Implanted Pulmonary Artery Pressure Sensor for Heart Failure Management

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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 beneficial for both HFrEF and HFpEF patients.
b) History of HF hospitalization or urgent HF visit (emergency room or other outpatient visit requiring intravenous diuretic therapy) within the past 12 months, or elevated natriuretic peptides within the past 30 days.
*Agree that this broadened definition of urgent visit that will now inlcude outpatient visits that require IV diuresis will allow for more inpatients to be referred for a CardioMEMS PA Sensor.
c) On maximally tolerated guideline-directed medical therapy (GDMT) for at least 3 months prior to PAPS implantation.
*Do not agree with this criteria. Many patients are referred for CardioMEMS and are not on optimal therapy. With use of PA Sensor our prgram has proven great success with initiating and titrating patients on the pillars of GDMT, whether HFrEF or HFpEF. The "real-time" data from a patients pillow reading has allowed our team to optimize patients and move them to maintenance phase more succesffuly and with minimal side effects.

2. Physician Criteria
The IPAPS items and services are furnished by practitioners who meet the following criteria, as applicable:
a) Physicians referring Medicare patients and managing them post implantation must be cardiologists with experience in advanced HF management.
*Do not agree with this comment. As an APP in the State of CT I have referred many patients for a CardioMEMS device and have had many other APP's across our Hartford Healthcare System refer as well. Limiting referrals to Physicians only will greatly impact patient care. This will limit the amount of patients referred and implanted given that most programs are successfully driven by APP's.

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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. During this time, the patient’s health can become worse. Denials delay the implantation of the sensor and prevent timely monitoring of the pulmonary artery pressure. This delay can result in additional hospitalizations and can increase the risk of the progression of heart failure, the patient’s quality of life, and mortality. Delays could also increase psychological stress on the patient that can worsen symptoms and could increase healthcare costs due to more frequent hospitalizations and more intensive treatments.

Prior authorizations are critical to ensuring that patients with heart failure have the care they need in a timely manner and have access to advanced monitoring that can lead to improving their health and overall healthcare outcomes.

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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 potential for heart failure exacerbations. The ability to intervene proactively has been pivotal in preventing hospitalizations, which not only improves patient outcomes but also fosters a stronger sense of empowerment among my patients.

Patients have expressed their relief and gratitude for this continuous and non-invasive monitoring, as it allows them to maintain a level of independence while being closely watched. The combination of timely intervention and personalized care has led to improved adherence to treatment plans and overall quality of life.

In summary, CardioMEMS has not only streamlined the management of heart failure in my practice but has also cultivated a collaborative relationship with my patients. Together, we are navigating their health journeys with data-driven insights and proactive care strategies, ultimately enhancing their heart failure management experience.

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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 cases of insurance stating that this an "experiment" procedures and they are not willing to approve it. On multiple patient cases, we have had to do 2nd or even 3rd level of appeal to insurance denials and only in a few cases have been approved to proceed.

I think more centralized and standardized regulation for the approval of this life changing device would be greatly beneficial to many in the healthcare profession, including physicians and patients with HF.

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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 were unable to implant the sensor prior to maximum GDMT.

For criteria G) "Must not have PAPS implantation occur during a hospital admission for an acute HF episode". There are certainly scenarios where an inpatient implant is beneficial for a patient. There are often patients who lack access to larger medical centers and are unable to schedule transportation/travel a great distance for an additional procedural appointment. Also, there are certain patient populations who are more engaged while hospitalized, and would otherwise be lost to follow-up if the only option is to have them come back for a separate appointment for implant.

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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 improve patient outcomes is vital and therefore a provider can use the IPAPS to achieve that goal. The IPAPS is a useful diagnostic tool that allows providers an inside view of fluid volume and stress on the RV.

Criteria F: The original IPAPS uses multiple forms of technology to transmit the reading to the clinic. This should be decided at the clinic level to determine if the patient's demographics are appropriate. After 6 yrs of working with an IPAPS, I have not encountered a patient living in a rural area where the IPAPS could not transmit.

Criteria G: Completely disagree with not having an IPAPS implanted during an acute HF episode. The patient is in the hospital because their medication regime is not working. If they are not on maximally tolerated GDMT, this is a great opportunity to implant the IPAPS and put them on GDMT. HF length of stays are a problem due to the complexity of the disease process. Implanting an IPAPS is vital not only for the patient's quality of life, but also to decrease the hospital LOS and reduce the overall cost to the insurance company. Placing an IPAPS on an appropriate inpatient HF hospitalization will decrease 30 day readmissions rates. This is important, not only for the patient but for the hospitals and insurance companies.

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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 of heart failure for our patients. As the Cardiology / Heart failure community is aware, physical exam alone can be limited in accurately treating / managing HF. As such the readmission rates for HF are uncertainty high, our own program has shown a 60% risk reduction in readmissions for HF using CardioMEMS - this benefit has been seen for both HFrEF and HFpEF. As you may know, there are not tools we have to decrease readmissions for HFpEF, but CardioMEMS is a notable exception.

We have been able to accurately and intelligently manage outpatients irrespective of their geography. Some of our patients, previously hesitant to travel given the frequent readmissions prior to CardioMEMS, have had the joy of traveling and knowing that their HF status was being monitored whether they are at home, or traveling abroad.

We've also been able to more intelligently identify those patients whose HF status progressed from stage C —> Stage D using this tool. CardioMEMs has been pivotal in this select cohort to identify those patients that may benefit from Advanced HF therapies (i.e. - LVAD or Heart Transplant).

In conclusion, CardioMEMs has been an incredibly helpful tool in the management of ambulatory heart failure. There are several clinical trials to objectively measure this benefit. But as a practicing physician "in the trenches", it has been transformative in these patients' quality of lives. I hope you consider these factors in your decision making.

thank you for allowing me to contribute to this

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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 Decision Memo.

      1. Expanding Access to Technology
I strongly advocate for making this technology available to as many eligible patients as possible. In my experience, particularly as a physician working in a safety net hospital serving underserved populations, minorities, and patients facing significant challenges related to social determinants of health, this intervention has proven to bridge gaps between patients and the high-level care they need. Remote monitoring allows for more focused and dedicated interventions tailored to patients’ needs, addressing barriers such as transportation, limited access to specialist care, and fragmented follow-up. Our experience at Boston Medical Center demonstrates that even among populations historically perceived as non-compliant, this technology significantly improves engagement with medical care. Patients feel more connected to their healthcare team, and timely data-driven interventions reduce morbidity and foster better health outcomes. This approach has been particularly impactful in reducing disparities in heart failure outcomes within our community.
      2. Inpatient and Outpatient Implantation Flexibility
I urge the committee to support the availability of both outpatient and inpatient implantation options. At Boston Medical Center, inpatient implantation has proven to be particularly advantageous, allowing us to shorten hospital stays and facilitate earlier discharges. Knowing that we can seamlessly continue monitoring patients after discharge has provided both patients and clinicians with confidence in managing complex cases effectively.
      3. Broadening Access through Collaboration
I recognize the committee’s emphasis on ensuring experienced clinicians use this technology appropriately. However, requiring advanced heart failure specialists for every implantation may limit access in many communities. As an alternative, I propose creating a framework for collaboration with experienced centers like ours. This would allow hospitals without advanced heart failure specialists to consult with specialized centers to confirm indications and meet requirements for implantation, ensuring both broader access and adherence to best practices.

Once again, I commend the committee for addressing this critical area in heart failure management. I am confident that expanding access to Implanted Pulmonary Artery Pressure Sensors will significantly improve care for heart failure patients across the country. Please feel free to reach out if additional insight or data from our experience at Boston Medical Center would be helpful in your deliberations.

Sincerely,
Nir Ayalon, MD
Director, Heart Failure Remote Monitoring Program
Boston Medical Center
Cell 6178-319-5423. Email nir.ayalon@bmc.org

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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 conducted an analysis of each of our CardioMems patients looking comparing ED visits or hospitalization pre and post CardioMems implant, and found the number of ED visits and hospitalization were dramatically reduced post CardioMems implant.

The CardioMems has been a game changer in how well we are able to manage both our HFrEF and HFpEF patients. It has been very frustrating when we have requested insurance authorization for a patient who would benefit from CardioMems and getting a denial, and the appeal process has become cumbersome and managed by a 3rd party without medical or cardiac experience. The denial is always worded "because there is not enough evidence of the helpfulness of the procedure".

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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

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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.

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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.

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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 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.
4. 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.

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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

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