter covered. We struggle to get Medicare Advantage insurers to cover the procedure (even after appeals) and see these denied patients continue to struggle. I highly recommend that the implantation and remote monitoring of pulmonary artery sensors be fully covered by Medicare as a method of proactive care for a patient population that continues to struggle with repeat hospitalization and 50% mortality in 5 years. We know that repeat hospitalization increases mortality and overburdens hospitals. This technology can help improve the situation.

Thank you!

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Background: Advanced Heart Failure and Transplant Cardiologist with about 10 years of post-training experience. About 6 years of CardioMEMS management experience, including about 5 years as a member of the research consortium "Hemodynamic Frontiers in Heart Failure," or "HF squared." This group has published manuscripts and abstracts in peer-reviewed journals regarding their experience managing HF patients with the device, as well as outcomes of said patients.

I am fully in support of approving NCD for CardioMEMS. I have seen the tremendous positive impact this device has had on patients' lives.

I have also directly struggled with insurance companies (commercial and Medicare Advantage) to get the device approved, despite meeting FDA approved indications and medical necessity. I have been asked to participate in peer-to-peer reviews with MDs who I would not consider to be my peer (non-Cardiologist), and have had patients' denied because "the device is investigational," or "it's not on the guidelines [or only 2b]."

Please help HF Cardiologists like myself provide more comprehensive care to our patients with a device that has been demonstrated to improve quality of life, decrease HF hospitalizations and mortality.

Thank you for your consideration.

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I am a physician assistant working in HF clinic and within our HF remote monitoring team.

I am writing to address the issue of Medicare Advantage plans increasingly denying CardioMEMS implants. We know that CardioMEMS reduces HF hospitalizations and improves QOL. We also know that the more our HF pts are hospitalized, the worse outcomes they have.

Attempting to obtain approval for a CM implant with a Medicare Advantage has become a joke at this point. With almost 100% certainty they will deny, though we know that if even 1 HFH was prevented the insurance plan would ultimately save money. Denials are upheld despite appeals and peer to peers. The reasons for denial are often placed on the other entity (BCBS/UHC/Aetna will blame Medicare and Medicare will blame the insurance issuer). We don't even attempt to obtain approval for most pts after 1 HFH, we defer until they are routinely admitted because we know those are the pts who would benefit the most. At this point it is not worth our time to even attempt to get approval for most Advantage plans as their greed vastly minimizes any chance we will get approval.

These denials are leading to less than adequate care for our most sick pts. Pts are frustrated and across the board regret getting talked into an Advantage plan. It's sickening what these Advantage plans do to their customers.

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