National Coverage Analysis (NCA) View Public Comments

Implanted Pulmonary Artery Pressure Sensor for Heart Failure Management

Public Comments

Commenter Comment Information
Edwards-Small, Amy Title: Registered Nurse
Organization: Hartford Healthcare
Date: 11/29/2024
Comment:

I have been involved in the management of patients with a CardioMEMS system since May 2019. I see this device as crucial to keeping individuals with heart Failure out of the hospital and able to enjoy a quality of life not limited by repeated hospitalizations for HF exacerbations.

The cardioMEMS device has enabled us to guide Heart Failure GDMT titration especially in individuals where it was not possible before the CardioMEMS due to hemodynamic instability. The device has

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Zuckerman, Diana Title: President
Organization: National Center for Health Research
Date: 11/29/2024
Comment:

Public Comment on Proposed Medicare Coverage for Implanted Pulmonary Artery Pressure Sensors (IPAPS) for Heart Failure Management
National Center for Health Research

The research does not indicate that IPAPS meaningfully improve health outcomes and so we conclude that they do not meet the standards for coverage by Medicare for the reasons specified below.

The GUIDE-HF found no statistically significant difference in a composite measure of mortality, HF

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Tullia, Kirsten Title: SVP, Payment & Health Care Delivery Policy
Organization: AdvaMed
Date: 11/29/2024
Comment:
On behalf of the MedTech Association (AdvaMed), we appreciate the opportunity to submit comments on the National Coverage Analysis (NCA) for Implanted Pulmonary Artery Pressure Sensor(s) (IPAPS) for Heart Failure (HF) Management, CAG-00466N. IPAPs are used to measure and transmit blood flow pressure and heart rate data and wirelessly transmit to the beneficiary and their care team. This monitoring loop enables the beneficiary’s care team to closely monitor changes in the beneficiary’s

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Grafton, Gillian Title: D.O.
Organization: Henry Ford Health
Date: 11/29/2024
Comment:
I commend your effort to improve access to IPAPS for the many patients diagnosed with heart failure. I have outlined a few comments below for your consideration:
1. GDMT Initiation: I fully support the initiative to ensure adequate initiation of guideline-directed medical therapy (GDMT). However, I recommend a three-month period for GDMT optimization. While "maximally tolerated doses" can be challenging to define, in my experience managing patients with IPAPS, the device itself plays a

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Kaleta, Christine Title: Heart Failure Nurse Coordinator
Organization: Baystate Health/ Baystate Medical Center
Date: 11/29/2024
Comment:
This will hopefully help to extend the reach of CardioMEMS and decrease the hoops needed to be jumped thru for some prior auth. We have been able to decrease HF admit and all cause significantly for our heart failure population when we can get insurance approval.
The qualification that prior to implant 3 months of max tolerated GDMT may not be in the best interest of the patient. Monitoring PAD while titrating GDMT can be very effective and ultimately safer for patients reducing the

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Briseno Jr, Oscar Title: Invasive Cardiologist
Organization: Skagit Regional Health
Date: 11/27/2024
Comment:

As someone who has witnessed its benefits based on my patients who have CardiomMEMS, I believe CardioMEMS is a game-changer for managing a condition as complex and costly as heart failure. I highly recommend CMS to continue supporting this innovative technology to reduce hospitalizations and costs but more importantly to improve the quality of life and longevity for patients with chronic HF. My patients feel assured and empowered knowing their condition is being closely monitored. If we

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Redberg, Rita Title: Professor of Medicine
Organization: UCSF
Date: 11/27/2024
Comment:

We appreciate the opportunity to comment on this proposed decision memo for Implanted Pulmonary Artery Pressure Sensor (IPAPS) for Heart Failure (HF) management. Based on available trial results and evidence of increasing adverse events, we believe that there is sufficient evidence to determine that IPAPS for Medicare beneficiaries does not meet the “reasonable and necessary” criteria and should therefore not be covered by Medicare. If Coverage with Evidence Development (CED) is provided

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Bush, Heather Title: RN
Organization: Skagit Regional Clinic Cardiology
Date: 11/27/2024
Comment:
I am currently working as the Heart Failure nurse in the Cardiology Clinic. I directly monitor patients who have been implanted with CardioMEMS and see in real time to benefit this can add to those suffering with heart failure. This is an instrumental tool for the future management of CHF in helping avoid readmission and readmission. This gives the patient improved quality of life and saves so much money.
benjo, Alexandre Date: 11/27/2024
Comment:
Fantastic tool for keeping my patients stable and out of the hospital
Rathman, Lisa Title: HF Nurse Practitioner
Organization: PENN Medicine Lancaster General Health
Date: 11/27/2024
Comment:
Proposed patient criteria a and b are appropriate. I would remove criteria for evaluation for ICD. This device monitors heart rhythm; treats lethal rhythm. It is not a treatment for HF. I would remove section g. I would allow PAPS during acute HF admission. If implanted early in hospital stay, patient can be discharged to home with ongoing optimization of diuretics and GDMT as outpatient. This would also decrease HF readmission for congestion.
Physician criteria - I would absolutely

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Alalwan, Yusuf Title: MD
Date: 11/27/2024
Comment:
This groundbreaking technology is poised to have a significant positive impact on the management of patients with heart failure. I look forward to the next steps in facilitating broader access to this technology, which will ultimately help improve the quality of care for heart failure patients. As a cardiologist, I have witnessed firsthand how implantable pulmonary artery pressure sensors enhance our ability to not only improve patient well-being but also reduce hospital admissions.
Beach, Holly Title: Regulatory Process Manager
Organization: Mayo Clinic
Date: 11/27/2024
Comment:

The Honourable Chiquita Brooks-LaSure
Office of the Administrator
Centers for Medicare and Medicaid Services
7500 Security Blvd
Baltimore, MD 21244

Dear Administrator Brooks-LaSure,

On behalf of Mayo Clinic, we appreciate the opportunity to comment on the Centers for Medicare and Medicaid Services (CMS) proposed national coverage decision (NCD) for implantable pulmonary artery pressure sensors (IPAPS). Although IPAPS have been widely available since FDA

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Rowland, Harry Title: SVP Implantable Heart Failure Management
Organization: Edwards Lifesciences
Date: 11/27/2024
Comment:

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

Re: National Coverage Analysis (NCA) for Implanted Pulmonary Artery Pressure Sensor for Heart Failure Management (IPAPS)

Edwards Lifesciences (“Edwards”) appreciates the opportunity to comment on the National Coverage Analysis (NCA) for Implanted Pulmonary Artery Pressure Sensor for Heart Failure Management

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Clout, Christina Title: APRN
Date: 11/27/2024
Comment:
I think cardiomems is a great device to keep patients out of the hospital and guide diuretic and GDMT therapies. I do not agree that patients should be on maximum doses of GDMT for three months prior to cardiomems implantation. I feel that the device can help optimize gdmt. Therefore it would be ideal for patients to have the device prior to escalating medications.
Ramirez, John Title: Registered Nurse
Organization: Mayo Clinic
Date: 11/27/2024
Comment:
Our patients have benefitted in a very positive way since getting a CardioMEMS. It offers a unique way to manage hemodynamics in our patients who are living with Heart Failure. It has allowed our Heart Failure Team the opportunity to adjust the patient’s plan of care safely and with reliable data. We hope to see more coverage for the CardioMEMS so patients can continue to benefit from this unique piece of technology.
Stirling, Amanda Organization: American College of Cardiology and Heart Failure Society of America
Date: 11/27/2024
Comment:

November 27, 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 Determination (NCD) proposed decision memo

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Draper, Gabrielle Organization: Preventive Cardiovascular Nurses Association
Date: 11/27/2024
Comment:

November 27th, 2024

The Honorable Chiquita Brooks-LaSure
Centers for Medicare and Medicaid Services
US Department of Health and Human Services
200 Independence Avenue SW
Washington, DC 20201

Re: NCA Proposed Decision Memo for Implanted Pulmonary Artery Pressure Sensor for Heart Failure Management

Dear Administrator Brooks-LaSure:

On behalf of the Preventive Cardiovascular Nurses Association (PCNA), thank you for the opportunity to comment on

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Cowger, MD, MS, Jennifer Title: Section Head of Advanced Heart Failure/Transplant
Organization: Henry Ford Health
Date: 11/27/2024
Comment:
As a board certified advanced heart failure specialist in a high density, at risk patient population, I am writing to support coverage of PA sensor monitoring for patients with heart failure (HF) and high risk criteria as outlined herein. While guideline directed medical therapies (GDMT) are obligatory for HF, even the most compliant of patients will have readmissions. It is the disease process- akin to cancer spreading despite chemo. This is supported by the high readmission and mortality

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Hasegawa, James Title: Sr. Director, Health Economics and Reimbursement
Organization: Abbott
Date: 11/26/2024
Comment:

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. Jensen:

Abbott welcomes the opportunity to comment on the National Coverage Analysis (NCA) - Implanted Pulmonary Artery Pressure Sensor for Heart Failure Management (CAG-00466N) - Proposed Decision Memo for implanted PA

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Churchwell, MD, FAHA, Keith Title: President
Organization: American Heart Association
Date: 11/26/2024
Comment:

The American Heart Association (AHA) appreciates the opportunity to provide comments on the proposed decision memo on implanted pulmonary artery pressure sensors for heart failure management.

According to the decision memo, the Centers for Medicare and Medicaid Services (CMS) intends to cover implantable pulmonary artery pressure sensors (IPAPS) under the Coverage with Evidence Development (CED) paradigm. We provide feedback below on the proposed patient and physician criteria and

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Betterton, Eddie Title: Associate Director
Organization: Banner University Medical Center Tucson
Date: 11/26/2024
Comment:
CardioMEM's is a tremendous therapy that has greatly helped to reduce heart failure hospitalizations. One of the largest barriers we experience with using this therapy is insurance denials. This NCD would help patients to receive the therapy that is needed.
Beauperlant, Patrick Date: 11/26/2024
Comment:
This technology needs to be available to everyone without the patient or the clinics having to deal with authorization issues. The insurance denials and "hoops" they have to jump through to get approvals needs to come to an end. Hopefully, with the CMS decision this technology will be available to more people. Letting them live longer, better lives without constant hospitalizations and heart failure symptoms.
Nall, Jason Title: PA-C
Organization: UConn Health
Date: 11/26/2024
Comment:

I have the following thoughts on proposed patient and physician criteria based on my experience managing heart failure patients with PAPS.
Patient Criteria
c)
Patients have benefited from utilizing PAPS to help titrate GDMT. Many times, loop diuretics need to be downtitrated when adding GDMT; having the ability to more closely monitor PA pressures can help avoid rehospitalizations due to AKI or hypotension. Additionally patients may be sicker when they are first diagnosed,

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Aberton, Sami Title: NP
Organization: HCA
Date: 11/26/2024
Comment:
CardioMEMs has been an essential device in helping manage heart failure patients. It has allowed close monitoring of patients to help further optimize therapy, decrease hospitalizations and improve quality of life with having decreased decompensation of heart failure.
Cipriani, Kerry Title: Cardiology APRN
Organization: UCONN Health
Date: 11/26/2024
Comment:

Wonderful that this will hopefully help to extend the reach of CardioMEMS. This is a valuable tool for some of our sickest HF patients. Some comments on the criteria:

1. Agree with many of the comments here that implanting prior to 3 months of max tolerated GDMT may not be in the best interest of the patient. Monitoring PAD while titrating GDMT can be very effective and ultimately safer for patients. This may also limit MEMS to patients with HFrEF as guidelines for HFpEF are less

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Grzegorczyk, Jillian Title: Cardiac/Heartfailure NP
Organization: Covenant Health care
Date: 11/26/2024
Comment:

Implantable pulmonary artery pressure sensors are an imperative part of monitoring patients with heart failure.

Every time a patient is admitted to the hospital it increases. The risk of morbidity and mortality is extremely costly to both insurance companies and healthcare systems.

By approving this device more easily for heart, failure, patience, and certainly we will be saving thousands across the board .

This should be easily approved without strict criteria as

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Racu, Emily Title: CardioMEMS Nurse Coordinator
Organization: Northwestern Medicine
Date: 11/26/2024
Comment:
I have been a CardioMEMS nurse coordinator for three years. I handle all of the education, procedure scheduling, prior authorization and post implant PA monitoring for our systems region. Over the years, I have had to deny the potential of a better quality of life to many patients because their insurance would not provide procedure coverage for the CardioMEMS pulmonary artery pressure sensor. My institution has been implanting this device since 2016 and have had the knowledge backed by

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Niernberg, Laurie Title: ARNP
Organization: Swedish Medical Center - Cherry Hill
Date: 11/25/2024
Comment:
Our program has been placing Cardiomems since its inception as a participant in the CHAMPION trial and can certainly speak to the clear benefit of this device in this patient population that is very often implicated in high cost, labor-intensive care with frequent hospitalizations. As health care evolves to a model that is focused on preventing costly hospitalizations, this device is paramount for this population. For those without the device, it has been well documented that changes in

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RASHTIAN, MAYER Title: Director of cardiac EP Huntington hospital
Organization: foothill cardiology
Date: 11/25/2024
Comment:
Dear CMS Leadership,
Heart failure (HF) is one of the most significant challenges facing healthcare systems today, with high rates of hospitalization, morbidity, and associated costs. Since its FDA approval in 2014, the CardioMEMS HF System has proven to be a revolutionary tool in the outpatient management of HF. As practitioners with extensive experience utilizing this technology, we would like to emphasize its critical importance in transforming patient outcomes and guiding care.
The

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Kelley, Glen Title: Patient Voice and Advocacy Leader
Organization: The Mended Hearts, Inc.
Date: 11/25/2024
Comment:
As the world’s largest peer to peer heart patient support organization, The Mended Hearts, Inc. is dedicated to supporting heart disease patients and their families. We strongly endorse the proposed decision memo supporting the coverage of the Implantable Pulmonary Artery Pressure Sensor (IPAPS) for heart failure management.
Heart failure is a chronic condition that imposes significant burdens on patients and healthcare systems. The CardioMEMS sensor, a type of IPAPS, has demonstrated

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King-Dailey, Kathaleen Title: Nurse Practitioner
Date: 11/25/2024
Comment:
I reviewed the proposed decision memo for the IPAPS for heart failure management. For item under category B item C the recommendation for patient to be on optimal GDMT for at least 3 months prior to consideration for implant may be too long. Maybe a softer time frame such as 6-8 weeks? There are circumstances where an earlier implant may be helpful in keeping the patient out of the hospital or aid in continued optimization of their GDMT. However, I do appreciate the thought that there

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Seto, Arnold Title: MD, Advocacy Committee Chair
Organization: Society for Cardiovascular Angiography and Interventions
Date: 11/25/2024
Comment:

The Society for Cardiovascular Angiography and Interventions (SCAI) appreciates this opportunity to submit comments on the proposed decision memorandum and national coverage determination (NCD) for implantable pulmonary artery pressure sensor(s) (IPAPS) for heart failure (HF) management. SCAI has dedicated its work to advancing the profession and is the designated society for guidance, representation, professional recognition, education, and research opportunities for invasive and

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Marieb, Mark Title: MD
Organization: Griffin Health
Date: 11/24/2024
Comment:
I wonder whether waiting on three months of guideline directed medical therapy is appropriate. First of all are we waiting for patients to be readmitted while those medications are being adjusted? It seems that it would be extremely beneficial to have a right heart catheterization (as a baseline) and Cardiomems in place while these medicines are being adjusted. It certainly would make sense to do a study randomizing patients with new onset of heart failure to a Cardiomems device versus simply

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Torres, Charon Title: RN, Coordinator HF Clinic
Organization: St. Vincents Medical Center HHC
Date: 11/24/2024
Comment:
I am in support of the decision because IPAP’s are a great tool to help keep patients out of the hospital and give them a better quality of life. I agree with most of the criteria, but I do feel that a couple of things can be adjusted 1(c) early implementation of IPAP’s help guide the decision making for up titration of GDMT so waiting 3 months is too long. IPAP’s give the team the necessary data to help guide the decision making while incorporating GDMT. 1(g) depends on patients because some

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kernizan, jessica Title: LVAD Coordinator
Organization: Virtua Health
Date: 11/22/2024
Comment:
Having the ability to monitor outpatients and help decrease the amount of readmissions to the hospital is a wonderful tool that everyone should be using. This should be available to all patients who quality and could benefit.
Griffiths, Jessica Title: PA-C
Organization: Prisma Health
Date: 11/22/2024
Comment:
As an Advanced Heart Failure provider, the CardioMEMS sensor has become a pivotal treatment option for my patients. Dozens of patients under my care have received the sensor and had a significant reduction in heart failure hopsitalizations as well as improved mortality. The sensor enables not just closer, accurate, personalized monitoring of a patient's volume status, it also facilitates a closer provider-patient relationship that improves overall quality of care. I recommend this technology

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Zwack, Elana Title: RN, CHFN
Organization: VA Heart
Date: 11/22/2024
Comment:
I am a certified HF Nurse working with our Advanced HF team at the largest cardiology practice in Northern VA. We see many patients affected by HF with frequent hospital readmissions. In regard to CardioMems, we see real time benefits for our patients who were fortunate enough to receive approval for implant. Benefits include reduced HF readmissions, improved mortality rate, better KCCQ scores, and increased QOL. The monitoring has shown to be a very beneficial tool for these chronically ill

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Brown, Kimberly Title: Clinical Heart Failure Navigator
Organization: Virtua Health
Date: 11/21/2024
Comment:
Cardiomems offers our HF patients a valuable tool in managing their disease.
Ghantous, Andre Title: MD
Date: 11/21/2024
Comment:
Couple of comments regarding the CMS proposed decision member for the National coverage for CardioMEMS.
1–cardiologist need to follow this patient should be experience cardiologist and heart failure but not necessarily advanced heart failure we have a lot of cardiologist who are well experienced in taking care of patient with heart failure and if they need any help they can always reach to advanced heart failure subspecialty.
2-is for inpatient who had frequent heart failure

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Strobel, Pam Date: 11/21/2024
Comment:
Cardiomems should always be covered by insurance
Surprenant, Dawn Title: Lead APP - CardioMEMS Program
Organization: Hartford HealthCare
Date: 11/21/2024
Comment:

1. Patient Criteria:
a) Diagnosis of chronic HF of at least 3 months duration and in New York Heart Association (NYHA) functional Class II or III within the past 30 days, prior to PAPS implantation, regardless of left ventricular ejection fraction (LVEF).
*Agree that this criteria will allow organizations to contiue to increase referrals and implants for patients across the system to reach more Heart Failure patients in not only General Cardiology. Device has proved

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Robertson, Rhonda Date: 11/21/2024
Comment:

Prior authorization approvals play an important role in the implantation of the CardioMEMS PA pressure sensors. Prior authorization denials for the sensors can have a significant effect on a patient’s health. Often, we are on hold for over an hour with the insurance company prior to speaking with a representative. We then must fax in information and wait another ten to fourteen business day to receive a decision. If the request is denied, we must do an appeal which can take up to 30 days.

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Rice, Randy Organization: UAMS
Date: 11/21/2024
Comment:

As a healthcare provider dedicated to improving the lives of my patients with heart failure, I have found the integration of CardioMEMS technology to be transformative. CardioMEMS offers a patient-centric approach that significantly enhances monitoring and management of heart failure.

Through the use of this innovative remote monitoring system, I can gather real-time data on my patients' pulmonary artery pressure. This capability allows for early detection of fluid retention and the

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Kemner, Lindsay Title: RN
Organization: Virtua Heart Failure
Date: 11/21/2024
Comment:
every insurance should cover cardiomems
Patel, Harsh Date: 11/20/2024
Comment:

As a practicing HF cardiologist, I see daily the effects over hypervolemia in my patients. Having the capability to monitor ambulatory pulmonary artery pressures can be a very effective way to monitor fluid level in my patients, thereby allowing titrations of their diuretics and effectively avoiding frequent hospitalization for heart failure exacerbation.

The insurance process of approval to proceed with CardioMEMs place has proved to be very challenging. There have been multiple

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Winkler, Katie Title: Heart Failure RN
Organization: HCA/HFCCA
Date: 11/20/2024
Comment:
Great job, this needs to be accessible to ALL patients in a responsible way, that need it! This will help provide access to iPAP sensor to all, by establishing a presence for ALL insurance companies to follow.
I have witnessed dozens of patients and their loved ones benefit from this technology.
Agunbiade, Tolu Organization: Virtua
Date: 11/20/2024
Comment:
Agree with proceeding with this important NCD to allow better access
Bucci, Mary Title: Heart Failure Navigator
Organization: Virtua
Date: 11/20/2024
Comment:
Agree - this is a great tool in treating and preventing hospital readmission for Heart Failure
Rowe-Ruffin, Theresa Title: Administration Director of Heart Failure Services
Organization: Virtua Health
Date: 11/20/2024
Comment:
This monitoring has really served as an important tool in the management of all Heart Failure patients. Medications are great when patients can tolerate them but being able to prevent a hospitalization and bring patients into the office or titrate meds right at home is something that is very beneficial for these chronically ill patients. We are identifying these patients on their index HF hospitalization and informing them how this monitoring can give them more healthy days at home. ALL

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Echterling, Jon Title: Heart Failure Nurse Pracitioner
Organization: Penn Medicine Lancaster General Health
Date: 11/20/2024
Comment:
I agree with all the prior needs to implant other than, if you are inpatient on a readmittion, I would favor the ability to implant the device during the readmit stay as long as the other pre requisites are met.
Basuray, Anupam Title: MD
Organization: OhioHealth
Date: 11/20/2024
Comment:
Implant during an acute hospitalization should be allowed to prevent the next hospitalization. If the patient has been on gdmt for 3 months, an acute hospitalization signifies a failure in therapy and warrants prompt treatment. Pa sensor placement at that time should be allowed to be part of that treatment plan.
B, Mary Title: RN
Organization: Hartford healthcare
Date: 11/20/2024
Comment:
Very helpful tool to manage HF patients. We consistently see reduced hospital admissions. The criteria looks good.
Rogers, Cheryl Title: Nurse Practitioner
Organization: Riverside Medical Center
Date: 11/20/2024
Comment:
It is imparative that coverage be expanded for providing this monitoring therapy to all qualified patients. The data and research support it being impactful to clinical therapies and more so improving QOL and preventing heart failure re-hospitalizations.
Baker, Nicole Title: RN
Date: 11/20/2024
Comment:

I have particular concerns about Patient Criteria items C and G.
For criteria C) "On maximally tolerated GDMT for 3 months prior to PAPS implantation"- I feel our program has found success in using the PA sensor as a tool to uptitrate/optimize GDMT regimens, especially in patients who have been sensitive to medication changes, etc. This has been a useful tool to show improvement in a patient's HF status as GDMT is optimized. I think it would limit our ability to optimize patients if we

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Carey, charles Title: physician Cardiologist
Organization: Mercy Clinic
Date: 11/19/2024
Comment:
I believe PA sensor has an important role in improving the quality of life and in select patients quantity of life in heart failure which has a high morbidity and mortality. I think any cardiologist should be able to refer a patient for a PA sensor. The randomized control trials did not limit patients only seen by heart failure specialist.
Chawla, Kunal Title: Physician
Date: 11/19/2024
Comment:
Very important device with evidence of both reduced hospitalizations as well as mortality benefit. Improves health care expenditures and allows patients to be monitored from home. This is a safe device to implant and should be made more widely available.
Smith, Sarah Title: Nurse practitioner
Organization: Vanderbilt Heart Transplant
Date: 11/19/2024
Comment:
I have seen firsthand how CardioMems can improve quality of life and reduce hospitalizations for my heart failure patients. I feel strongly that all patients should have access to this care regardless of their insurance product.
Patel, Nishi Title: Heart Failure Cardiologist
Organization: Wellspan York Hospital
Date: 11/18/2024
Comment:
CardioMems has been a valuable tool for the outpatient management of heart failure. We have been able to achieve an 86% reduction in heart failure hospitalizations over one year after implant in our health system. Unfortunately such an effective tool has been underutilized by most physicians and providers seeing patients with heart failure. While I agree with the spirit of the proposed coverage changes to allow for a broader symptom range of HF patients to qualify for implant, I disagree with

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Delano, Elizabeth Title: Director of Special Procedures
Organization: Griffin Health
Date: 11/18/2024
Comment:

In regards to the implantation of the IPAPS criteria, I feel A, B D, & E are appropriate. The IPAPS is a beneficial tool that can be used to make changes that will affect the future course of a patients HF disease trajectory.

As for criteria C: I disagree, as the IPAPS should be used to achieve the maximally tolerated GDMT. Often, after a patient is implanted, the provider realizes that what they thought was maximally tolerated GDMT, was not the case. Rapid sequencing of GDMT to

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Bhatt, Kunjan Title: Cardiologist and Heart Failure Specialist
Organization: Austin Heart
Date: 11/18/2024
Comment:

CardioMEMs has been an incredibly helpful diagnostic tool for the management of heart failure (HF), since its FDA approval in 2014. Our Heart Failure program has implanted > 300 CardioMEMs sensors since 2014 (which represents almost 1% of total number of implants worldwide). We have also led in several clinical trials regarding CardioMEMs. As such, we have extensive experience regarding the utility of this simple diagnostic tool

CardioMEMs has bene transformative in the management

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Ayalon, Nir Title: MD
Organization: Boston Medical Center
Date: 11/17/2024
Comment:

Dear CMS Committee,

Thank you for your attention to the critical topic of Implanted Pulmonary Artery Pressure Sensors for Heart Failure Management. I am Dr. Nir Ayalon, the Director of the Boston Medical Center Heart Failure Remote Monitoring Program, an implanting physician for CardioMEMS devices, and the physician responsible for monitoring and managing heart failure patients post-implantation. I appreciate the opportunity to share my experiences and offer comments on the Proposed

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Reichert, Doug Title: Medicare Recipient/ Human
Organization: American / Human
Date: 11/17/2024
Comment:
[PHI Redacted], I wholeheartedly recommend that the CMS include this remedy in their list of "How to make American Lives and the World Better through Science". Reading the statements made on this subject, I can see myself as a willing participant and benefactor. My daily dream is to continue my life as a Father and Grandfather to the best of my ability. This device would give me an edge over an alternative and mostly, too early conclusion. Where would we be today if it

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Narang, Nikhil Title: Advanced HF Cardiology
Organization: Advocate Christ
Date: 11/15/2024
Comment:
Several pivotal trials have demonstrated the ongoing benefit of the CardioMEMs device in reducing HF hospitalizations, and greatly assist in the optimization and monitoring of patients with chronic heart failure of all types, It has been an truly instrumental tool that I use in our large practice, and undeniably has lessened the burden of heart failure for our patients and our hospital system
Sarkis, Patrick Title: Advanced heart failure and transplant fellow
Organization: Mayo Clinic Arizona
Date: 11/15/2024
Comment:
CardioMEMS is a minimally invasive, wireless implantable device that continuously monitors pulmonary artery pressure, providing real-time data that helps us detect early signs of worsening heart failure before symptoms become severe. This allows for timely interventions, reducing hospitalizations and improving long-term outcomes. By incorporating this innovative in our practice, we offfer our patients more personalized, proactive care and ultimately help them lead healthier, more fulfilling

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Mader, Jason Date: 11/15/2024
Comment:
Pulmonary artery pressure sensor for heart failure is a key part to minimizing hospital readmission and maximizing patient care. It can improve symptom management and reduce cost of hospitalization.
Cruz, Daniel Title: MD
Organization: UCLA MEDICAL CENTER
Date: 11/13/2024
Comment:
The CardioMEMS system has been a key strategy for reducing heart failure admissions in our heart failure program. In the right patient, it makes an immense difference. We are grateful to be able to offer it to our patients who most need it.
Gawron, Heather Title: Arnp
Organization: NYU langone health
Date: 11/13/2024
Comment:
This is a very useful tool in our more difficult patients. This should continue to reimbursed
Cromer, Courtney Title: RN
Organization: Houston Methodist Hospital
Date: 11/13/2024
Comment:
This device has been of great importance in helping manage heart failure patient's inpatient. It can be used as a non-invasive guide for hemodynamic management and optimization of fluid status. It can aid RNs in understanding patient status and effect of diuretic therapy.
Bladen, Susan Title: HF Program RN Coordinator
Organization: Legacy Health
Date: 11/12/2024
Comment:

Recently we implanted a CardioMems PA sensor in a patient who was using a Furoscix pump multiple time a week. Given his co-morbidities, COPD, CKD IIIB, DMM2, and lymphedema, it was challenging to determine when or how often to use the Furoscix pump based on weight gain, lower extremity edema, with or without other symptoms. Since the CardioMems implant it has been much easier to manage this patient and prevent either an ED or admission for exacerbated heart failure.

We have also

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Wright, Greg Title: RN
Organization: Legacy Medical Group Cardiology
Date: 11/12/2024
Comment:
I am a Program Coordinator for the Heart Failure team in the Legacy system in Portland, OR. I have been working closely with our patient base that currently have the implanted CardioMems device and have been able to regulate therapy based on the remote readings and trends. Our team feels that we have prevented several ED visits and hospitalizations re: fluid overload and exacerbated acute on chronic heart failure. Our team anticipates implanting many more of our patients given that insurance

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Bair, Dorothy Title: APRN-CNP
Organization: OhioHealth Doctor's Hospital Heart Failure clinic
Date: 11/12/2024
Comment:
Implanted pulmonary artery pressure sensors are a very helpful and accurate way for providers in heart failure clinics to remotely monitor & manage heart failure patients to reduce CHF episode & hospitalizations. We are able to reduce hospitalizations/readmissions by using this type of device. Our readmission rates are below the national average as a results & are patients are healthier as a result.
White, Dedrea Title: DNP, APRN
Organization: Arkansas Heart Hospital Clinic
Date: 11/12/2024
Comment:
I strongly support the coverage of the CardioMEMS HF System. Doing so allows for patients to live fuller lives within the limitations of the disease process, by limiting the impact on ADLs and providing a means to participate proactively in self-care. This ability to recognize and intervene early ultimately reduces acute inpatient admissions saving medical dollars to the patient, healthcare facility and Medicare program. Arkansas is a heavily rural state and access to care and providers

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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.

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Desai, Prakash Title: MD
Organization: Lake View Cardiology
Date: 11/04/2024
Comment:
  1. The technical aspect of implantation is more complex than simple Right heart CAth The RVU should be higher
  2. 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.
  3. The cost of device that the company charges is prohibitive for

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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

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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

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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

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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

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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

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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

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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