Implanted Pulmonary Artery Pressure Sensor for Heart Failure Management

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O’Hara, Donna	Date: 11/12/2024 Comment: As a provider who treats heart failure patients and implants Cardiomems, these guidelines look appropriate.
Wilson, Kaylee	Title: Heart Failure Nurse Navigator Organization: Riverside Medical Center Date: 11/11/2024 Comment: I would ask that coverage extend to include implantation for patients who are admitted to the hospital. The benefits of implant and monitoring do not cease when the patient is hospitalized, so their location whether inpatient or outpatient should not determine their level of need. If anything, a patient who is presently hospitalized for HF should rank higher in need for implant, as they are presently in exacerbation and in need of close monitoring. Additionally, some patients are so deconditioned that they are unable to go 1-2 weeks post discharge without readmission. Meaning, they do not make it to their outpatient Cardiology appointment before they are readmitted. If we were able to implant patients during a hospitalization, this would significantly reduce the risk of readmission, especially in this sensitive group of patients. Less I would ask that coverage extend to include implantation for patients who are admitted to the hospital. The benefits of implant and monitoring do not cease when the patient is hospitalized, so their location whether inpatient or outpatient should not determine their level of need. If anything, a patient who is presently hospitalized for HF should rank higher in need for implant, as they are presently in exacerbation and in need of close monitoring. Additionally, some patients are so More
Volz, Elizabeth	Title: MD, FACC Organization: UNC Rex Heart Failure Clinic / UNC School of Medicine Date: 11/11/2024 Comment: I am an Advanced Heart Failure Cardiologist with nearly 10 years of experience, including implanting and managing the CardioMEMS HF System. I find it an invaluable tool in managing HF patients' symptoms and quality of life, and the device has been shown repeatedly to reduce HF hospitalizations. Unfortunately, many eligible non-Medicare patients are denied coverage, and I have been quoted it's because the device is "investigational" or doesn't have a National Coverage Determination. I strongly urge CMS to approve this measure! Less I am an Advanced Heart Failure Cardiologist with nearly 10 years of experience, including implanting and managing the CardioMEMS HF System. I find it an invaluable tool in managing HF patients' symptoms and quality of life, and the device has been shown repeatedly to reduce HF hospitalizations. Unfortunately, many eligible non-Medicare patients are denied coverage, and I have been quoted it's because the device is "investigational" or doesn't have a National Coverage Determination. I strongly More
Farah, Ajwad	Title: Manager Ross Medical Advanced Practice Providers Organization: The Ohio State Date: 11/11/2024 Comment: I would recommend a section that incorporate patient selection. One primary issue with implanation of this product is patient selection and follow up and compliance. We have decreased these complications at our institution by the utilization of the HFMS device from Zoll. This provides us input on the patients response to hemodynamic monitoring and follow up. If we have a patient use the HFMS and not be called over 3 months or they have not followed our recommendations and continued to be hospitalized - No need for CardioMems. If they demonstrated success with outpatient/remote monitoring of their hemodynamics than they are set up for CardioMems evaluation. Less I would recommend a section that incorporate patient selection. One primary issue with implanation of this product is patient selection and follow up and compliance. We have decreased these complications at our institution by the utilization of the HFMS device from Zoll. This provides us input on the patients response to hemodynamic monitoring and follow up. If we have a patient use the HFMS and not be called over 3 months or they have not followed our recommendations and continued to be More
Foley, Ann	Title: Nurse Navigator CHF/MI (MSN, RN, CCRN, CNL) Organization: HHC Saint Vincent's Medical Center Date: 11/11/2024 Comment: I agree with 1. a,b,e and f, and 2 b. For 1 c) I think it can be helpful to have an IPAP to assist with titration of GDMT and patients can benefit from having device before they are maximized on GDMT(at 3 mos timeframe). For 1 g) If patient having RHC as an inpatient, it may make sense to have the IPAP implanted at that time instead of having another procedure(RHC) to implant the IPAP. For 2 a) A hospitalist who has frequent heart failure readmissions should also be able to refer patients for IPAPs. Not all patients have a cardiology consult. The cardiologist should be contacted and the cardiologist or APP would manage readings from the device. Less I agree with 1. a,b,e and f, and 2 b. For 1 c) I think it can be helpful to have an IPAP to assist with titration of GDMT and patients can benefit from having device before they are maximized on GDMT(at 3 mos timeframe). For 1 g) If patient having RHC as an inpatient, it may make sense to have the IPAP implanted at that time instead of having another procedure(RHC) to implant the IPAP. For 2 a) A hospitalist who has frequent heart failure readmissions should also be able to refer patients for More
Gordon Patti, Karl	Title: MD Organization: South Denver Cardiology Date: 11/11/2024 Comment: Implanted pulmonary artery pressure monitors on evidence based adjunctive therapy for the management of ambulatory heart failure. They clearly demonstrate a reduction in hospitalizations, and help improve patient's symptom burden. In reduced systolic function heart failure hospitalizations are associated with a predictable increase in mortality. Therefore, any therapy that contributes to reduction hospitalizations is likely reducing patient mortality. Furthermore, patients with heart failure often are complex with multiple medical comorbidities including pulmonary hypertension, valvular disease and renal dysfunction which can confound laboratory workup and limit the utility of physical exam. Invasive monitoring provides and objective and vital data point to help guide guideline directed and diuretic therapies. Less Implanted pulmonary artery pressure monitors on evidence based adjunctive therapy for the management of ambulatory heart failure. They clearly demonstrate a reduction in hospitalizations, and help improve patient's symptom burden. In reduced systolic function heart failure hospitalizations are associated with a predictable increase in mortality. Therefore, any therapy that contributes to reduction hospitalizations is likely reducing patient mortality. Furthermore, patients with heart More
Flint, Kelsey	Title: advanced heart failure cardiologist Organization: South Denver Cardiology Associates Date: 11/10/2024 Comment: I agree with the NCD. This is a thoughtfully put together coverage decision that allows PAP to be used in the manner in which they are typically most effective - which is as part of a multidisciplinary HF team
Pulukurthy, Satyavardhan	Date: 11/08/2024 Comment: Dear Madam/ Sir Please consider covering the cardiomems implantable pulmonary artery catheter. This is an amazing development that significantly reduces hospitalization for heart failure, reduces use of medicare dollars for hospitalization and will pay for itself and save more patients and medicare. The procedure itself should be low risk but involves flouroscopy and significant education and training. The device will need electronic follow up almost on a daily basis to make sure we catch any heart failure exacerbations early which will need remote device follow up personnel and provider rembursements. Thank you Sincerely Satya Pulukurthy, MD Less Dear Madam/ Sir Please consider covering the cardiomems implantable pulmonary artery catheter. This is an amazing development that significantly reduces hospitalization for heart failure, reduces use of medicare dollars for hospitalization and will pay for itself and save more patients and medicare. The procedure itself should be low risk but involves flouroscopy and significant education and training. The device will need electronic follow up almost on a daily basis to make sure More
Alakbarli, Javid	Organization: Kelsey Seybold Clinic Date: 11/08/2024 Comment: Dear CMS, I am an interventional cardiologist and I would like to advocate for the extension of coverage for implantable pressure sensors, which have shown significant benefits in reducing heart failure hospitalizations. These devices provide continuous, real-time monitoring of pulmonary artery pressure, allowing for proactive management of heart failure patients. Clinical studies have demonstrated that the use of these monitors leads to a substantial decrease in hospitalization rates by enabling timely interventions. The reduction in hospital admissions not only improves patient outcomes but also results in significant cost savings for the healthcare system. By preventing exacerbations of heart failure, patients experience improved quality of life and reduced morbidity. The current coverage limitations restrict access to this life-changing technology for many patients who could benefit from early intervention. Thank you for considering this request to improve the management of heart failure for our patients. Sincerely, Javid Alakbarli Less Dear CMS, I am an interventional cardiologist and I would like to advocate for the extension of coverage for implantable pressure sensors, which have shown significant benefits in reducing heart failure hospitalizations. These devices provide continuous, real-time monitoring of pulmonary artery pressure, allowing for proactive management of heart failure patients. Clinical studies have demonstrated that the use of these monitors leads to a substantial decrease in hospitalization More
Smith, Phillip	Date: 11/08/2024 Comment: Dear Centers for Medicare & Medicaid Services, As an interventional cardiologist, I strongly support the proposed expansion of coverage for implantable pulmonary artery pressure sensors (IPAPS) in heart failure (HF) management. Clinical evidence, including the CHAMPION trial, demonstrates that the CardioMEMS HF System significantly reduces HF hospitalizations. The device has a low complication rate, with only 1% of patients experiencing device-related issues. Economic analyses indicate its cost-effectiveness, with an incremental cost-effectiveness ratio of $44,832 per quality-adjusted life year. In my practice, I have observed that patients using the CardioMEMS device experience fewer hospitalizations and improved quality of life. I urge CMS to finalize the proposed decision to make this valuable technology more accessible to patients in need. Less Dear Centers for Medicare & Medicaid Services, As an interventional cardiologist, I strongly support the proposed expansion of coverage for implantable pulmonary artery pressure sensors (IPAPS) in heart failure (HF) management. Clinical evidence, including the CHAMPION trial, demonstrates that the CardioMEMS HF System significantly reduces HF hospitalizations. The device has a low complication rate, with only 1% of patients experiencing device-related issues. Economic analyses More
Mazurek, Jeremy	Title: MD Organization: Catholic Health Services of Long Island Date: 11/08/2024 Comment: CardioMems is an essential device in the optimal management of heart failure patients. The coverage of this device should be established and recognized by CMS.
Erskine, Jessica	Title: AGNP Organization: Caring Heart Cardiology Date: 11/08/2024 Comment: As a Cardiology NP, I utilize implantable pulmonary artery pressure measurement to monitor patients with heart failure to avoid hospitalizations and more effectively manage their HF when hospitalized. I work mostly inpatient and it is especially helpful when we are titrating diuretics and HF GDMT and they are renally compromised. In addition to their weight, intake/outputs and vital signs, it provides objective data to drive treatment decisions. There are many HF patients that do not present with overt signs and symptoms of heart failure. This tool is central in my current practice to improving heart failure outcomes. Less As a Cardiology NP, I utilize implantable pulmonary artery pressure measurement to monitor patients with heart failure to avoid hospitalizations and more effectively manage their HF when hospitalized. I work mostly inpatient and it is especially helpful when we are titrating diuretics and HF GDMT and they are renally compromised. In addition to their weight, intake/outputs and vital signs, it provides objective data to drive treatment decisions. There are many HF patients that do not present More
Daniels MD, Curt	Title: Director, Adult Congenital Heart Disease Organization: The Ohio State University and Nationwide Children's Hospital Date: 11/08/2024 Comment: Cardiomems IHM has become a vital part of the care of those with complex cogenital heart disease and in particluar those with single ventricle and Fontan palliation and those with a systemic right ventricle. First, those with Fontan palliation universally develop heart failure and either die of HF or if fortunate and timely may be listed for heart or heart liver txpl, survive a lenglthy wait list period and then if transplanted may survive. There are abour 10-20,000 patients with Fontan in the US. Patients with single ventricle and Fontan palliation have no means to non invasively assess their hemodynamics. ECHO or advanced imaging with CMR and CT cannot determine their central venous pressure nor their Fontan presssure becuase of their anatomy. Therefore invasive cardiac catheterization is required any time this information woudl be helpful for patient care. As patients with Fontan develop HF, obtaining hemodynamics is critical and necessary for medicatl therapy options, volume status and for listing and continued surveillance once listed. Their heart caths are unique and complex and typically require expertise to perform, and add to the already large accumulation of radiation received through continuous medical since birth. Cardiomems provides this information in a safe and efffective manner with the need for repeat continued surveillance cardiac caths or when admitted with HF. Simply obtained this information at home or with a hospitalization can direct proper medical therapy and decision making and is more accurate and supplies real time ambulatory data as opposed to data in the cathlab with anesthesia and lying supine. The largest study to date also showed that Cardiomems data correlated better with advanced liver disease than a traditional heart cath. Marshall et al. Journal of the American Heart Association. 2023. Volume 12, Number 24. https://doi.org/10.1161/JAHA.123.031836. This patient population is challenging and Cardiomems has improved care and hopefully with more data it will improve outcomes. Our only barrier has been insurance approval. Less Cardiomems IHM has become a vital part of the care of those with complex cogenital heart disease and in particluar those with single ventricle and Fontan palliation and those with a systemic right ventricle. First, those with Fontan palliation universally develop heart failure and either die of HF or if fortunate and timely may be listed for heart or heart liver txpl, survive a lenglthy wait list period and then if transplanted may survive. There are abour 10-20,000 patients with Fontan in the More
Kukla, Lisa	Title: APN Organization: Advocate Christ Medical Center Date: 11/08/2024 Comment: PAP pressures help keep patients out of the hospital so this can help support the heart failure population
Becker, Candace	Date: 11/07/2024 Comment: Cardiac monitoring via implantable pulmonary artery pressure measurement provides a simple yet very effective way to monitor patients with heart failure to improve symptoms and avoid hospitalizations. Oklahoma is a rural state and does not allow patients the ability for frequent office visits to closely monitor rapidly changing heart failure hemodynamics. In particular, pulmonary artery catheter monitoring is an excellent way to catch early changes in heart failure hemodynamics in order to implement therapies to halt the devastating progression of acute heart failure. This is a big win for healthcare costs but most importantly, a win for those that suffer from this terrible disease process. In addition, this therapy does not require an advanced heart failure specialist or even a cardiologist to implant or monitor, which allows more coverage for those patients with the greatest need. Less Cardiac monitoring via implantable pulmonary artery pressure measurement provides a simple yet very effective way to monitor patients with heart failure to improve symptoms and avoid hospitalizations. Oklahoma is a rural state and does not allow patients the ability for frequent office visits to closely monitor rapidly changing heart failure hemodynamics. In particular, pulmonary artery catheter monitoring is an excellent way to catch early changes in heart failure hemodynamics in order to More
Masha, Luke	Organization: Oregon Health Science University Date: 11/07/2024 Comment: I am in favor of the current CMS proposal
Adams, Rachael	Title: ACNP Organization: THVS Date: 11/07/2024 Comment: Approval of the cardioMEMS device would our practice to provide this device to more of our patients to prevent heart failure exacerbation hospitalizations which can lead to increased mortality. We have utilized this device many times and have found it a helpful tool in monitoring fluid status and allows for more accurate diuretic titration.
Davis, Shannon	Title: Cardiology RN (Heart Failure) Organization: Ballad CVA Heart Institute Date: 11/07/2024 Comment: Cardiomems has been such a great tool for our heart failure clinic. We have reduced hospital admissions for our 30 current patients active with Cardiomems. Our rep is always easy to contact for any questions or concerns. We have been very pleased with Abbott in general.
Macy, Ashley	Date: 11/07/2024 Comment: As a heart failure nurse practitioner, I urge CMS to recognize the critical importance of pulmonary artery (PA) pressure sensor monitors for patients with heart failure. These devices provide continuous, real-time data on a patient’s PA pressures, allowing for proactive management and timely adjustments in therapy. Studies have shown that PA sensors reduce heart failure hospitalizations and improve quality of life by enabling early intervention before symptoms worsen. I have seen these benefits first hand and they have a significant impact on patients lives. PA monitoring empowers us to deliver personalized, precise care, reduce healthcare costs, and ultimately enhance patient outcomes. Expanding access to PA sensors is an essential step in advancing heart failure management and providing equitable access to care for all patients . Less As a heart failure nurse practitioner, I urge CMS to recognize the critical importance of pulmonary artery (PA) pressure sensor monitors for patients with heart failure. These devices provide continuous, real-time data on a patient’s PA pressures, allowing for proactive management and timely adjustments in therapy. Studies have shown that PA sensors reduce heart failure hospitalizations and improve quality of life by enabling early intervention before symptoms worsen. I have seen these More
Case, Rachel	Title: FNP-C Organization: Advanced Cardiology Associates Date: 11/07/2024 Comment: We have utilized the implanted pulmonary artery pressure sensor in our facility since 2019 and have seen direct benefit in patient care with regards to managing volume status. We have found that patients that transmit regularly and are adherent with medical therapy for heart failure experience improvement in general QOL and also experience reduction in heart failure admissions. I would not hesitate to recommend CardioMEMs for any of my appropriate patients.
Holtzclaw, Holly	Title: RN, BSN Organization: Wellstar Health System Date: 11/07/2024 Comment: I work as a Heart Failure Nurse Navigator and it's very disheartening to see some patients get turned away for a device that has been shown to greatly help improve their peer's quality of life and prevent hospital readmissions. My hospital has decreased HF-HF readmissions to 7.84% from 13.43% since using CardioMEMS. It is proven that each patient that has a HF exacerbation never fully recovers. I have coworkers who are turned down for CardioMEMS even though we see other patients stay out of the hospital with this device. Less I work as a Heart Failure Nurse Navigator and it's very disheartening to see some patients get turned away for a device that has been shown to greatly help improve their peer's quality of life and prevent hospital readmissions. My hospital has decreased HF-HF readmissions to 7.84% from 13.43% since using CardioMEMS. It is proven that each patient that has a HF exacerbation never fully recovers. I have coworkers who are turned down for CardioMEMS even though we see other patients stay out of More
Smith, Alison	Title: PA-C Date: 11/07/2024 Comment: As a cardiology PA who helps manage and run our CardioMEMS program in my facility I have several comments regarding this proposal. CardioMEMS should be available to patients with NYHA class II or III HF regardless of EF with either hospital stay/urgent visit OR elevated BNP. Some patients will not get to maximum tolerated GDMT and waiting for them to get to that prior to implantation is not something I would recommend as it could lead to further decompensations and possible hospitalizations that adversely affects a patient's mortality. Waiting for an ICD or CRT device is much the same as you then wait 90 days post implant. It may delay optimal care for our patients to have these waiting periods. I do not think advanced heart failure physicians are the only ones who should be implanting PA pressure devices. This will drastically limit the ability of patients to receive a device they need and it can drive up healthcare and patient costs if they have to travel to be able to get a device. It is best for a patient to get the care in their community if they are able to. Interventional cardiologists are more than capable of placing this device safely and effectively. Furthermore patients should absolutely be able to get the devices when admitted to the hospital as it can shorten the length of stay and help guide optimal treatment with both afterload reduction and diuretics. As a healthcare provider I feel responsible for my patients and their outcomes and limiting my ability to treat them to the full capacity is detrimental to their long-term care. It would be a shame to limit access to a device that can improve my patients quality of life, decrease hospitalizations and urgent visits which can lead to better quality of life and impact their mortality. HF is a chronic disease that is a major factor in cost, hospitalization and patient mortality and we should be aggressive in our treatment and care to give patients their best care and quality of life. I have seen amazing outcomes when CardioMEMS is utilized appropriately and it would be very detrimental to take that away from patients. Less As a cardiology PA who helps manage and run our CardioMEMS program in my facility I have several comments regarding this proposal. CardioMEMS should be available to patients with NYHA class II or III HF regardless of EF with either hospital stay/urgent visit OR elevated BNP. Some patients will not get to maximum tolerated GDMT and waiting for them to get to that prior to implantation is not something I would recommend as it could lead to further decompensations and possible More
Gluck, Jason	Title: Dr. Date: 11/07/2024 Comment: I am in support of this decision as I think the PA sensor monitor is a valuable tool int he Heart Failure quivor. I wonder if the criteria listed under section 2a may not represent the entire population of the US as many cardiologists do not have easy access to advanced heart failure specialties. I feel general cardiologists are well qulaified in heart failure and probably should be able to refer for this device as it may ultimately help discern the patients most likely to benefit from advanced heart failure expertese. Less I am in support of this decision as I think the PA sensor monitor is a valuable tool int he Heart Failure quivor. I wonder if the criteria listed under section 2a may not represent the entire population of the US as many cardiologists do not have easy access to advanced heart failure specialties. I feel general cardiologists are well qulaified in heart failure and probably should be able to refer for this device as it may ultimately help discern the patients most likely to benefit from More
Davies, DO, Rhian E.	Date: 11/07/2024 Comment: CardioMEMS is a necessary device to prevent recurrent hospitalizations and heart failure exacerbations.
Cendan, Mario	Title: Nurse Practitioner - Heart Failure Bridge Clinic Organization: Ascension Texas Cardiovascular Date: 11/06/2024 Comment: Implantable PAP sensors have been pivotal in the management of chronic heart failure patients on several levels. First, it allows for more aggressive volume management by treating increasing pressures proactively, especially for remote patients in rural counties in Central Texas, thus reducing frequent hospitalizations that were commonplace for several of these patients. Being able to intervene in a timely manner with the use of these sensors also dramatically increases a patient's quality of life that is no longer spent in a hospital setting or in multiple clinic visits for weekly diuretic adjustments that may not be effective for faster intervention of volume overload. Additionally, it helped patients engage in their own care by understanding what PA pressures are, and why it is important in their management. These devices also offer a more personalized approach to managing chronic heart failure. I firmly believe that offering coverage for these patients can vastly be beneficial from a patient's quality of life perspective, a reduced economic burden given reduced hospitalizations and better resource allocation with accurate, real-time data, and reduction of complications from over/under diuretic and GDMT use, decreasing the need for intensive care, long-term treatments, and rehabilitation. Less Implantable PAP sensors have been pivotal in the management of chronic heart failure patients on several levels. First, it allows for more aggressive volume management by treating increasing pressures proactively, especially for remote patients in rural counties in Central Texas, thus reducing frequent hospitalizations that were commonplace for several of these patients. Being able to intervene in a timely manner with the use of these sensors also dramatically increases a patient's quality of More
Payne, Whitney	Title: NP Organization: Mercy Date: 11/06/2024 Comment: Cardiomems sensor has been a crucial tool to monitor and manage patients with refractory heart failure. It has helped minimize repeated hospitalizations in this complex cohort of patients.
HALOG, JESSICA GRACE	Title: RN Organization: HCA FLORIDA KENDALL HOSPITAL Date: 11/06/2024 Comment: LOOKING FORWARD TO USE THE SENSOR IN OUR UNIT
Thompson, Terra	Date: 11/06/2024 Comment: The need for this medical device can assist patients in being pro-active in their chronic illness. Most times patients have to get to a point of their PH-HF being exacerbated to be able to get the care they need. At this point most patients are down for a couple weeks minimum to get their energy and levels back to normal. Having this type of device can intervene before a patient gets to that point for care and in turn help preserve their heart and reduce hospitalizations, outpatient visits and emergency visits. This will assist in prolonging the patient heart to avoid a transplant. Less The need for this medical device can assist patients in being pro-active in their chronic illness. Most times patients have to get to a point of their PH-HF being exacerbated to be able to get the care they need. At this point most patients are down for a couple weeks minimum to get their energy and levels back to normal. Having this type of device can intervene before a patient gets to that point for care and in turn help preserve their heart and reduce hospitalizations, outpatient visits More
Minich, Tanya	Title: CRNP Organization: Wellspan Date: 11/06/2024 Comment: My team has been using CardioMEMs since 2021. We have been keeping our own data. We have found that in the year prior to implanting vs the year after implanting the number of admissions with these patients was reduced by 21%. I find the tool very valuable in the day-to-day management of my patient at not only decreasing the risk of admission but in improving QOL and preventing worsening renal function with overuse of diuretics.
Peyton, Josh	Title: RN Manager of Cardiovascular Lab Organization: St. Francis Hospital/Virgina Mason Franciscan Health Date: 11/06/2024 Comment: I highly advocate for this PA device to be approved to the fullest, for inpatients and oupatients. It is an exceptional device for patients, keeps them out of hospitals with managing their heart failure, and should be reimbursed at a higher rate.
Selby, Shawn	Date: 11/05/2024 Comment: As a Heart Failure NP, I have seen first-hand how much of a difference pulmonary artery monitoring (via CardioMEMS) can make in the life of a patient with heart failure. In particular, patients with hard-to-assess volume assessment benefit from rapid escalation of diuretics at home to keep them out of the hospital for distressing symptoms like shortness of breath and leg swelling. Patients' kidney functions also benefit from tight volume control, and in many cases, are able to come off high-dose diuretics. Please consider increasing access through coverage, it is a cost-saving, life-changing device! Less As a Heart Failure NP, I have seen first-hand how much of a difference pulmonary artery monitoring (via CardioMEMS) can make in the life of a patient with heart failure. In particular, patients with hard-to-assess volume assessment benefit from rapid escalation of diuretics at home to keep them out of the hospital for distressing symptoms like shortness of breath and leg swelling. Patients' kidney functions also benefit from tight volume control, and in many cases, are able to come off More
Rasmussen, Lauren	Date: 11/05/2024 Comment: This data is valuable and accessible not only to physicians but also to advanced practice providers as well as nurses who collaborate to take care of this challenging patient population to help prevent heart failure hospitalizations and improve patients quality of life.
Sand, Deneille	Title: Heart and Vascular Director Organization: Altru Hospital Date: 11/05/2024 Comment: This device has been life changing for so many of our patients. It has been proven time and time again to keep patients out of the hospital, and lower costs to patients and organizations. It would be great to see it used more frequently to give patients a better quality of life. A change in coverage would benefit all parties, especially patients.
Hahn, Samuel	Title: Md Date: 11/04/2024 Comment: I am writing in strong support of a national coverage decision for wireless pressure monitoring for heart failure. As a physician, I am extreme aware in order to manage a chronic condition, we must measure it, easily and often. How would we manage hypertension, asthma, diabetes without sphygomanometers, peak flow meters, and glucometers? The answer: we couldn't. 3rd party payors have been dragging their feet on wireless PA pressure sensing despite tens of thousands of patient-years of data. The nonsense must end. Less I am writing in strong support of a national coverage decision for wireless pressure monitoring for heart failure. As a physician, I am extreme aware in order to manage a chronic condition, we must measure it, easily and often. How would we manage hypertension, asthma, diabetes without sphygomanometers, peak flow meters, and glucometers? The answer: we couldn't. 3rd party payors have been dragging their feet on wireless PA pressure sensing despite tens of thousands of patient-years of data. More
Desai, Prakash	Title: MD Organization: Lake View Cardiology Date: 11/04/2024 Comment: The technical aspect of implantation is more complex than simple Right heart CAth The RVU should be higher The follow up is where extensive review of data occurs and patient care is tailored. There should be additional rvus per month of management. There should be a technical component independent of professional component as there is lot of nursing and other employee time spent with phone calls and management. The cost of device that the company charges is prohibitive for use of the device in many patients and there should be differential between what hospitals charge and what they pay for device. In some cases it is around 95 % so the hospital profit is very limited. There is self promotion by device companies selling such products as it the products alone manages heart failure and the role of physicians, heart failure nurses etc. is marginalized and not recognized and appreciated based on how CMS treats the profession component allocations. Less The technical aspect of implantation is more complex than simple Right heart CAth The RVU should be higher The follow up is where extensive review of data occurs and patient care is tailored. There should be additional rvus per month of management. There should be a technical component independent of professional component as there is lot of nursing and other employee time spent with phone calls and management. The cost of device that the company charges is prohibitive for More
Antoine, Steve	Title: Heart failure cardiologist Organization: Baylor College of medicine Date: 11/04/2024 Comment: As a heart failure cardiologist I think this technology which allows clinicians to monitor heart filling pressures from home has never been done before and is the future in preventing readmissions for heart failure decompensation. It is a lot of data that requires a dedicated monitoring program, as such the proper reimbursement should be determined and given. I fully support this technology and currently manage approximately 30 patients at my hospital with this device and it has kept them out of the hospital Less As a heart failure cardiologist I think this technology which allows clinicians to monitor heart filling pressures from home has never been done before and is the future in preventing readmissions for heart failure decompensation. It is a lot of data that requires a dedicated monitoring program, as such the proper reimbursement should be determined and given. I fully support this technology and currently manage approximately 30 patients at my hospital with this device and it has kept them out More
Wilson, Dawn	Title: RN, CCRN, VAD Coordinator Organization: Texas Children's Hospital Date: 11/04/2024 Comment: CardioMEMS has proven to be very beneficial for HF patient, particularly LVAD patients. Reducing the need for admissions for diuresis as the device allows patients fluid status to be managed in the outpatient setting. CardioMEMS has improved outcomes in management of DCM and Congenital Heart Disease, as well as the quality-of-life in patients with heart failure. Please consider covering this device and the associated costs.
Waxman, Aaron	Title: Director, Pulmonary Vascular Disease Program Organization: Brigham and Women’s Hospital Date: 11/04/2024 Comment: Hemodynamic targeted therapy is fast becoming recognized as central to management of pre-capillary pulmonary hypertension. We are pushing for titrating pulmonary vasodilator therapy to a 50% reduction in mean pulmonary artery pressure. An implanted Pulmonary Artery Pressure Sensor would provide clear daily insight as to response and progress. This would also allow for more aggressive approach to therapy with a clear goal of that aggressive approach to therapy.
Lau, Theodore	Title: MD Organization: Franciscan Heart and Vascular Associates Date: 11/04/2024 Comment: Physician reimbursement should be increased. Procedure usually takes 60-90 minutes to do. Sometimes it can take up to 120 minutes. The right heart catherization and pulmonary angiogram components should be reimbursed and not be bundled. This procedure has been proven to be beneficial to patients with congestive heart failure. The procedure carries risks and liability for the performing physicians.
Montpetit, Michelle	Title: MD Organization: NORTHWESTERN MEMORIAL HOSPITAL Date: 11/04/2024 Comment: I am a busy heart failure cardiologist and we follow over 50 patients with PA sensors. Readmissions in these patients has declined by 75% (small data numbers, admittedly). Doctors all know the "frequent flyers," and these patients particularly have benefited from this device. This has to be a cost savings, and should be welcomed by insurance companies.
Waters, Andrew	Title: MD Organization: AdventHealth Shawnee Mission Date: 11/01/2024 Comment: This technology has really helped a number of my patients reduce the number of heart failure hospitalizations and had significantly improved their quality of life. The largest barrier to greater utilization of this technology is insurance coverage. Hopefully with this decision there will be significant improvement in this regard.
Brown, Tammy	Title: Nurse practitioner Organization: AdventHealth Shawnee Mission Date: 11/01/2024 Comment: I am writing in support of coverage for CardioMEMS. When we compared the number of heart failure hospitalizations in the year before implant vs the year after implant, there was a 69% reduction in hospitalizations. Additionally, patients report improved quality of life and symptom management
Ampadu, James	Title: Heart Failure Cardiologist Organization: Prisma Richland-USC Date: 11/01/2024 Comment: Heart failure management has evolved tremendously over the years to reflect the needs of our patients. It is very naïve to think that prescribing a specific diuretic dose at one point in time will continue to be the same diuretic dose in another point in time. We know very well, heart failure is a dynamic, fluid condition, dietary influences, blood pressure influences, and medications influences will effect a patient's volume status. For these reasons, we need technology to combat these influences allowing remote volume management. The data is clear, as patients have more heart failure hospitalizations, they have a higher mortality. We need to utilize our technology to reduce recurrent hospitalizations and dramatically impact heart failure survival and quality of life. Implanted pulmonary artery pressure sensors have shown to do this. They should be offered to the right patients without hesitation. Less Heart failure management has evolved tremendously over the years to reflect the needs of our patients. It is very naïve to think that prescribing a specific diuretic dose at one point in time will continue to be the same diuretic dose in another point in time. We know very well, heart failure is a dynamic, fluid condition, dietary influences, blood pressure influences, and medications influences will effect a patient's volume status. For these reasons, we need technology to combat these More
Panichelli, Kristy	Title: CRNP Organization: Cardiology Consultants of Philadelphia Date: 11/01/2024 Comment: Cardiomems has been an extremely valuable tool in managing my patients with heart failure. There is more need for use of technology due to the growing population of people with heart failure. I believe this should be covered by Medicare, in addition to all insurers, due to the benefits proven in the Cardiomems studies.
MAdore, Sharon	Title: RN, LVAD Coordinator Organization: Yale Advanced Heart Failure Date: 10/31/2024 Comment: Cardiomems implant has avoided numerous hospital admissions for our LVAD patients and allows for appropriate outpatient diuretic management .
Thomas, Jerome	Date: 10/31/2024 Comment: The implantation of a pulmonary artery (PA) sensor, offers a significant advancement in the proactive management of heart failure. By enabling real-time monitoring of PA pressures, clinicians can detect worsening heart failure before symptoms arise, allowing for timely adjustments to treatment. This approach not only improves patient outcomes but also helps to reduce hospital readmissions. Integrating such technology with other interventional devices, has the potential to enhance heart failure care holistically, benefiting both patients and healthcare systems.” Less The implantation of a pulmonary artery (PA) sensor, offers a significant advancement in the proactive management of heart failure. By enabling real-time monitoring of PA pressures, clinicians can detect worsening heart failure before symptoms arise, allowing for timely adjustments to treatment. This approach not only improves patient outcomes but also helps to reduce hospital readmissions. Integrating such technology with other interventional devices, has the potential to enhance heart failure More
Carpenter, Jimel	Organization: TDX Date: 10/31/2024 Comment: The Cardiomems HF system has shown a tremendous impact in reducing hospitalization and improving quality of life for CHF patients. It is a very beneficial tool in the physician's arsenal to manage patients that are traditional high utilizers of hospital beds and financial resources of the healthcare system.
Hudson, Sarah	Date: 10/31/2024 Comment: The cardiomems system should be a covered service. It has improved symptoms of patients with heart failure and prevented and reduced re-admissions for heart failure. Follow up care for cardiomems such as remote monitoring and medication adjustments should also be covered as part of the coverage criteria.
Silverman, Daniel	Title: Assistant Professor of Medicine/Cardiology Organization: Medical University of South Carolina Date: 10/31/2024 Comment: Fully support this - the evidence is strong in heart failure across the LVEF range and for too long, we have struggled to get our patients coverage for a device that can reduce healthcare costs and improve morbidity and mortality. Although I am trained as an advanced heart failure & transplant cardiologist, I don't know that this is a necessary criterion for referral. A vigilant general cardiologist, particularly in the community, would be entirely capable of making the judgment of whether such a device would be indicated and should be able to make such a referral. Less Fully support this - the evidence is strong in heart failure across the LVEF range and for too long, we have struggled to get our patients coverage for a device that can reduce healthcare costs and improve morbidity and mortality. Although I am trained as an advanced heart failure & transplant cardiologist, I don't know that this is a necessary criterion for referral. A vigilant general cardiologist, particularly in the community, would be entirely capable of making the judgment of whether More
Duck, Gregory	Title: Cardiology / Heart Failure Physician Assistant Date: 10/31/2024 Comment: I am writing to submit my endorsement for this technology of remote PA pressure monitoring for CHF patients. In patient cohorts who respond to clinician input appropriately when notified about their elevated pulmonary pressures, good outcomes follow. I have seen the impact of optimizing medical therapy on decongesting patients and lowering their likelihood of being readmitted. In particular, this technology is great for more rural populations who are unable to be evaluated in far-away cardiology practices. It has been great help for our patients who are compliant. Please consider this in your decision making. Thanks! G Less I am writing to submit my endorsement for this technology of remote PA pressure monitoring for CHF patients. In patient cohorts who respond to clinician input appropriately when notified about their elevated pulmonary pressures, good outcomes follow. I have seen the impact of optimizing medical therapy on decongesting patients and lowering their likelihood of being readmitted. In particular, this technology is great for more rural populations who are unable to be evaluated in far-away More
Rumora, Janine	Title: ACNP-BC, VAD-C Organization: University of Rochester Medical Center Date: 10/31/2024 Comment: Obtaining NCD for CardioMems implant would significantly impact my patient population in a positive way. VAD patients with RV dysfunction, pulmonary hypertension and mod-severe AI that currently have cardioMems have seen a gross improvement in quality of life, decreased hospitalization and aggressive medication management.
McCann, Patrick	Title: Heart Failure Cardiologist Organization: PRISMA Date: 10/31/2024 Comment: Congestive heart failure, regardless of etiology, is a chronic disease without a cure at this time. The prevalence is increasing as our population ages with devastating outcomes related to hospitalizations and mortality. Current passive management focused solely on guideline directed medical therapy is insufficient as the disease process requires active engagement from healthcare teams and patients. The proactive nature of remote patient management with CardioMEMS allows health care providers to reduce hospitalizations, reduce mortality and improve the overall quality of life for patients. The ongoing management with PA pressure monitoring is necessary to help provide earlier intervention that will continue to reduce the burden of heart failure for patients and the healthcare system overall. Enabling utilization of PA pressure monitors increases access to care, improves equity for all patients and reduces clinical bias through objective feedback provided by the sensor. This will help evolve and implement heart failure care for all patients. Providing a national coverage decision for PA pressure monitoring will improve healthcare for the heart failure population, reduce clinical inertia and remove the impedance limiting our ability to significantly impact the care for heart failure patients Less Congestive heart failure, regardless of etiology, is a chronic disease without a cure at this time. The prevalence is increasing as our population ages with devastating outcomes related to hospitalizations and mortality. Current passive management focused solely on guideline directed medical therapy is insufficient as the disease process requires active engagement from healthcare teams and patients. The proactive nature of remote patient management with CardioMEMS allows health care More
Hayden, Kathleen	Title: RN, BSN Organization: University of Rochester Medical Center Advanced Heart Failure Program Date: 10/31/2024 Comment: I cannot over emphasize the efficacy of the CardioMEMS—we have implanted over 125 and the benefits are ongoing. Insurance denial is a major frustration, especially when we know CardioMEMS can help a patient. The numerous clinical studies and peer reviews are added proof to the need for NATIONAL COVERAGE!
Quinlan, Amy	Title: ANP-BC Date: 10/31/2024 Comment: I would strongly advocate for a national coverage determination for the CardioMEMS HF system. This device helps patients to have an improved quality of life and significantly decreases HF readmissions, which as we all know, are a significant burden (physically and financially) on the healthcare system. We have also used this amazing device to diagnose arrhythmias and other illnesses.
Jones, Gordon	Title: Mech Engineer Organization: Consult Date: 10/31/2024 Comment: It seems to me that this sensor may also be beneficial for patients with Pericardial Effusions maybe even for those with Plueral Effusions? Gordon

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Implanted Pulmonary Artery Pressure Sensor for Heart Failure Management

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