Artificial Hearts and related devices, including Ventricular Assist Devices for Bridge-to-Transplant and Destination Therapy

The Emory LVAD and Thoracic Transplant programs have reviewed the proposed elimination of NCD § 20.9 and the proposed changes to NCD § 20.9.1

With regards to NCD § 20.9.1, we would like to applaud CMS for eliminating the antiquated designations of "Destination Therapy" and "Bridge to Transplantation". It is now clear, by a large body of evidence, that LVAD therapy is life saving and should be considered for any patient with stage D heart failure. However, pigeon holing patients into the categories of "Destination Therapy" or "Bridge to Transplant" is no longer appropriate or relevant. Heart Transplant is still the therapy with highest quality of life and duration of life improvement for end stage heart failure patients. At any point in their care, patients may or may not be candidates for transplant. Many patients who do not meet transplant criteria, have clinical improvement with LVAD therapy and do become transplant candidates, while other candidates who receive and LVAD for bridge therapy never get transplanted. These classifications were contrived and their elimination will resolve significant wasted administrative efforts. However, these designations did provide a benefit; specifically, they enforced a relationship between "LVAD Only" centers and transplant centers. This relationship is key to the dissemination of appropriate, life saving therapy throughout the country. We urge CMS to modify the proposed changes to § 20.9.1 to codify these relationships in order to ensure continued appropriate use and access for their members. It is conceivable that without guidelines from CMS, "LVAD Only" centers may develop that do not have relationships with transplant centers potentially preventing access of some patients to a therapy that continues to be superior.

With regards to NCD § 20.9, we are very concerned regarding the proposed elimination of national coverage for artificial heart development and research. Currently, there is only 1 device available and this is based on 40-50 year old technology. By removing the NCD that supports active research in artificial heart technology and relegating its coverage to MACs, CMS is leaving a gaping hole in heart failure therapy. With improvements of medical therapy, patients are coming to heart replacement (LVAD, Transplant, etc) later and with more advanced disease. Often times, these patients have severe biventricular dysfunction. The field of biventricular support is really in its infancy. CMS, with the proposed elimination of § 20.9, risks terminating burgeoning advances in biventricular support. Given the continued scarcity of transplant organs, it is irresponsible to not have a uniform and national coverage for biventricular support devices research. We therefore urge CMS to reconsider elimination of § 20.9 as the variability in MAC coverage will significantly hinder this important progress.

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Medtronic
CRHF Economics & Reimbursement
8200 Coral Sea Street NE, MVS33
Mounds View, MN 55112
USA
www.medtronic.com

September 11, 2020

Ms. Tamara Syrek Jensen, J.D.
Director, Coverage & Analysis Group, CCSQ
Centers for Medicare & Medicaid Services
7500 Security Boulevard, C1-14-15
Baltimore, Maryland 21244

Dear Ms. Jensen,

Medtronic is the world's leading medical technology company, specializing in implantable and interventional therapies that alleviate pain, restore health, and extend life. We are committed to the continual research and development necessary to produce high-quality products and to support innovative therapies that improve patients' lives. We appreciate the opportunity to provide comment on the Proposed Decision Memo for Artificial Hearts and related devices, including Ventricular Assist Devices for Bridge-to-Transplant and Destination Therapy (CAG-00453N). We support continuing national coverage for left ventricular assist devices (VADs) and we believe the language in the proposed decision memo will achieve this goal.

Medtronic is pleased with the inclusionary language put forth by CMS in the proposed decision memorandum. We believe this language ensures that all indications for FDA-labeled devices remain covered and that existing coverage for any FDA-labeled VADs is not abruptly discontinued. Specifically, we recommend that CMS finalize the following language in the National Coverage Decision:

Left ventricular assist devices (LVADs) are covered if they are FDA approved for short-term (e.g., bridge-to-recovery and bridge-to-transplant) or long-term (e.g., destination therapy) mechanical circulatory support for heart failure patients.

Medtronic also supports CMS’s proposal to refine the clinical coverage criteria for VAD patients regardless of therapeutic intent-to-treat at the time of initial VAD implantation. We agree with CMS that these changes, which extend evidence-based patient selection criteria to all patients, will facilitate access and clinical care for all appropriate VAD patients, regardless of the initial therapeutic intention. We agree that these changes will ensure VAD candidates who are likely to benefit from the therapy receive access, while maintaining an adequate safety profile.

Medtronic appreciates our long-standing collaboration with the CMS Coverage and Analysis Group, which we believe has helped to ensure appropriate access to advanced medical technologies in the Medicare population. We also appreciate your consideration of these comments related specifically to VADs and look forward to continuing discussions with the Agency to maintain coverage for this critical therapy.

Please do not hesitate to reach out with any questions or if we can provide any further information during the coverage revision process.

Sincerely,
Amy Palatiello
Director, CRHF Reimbursement
Amy.t.palatiello@medtronic.com
763-505-3551

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We have reviewed the proposed decision memo for artificial heart and related devices, including ventricular assist devices for bridge to transplant and destination therapy (CAG–00453N). On behalf of INTEGRIS Advanced Cardiac Care at INTEGRIS Baptist Medical Center in Oklahoma City, Oklahoma, commentary for support as well additional consideration is provided.

With respect to ending coverage with evidence development for ARTIFICIAL HEARTS and permitting Medicare coverage determination for artificial hearts to be made by the Medicare Administrative Contractors (MACs), we would DISAGREE with portions of this recommendation as written, believing that there should be a singular national coverage decision for the use of a total artificial heart.

Our program has utilized the total artificial heart (TAH) for our patients, having done multiple implants and actively contributed to the evidence development for the use of this device by participation in clinical trials. Our thoughts are as follows:

We respectfully disagree that coverage decisions should be made by the MACs. We prefer a national coverage decision for the following reasons:

• Need to assure consistency of national standards of use. Until improved, next-generation TAH’s are available, the volume of TAH’s used will remain extremely low, appropriately so. In that context, standardizing practices while reducing variation as much as possible is essential to achieving quality and cost-effective outcomes. This will be best facilitated by having a single source of reimbursement approval.
• Need to avoid delays in clinical decisions. Timing is critical for success with total artificial heart implantation. These patients are often critically ill, being supported by temporary support devices, and are at progressive risk for adverse events that could eliminate the possibility of this therapy for them. Deferring decisions to individual MACs is likely to lead to delay in implantation while coverage is determined. These delays in decisions would lead to added cost, hospitalization time, and clinical risk to patients, as well as financial risk for implanting centers.
• Need to avoid excessive financial risk for hospitals. There is a concern that if there is no baseline or prior approval provided by Medicare, it is possible that coverage would be decided after the fact of implantation (especially if a TAH were needed on a semi-emergent basis), which would lead to substantive financial risk for implanting centers that the MAC would deny coverage. This could make implantation of the heart by centers prohibitive from a financial risk perspective, and therefore prevent access to this life extending technology.
• Need to avoid disincentives to hospitals willing to support proper use of TAH’s. It is critical that we maintain access to durable biventricular support technologies, as there are no good alternatives to this therapy for patients with severe biventricular heart failure, refractory ventricular arrhythmias, or complex congenital heart disease. Anything that adds to the uncertainty of access could stifle further progress in development of this or alternative technologies to fill this important niche.

Overall, we prefer that CMS have a singular national coverage determination for use of total artificial heart as bridge to transplantation with any coverage, either with or without evidence development requirement.

With respect to durable intracorporeal LEFT VENTRICULAR ASSIST DEVICES, we AGREE with the adjustments to the patient selection criteria.

• Elimination of the intent-to-treat definitions of bridge to transplant and destination therapy is consistent with clinical trial data as published in the MOMENTUM 3 series of studies, of which we were a participating center.
• Elimination of VO2 criteria is acceptable, as there are certainly patients that could benefit from a device that do not meet this somewhat arbitrary definition of benefit, particularly with the markedly improved outcomes with the HeartMate 3 left ventricular assist device.
• The ongoing standard of requirements of a cohesive multidisciplinary team with appropriate qualifications, training, and experience continues to be appropriate.
• Likewise, team members as defined are appropriate and we are in agreement with this.

Lastly, we firmly support the importance of credentialing for VAD-implanting facilities.

• The importance of this cannot be understated, as these adjustments to coverage will allow for more centers that do not have access to transplant and may have smaller teams of individuals to provide important and complex care.
• Maintenance of excellence in outcomes depends on excellence in patient selection, surgical management, postop critical care, and subsequent outpatient maintenance and management, with eventual transition into a palliative care pathway, often after years of successful support.
• Credentialing, whether by CMS or other approved credentialing organizations, remains a critical part of future success in this field, and we look forward to being part of this on an ongoing basis.

Thank you very much for your efforts and consideration. On behalf of the INTEGRIS Advanced Cardiac Care team, we express appreciation for the partnership with CMS in the progress that the field of mechanical circulatory support has made and look forward to ongoing developments in the future.

Sincerely,

Douglas Horstmanshof, MD, FACC
Co-Director, INTEGRIS Advanced Cardiac Care
Associate Chief Medical Officer, INTEGRIS Health / NZTI

James W. Long, MD PhD
Director, Nazih Zudhi Transplantation Institute
INTEGRIS Healthcare

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September 11, 2020

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

Dear Ms. Syrek-Jensen,

The Society of Thoracic Surgeons, the American College of Cardiology, the Heart Failure Society of America, and the American Association for Thoracic Surgery are submitting comments on the proposal to eliminate national coverage for artificial hearts and related devices.

We oppose eliminating national coverage for artificial hearts and related devices. It is the societies’ experience that National Coverage Decisions are deployed when disparate coverage policies across contractors exist or are expected, when complex or novel or resource-intensive services are under consideration, or when concerns about overutilization/misutilization exist. Several of these considerations apply to artificial hearts, the most important of which is the potential to limit access to therapy due to coverage. Inconsistent and inaccurate coverage policy creates access limitations and disparities that impose significant administrative burden on providers and stress on seriously ill patients. Sometimes patients are referred to another state where coverage is more appropriate and allows a therapy the physician and patient agree is necessary. Local factors are not irrelevant, but the societies believe in and affirm the value of having a floor for coverage for artificial hearts.

Significantly, current gaps in our understanding of the utility of treatment using artificial hearts and related devices could contribute to disparate local coverage decisions. Therefore, we reiterate our request to restore coverage with evidence development (CED) for artificial hearts. There are many clinical questions about artificial hearts that still need to be answered. Proposed clinical questions for continued CED include:

1. In what clinical scenarios is the total artificial heart appropriate to use rather than a left ventricular assist device or biventricular assist device support.
2. What are long-term risks inherent with TAH use?
3. Does the TAH have a safety and durability profile acceptable for long-term use; i.e., 2 years or greater?
4. Are patient-centered outcomes on the TAH acceptable and improved compared to patients with advanced heart failure or patients living with left ventricular assist device support?
5. Are results from pre-market clinical trials replicable in real word populations?

Thank you for the opportunity to provide comments. Should you have any questions, please contact Courtney Yohe Savage, Director of Government Relations for The Society of Thoracic Surgeons at 202-787-1222 or cyohe@sts.org.

Sincerely,

Joseph A. Dearani, MD
President
The Society of Thoracic Surgeons

Athena Poppas, MD, FACC
President
American College of Cardiology

Marc R. Moon, MD
President
American Association for Thoracic Surgery

Biykem Bozkurt, MD, PhD, FHFSA
President
The Heart Failure Society of America

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September 11, 2020

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

Dear Ms. Syrek Jensen,

The Society of Thoracic Surgeons, the American College of Cardiology, the Heart Failure Society of America, and the American Association for Thoracic Surgery are submitting comments on the proposed revisions to the National Coverage Decision (NCD) for Ventricular Assist Devices (VADs)

We appreciate that CMS has proposed to eliminate the unnecessary distinction between bridge-to-transplant (BTT) and destination therapy (DT) for coverage of durable VAD implantation by introducing the terminology of short and long term support. We believe that elimination of any terminology to characterize the intent of device implantation is in the best interest of the patient and consistent with the results of the MOMENTUM 3 clinical trial which demonstrates a strong therapeutic benefit of left ventricular assist devices regardless of device intent. We also appreciate that these changes may result in utilization of durable VADs expanding outside of transplant centers The policy change, which may make VADS more accessible to the general population, could have the unintended consequence of limiting some patients’ access to transplants if they do not seek care at a certified transplant center. CMS must take steps to ensure that patients are presented with all possible treatment options, including VAD implantation at all certified VAD centers.

Indications, Covered Devices and Treatments

We support the revisions to approved indications as follows:
2. Left ventricular assist devices (LVADs) are covered if they are FDA approved for short-term (e.g., bridge-to-recovery and bridge-to-transplant) or long-term (e.g., destination therapy) mechanical circulatory support for heart failure patients who meet the following criteria:

• Have New York Heart Association (NYHA) Class IV heart failure;
• Have a left ventricular ejection fraction (LVEF) ≤ 25%;
• [Are inotrope dependent]
  OR have a Cardiac Index (CI) < 2.2 L/min/m2, while not on inotropes, and also meet one of the following:
  • Are on optimal medical management (OMM), based on current heart failure practice guidelines for at least 45 out of the last 60 days and are failing to respond; or
  • Have advanced heart failure for at least 14 days and are dependent on an intra-aortic balloon pump (IABP) or similar temporary mechanical circulatory support for at least 7 days.

We also appreciate that CMS has clarified that this coverage decision does not include temporary VADs or extracorporeal membrane oxygen (ECMO).

Data Collection

We maintain that ensuring that patient outcomes are being captured in a national registry will help to alleviate any concerns about the applicability of the MOMENTUM 3 study definitions to other durable VAD devices and will help to monitor patient outcomes as utilization of durable VADs is likely to expand outside of transplant centers, among other benefits. Data collection to monitor patient outcomes could serve to help ensure that patients are receiving the right type of intervention. As mentioned above, expanding VADs access outside of transplant centers may have the unintended consequence of creating health care disparities. Patients who are in underserved segments of society tend to have more modifiable risk factors prohibiting direct transplant. Using Intermacs data 2012-2015, only 8.5% of Caucasians undergoing LVAD were ages 20-39 yet 18.6% of African Americans and 17.9% of Hispanics fell into this young age group. Those with modifiable risk factors are now reviewed regularly at transplant centers for listing potential. In the renal transplant field, health care disparities are a concern. In one study , access to transplant within the first year of ESRD was 65% lower in nonhispanic blacks and 43% lower in Hispanics compared with Caucasians.

One means of reducing the risk for health care disparities is to ensure patients have appropriate referral for transplant consideration before or after LVAD implant. In addition, participation in a national clinical data registry is an effective way for CMS to track patient characteristics as they relate to health care disparities, as well as allow centers to continue to track patient outcomes including survival, adverse events (e.g., bleeding, infection, stroke, device malfunction, and cardiovascular complications including recurrent heart failure), functional status, and quality of life in a way that allows comparisons with other institutions and facilitates internal quality monitoring and improvement. Collection and analysis of these data points may allow the development of risk adjustment models which can be utilized in patient selection and management.

Registry participation will also provide appropriate risk modelling that allows sites to be compared on patient population characteristics for key outcome metrics. This modeling has to be sensitive to changes in therapeutic application as well as new devices. Accurate risk modeling and quality assessment will be increasingly important if durable VADs utilization is expanded into centers that do not maintain transplant programs. We believe that registry participation as a condition of coverage is important to address unanswered questions in the field; e.g., 1) outcomes of durable VAD therapy for less advanced stages of heart failure; 2) outcomes of durable biventricular VAD therapy; and 3) appropriate timing and identification of high risk populations. We would propose these questions be adopted for coverage with evidence development to advance our knowledge and application of durable VADs technology.

Surgeon Volume Requirements

In addition, we believe that the requirement that surgeon members of a durable VADs team perform at least 10 implants over the course of 36 months is an arbitrary requirement that limits patients’ access to care. Cowger, et al , have demonstrated an association between overall center volume and patient outcomes3, but these data do not demonstrate that ten surgeon implants are required to ensure good patient outcomes. In addition, centers may also be inappropriately focusing on surgeon experience rather than devoting resources to the overall infrastructure necessary to support a durable VAD program. It is more important that facilities demonstrate a substantive commitment to the care of these complex patients utilizing a multidisciplinary care team than for an individual operator maintain a specific volume standard. Measuring quality performance through data collection as discussed above will also inform better care more meaningfully than a volume surrogate. Further exploration of this volume requirement would be appropriate as part of the reconsideration.

Thank you for the opportunity to provide comments. Should you have any questions, please contact Courtney Yohe Savage, Director of Government Relations for The Society of Thoracic Surgeons at 202-787-1222 or cyohe@sts.org.

Sincerely,

Joseph A. Dearani, MD
President
The Society of Thoracic Surgeons

Athena Poppas, MD, FACC
President
American College of Cardiology

Marc R. Moon, MD
President
American Association for Thoracic Surgery

Biykem Bozkurt, MD, PhD, FHFSA
President
The Heart Failure Society of America

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In my role as the Transplant Executive Director at UofL Health – Jewish Hospital in Louisville, KY, I have a unique perspective and duty both to our individual patients and their outcomes, as well as to the broader community. I must guarantee that our programs will be here to care for all those who may need our services now and in the future. In addition to my role at UofL Health, I am also on the OPTN/UNOS Board of Directors as the patient and donor affairs representative, and I am the daughter of a deceased donor, niece of an Uncle who donated his kidney and a niece of an Uncle who died on the waitlist waiting for a heart donor. I agree that coverage with evidence development should be ended for artificial hearts, but there needs to a be national coverage determination. Leaving coverage determination entirely to Medicare Administration Contractors (MACs) will not provide enough certainty on coverage to use the technology and patients will suffer as a result.

• The artificial heart has demonstrated the ability to act as an effective durable bridge to heart transplantation. With deceased donation rates remaining flat for many years and the increased need for deceased donor organs, it is vitally important that alternative medical and surgical interventions be available for both end stage organ disease therapy and as a bridge for transplant. Heart transplantation requires a donor organ that is of the correct size and quality, something that is unique for each patient. Limiting access to devices, such as the artificial heart, has the potential to add additional suffering and cost to our weakest population in this country.
• Barriers to access created by insurance coverage, regulatory quality outcomes & volume requirements, organ allocation policy, and patient comorbidities all dictate how transplant centers select patients to be a candidate for organ transplantation. If coverage determination for artificial heart replacement is left to the decision of local MACs, the financial risk of non-payment rests solely with the implanting institution, thus creating another barrier to accessing care. Unlike with commercial insurance payors, there isn’t a mechanism available to obtain, in advance, a prior authorization for treatment. Therefore, if a MAC determines not to pay an artificial heart implant claim, the institution would have no choice but to halt all future implants until national coverage determination was in place. Institutions would not be able to shed the financial burden created with future patients. The risk of non-payment is in direct conflict, and not in spirt of, the current culture of HRSA and HHS to broaden access to life saving treatments, as evidenced by the recent organ allocation directives of broader sharing of deceased donor organs. We also know from experience that commercial insurance carriers will heavily determine payment for services based on the response for payment by CMS. The implications of CMS national coverage have far reaching potential positive or negative impact by the commercial payors.
• Healthcare teams face difficult decisions when determining the best care plan for end stage disease patients. When administrative workflows for financial authorization cause delays in decision making, patients are harmed. They suffer both emotional as well as physical agony while waiting for answers. Every minute not knowing the plan, is unacceptable. As uncomfortable and unethical as it may seem, healthcare teams do need to consider financial implications to the patient as well as the institution when making care decisions. It is imperative to make quick decisions determining and communicating all surgical care options to patients, including artificial heart if applicable, to ensure patients have all the information and choices available known to them. If a healthcare team chooses not to accept the financial risk and/or expense of a potential non-payment, the patient must be given every opportunity to seek care elsewhere. Delays due to inconsistencies in MAC determination and team decision making will cause unnecessary patient suffering. We have a moral obligation as care providers to tell patients their options, as quickly as possible.

As an end stage organ disease and transplantation professional for almost 25 years, I highly recommend these critically important, time sensitive decisions be granted national coverage determination. Experienced in operations, finance, regulatory and patient advocacy aspects of this work, I assure you my opinions on a national coverage determination represent the very best interest of all parties involved. We have a collective obligation to all patients in need of life saving therapy to advocate for national policy determinations on their behalf.

Thank you for your consideration of these comments.

Sincerely,

Kimberly A. Rallis, BS, MHA
Executive Director
UofL Health – Jewish Hospital
Louisville, KY

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September 4, 2020

Tamara Syrek Jensen, Director
Coverage and Analysis Group
Centers for Medicare & Medicaid Services
Mailstop S3-02-01
7500 Security Boulevard
Baltimore, MD 21244

RE: Comments on CMS proposed national coverage determination on artificial hearts

Dear Ms. Jensen:

As Division Director of Cardiac Surgery at The Ohio State University Wexner Medical Center, I am responsible for caring for the types of patients who would be affected by the proposed CMS National Coverage Determination on artificial hearts and the proposal to defer coverage decisions to Medicare intermediaries.

I am also responsible for the financial viability of our service line. This proposal has an instrumental effect on both aspects of healthcare delivery.

Over the last two years, we have treated two critically ill patients with total artificial hearts (TAH), both being successfully bridged to heart transplantation and alive and well today as a result of the TAH. Additionally, in the same time period we have implanted over 40 primary left ventricular assist devices (LVAD) improving the morbidity and mortality for these patients with life-threatening advanced heart failure. While I appreciate the proposal to end with coverage development, I believe that the lack of a national coverage determination will impede the use of the mechanical heart assist technologies and thus ask for coverage to be determined at the national level, for reasons I will explain.

The proposed determination reduces the administrative burden of evidence development on our centers, which is positive. Currently, many patients need to be enrolled in clinical studies to get an implant or meet arbitrary time of treatment criteria for coverage. This results in increased lengths of stay, additional testing, and increased risk of delayed treatment which can harm patients.

The significant benefit to end with coverage development in its current form is appreciably outweighed by the uncertainty of coverage being decided by the MACs separately for each case. With no prior approval in Medicare, coverage is decided after the fact, meaning that the hospital has to take the significant financial risk that the MAC will deny coverage. This financial uncertainty may cause patients, particularly the most vulnerable, not to receive the device.

With no other durable biventricular support technologies indicated to support these patients, centers are left with few other options other than orthotopic heart transplant which, by virtue of an artificial heart being considered, these patients likely do not have timely access to or may not be ideally suited for in their current condition.

In light of these concerns, I request that CMS continue to have a national coverage determination for the use of artificial hearts for a bridge to transplant and left ventricular assist devices with any coverage and remove the evidence development requirement. Alternatively, I would propose that CMS remove any incremental barriers to access and closely monitor utilization. Given the modest number of TAH and LVAD implants annually, the fiscal risk to CMS is modest while the morbidity and mortality experienced by patients who do not have timely access to these therapies is catastrophic.

Thank you for your consideration of these comments. An artificial heart is an important option for our advanced heart failure patients and the current proposal could be problematic in terms of patient treatment, timing and eventual outcomes.

Sincerely,
Nahush A. Mokadam, MD
Professor and Director
Division of Cardiac Surgery
G.S. Kakos, MD and T.E. Williams, Jr., MD, PhD Endowed Professor in Cardiac Surgery
Associate Director, Surgical Services, Heart and Vascular Center

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Dear Ms. Jensen:

As a practicing Cardiothoracic surgeon at The Ohio State University Wexner Medical Center, I am responsible for caring for the types of patients who would be affected by the proposed CMS National Coverage Determination on artificial hearts and the proposal to defer coverage decisions to Medicare intermediaries. Over the last two years, we have treated two critically ill patients with total artificial hearts (TAH), both being successfully bridged to heart transplantation and alive and well today as a result of the TAH. Additionally, in the same time period we have implanted over 40 primary left ventricular assist devices improving the morbidity and mortality for these patients with life-threatening advanced heart failure. While I appreciate the proposal to end with coverage development, I believe that the lack of a national coverage determination will impede the use of the mechanical heart assist technologies and thus ask for coverage to be determined at the national level, for reasons I will explain.

The proposed determination reduces the administrative burden of evidence development on our centers, which is positive. Currently, many patients need to be enrolled in clinical studies to get an implant or meet arbitrary time of treatment criteria for coverage. This results in increased lengths of stay, additional testing, and increased risk of delayed treatment for the patient which can harm patients.

The significant benefit to end with coverage development in its current form is significantly outweighed by the uncertainty of coverage being decided by the MACs separately for each case. With no prior approval in Medicare, coverage is decided after the fact, meaning that the hospital has to take the significant financial risk that the MAC will deny coverage. Timing is critical for successful TAH and LVAD outcomes and delays caused by uncertain coverage could negatively impact long term patient outcomes. Additionally, the financial uncertainty may cause patients, particularly the most vulnerable, not to receive the device.

With no other durable biventricular support technologies indicated to support these patients, centers are left with few other options other than orthotopic heart transplant which, by virtue of an artificial heart being considered, these patients likely do not have timely access to or may not be ideally suited for in their current condition.

In light of these concerns, I request that CMS continue to have a national coverage determination for the use of artificial hearts for a bridge to transplant and left ventricular assist devices with any coverage with evidence development requirement. Alternatively, I would propose that CMS remove any incremental barriers to access and closely monitor utilization. Given the modest number of TAH and LVAD implants annually, the fiscal risk to CMS is modest while the morbidity and mortality experienced by patients who do not have timely access to TAH is catastrophic.

Thank you for your consideration of these comments. An artificial heart is an important option for our advanced heart failure patients and the current proposal could be problematic in terms of patient treatment, timing and eventual outcomes.

Sincerely yours

Bryan Whitson

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September 10, 2020

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

Via electronic submission

RE: Comments on Proposed Decision Memo for Artificial Hearts and related devices, including Ventricular Assist Devices (VADs) for Bridge-to Transplant (BTT) and Destination Therapy (DT) (CAG-00453N)

Dear Ms. Syrek-Jensen,

Abbott is pleased to submit comments on the proposed decision memo for Ventricular Assist Devices (NCD 20.1.9) to treat advanced heart failure. Abbott appreciates that CMS has proposed coverage updates that remove the intent to treat designations (bridge-to-transplantation and destination therapy) in favor of patient criteria that better identify Medicare candidates eligible for ventricular assist device (VAD) therapy. We applaud CMS for making improvements in each iteration of the NCD for VADs especially with the most recent proposed decision to update coverage criteria that reflects the latest comprehensive evidence and support of the clinical community.

Abbott is the manufacturer of the HeartMate™3 Left Ventricular Assist System (LVAS) which received the current FDA approval in 2018 based on the results of the MOMENTUM 3 clinical trial for the following indication:

The MOMENTUM 3 clinical trial was the largest (n= 1028) left ventricular assist device (LVAD) trial to date that enrolled patients under a single inclusion and exclusion criteria, regardless of intended use of the device. The trial compared the HeartMate II™. Left Ventricular Assist System (LVAS) with the HeartMate™3. LVAS and demonstrated the superior outcomes of the HeartMate™3. for patients eligible for LVADs regardless of the intention to treat (bridge to transplant or destination therapy). The evidence from this pivotal trial helped to inform the NCD reconsideration request in re-examining whether the intent-to-treat designations remain valid in light of the new data.

Our comments relate specifically to requested input on the proposed NCD as it relates to:

• Covered devices and treatment
• Coverage criteria
• Facility criteria (multi-disciplinary team, surgeon volume, and credentialing)
• Maintaining coverage at a national level for Total Artificial Hearts (TAH) and VADs

Abbott supports the proposed coverage updates for VADs with respect to the covered devices and treatment, coverage criteria, and facility criteria. We would like CMS to finalize their proposed policy to reflect similar coverage in the final decision memo.

Covered devices and treatment
Abbott supports the covered devices and treatment language as reflected in the proposed decision memo. CMS clarifies that covered devices be limited to durable, intracorporeal LVADs and does not include temporary devices that have not received FDA approval for short-term (e.g., bridge-torecovery and bridge-to-transplant) or long-term (e.g., destination therapy) mechanical circulatory support, nor the use of mechanical support for ECMO. This coverage update covers the commercially available LVADs on the market where there has been robust clinical data supporting regulatory approval. The crosswalk language associated with 'short-term or long-term mechanical circulatory support' help accommodate manufacturers with approved LVAD systems during this transition as well as clarify that temporary, short-term acute devices would continue not to be addressed under the proposed decision memo.

Coverage criteria
Abbott supports CMS removing the intent to treat designations and allowing for one pathway for qualification of VAD candidacy that greater reflects the movement of clinical practice towards the outcomes reflected in the latest evidence. In the subgroup analysis, Goldstein et al. (2020 JAMA Cardiology) showed that outcomes observed in the MOMENTUM 3 trial were not affected by the pre-implant clinical intent of BTT/BTC or DT in terms of patients deriving the same clinical benefit from LVAD therapy for both groups in the HeartMate™3. and HeartMate II™ clinical arms.¹ Therefore, the artificial intent-to-treat designation should be removed in favor of patient clinical criteria. The INTERMACS 2019 Annual Report supported the same recommendation in demonstrating increased survival and reduction in adverse events (stroke, gastrointestinal bleeding, and infection) with the advent and improvement in contemporary LVADs where their utilization and outcomes have been tracked outside of clinical trials.²

As a result of the totality of the recent evidence, the proposed decision memo focuses on patients who would qualify for LVADs by meeting the following criteria for coverage:

• Have New York Heart Association (NYHA) Class IV heart failure;
• Have a left ventricular ejection fraction (LVEF) ≤ 25%;
• Are inotrope dependent
• OR have a Cardiac Index (CI) < 2.2 L/min/m2, while not on inotropes, and also meet one of the following:
  • Are on optimal medical management (OMM), based on current heart failure practice guidelines for at least 45 out of the last 60 days and are failing to respond; or
  • Have advanced heart failure for at least 14 days and are dependent on an intraaortic balloon pump (IABP) or similar temporary mechanical circulatory support for at least 7 days

We appreciate that CMS provides a coverage option for patients who are not inotrope dependent in providing consideration for the cardiac index threshold with additional evaluation of failure on OMM based on current heart failure practice guidelines or being on IABP or temporary mechanical support for designated period of time. The cardiac index threshold provides greater inclusivity for VAD candidacy in allowing appropriate access that evaluates cardiac output based on body surface area for clinician consideration. We support that CMS has provided coverage based on central pathway that evaluates patient characteristics that support candidacy in removing the listing requirement and administrative challenges for patients classified as bridge-to-transplant by allowing for short-term or long-term support options should patients' status change over time.

Facility criteria
CMS did not propose to make any changes to the facility criteria as they remain unchanged from the current NCD 20.9.1.

Abbott supports maintaining the facility requirements that have been in place since the last update in 2013, primarily because there has been no direct association between operator volume and outcomes based on the available literature. We strongly believe that having the facility infrastructure in place as it relates to the multi-disciplinary team approach and hospital credentialing by an organization approved by CMS. Both of these items facilitate consistency and promote quality outcomes as it brings all VAD implants performed by accredited institutions under the commissioning process. Currently, the institutions (171) that participate in the accreditation process administered by an approved CMS vendor (DNV or The Joint Commission). As a result, we believe that maintaining the current facility criteria will not limit appropriate access but ensure consistent quality of care afforded Medicare patients. The accrediting bodies provide validated standards for institutions that perform VAD implants to ensure that patients are best advised and assessed of the most appropriate treatment options. In addition, the CMS approved accrediting bodies require participation in a national registry or the INTERMACS Registry to track and monitor safety and long-term outcomes.

Greater representation of racial minorities and women
In the NCA discussion, CMS expressed concerns about access of racial minorities and women to VADs as more outcome data is needed in these target groups. Abbott supports CMS's concern that there needs to be greater representation of racial minorities and women to address health disparities and treatment access when evaluating the impact of advanced heart failure. Though disparities still exist, we are hopeful that recent data show increased access of minority groups to LVAD implantation across most UNOS regions between 2008 to 2014. Specifically, the rates for non-whites has increased by 50% to over 400% with the average increase of minority implants being 173%.3 In addition, the 2019 INTERMACS Database Annual Report does show some improvement for non-whites receiving VADs at ~40%.2 We will continue to work with CMS to ensure future clinical trials in this space are more representative in enrollment of racial minorities and women to better address treatment efficacy and assist with removing unintended barriers to access.

Total Artificial Hearts (TAH) and Local Coverage Consideration
Although Abbott does not have products associated with the implantation of a TAH, we treat similar patients who have advanced heart failure and work closely with our institutions that specialize in these treatment options. Based on concerns from the clinical community, we request that CMS maintain the national coverage of TAH due to potential inconsistencies in application of coverage at the local level. Inconsistent local policies would result in variation in coverage and reduce the ability to acquire consistent, comprehensive evidence to effectively monitor outcomes for these patients, and also could delay care for this sensitive population. We therefore urge CMS to maintain positive coverage for TAH and VADs at the national level to ensure consistency and safeguard patient access to these therapies.

Conclusion and Summary of Request
Given the life-saving benefits of the HeartMate™3. LVAS therapy, as demonstrated in MOMENTUM 3 trial, we urge CMS to revise NCD 20.1.9 and update coverage for VADs based on appropriate patient characteristics as drafted in the proposed coverage memo which would ultimately replace the preimplant designations of BTT and DT.

In summary, we support the following:

• Proposed nationally covered indications as stated in Appendix B
• FDA approved devices covered in the NCD should only be chronic, durable VAD systems with indication for providing short term or long term mechanical circulatory support. These would crosswalk to the predecessor language of BTT and DT.
• Maintaining the existing facility criteria established in NCD 20.9.1
• Maintaining coverage for TAH and VADs under national coverage determination.

Abbott looks forward to working with CMS to update the coverage criteria for VADs with the goal of providing Medicare beneficiaries access to this life-saving therapy for treating advanced heart failure.

Thank you for considering our comments. Please let me or Wendy Chan, Global Director of Health Economics and Reimbursement for Heart Failure (wendy.chan1@abbott.com) know if you have any questions or require additional information.

Sincerely,
Robert Kormos, M.D., FACS, FRCS (C), FAHA
Robert.Kormos@abbott.com
Abbott
Divisional Vice President
Global Medical Affairs
Heart Failure

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1 Goldstein, DJ et al. Association of Clinical Outcomes with Left Ventricular Assist Device Use by Bridge to Transplant or Destination Therapy Intent: The Multicenter Study of MagLev Technology in Patients Undergoing Mechanical Circulatory Support Therapy with HeartMate 3 (MOMENTUM 3) Randomized Clinical Trial. JAMA Cardiol. 2020 Jan 15. [Epub ahead of print]
2 Teuteberg, JJ et al. The Society of Thoracic Surgeons Intermacs 2019 Annual Report: The Changing Landscape of Devices and Indications. Annals of Thoracic Surgery. Vol 109 (3), 649-660. March 1, 2020.
3 Thompson MP, Pagani FD, Liang Q, Franko LR, Zhang M, McCullough JS, Strobel RJ, Aaronson KD, Kormos RL, Likosky DS; Michigan Congestive Heart Failure Investigators. Center Variation in Medicare Spending for Durable Left Ventricular Assist Device Implant Hospitalizations. JAMA Cardiol. 2019 Feb 1;4(2):153-160.

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September 11, 2020

Ms. Tamara Syrek-Jensen, Director
Coverage & Analysis Group
Centers for Medicare and Medicaid Services
7500 Security Blvd.
Baltimore, Maryland 21244

Via Electronic Submission

Re: Proposed Decision Memo for Artificial Hearts and related devices, including Ventricular Assist Devices for Bridge-to-Transplant and Destination Therapy (CAG-00453N)

Dear Director Syrek-Jensen:

Spectrum Health appreciates the opportunity to provide comments on the Centers for Medicare and Medicaid Services (CMS) proposed decision memo for Artificial Hearts and related devices, including Ventricular Assist Devices for Bridge-to-Transplant and Destination Therapy. Spectrum Health System, is a not-for-profit, integrated health system, committed to improving the health and wellness of our communities. We live our mission every day with 31,000 compassionate professionals, 4,600 medical staff experts, 3,300 committed volunteers and a health plan serving 1 million members. Our talented physicians and caregivers are privileged to offer a full continuum of care and wellness services to our communities through 14 hospitals, including Helen De Vos Children's Hospital, 150 ambulatory sites and telehealth offerings. We pursue health care solutions for today and tomorrow that diversify our offerings. Locally-governed and based in Grand Rapids, Michigan, our health system provided $585 million in community benefit in fiscal year 2019. It is from the perspective of an integrated health system; we offer the following comments.

ARTIFICIAL HEARTS

CMS is proposing to eliminate the NCD at §20.9, ending coverage with evidence development for artificial hearts and permitting Medicare coverage determinations for artificial hearts to be made by the Medicare Administrative Contractors (MA Cs) under §1862(a)( I )(A) of the Social Security Act.

Spectrum Health supports this proposal.

VENTRICULAR ASSIST DEVICES

CMS is proposing to establish coverage according to the following conditions:

Patient Selection Criteria
Remove the current therapeutic intent-to-treat criteria of bridge-to-transplant (BIT) and destination therapy (OT), by removing the following BIT requirements: Removing the waitlist maintained by the Organ Procurement and Transplantation Network (OPTN); Removing the requirement that the implanting site, if different than the Medicareapproved transplant center, must receive written permission from the Medicare-approved transplant center prior to implantation of the V AD; Extend evidence based patient selection criteria, that previously applied only to OT, for all LV AD procedures for short-term (e.g., bridge-to-recovery and bridge-to-transplant) or long-term (e.g., destination therapy) mechanical circulatory support (see below in covered indications); Modify patient selection criteria: Patients are inotrope dependent or have a cardiac index (Cl) < 2.2 Umin/m2, while not on inotropes and also meet one of the following: Are on optimal medical management (OMM), based on current heart failure practice guidelines for at least 45 out of the last 60 days and are failing to respond; or have advanced heart failure for at least 14 days and are dependent on an intra-aortic balloon pump (IABP) or similar temporary mechanical circulatory support for at least 7 days.

Facility Criteria
The facility criteria remain unchanged from the current NCD. The removal of therapeutic intent is not expected to decrease appropriate patient access to LVADs.

Spectrum Health supports the proposed changes for Left Ventricular Assist Device NCD with the following recommended clarifications and considerations:

1. Patient Selection Criteria: IABP dependency for 7 days is a significant amount of time. We would suggest a timeframe of 3-5 days, depending on patient clinical status.
2. Removing the requirement that the implanting site, if different than the Medicare-approved transplant center, must receive written permission from the Medicare-approved transplant center prior to implantation of the V AD. Removing this requirement could negatively impact patient's road to heart transplant and impact the implanting center's incentive to transfer care to a transplant center. Clinical studies and recent literature suggest that increased volume produces higher quality outcomes and therefore keeping these procedures at a transplant center will help ensure high quality care for patients.

ADVANCED HEART FAILURE

CMS is proposing that left ventricular assist devices (LV ADs) are covered if they are FDA approved for short.term (e.g., bridge-to-recovery and bridge-to-transplant) or long-term (e.g., destination therapy) mechanical circulatory support for heart failure patients who meet the following criteria: Have New York Heart Association (NYHA) Class IV heart failure; Have a left ventricular ejection fraction (LVEF) 5 25%; OR have a Cardiac Index (CI)< 2.2 Umin/m2, while not on inotropes, and also meet one of the following: Are on optimal medical management (OMM), based on current heart failure practice guidelines for at least 45 out of the last 60 days and are failing to respond; or Have advanced heart failure for at least 14 days and are dependent on an intra-aortic balloon pump (IABP) or similar temporary mechanical circulatory support for at least 7 days.

Spectrum Health respectfully requests CMS clarify if the advanced heart failure covered indication is an and or an or statement. Specifically, would a patient be required to have NYHA Class IV heart failure AND LVEF ≤ 25%, or NYHA Class IV heart failure OR L VEF ≤ 25%. This is further illustrated below.

• Have New York Heart Association (NYHA) Class JV heart failure; (and/or)
• Have a left ventricular ejection fraction (LVEF) ≤ 25%;
• OR
  have a Cardiac Index (CI)< 2.2 Llminlm2, while not on inotropes, and also meet one of the following:
  • Are on optimal medical management (OMM), based on current heart failure practice guidelines for at least 45 out of the last 60 days and are failing to respond; or
  • Have advanced heart failure for at least 14 days and are dependent on an intra-aortic balloon pump (IABP) or similar temporary mechanical circulatory support for at least 7 days.

Spectrum Health also noted that several of the referenced research articles are more than five years old. We respectfully request considering more recent research, if it is available.

CONCLUSION

Thank you for consideration of our comments. We believe that our recommended changes and clarifications would result in improvements for transplant centers and the patients they serve. Should you have any questions regarding these comments or if you would like any additional infonnation, please contact David Walker, Advisor, Government Relations at Spectrum Health, or David.walkerii@spectrumhealth.org .

Sincerely,

Joshua Kooistra, DO
SVP, Chief Medical Officer
Spectrum Health West Michigan

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September 10, 2020

Tamara Syrek Jensen, Director
Coverage and Analysis Group
Centers for Medicare & Medicaid Services
Mailstop S3-02-01
7500 Security Boulevard
Baltimore, MD 21244

RE: Comments on CMS proposed national coverage determination on artificial hearts

Dear Ms. Jensen:

I am a Heart Failure Cardiologist at Cedars-Sinai Medical Center, subspecializing in the care and management of patients with end-stage heart disease.  I also serve as the Medical Director of the Mechanical Circulatory Support (MCS) Program and provide critical care for patients who are failing medical therapy and require various temporary and durable mechanical pumps that support the human circulation.  Many of my patients will be directly affected by the proposed CMS National Coverage Determination on artificial hearts and the proposal to defer coverage decisions to Medicare intermediaries.

Over the past 3 decades, I have worked closely with literally thousands of patients with end-stage heart disease utilizing a variety of durable devices for support until a suitable donor heart became available.  Although the LVAD, and particularly the continuous flow devices such as the HM II, HM III and HVAD, has played a major role in “bridging” patients to transplant, there exists a subpopulation of heart failure patients for whom the LVAD is inadequate or associated with poor outcomes.  For the majority of these patients, the only reasonable MCS device is the total artificial heart (Syncardia TAH).  Specifically, patients with severe, irreversible, biventricular heart failure, extensive myocardial infarctions c/b VSD, restrictive cardiomyopathy, certain patients with congenital heart disease, refractory VT, primary cardiac tumors and INTERMACS (IM) I (2) patients will have the highest survival/best outcomes as bridge to transplant using the TAH. We have performed nearly 100 TAHs at our institution over the past 7 years with a 1 yr survival/successful bridge to transplant of 65%.  While these outcomes appear substantially less than the 85% seen with LVADs, the patients within the TAH group were more critically ill (IM profile 1.4 vs 2.5) and outcomes w/o TAH in this group of patient would often be uniformly fatal.   

Under the current CMS proposed policy changes, while I certain agree that there is no need for ongoing CED requirement, I am deeply concerned about the decision to delegate authorization for TAH coverage to regional MACs.  As decisions to pursue MCS in patients with cardiogenic shock demand expeditious management, this authorization change may potentially result in non-coverage or delay in decisions which could place undue financial liability to individual implanting centers.  This obviously could lead to regional inequities in availability of a life-saving procedure (TAH).  If this CMS change occurs, I would propose that guidelines for accepted indications for TAH implantation and associated authorization/financial coverage be passed down from CMS to regional MACs to clarify and expedite authorization.

I am in favor of CMS elimination of intent to treat designations of BTT vs DT since it has proven to be clinically irrelevant.  Likewise, previous mandate for non-Tx LVAD centers to affiliate with a Tx center and review of cases for appropriate intervention is also unnecessary.  Other changes in LVAD patient selection criteria are also reasonable.

I deeply appreciate the opportunity to provide comment regarding the proposed CMS changes to MCS and anxiously await your final decisions.

Respectfully submitted,

(electronically signed)
Jaime D. Moriguchi, MD
Medical Director, MCS Program
Cedars-Sinai Smidt Heart Institute

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September 11, 2020

Tamara Syrek-Jensen, J.D.
Director, Coverage and Analysis Group
Center for Clinical Standards and Quality
Centers for Medicare & Medicaid Services
Mail Stop C3-02-01
7500 Security Boulevard
Baltimore, MD 21244

VIA ELECTRONIC DELIVERY TO CAGinquiries@cms.hhs.gov

Re: Proposed Decision Memorandum for Artificial Hearts and Related Devices (CAG-00453N)

Dear Ms. Syrek Jensen:

SynCardia Systems, LLC (SynCardia) appreciates this opportunity to comment on the Centers for Medicare & Medicaid Services (CMS) Proposed Decision Memorandum for Artificial Hearts and Related Devices, including Ventricular Assist Devices (VADs) for Bridgeto-Transplant and Destination Therapy (the “Proposed Decision”).¹

SynCardia has developed and manufactures a biventricular replacement device that has been marketed as the SynCardia temporary Total Artificial Heart (TAH-t). We are pleased to offer these comments on the Proposed Decision and we welcome the proposal to end coverage with evidence development (CED) for artificial hearts. However, we have serious concerns with CMS’s proposal to remove the National Coverage Decision (NCD) for artificial hearts and instead to permit coverage determinations for artificial hearts to be made by the Medicare Administrative Contracts (MACs). As we explain in further detail below, we are concerned that removing the NCD for artificial hearts will create significant uncertainty regarding coverage for hospital providers, which in turn will impermissibly delay or render unavailable a potentially life-saving technology for Medicare beneficiaries.

Our comment has two aims: first, to describe our concern that the CMS proposal to remove the NCD for artificial hearts will have unintended consequences for beneficiary access to a potentially life-saving treatment; and second, to propose CMS adopt national coverage of the artificial heart consistent with the labeled indication and any contraindications in the label. At the core, and as we set forth in more detail in our request for reconsideration, we believe there is sufficient clinical evidence to demonstrate that the use of the artificial heart is reasonable and necessary under section 1862(a)(1)(A) of the Social Security Act (SSA), and that a favorable NCD for artificial hearts is warranted.

BACKGROUND

As we explain in more detail in our request for reconsideration, heart failure is a disease of progression. Over time, patients progress through a series of stages of increasing symptoms, with progressive shortness of breath, reduction in exercise capacity, and body and organ edema and congestion. As patients deteriorate, medical therapy fails and the only effective therapy is that of physical replacement of the diseased heart. The speed of deterioration in these patients can be rapid, or can rapidly accelerate, requiring providers to make quick decisions about treatment options. While heart transplantation has been shown to be an effective treatment in the elderly patient population, a significant limitation of cardiac transplantation affecting all ages relates to donor organ availability, and many patients die waiting for a donor heart because of lack of organ availability at the time of decompensation.² According to United Network for Organ Sharing data, between 2006 and 2017, the number of patients on heart transplant waiting lists increased by approximately 49% from 2,424 to 3,623. As the prevalence of heart failure grows in the aging American population, organ shortages are expected to grow by approximately 46% by 2030.³ There is also a subset of patients who are deemed too sick to be eligible for heart transplantation. It is exactly for this problem that the field of durable mechanical circulatory support emerged: to support (or replace) the body’s hemodynamic capacity to reduce or eliminate end organ damage and other potentially irreversible effects of end-stage heart failure. While some hospitals continue to use dual continuous flow left ventricular assist devices (LVADs) as biventricular VADs (an off-label use of an approved device), there are currently no other durable FDA-approved devices for biventricular failure in the adult population. The TAHt, an implantable artificial heart that is implanted into the chest to replace the patient’s left and right ventricles, could serve many patients who die waiting for a donor heart, as well as patients who are too sick to be on the transplant list, and has the potential to save these patients from near certain death.

DISCUSSION

The artificial heart is for use in patients with biventricular failure who are at imminent risk of death, and has been shown to dramatically improve survival odds for that patient population. Recently, Francisco A. Arabia et al. completed a comprehensive, multi-institutional registry study (“Arabia-Intermacs Study”) on the TAH-t and found that, although the patients who receive the artificial heart tend to be sicker than the population on LVAD support, over 53% of the 450 patients who have received an artificial heart survived to heart transplantation within 12 months and another 13% continued to survive on the artificial heart at the twelve month mark.⁴ Thus, at one year, 66% of patients who were previously facing certain death and received the artificial heart were alive – most of whom had received a heart transplant by then, but some of whom remained on the artificial heart. An August 2020 publication of the SynCardia TAH-t experience at Nantes Hospital University reported that of 73 consecutive TAH-t patients (82% of whom were Intermacs Patient Profile Classification 1 or 2, i.e., the sickest of the sick) 68% were successfully bridged to transplant. Survival post-transplant was reported as over 79% at five years, 76% at 10 years and 72% at 12 years.⁵ In addition, as CMS notes in the Proposed Decision, investigators at Virginia Commonwealth University studied patients implanted with an artificial heart over a 6 year period and found survival after implant rates of 76% at 6 months and 71% at 12 months.

These clinical studies, along with other evidence, demonstrate the use of an artificial heart for patients in biventricular failure is reasonable and necessary under section 1862(a)(1)(A) of the SSA, and that a favorable NCD for artificial hearts is warranted. Nonetheless, CMS proposes leaving coverage of the artificial heart to the discretion of the MACs, which is highly problematic. Below, we explain why that is so and our resulting recommendation for the final coverage determination on artificial hearts.

In the Proposed Decision, in light of the low volume of cases, CMS proposes to remove the NCD for artificial hearts and to permit the MACs to determine, based on a beneficiary’s particular clinical circumstances, whether to cover the artificial heart. The Proposed Decision thus does not provide an affirmative coverage for an artificial heart despite the evidence discussed above. This proposed approach would generate uncertainty regarding coverage for a vitally important technology for which decisions on its use typically must be made very quickly. First, while we appreciate CMS’s favorable statements about the evidence, without a clear statement from CMS, and combined with the uncertainty of how each MAC will interpret the evidence, we think those statements will not be enough to give hospitals the confidence to proceed with using the technology. We are also concerned that different MACs may take different approaches to coverage of the artificial heart through varied restrictions or covered indications. This would lead to inequity in coverage, where beneficiaries in certain parts of the country have access to the artificial heart and others would have reduced access. Second, CMS’s comments about the small patient population could be read to endorse case-by-case determinations rather than published Local Coverage Determinations (which themselves likely would take a year or more to establish). This would further compound uncertainty as to whether an artificial heart would be covered for any given patient, and without the ability to confirm coverage in advance, would deter providers from using the technology, even for patients for whom it would be a life-saving option.

SynCardia acknowledges that the percentage of the Medicare population who may benefit from an artificial heart is less than 1%; however, we do not think that should be a deciding factor on whether an NCD on artificial hearts is appropriate due to the unique aspects of the technology and how it is used. First, although the patient population is small, the availability of an artificial heart carries life and death ramifications for those patients, exemplified by the current labeling for the TAH-t, which says it is for patients at “risk of imminent death.” Further, as described above and in more detail in our request for reconsideration, the artificial heart is a last option treatment for patients who no longer respond to medical treatment, require physical replacement of the diseased heart, and who cannot immediately access or are not eligible for a donor heart. Although there may not be a significant number of Medicare beneficiaries, the life and death implications of the technology weigh heavily in favor of clear national coverage and not leaving coverage to the vagaries of individual MAC determinations.

Second, these patients can rapidly deteriorate, requiring physicians and providers to make quick decisions to use the technology. As discussed above, deferring coverage decisions to the MACs will generate uncertainty as to whether any given beneficiary will be eligible for the artificial heart. This uncertainty can delay the decision to treat, during which time patients can further deteriorate, and the delay could lead to additional complications up to and including mortality.

Third, and relatedly, we understand hospitals may be reluctant to use the technology given uncertainty about coverage. Indeed, hospital concerns can be seen in the comments submitted on the Proposed Decision by Todd Seiger, Transplant Business Manager, Providence Sacred Heart Medical Center; Raymond L. Benza, Professor and Director, Ohio State University Wexner Medical Center; Shelley Hall, Chief, Transplant Cardiology and MCS, Baylor University Medical Center; Mary Johnson, Professor of Medicine, University of Wisconsin- Madison; and Brent C. Lampert, Associate Professor of Clinical Medicine, Ohio State University Wexner Medical Center. Without guidance on which patients the MACs will determine to be appropriate candidates, and faced with the financial risks of implanting the device without reimbursement, resource-strapped hospitals will have to decide whether to take a reimbursement gamble on a technology that may be the last option for a patient facing certain death or to continue other treatments that may be less effective or of shorter duration.

In sum, while we understand CMS’s desire to leave coverage decisions to MACs for items and services with a low volume, such as 1% or less utilization by Medicare beneficiaries, we urge CMS not to apply that standard as a bright line rule without exception. CMS should look at the circumstances involved with the individual item or service and assess whether an NCD should be established. Here, where there has been national coverage for a dozen years and given the factors stated above, we do not believe that artificial hearts is appropriate for the application of this concept of leaving low volume items and services to the MACs.

To better ensure beneficiary access to artificial hearts, we recommend CMS adopt full coverage of the TAH-t, in both the 70cc and 50cc sizes, and for both intent-to-treat outcomes: Bridge to Transplant (BTT) and Destination Therapy (DT), in a manner that is consistent with the labeled indication, including any contraindications on the label.

In the over ten years since CMS last considered coverage of the artificial heart NCD, additional scientific evidence has been collected that demonstrates positive patient outcomes across diverse clinical sites and diverse patients. We provided more detail on this additional scientific evidence in our request for reconsideration, and specifically how this additional evidence conclusively answers the questions CMS posed when it first covered artificial hearts through CED. Critical among this evidence is the publication of the Arabia-Intermacs Study, a large scale analysis of registry data related to survival, adverse events, and competing outcomes for 450 patients available in the Intermacs database. The population studied represents all patients 19 years of age and older that received the 70cc TAH-t as a bridge to transplant from June 23, 2006 to April 30, 2017 and for whom data were entered into the Registry (79% of TAHt implants in the US during that period). The Arabia-Intermacs Study found that about twothirds of patients with severe biventricular failure remain alive at one year – 53% are transplanted and 13% remain alive on the TAH-t. It is important to keep in mind that these are patients who are suffering the effects of end-stage heart failure, and that the TAH-t provided a viable alternative to waiting for a heart transplant with a different type of mechanical assistance or in a state of severe hemodynamic compromise offered by their failing native heart.

The Arabia-Intermacs study focused only on the 70cc TAH-t used as BTT. However, we think there are strong arguments to support expansion of full coverage to the 50cc TAH-t and to the use of the TAH-t without regard for treatment intention. First, the U.S. Food & Drug Administration (FDA) has recognized that the 50cc is identical to the 70cc, apart from the size of the chamber, as evidenced by the approval of a single Instructions for Use (IFU) that is now distributed with shipped devices regardless of device size. SynCardia submitted to FDA (P030011/S070) data from patients supported by the 50cc TAH-t globally in support of approval for the device (11 subjects enrolled in the IDE study, 18 patients implanted under compassionate or emergency use provisions in the United States, and 57 patients implanted outside of the United States). Overall positive outcomes (transplanted or alive on device as of 04/15/2019) were consistent between the two sizes of TAH with 70cc TAH-t positive outcomes of 48.5% and 50cc TAH-t positive outcomes of 50%. In the United States, the same assessment resulted in 70cc positive outcomes of 59.0% and 50cc TAH-t positive outcomes of 61.3%. It is therefore reasonable to conclude that the data related to survival, adverse events, and competing outcomes for the 70cc would be similar for the 50cc. Moreover, expanding coverage to the 50cc chamber is important for ensuring access to a more diverse patient population. In the Arabia-Intermacs Study, 87% of the 450 patients receiving the 70cc TAH-t from June of 2006 to April of 2017 were men. A significant contributor to that statistic is the size of the 70cc TAH-t and the inability to accommodate the device in the chest cavity of small statured adults, particularly women. Thus, the decreased size of the 50cc TAH-t makes this technology increasingly available to women, evidenced by the fact that 64.3% of the patients enrolled in the now completed 50cc TAH-t study were women. Thus, the 50cc is identical in all respects to the 70cc TAH-t, apart from size, and expanding national coverage to include the 50cc would provide access to this life-saving technology to a more diverse patient population.

Second, just as CMS is proposing to discontinue distinguishing LVAD coverage based on whether the use would be for BTT or DT, so too should this distinction no longer be relevant to coverage of the artificial heart. SynCardia has submitted to FDA (P030011/S075) data from the ongoing 70cc TAH-t for Destination Therapy IDE Study and from real-world data to support approval of the TAH-t for both BTT and DT, potentially without the requirement for the declaration of intended use prior to implant. Outcome data for US patients entered in the Society for Thoracic Surgeons Intermacs Registry show that patients who are on TAH-t support for less than six months have a positive outcome rate (transplanted or alive on device) of 56.9%, whereas patients on support for greater than six months have a positive outcome rate of 77.2%. The patients on support for greater than six months achieve a positive outcome rate at two years post implant (transplanted or alive on device) of 81.9%.

This is indicative of the impact of pre-implant patient condition on overall outcomes and supports the acceptability of artificial hearts for patients who are ineligible for transplant and not expected to become eligible. A recent article reviewed the viability of the artificial heart for patients awaiting orthotopic heart transplantation who are at high risk because they are highly sensitized and in need of desensitization protocols. It stated that these patients would potentially have had a better outcome, with lower incidence of infectious complications, if they were to be identified early and selected for artificial hearts as DT instead of as BTT.⁶ The BTT/DT distinction has become clinically irrelevant for artificial hearts, as CMS has recognized to be the case for LVADs in the Proposed Decision, and the BTT/DT distinction artificially limits access to a subset of the patient population experiencing biventricular failure.

CONCLUSION

As explained above, we agree with CMS that the time has come to end coverage of artificial hearts contingent on being in a clinical study. All of the concerns that CMS hoped to address when issuing the prior NCD have been addressed and there is further published, peerreviewed literature that demonstrates that, instead of dying, patients who receive the artificial heart have a one year survival rate upwards of 65%. Certainly, that meets the Medicare reasonable and necessary standard. As such, there is no reason to take a step back from national coverage and leave the coverage decision to MACs, as CMS has proposed. That surely will impede access to care and could result in beneficiaries dying. Accordingly, for the sake of Medicare beneficiaries, we urge CMS to finalize an NCD with affirmative coverage for artificial hearts consistent with the product label including any contraindications.

We appreciate your consideration of our comments. Please do not hesitate to contact me, Judy Skroback (520-405-0654 or jskroback@syncardia.com), or Stuart Langbein of Hogan Lovells (202-637-5744 or stuart.langbein@hoganlovells.com), with any questions.

Sincerely,

Judy Skroback, CIP, CRCP
Director of Clinical Research
SynCardia Systems, LLC
cc: Stuart Langbein (Hogan Lovells)

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1 Proposed Decision Memo for Artificial Hearts and related devices, including Ventricular Assist Devices for Bridge-to-Transplant and Destination Therapy (CAG-00453N), Aug. 12, 2020, https://www.cms.gov/medicare-coverage-database/details/nca-proposed-decision-memo.aspx?NCAId=298
2 Copeland, J, et al., Cardiac Replacement with a Total Artificial Heart as a Bridge to Transplantation, 351 N. Engl. J. Med 859, 860 (2004).
3 Maynes EJ et al. Comparison of SynCardia total artificial heart and HeartWare HVAD biventricular support for management of biventricular heart failure: a systematic review and meta-analysis. Ann Cardiothorac Surg 2020;9(2):69-80. doi: 10.21037/acs.2020.03.07
4 Arabia, F. et al., Interagency registry for mechanically assisted circulatory support report on the total artificial heart, 37 J. Heart & Lung Transplantation 1304, 1305 (Nov. 2018) (hereinafter “Arabia- Intermacs Study”).
5 David C-H, Lacoste P, Nanjaiah P, Bizouarn P, Lepoivre T, Michel M et al. A heart transplant after total artificial heart support: initial and long-term results. Eur J Cardiothorac Surg 2020; doi:10.1093/ejcts/ezaa261.
6 Zabner R, Lam LD, Runyan C. An infectious disease perspective—is destination therapy a viable option for total artificial hearts? Ann Cardiothorac Surg 2020;9(2):126-127. doi: 10.21037/acs.2020.02.07

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September 10, 2020

Tamara Syrek Jensen, JD
Director, Coverage & Analysis Group
Center for Clinical Standards and Quality
Centers for Medicare & Medicaid Services
Mailstop S3-02-01
7500 Security Blvd
Baltimore MD 21244

RE: Proposed Decision Memo for Artificial Hearts and Related Devices, including Ventricular Assist Devices (VADs) for Bridge-to-Transplant and Destination Therapy (CAG-00453N)

Dear Ms. Jensen:

The Advanced Medical Technology Association (AdvaMed) is pleased to offer the following comments on the Centers for Medicare & Medicaid Services’ (CMS) proposed decision memorandum for Artificial Hearts and Related Devices, including Ventricular Assist Devices (VADs) for Bridge-to-Transplant and Destination Therapy (CAG-00453N)¹.

AdvaMed’s member companies produce the life-saving and life-enhancing medical devices, diagnostic products and health information systems that are transforming health care through earlier disease detection, less invasive procedures and more effective treatments. AdvaMed members range from the largest to the smallest medical technology innovators and companies.

Our comments below relate to the proposal to eliminate the existing NCD for artificial hearts and to shift Medicare coverage determinations to the Medicare Administrative Contractors (MACs), coverage with evidence development (CED), and the LVAD proposals to remove current intent-to-treat criteria for bridge-to-transplant (BTT) and destination therapy (DT), and to extend evidence-based patient-selection criteria to all LVAD procedures for short-term and long-term mechanical support.

Proposal to Eliminate Artificial Heart NCD and Shift Coverage to MAC Discretion

In the proposed national coverage memorandum, CMS proposes to eliminate the existing NCD at §20.9, ending coverage with evidence development for artificial hearts and shifting Medicare coverage determinations for artificial hearts to the Medicare Administrative Contractors (MACs) under §1862(a)(1)(A) of the Social Security Act.

CMS states as a rationale for this proposal that a national coverage determination for artificial hearts is no longer necessary or appropriate, based on the “totality of the limited evidence generated through coverage with evidence development and peer-reviewed articles.” CMS further states that, given the very low number of procedures and the varying patient characteristics and need for careful patient selection, the MACs are better suited to making coverage determinations based on a beneficiary’s particular clinical circumstances.

AdvaMed disagrees with this approach. We do not agree that national coverage could be unnecessary or inappropriate for a complex procedure such as implantation of an artificial heart. While the total number of artificial heart procedures in the Medicare population may be low, the procedure is nevertheless significant for those patients who need it. Shifting coverage determinations for such a critical and time-sensitive procedure to the MACs without clear guidance from CMS may not provide enough certainty regarding coverage for providers and patients, and will create barriers to patient access, including the need to endure long wait times, or limited access to a transplant.

Additionally, these procedures, as well as the devices themselves, are complex and costly and require specific staffing experience and proficiency to perform them.

AdvaMed is concerned that placing coverage decision-making with the MACs, in the absence of a national coverage decision, could create clinical risks for patients and financial risks for hospitals and providers who no longer have a clear, articulated coverage decision on which to base their own clinical decisions on behalf of vulnerable patients.

AdvaMed recommends that CMS retain the NCD, rather than shift coverage to the MACs. We do not see an appropriate rationale for removing existing national coverage and replacing it with local coverage or claim-by-claim adjudication for a serious and complex procedure such as implanting an artificial heart.

Furthermore, AdvaMed has long supported evidence-based coverage decision-making, including the use of coverage with evidence development to generate evidence in support of new and innovative devices and service. We also have advocated for revisions in coverage policy when new evidence calls for change and for policies that minimize burdensome requirements. In general, AdvaMed supports ending CED when the time is appropriate; but at the same time, CMS must ensure continued coverage of items and services to avoid disruption in coverage and continue to allow Medicare beneficiaries to benefit from important, life-saving technologies.

Ventricular-Assist Device (VAD) Proposals

CMS proposes to limit this NCD to durable, intracorporeal, left ventricular assist devices (LVADs), and to remove current intent-to-treat criteria for BTT and DT and apply evidence-based patient selection critera to all LVAD procedures for short-term (e.g., bridge-to-recovery and bridge-to-transplant) or long-term (e.g. destination therapy) mechanical circulatory support.

AdvaMed supports these proposals, consistent with our previous comments, which extend coverage to patients who require short-term and long-term mechanical circulatory support. We also were pleased to see that existing VADs with approved indications for BTT and DT will remain covered under the revised coverage policy.

As CMS knows well, AdvaMed has long supported coverage policies that enhance appropriate patient access based on advancements in technology and the medical landscape, as supported by the public literature, clinical evidence, and input from the relevant physician and specialty societies.

AdvaMed greatly appreciates the opportunity to provide comments on this draft coverage determination. If you have questions regarding these comments or if you require additional information, please contact me at (202) 434-7219 or cbranham@AdvaMed.org.

Sincerely,

/s/
Chandra N. Branham, JD
Vice President, Payment & Health Care Delivery Policy
AdvaMed

---

1 CMS Proposed Decision Memo for Artificial Hearts and Related Devices, including Ventricular Assist Devices (VADs) for Bridge-to-Transplant and Destination Therapy (CAG-00453N), https://www.cms.gov/medicarecoverage-database/details/nca-proposed-decision-memo.aspx?NCAId=298 (accessed August 12, 2020).

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To whom it may concern,

The Syncardia TAH-t was approved in 2004 by the FDA and by CMS in 2008. The accumulated world experience is over 2000 cases. What have we learned that might be important to consider before changing the mechanism of coverage determination for TAH implantation?

From the beginning, the TAH has been used as a bridge to transplantation in transplant eligible or likely eligible patients. It is not approved for destination therapy. As time passed and more centers have used the TAH, we have seen that delays in selection and in implantation have been common because of administrative rather than medical issues. Physicians and surgeons have been confronted with administrative issues and postponed lifesaving interventions.

We know from hundreds of cases in experienced TAH implantation centers that implantation of the TAH is an emergency not unlike the situation we see with dissecting aortic aneurysms. The window of opportunity is very small in the cardiogenic shock patient with irreversible bi ventricular failure. Within hours irreversible damage to kidneys, liver and brain are likely. TAH implantation within hours is optimal. If V-A ECMO is used to bridge to TAH, the TAH implant should be implanted within 3-4 days. Leaving this decision making to local Medicare intermediaries might cause delays that result in TAH failure and patient death. A clear message regarding financial support for the TAH will give guidance that allows institutions to move quickly without unnecessary delay. Further, this will send a message that if the physicians and surgeons feel there is an emergency they can proceed using their best judgement based upon evidence in the surgical and medical literature. This will help hospital administrators give timely approval.

This is very different from L V AD scenarios. L V ADs are not successful in bi ventricular failure, where waiting and urgent or semi-elective LV AD implantation is common. The Total Artificial Heart is only bridge to heart transplant for biventricular failure. Many patients lives have been saved, and enhanced, and people have gone onto transplantation to live many years to create many more family memories. The Total Artificial Heart cares for patients in cardiogenic shock, the emergent situation.

Respectfully,

Hannah Copeland, MD
Surgical Director of Heart Transplantation
Surgical Director of Mechanical Circulatory Support
Director of Extracorporeal Membrane Oxygenation
Cardiac Surgeon
Lutheran Medical Group
Lutheran Hospital
7910 W. Jefferson Blvd
Suite 102
Fort Wayne, IN 46804
Email: hannahcopeland411@gmail.com
Office Phone: 260-458-3556

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September 4, 2020

Tamara Syrek Jensen, Director
Coverage and Analysis Group
Centers for Medicare & Medicaid Services
Mailstop S3-02-01
7500 Security Boulevard
Baltimore, MD 21244

RE:  Comments on CMS proposed national coverage determination on artificial hearts

Dear Ms. Jensen:

As a practicing cardiothoracic surgeon at The Ohio State University Wexner Medical Center, I am responsible for caring for the types of patients who would be affected by the proposed CMS National Coverage Determination on artificial hearts and the proposal to defer coverage decisions to Medicare intermediaries. Over the last two years, we have treated two critically ill patients with total artificial hearts (TAH), both being successfully bridged to heart transplantation and alive and well today as a result of the TAH.  Additionally, in the same time period we have implanted over 40 primary left ventricular assist devices (LVAD) improving the morbidity and mortality for these patients with life-threatening advanced heart failure.  While I appreciate the proposal to end with coverage development, I believe that the lack of a national coverage determination will impede the use of the mechanical heart assist technologies and thus ask for coverage to be determined at the national level, for reasons I will explain.

The proposed determination reduces the administrative burden of evidence development on our centers, which is positive.  Currently, many patients need to be enrolled in clinical studies to get an implant or meet arbitrary time of treatment criteria for coverage.  This results in increased lengths of stay, additional testing, and increased risk of delayed treatment which can harm patients. 

The significant benefit to end with coverage development in its current form is appreciably outweighed by the uncertainty of coverage being decided by the MACs separately for each case.  With no prior approval in Medicare, coverage is decided after the fact, meaning that the hospital has to take the significant financial risk that the MAC will deny coverage.  This financial uncertainty may cause patients, particularly the most vulnerable, not to receive the device.

With no other durable biventricular support technologies indicated to support these patients, centers are left with few other options other than orthotopic heart transplant which, by virtue of an artificial heart being considered, these patients likely do not have timely access to or may not be ideally suited for in their current condition.

In light of these concerns, I request that CMS continue to have a national coverage determination for the use of artificial hearts for a bridge to transplant and left ventricular assist devices with any coverage and remove the evidence development requirement.  Alternatively, I would propose that CMS remove any incremental barriers to access and closely monitor utilization. Given the modest number of TAH and LVAD implants annually, the fiscal risk to CMS is modest while the morbidity and mortality experienced by patients who do not have timely access to these therapies is catastrophic.

Thank you for your consideration of these comments. An artificial heart is an important option for our advanced heart failure patients and the current proposal could be problematic in terms of patient treatment, timing and eventual outcomes.

Sincerely yours,

Asvin M. Ganapathi M.D.

Assistant Professor, Division of Cardiac Surgery

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September 9, 2020

Tamara Syrek Jensen, Director
Coverage and Analysis Group
Centers for Medicare & Medicaid Services
Mailstop S3-02-0l
7500 Security Boulevard
Baltimore, MD 21244

RE: Comments on CMS proposed national coverage determination on artificial hearts

Dear Ms. Jensen:

As a practicing cardiothoracic surgeon at The Ohio State University Wexner Medical Center, I am responsible for caring for the types of patients who would be affected by the proposed CMS National Coverage Determination on artificial hearts and the proposal to defer coverage decisions to Medicare intermediaries. Over the last two years, we have treated two critically ill patients with total artificial hearts (TAH), both being successfully bridged to heart transplantation and alive and well today as a result of the TAH. Additionally, in the same time period we have implanted over 40 primary left ventricular assist devices (LVAD) improving the morbidity and mortality for these patients with lifethreatening advanced heart failure. While I appreciate the proposal to end with coverage development, I believe that the lack of a national coverage determination will impede the use of the mechanical heart assist technologies and thus ask for coverage to be determined at the national level, for reasons I will explain.

The proposed determination reduces the administrative burden of evidence development on our centers, which is positive. Currently, many patients need to be enrolled in clinical studies to get an implant or meet arbitrary time of treatment criteria for coverage. This results in increased lengths of stay, additional testing, and increased risk of delayed treatment which can harm patients.

The significant benefit to end with coverage development in its current form is appreciably outweighed by the uncertainty of coverage being decided by the MACs separately for each case. With no prior approval in Medicare, coverage is decided after the fact, meaning that the hospital has to take the significant financial risk that the MAC will deny coverage. This financial uncertainty may cause patients, particularly the most vulnerable, not to receive the device.

With no other durable biventricular support technologies indicated to support these patients, centers are left with few other options other than orthotopic heart transplant which, by virtue of an artificial heart being considered, these patients likely do not have timely access to or may not be ideally suited for in their current condition.

In light of these concerns, I request that CMS continue to have a national coverage determination for the use of artificial hearts for a bridge to transplant and left ventricular assist devices with any coverage and remove the evidence development requirement. Alternatively, I would propose that CMS remove any incremental barriers to access and closely monitor utilization. Given the modest number of TAH and LVAD implants annually, the fiscal risk to CMS is modest while the morbidity and mortality experienced by patients who do not have timely access to these therapies is catastrophic.

Thank you for your consideration of these comments. An artificial heart is an important option for our advanced heart failure patients and the current proposal could be problematic in terms of patient treatment, timing and eventual outcomes.

Sincerely yours,

Matthew C. Henn, MD
Assistant Professor, Division of Cardiac Surgery
N-813 Doan, 410 West 10th Avenue, Columbus, OH 43210
(614) 293-8878 (office)/ (614) 293-4726 (fax)
Matthew.Henn@osumc.edu

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September 9, 2020

Tamara Syrek Jensen, Director
Coverage and Analysis Group
Centers for Medicare & Medicaid Services
Mailstop S3-02-01
7500 Security Boulevard
Baltimore, MD 21244

RE: Comments on CMS proposed national coverage determination on artificial hearts

Dear Ms. Jensen:

As a practicing Congenital and Pediatric Heart Failure Surgeon at Cincinnati Children’s Hospital Medical Center responsible for caring for the types of patients who would be affected by the proposed CMS National Coverage Determination on artificial hearts and the proposal to defer coverage decisions to Medicare intermediaries. I have been implanting the TAH for over a decade and was the first one to implant the TAH in pediatric hospital. I have used this unique technology to support adults with congenital heart disease as well as adolescents who had no good support options and could not survive to transplantation. While I appreciate the proposal to end with coverage development, I believe that the lack of a national coverage determination will impede the use of the artificial heart and thus ask for coverage to be determined at the national level, for reasons I will explain.

The proposed determination reduces the administrative burden of evidence development on our centers, which is positive. However, this is definitely outweighed by the uncertainty of coverage being decided by the MACs separately for each case. Because of this many centers will not allow the TAH to be implanted because of the significant financial risk the hospital is taking that the MAC will not deny coverage. Therefore, we will not be able to offer the only technology available to help a patient survive.

Thank you for your consideration of these comments. An artificial heart is an important, and for a select few the only, option for our advanced heart failure patients and the current proposal could be problematic in terms of patient treatment, timing and eventual outcomes.

Sincerely,

David L.S. Morales
Professor of Surgery & Pediatrics
Clark-Helmsworth Chair and Director, Congenital Heart Surgery - Heart Institute
Director, Quality and Outcomes - Dept of Surgery
Cincinnati Children’s Hospital Medical Center
The University of Cincinnati College of Medicine
3333 Burnet Avenue – MLC 2004
Cincinnati, Ohio 45229
Phone: 513-636-4770
Fax: 513-636-3847
david.morales@cchmc.org

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Tamara Syrek-Jensen
Director, Coverage and Analysis Group
Centers for Medicare and Medicaid Services
7500 Security Blvd
Baltimore, MD 21244

We appreciate the opportunity to provide comment on the proposed CMS changes to the National Coverage Determination (NCD) for Durable MCS. We provide the following comments related to some aspects of the proposed NCD and the potential consequences of the proposed decisions as presently phrased.

Concern #1: Increased potential for health care disparities before and after LVAD- It is very clear that practitioners are not able to predict prior to LVAD who will or will not go on to heart transplant with reasonable accuracy and precision. However, absence of a requirement for patients of transplant age to be evaluated prior to LVAD and/or periodically after LVAD implant for transplant candidacy by a cardiac transplant program could increase health care disparities. Patients who belong to underserved segments of society (based on income, education, race/ethnicity, etc.) already have disparate access to LVAD(1). In addition, underserved individuals and minorities tend to have more modifiable risk factors prohibiting direct access to heart transplant and/or BTT LVAD (2-4). These risks could include BMI >35 (noted in Intermacs in African Americans (2-3)), tobacco use, marijuana/drug use (2), need to identify social support or reliable insurance, need to demonstrate compliance on LVAD therapy, or need to improve HgA1C levels through better care access. These same individuals with modifiable risk factors prohibiting transplant are presently undergoing implant as DT or bridge to candidacy (BTC) but are considered regularly after implant at transplant centers for transplant listing potential. Using Intermacs data 2012-2015, only 8.5% of Caucasians undergoing LVAD were ages 20-39, yet 18.6% of African Americans and 17.9% of Hispanics fell into this very young age group (2). In converse, Caucasians had the highest percentage of patients over age 60 (those less likely to be considered for transplant due to age)(2). Minorities undergoing LVAD were more likely to be obese (2-4), have lower income (2-4) and lower educational statuses in clinical LVAD study (2-4). In renal transplant field, health care disparities have been a focus of concern. In a study by Ku et al, access to transplant within the first year of ESRD is 65% lower in nonhispanic blacks and 43% lower in Hispanics compared with Caucasians (5). The underserved and underrepresented segments of society deserve to have a mechanism in place to ensure there is consideration and subsequent reconsideration for transplant after LVAD implant.

If we completely remove a DT/BTT consideration without requirement for re-evaluation, there is zero impetus for DT Programs to confer with a transplant program prior to LVAD implant or after LVAD implant for transplant potential. This removes the concept of the “heart team” or multidisciplinary care, which silos care between DT vs. BTT programs.

Finally, these are imperfect devices that carry much greater risk than dialysis, for example. In the present NCD proposal, CMS recognizes this risk and has not chosen to extend LVAD support to the less ill- those with NYHA IIIb heart failure. Complication burdens are high (stroke, infection, RV failure) and survival is only 50% at 4-5 years. Since many of these DT/BTC individuals are minorities and underserved, we may further increase health care disparities if we do not ensure that transplant is considered prior to LVAD and/or on some regular basis after LVAD for individuals of transplant age, especially those with LVAD complications. While the devices improve survival in NYHA IV heart failure, transplant is the gold standard and affords higher long-term survival, quality of life, and a lower complication profile than LVAD.

Concern #2: Impaired Share Decision Making- The new CMS NCD proposal removes “the requirement that the implanting site… must receive written permission from the Medicare-approved transplant center prior to implantation of the VAD for BTT.” Removing documentation of the critical interaction with a cardiac transplant program prior to LVAD eliminates the opportunity for patients to undergo shared decision making with the knowledge necessary for LVAD consent as it relates to permanent support vs. support with the goal for transplant. A patient may be more willing to undergo LVAD if he/she was informed that the surgery is to “get them to transplant.” Kathleen Grady et al has demonstrated the importance of “transplant potential” on patient adjustment after MCS and post-MCS health-related quality of life (6-7). If a patient is not evaluated by a transplant program who agrees to listing, he/she may never actually be listable. For example, if we consider the case of a female who would meet indications for transplant but has a 100% PRA, her trajectory is very different then if her PRA was 0%. Yet, the mentioned patient could have consented to LVAD surgery under the premise that she had no clear preoperative contraindications to transplant. It is not reasonable to expect a DT only program will know who is and who is not a suitable cardiac transplant candidate. It is not reasonable that a DT only program can work with the patient to remediate all relative contraindications to transplant after LVAD (e.g. PRA%).

Concern #3: Maintenance of surgical volume of 10 over 3 years. There are limited data guiding surgical and center experience for durable MCS. The present data would support a more stringent requirement for center experience and there are no data to support a specific surgeon volume for MCS. While there are several studies showing improved outcomes in cardiac surgery (CABG and valve) with higher surgeon volume, this is lacking for durable MCS. In an analysis of Intermacs, centers implanting <10 FDA approved durable devices per year had inferior survival outcomes, even on adjusted analyses (Adj HR 1.32 [1.11-1.56] for very low volume centers) (8). During derivation of the HeartMate II risk score using HMII BTT and DT patients, the only predictor of reduced longer-term survival (conditioned on survival at 90 days), was patient age and implant center volume (with a threshold of <15 implants, HR mortality 1.6) (9). Thus, present limited data supports a more stringent yearly center volume threshold. There are no strong data to support a specific surgeon volume.

We hope that you consider these important concerns.

Regards,

Jennifer Cowger, MD, MS Henry Ford Hospital, Detroit, MI on behalf of:

Teresa De Marco, MD, UCSF, San Francisco, CA
Maryl Johnson, MD, University of Wisconsin
Palak Shah, MD, MS, Inova Heart & Vascular, Falls Church, VA
Ezequiel Molina, MD, Medstar Hospital, Washington D.C.
Rebecca Cogswell, University of Minnesota
Todd Dardas, MD, MS, University of Washington, Seattle, WA

References:
1) Wang X, Luke AA, Vader JM. Circulation: Cardiovascular Quality and Outcomes 2020:12: e006284. DOI: 10.1161/CIRCOUTCOMES.119.006284
2) Breathett K, Allen LA, Helmkamp L. et al. Circulation: Heart Failure 2018; :e005008. DOI: 10.1161/CIRCHEARTFAILURE.118.005008.
3) Okoh AK, Chan O, Schultheis M, et al. Innovations 2019;14:236-42. https://doi.org/10.1177/1556984519836862
4) Van Meeteren A, Maltais S, Dunlay S. J Heart Lung Transplant 2017;36:64-70. DOI: 10.1016/j.healun.2016.08.027
5) Ku E, Lee BK, McCulloch CE, et al. Transplantation. 2020 Jul; 104(7):1437-1444. doi: 10.1097/TP.0000000000002962.
6) Grady K, Magasi S, Hahn EA, et al. J Heart Lung Transplant 2015;34:1292-304. DOI: 10.1016/j.healun.2015.04.003
7) Magasi S, Buono S, Yancy CW, Ramirez RD, Grady KL. Circulation: Cardiovascular Quality and Outcomes 2019;12: DOI: 10.1161/CIRCOUTCOMES.117.004414
8) Cowger JA, Stulak JM, Shah P, et al. JACC: Heart Failure 2017;5:691-99.
9) Cowger JA, Sundareswaran K, Rogers JG et al. JACC 2013;61:313-21.

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September 9, 2020

Tamara Syrek Jensen, Director
Coverage and Analysis Group
Centers for Medicare & Medicaid Services
Mailstop S3-02-01
7500 Security Boulevard
Baltimore, MD 21244

RE: Comments on CMS proposed national coverage determination on artificial hearts

Dear Ms. Jensen:

I am a practicing Cardiac Surgeon at Banner UMC Phoenix, responsible for caring for the types of patients who would be affected by the proposed CMS National Coverage Determination on artificial hearts (TAH) and the proposal to defer coverage decisions to Medicare intermediaries. I’ve been involved in the use of the TAH as a bridge to transplantation for close to 30 years. I have published extensively in its indication, implantation, and outcomes. While I appreciate the proposal to end with coverage development, I believe that the lack of a national coverage determination will impede the use of the TAH and thus ask for coverage to be determined at the national level, for reasons I will explain.

• The proposed changes leave the decision for the use of a TAH approval to the MAC. Although the TAH is proven and necessary therapy, now each MAC will have to be educated in the proper use of the technology. This is so they can make the right decision. This takes time from the Heart Failure team, but most important from the patient. The patient who needs a TAH usually has hours to a few days to live. This extra time burden could only be deleterious to the patient who is suffering from biventricular failure and is at imminent risk of death.


• The TAH is the only mechanical support that is FDA approved. With no other durable biventricular support technologies indicated to support these patients, centers are left with few other options, some of which have no FDA approval and are costly with no insurance coverage. Furthermore, centers might need to decide on earlier heart transplantation in patients who are at a higher risk of dying. This could increase the poor outcome, especially of UNOS Status 1 patients.


• There are patient populations that benefit from the TAH as a bridge to heart transplantation. Some of these include infiltrative cardiomyopathies, post-infarction ventricular septal defects, arrhythmias, Chagas’s Disease, severe biventricular heart failure unresponsive to ECMO or LVADs, some cardiac tumors, thrombosed ventricles, and congenital heart diseases. The TAH is the only device that can make a difference and improve survival in some of these patients.

I would request that CMS remove any incremental barriers to access and closely monitor utilization. Given the modest number of TAH implants annually, the risk to CMS is modest, while the morbidity and mortality experienced by patients who do not have timely access to TAH is catastrophic.

Thank you for your consideration of these comments. An TAH is an important option for our advanced heart failure patients, and the current proposal could be problematic in terms of patient treatment, timing, and outcomes.

Sincerely yours,

Francisco A. Arabía, MD MBA
Professor of Surgery and Medicine
Physician Executive, Advanced Heart Programs
Banner-University Arizona
University Medical Center
Phoenix, AZ 85006
Tel. 602-839-8514

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September 4, 2020

Tamara Syrek Jensen, Director
Coverage and Analysis Group
Centers for Medicare & Medicaid Services
Mailstop S3-02-01
7500 Security Boulevard
Baltimore, MD 21244

RE: Comments on CMS proposed national coverage determination on artificial hearts

Dear Ms. Jensen:

As a practicing Advanced Heart Failure Cardiologist at The Ohio State University Wexner Medical Center, I am responsible for caring for the types of patients who would be affected by the proposed CMS National Coverage Determination on artificial hearts and the proposal to defer coverage decisions to Medicare intermediaries. Over the last two years, we have treated two critically ill patients with total artificial hearts (TAH), both being successfully bridged to heart transplantation and alive and well today as a result of the TAH. Additionally, in the same time period we have implanted over 40 primary left ventricular assist devices (LVAD) improving the morbidity and mortality for these patients with life-threatening advanced heart failure. While I appreciate the proposal to end with coverage development, I believe that the lack of a national coverage determination will impede the use of the mechanical heart assist technologies and thus ask for coverage to be determined at the national level, for reasons I will explain.

The proposed determination reduces the administrative burden of evidence development on our centers, which is positive. Currently, many patients need to be enrolled in clinical studies to get an implant or meet arbitrary time of treatment criteria for coverage. This results in increased lengths of stay, additional testing, and increased risk of delayed treatment which can harm patients.

The significant benefit to end with coverage development in its current form is appreciably outweighed by the uncertainty of coverage being decided by the MACs separately for each case. With no prior approval in Medicare, coverage is decided after the fact, meaning that the hospital has to take the significant financial risk that the MAC will deny coverage. This financial uncertainty may cause patients, particularly the most vulnerable, not to receive the device.

With no other durable biventricular support technologies indicated to support these patients, centers are left with few other options other than orthotopic heart transplant which, by virtue of an artificial heart being considered, these patients likely do not have timely access to or may not be ideally suited for in their current condition.

In light of these concerns, I request that CMS continue to have a national coverage determination for the use of artificial hearts for a bridge to transplant and left ventricular assist devices with any coverage and remove the evidence development requirement. Alternatively, I would propose that CMS remove any incremental barriers to access and closely monitor utilization. Given the modest number of TAH and LVAD implants annually, the fiscal risk to CMS is modest while the morbidity and mortality experienced by patients who do not have timely access to these therapies is catastrophic.

Thank you for your consideration of these comments. An artificial heart is an important option for our advanced heart failure patients and the current proposal could be problematic in terms of patient treatment, timing and eventual outcomes.

Sincerely yours

Raymond L. Benza, MD, FACC
Professor and Director
Division of Cardiovascular Diseases
Bob and Corrine Frick Endowed Chair of Heart Failure
Department of Medicine
The Ohio State University Wexner Medical Center
473 W 12th Ave, Suite 200
Columbus, Ohio 43210
Office: 614-247-7779
Raymond.Benza@osumc.edu

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September 9, 2020

Centers for Medicare & Medicaid Services
7500 Security Boulevard
Baltimore, MD 21244

Re: CAG-00453N

To whom it may concern,

On behalf of the American Heart Association (AHA), including the American Stroke Association (ASA) and more than 40 million volunteers and supporters, we appreciate the opportunity to submit our comments in response to the Proposed Decision Memo for Artificial Hearts and related devices, including Ventricular Assist Devices (VAD) for Bridge-to-Transplant (BTT) and Destination Therapy (DT).

Due to the limited number of donor hearts and the long waiting times, cardiac transplantation is only available to a very small percentage of patients, and medical therapy alone does not suffice for many patients. The AHA has long recognized that implantation of mechanical circulatory support (MCS) is an important therapeutic option for individuals with life-threatening advanced heart failure despite optimal medical and device therapy. In the appropriate patient population, MCS implantation has been shown to improve survival, quality-of-life and functional status. Recognizing the importance of MCS, the AHA supports this proposed decision and offers the following comments and recommendations.

Total Artificial Heart (TAH)
In its proposed decision, CMS seeks to eliminate the NCD at §20.9, ending coverage with evidence development (CED) for artificial hearts and permitting Medicare coverage determinations for artificial hearts to be made by the Medicare Administrative Contractors (MACs). The AHA supports this decision, as it did in its initial NCA comments¹, and agrees that the CED stipulation should be removed so that the device may be implanted by experienced centers with the purpose of bridging patients to potential cardiac transplantation.

Ventricular Assist Devices (VAD)
With respect to LVAD therapy, CMS has proposed the removal of intent to treat criteria and the adoption of a universal selection criteria for all patients considered for implantable cardiac support. The removal of all BTT requirements and extension of prior DT requirements to all LVAD is supported by the evolution of the therapy, the evidence and current use. As such, the AHA supports the removal of the current therapeutic intentto- treat criteria.

Patient Selection Criteria
The relaxation of objective patient requirements indicating end-stage (stage D, advanced) heart failure allows for greater flexibility and simplicity in the use of devices. However, the AHA is concerned that a cardiac index (CI) <2.2 L/min/m2 as sole criteria for implant is not enough to define 'advanced' heart failure. Alternatively, the UNOS criteria for heart transplant listing² also have the goal of reserving advanced treatment for truly advanced disease, but use pulmonary capillary wedge pressure (PCWP) >15 mmHg and simultaneous cardiac index < 2.2 L/min/m2 while on inotropic or temporary mechanical circulatory support OR < 1.8 L/min/m2 off therapy as its criteria.³

As such, the AHA recommends using the UNOS criteria of PCWP >15 mmHg and simultaneous cardiac index < 2.2 L/min/m2 while on inotropic or temporary mechanical circulatory support OR < 1.8 L/min/m2 off therapy. While also remaining consistent with UNOS cardiac transplant policy, these more specific and rigorous hemodynamics (added to the other proposed criteria of optimal medical management for 45 of 60 days or advanced heart failure for at least 14 days and are dependent on an intra-aortic balloon pump or similar temporary mechanical circulatory support for at least 7 days) is likely to avoid overuse of LVAD therapy in non-advanced patients (INTERMACS 5-7 and less severe) for whom the risk/benefit ratio is unfavorable, while still allowing use in advanced ambulatory patients (INTERMACS 4) patients who are likely to benefit from LVAD.

The AHA thanks you for the opportunity to submit comments on this proposed decision memorandum. If you have any questions or require any additional information, please contact Tyler Hoblitzell of AHA staff at (202) 785-7901 or Tyler.Hoblitzell@heart.org.

Sincerely,

Mitchell S. V. Elkind, MD, MS, FAHA
President
American Heart Association/American Stroke Association

1 AHA comments in response to the National Coverage Analysis for Artificial Hearts and related devices, including Ventricular Assist Devices for Bridge-to-Transplant and Destination Therapy. March 4, 2020. https://www.cms.gov/medicare-coveragedatabase/ staticpages/public-comment.aspx?commentID=32884&ReportType=nca.
2 OPTN/UNOS Policy Notice Proposal to Modify the Adult Heart Allocation System. https://optn.transplant.hrsa.gov/media/2028/thoracic_policynotice_201612.pdf.
3 See Note 1 at pg. 10.

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September 9, 2020

Tamara Syrek Jensen, Director
Coverage and Analysis Group
Centers for Medicare & Medicaid Services
Mailstop S3-02-01
7500 Security Boulevard
Baltimore, MD 21244

RE: Comments on CMS proposed national coverage determination on artificial hearts

Dear Ms. Jensen:

I am a cardiac surgeon who has been implanting total artificial hearts in patients since 1982 when we implanted the first TAH in Dr. Barney Clark in 1982. I am now the Section Chief of Cardiac Surgery at the Medical College of Wisconsin and responsible for caring for the types of patients who would be affected by the proposed CMS National Coverage Determination on artificial hearts and the proposal to defer coverage decisions to Medicare intermediaries. Patients that are eligible for the total artificial heart are individuals who have no other option for correction of their heart failure. While I appreciate the proposal to end with coverage development, I believe that the lack of a national coverage determination will impede the use of the artificial heart in a timely fashion. My request is for coverage to be determined at the national level, for reasons I will explain.

Thank you for your consideration of these comments. An artificial heart is an important option for our advanced heart failure patients and the current proposal could be problematic in terms of patient treatment, timing, and eventual outcomes.

Sincerely,

Lyle D. Joyce
Lyle D. Joyce MD, PhD
Section Chief, Adult Cardiac Surgery
Medical College of Wisconsin
Milwaukee, WI

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The American Association of Heart Failure Nurses (AAHFN) is a specialty organization dedicated to the improvement of heart failure patient outcomes. With the aim of assuring impartial and just access to advanced therapies, we appreciate the opportunity to provide comment in response to the Proposed Decision Memo for Artificial Hearts and Related Devices.

Removing the current therapeutic intent-to-treat criteria of VADs (Bridge to Transplant and Destination Therapy) would result in shortened wait times for patients, diminished level of devastating disease burden, and expanded individualized clinical judgement, possibly leading to improved patient outcomes. The AAHFN supports the revision to 20.9.1 NCD (Ventricular Assist Devices) which removes the current therapeutic intent-to-treat criteria.

The AAHFN also supports eliminating the coverage with evidence development criteria for total artificial hearts (TAH); the American Heart Association has previously promulgated TAH should not be restricted to clinical trial settings. Advanced heart failure patients with conditions such as infiltrative cardiomyopathy, biventricular failure, and unrepairable ventricular septal defects do not have conventional mechanical circulatory support options, and TAH may be the only treatment option while awaiting transplant.

However, AAHFN does not agree with the Medicare coverage determination for TAH to be made by the Medicare Administrative Contractors (MACs). Local Coverage Determinations (LCD) can prohibit coverage for artificial hearts and related devices in some states/jurisdictions, but not others. This may limit access and create disparity in receiving advanced therapies. This position is supported by an HHS Office of the Inspector General study which found "that LCDs create inconsistency in Medicare coverage policy... collectively these LCDs create state-by-state disparities in Medicare beneficiaries' access to items and services." (Executive Summary OE1-01-11-00500, January 2014). The report further expressed concern “that MACs and CMS sometimes develop policies to limit coverage of specific items and services.” We advise the TAH benefit continue under National Coverage Determination. Thank you for consideration of our comments.

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As Transplant and Mechanical Assist Device Administrator, I have witnessed first hand the positive impact both the Artificial Heart and related devices can have on lives of patients and their families; particularly for those individuals who face long wait times, have limited access to a transplant, or may require additional therapy before being transplant eligible. We respectfully request that CMS continue to have a national coverage determination for the use of artificial hearts for a bridge to transplant with any coverage. Thank you.

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RECOMMENDATION: After “… and a palliative care specialist.”, add the following sentence: “Early in the evaluation process, a formal shared decision making encounter must occur between the patient and a physician or qualified non-physician practitioner (meaning a physician assistant, nurse practitioner, or clinical nurse specialist) using an evidence-based decision tool.”

The requirements remain unchanged for an “explicitly identified, cohesive, multidisciplinary team of medical professionals with appropriate qualifications, training, and experience … to offer optimal patient-centered care. Collectively, the team must ensure that patients and caregivers have the knowledge and support necessary to participate in informed decision making. The team members must … include … physician with cardiothoracic surgery privileges … a cardiologist trained in advanced heart failure … a VAD program coordinator … a social worker … and a palliative care specialist.” While we applaud this team approach and believe the specific multidisciplinary requirements should be retained, the language as written lacks specifics to ensure patient-centered care and informed decision making. For example, some programs include formal palliative consultation for all patients considering LVAD but many do not.

Medicare has required the use of formal patient decision aids for left atrial appendage closure and implantable cardioverter defibrillators (https://pubmed.ncbi.nlm.nih.gov/31266371/). LVAD represents a more substantial medical decision with a high degree of potential trade offs. Research shows that patients are making decisions based on fear and are often poorly informed about the potential benefits and risks of LVAD therapy (https://pubmed.ncbi.nlm.nih.gov/24823949/). Additionally, caregivers of these patients often experience increased stress and anxiety and are particularly unprepared for the inevitable time when the majority of patients who do not receive a transplant reach the end of life (https://pubmed.ncbi.nlm.nih.gov/30316931/).

We propose that the LVAD decision is perhaps the single best decision for a specific mandate for shared decision making for three reasons: 1) there is strong clinical trial evidence of effectiveness of a decision aid for left ventricular assist devices (https://pubmed.ncbi.nlm.nih.gov/29482225/); 2) the implementation of decision aids for LVADs is relatively simple given that all LVAD programs already have an embedded team of clinicians providing patient education (https://pubmed.ncbi.nlm.nih.gov/32428430/); and 3) existing education materials are often developed by industry and are perceived as biased (https://pubmed.ncbi.nlm.nih.gov/25316772/).

Additionally, to provide clarity around important definitions for a “shared decision making encounter” and for an “evidence-based decision tool”, we’d recommend using the definitions provided in the National Quality Partners Playbook Shared Decision Making in Healthcare (http://www.qualityforum.org/National_Quality_Partners_Shared_Decision_Making_Action_Team_.aspx). This document also includes information on certified decision aids.

Thank you for your consideration.
Larry A. Allen, MD, MHS
University of Colorado, School of Medicine
Professor of Medicine, Kenneth Poirier Chair
Associate Head for Clinical Affairs, Cardiology
Medical Director, Advanced Heart Failure

Daniel D. Matlock, MD, MPH
University of Colorado, School of Medicine
Associate Professor of Medicine, Division of Geriatrics
Director, Colorado Program for Patient Centered Decisions

Colleen K. McIlvennan, PhD, DNP, ANP
University of Colorado, School of Medicine
Associate Professor of Medicine, Division of Cardiology
Lead Advanced Practice Provider, Section of Advanced Heart Failure and Transplantation

Jocelyn S. Thompson, MA
University of Colorado, School of Medicine
Project Manager, Colorado Program for Patient Centered Decisions

Monica D. Fitzgerald
University of Colorado, School of Medicine
Project Manager, Colorado Program for Patient Centered Decisions

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September 4, 2020

Tamara Syrek Jensen, Director
Coverage and Analysis Group
Centers for Medicare & Medicaid Services
Mailstop S3-02-01
7500 Security Boulevard
Baltimore, MD 21244

RE: Comments on CMS proposed national coverage determination on artificial hearts

Dear Ms. Jensen:

As a practicing Advanced Heart Failure Cardiologist at The Ohio State University Wexner Medical Center, I am responsible for caring for the types of patients who would be affected by the proposed CMS National Coverage Determination on artificial hearts and the proposal to defer coverage decisions to Medicare intermediaries. Over the last two years, we have treated two critically ill patients with total artificial hearts (TAH), both being successfully bridged to heart transplantation and alive and well today as a result of the TAH. Additionally, in the same time period we have implanted over 40 primary left ventricular assist devices (LVAD) improving the morbidity and mortality for these patients with life-threatening advanced heart failure. While I appreciate the proposal to end with coverage development, I believe that the lack of a national coverage determination will impede the use of the mechanical heart assist technologies and thus ask for coverage to be determined at the national level, for reasons I will explain.

The proposed determination reduces the administrative burden of evidence development on our centers, which is positive. Currently, many patients need to be enrolled in clinical studies to get an implant or meet arbitrary time of treatment criteria for coverage. This results in increased lengths of stay, additional testing, and increased risk of delayed treatment which can harm patients.

The significant benefit to end with coverage development in its current form is appreciably outweighed by the uncertainty of coverage being decided by the MACs separately for each case. With no prior approval in Medicare, coverage is decided after the fact, meaning that the hospital has to take the significant financial risk that the MAC will deny coverage. This financial uncertainty may cause patients, particularly the most vulnerable, not to receive the device.

With no other durable biventricular support technologies indicated to support these patients, centers are left with few other options other than orthotopic heart transplant which, by virtue of an artificial heart being considered, these patients likely do not have timely access to or may not be ideally suited for in their current condition.

In light of these concerns, I request that CMS continue to have a national coverage determination for the use of artificial hearts for a bridge to transplant and left ventricular assist devices with any coverage and remove the evidence development requirement. Alternatively, I would propose that CMS remove any incremental barriers to access and closely monitor utilization. Given the modest number of TAH and LVAD implants annually, the fiscal risk to CMS is modest while the morbidity and mortality experienced by patients who do not have timely access to these therapies is catastrophic.

Thank you for your consideration of these comments. An artificial heart is an important option for our advanced heart failure patients and the current proposal could be problematic in terms of patient treatment, timing and eventual outcomes.

Sincerely yours,

Brent C. Lampert, DO, FACC
Medical Director, Heart Transplantation and Mechanical Circulatory Support
Associate Professor of Clinical Medicine
The Ohio State University Wexner Medical Center
473 W. 12th Avenue, Suite 200
Columbus, OH 43210
Phone: 614-247-4967
Fax: 614-392-5614
Brent.Lampert@osumc.edu

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August 19, 2020

Centers for Medicare and Medicaid Services
Department of Health and Human Services
7500 Security Boulevard
Baltimore, MD 21244

RE: CAG-00453N

Submitted electronically via: CAGinquiries@cms.hhs.gov

Cleveland Clinic is a not-for-profit, integrated healthcare system dedicated to patient-centered care, teaching and research. Our health system is comprised of a main campus, 11 community hospitals and 21 family health centers, with over 3,400 salaried physicians and scientists. Last year, our system cared for 2.4 million unique patients, including 10 million outpatient visits and 309,000 hospital admissions and observations. The following is a description of the changes CMS has included in the above captioned proposed Decision Memo and the response to the changes from Cleveland Clinic.

CMS Proposal: Eliminate the NCD at§ 20.9, ending coverage with evidence development for artificial hearts and permitting Medicare coverage determinations for artificial hearts to be made by the Medicare Administrative Contractors (MACs) under§ 1862(a)(1)(A) of the Social Security Act.

Ventricular Assist Devices
The proposed decision is limited to durable, intracorporeal, left ventricular assist devices (L VADs), and does not include temporary VADs or extracorporeal membrane oxygen (ECMO). CMS is proposing to establish coverage according to the following conditions:

Patient Selection Criteria

• Remove the current therapeutic intent-to-treat criteria of bridge-to-transplant (BTI) and estination therapy (DT), by removing the following BTT requirements:
• Removing the waitlist maintained by the Organ Procurement and Transplantation Network (OPTN).

Cleveland Clinic Response:
We agree with this change as we do not believe that patients should be required to be UNOS listed as a candidate for heart transplant to receive a V AD. Our position is supported by the fact that the FDA approves V ADs for patients who are "eligible" for heart transplantation (bridge-to-transplant) or "ineligible" for heart transplantation (destination therapy). The FDA does not require patients to be listed for transplantation under either indication. Additionally, the majority of commercial insurers cover V ADs for patients who are eligible or could become eligible for a transplant, without requiring the patient to be actively listed as a candidate for transplantation. In fact, many physicians believe that there is no clear clinical distinction between bridge-to-transplant and destination therapy as the patient populations are so similar. We believe that elimination of any terminology to characterize the intent of device implantation is in the best interest of the patient and consistent with the results of the MOMENTUM 3 clinical trial which demonstrates a strong therapeutic benefit ofleft ventricular assist devices regardless of device intent.

CMS Proposal: Remove the requirement that the implanting site, if different than the Medicareapproved transplant center, must receive written permission from the Medicare-approved transplant center prior to implantation of the VAD.

Cleveland Clinic Response: We agree with this change. Removing this requirement will have the added benefit of expanding the use of V ADs in facilities not designated as transplant centers. Currently, VADs may be placed for bridge-to-transplant indication in non-transplant centers only if there is an established care link to a transplant center. This requirement adversely affects access to the life-saving benefit of V AD therapy if patients do not reside near a transplant center.

CMS Proposal: Extend evidence-based patient selection criteria, previously applied only to DT, for all LV AD procedures for short-term ( e.g., bridge-to-recovery and brirlgt>-tn-tninsphnt) nr lnng-term (e.g., destination therapy) mechanical circulatory support

Cleveland Clinic Response: We agree with this change. Evidence-based patient selection criteria permits consistency in the care of this patient population and aligns with the current clinical application of short-term mechanical circulatory support as a bridge to cardiac transplantation, myocardial recovery, or as a bridge to a durable L V AD for extended support.

CMS Proposal: Modify the patient selection criteria:

• Patients are inotrope dependent or
• Have a cardiac index (CI) < 2.2 L/ min/ m2, while not on inotropes and also meet one of the following:
  • Are on optimal medical management (OMM), based on current heart failure practice guidelines for at least 45 out of the last 60 days and are failing to respond; or
  • Have advanced heart failure for at least 14 days and are dependent on an intra-aortic balloon pump (IABP) or similar temporary mechanical circulatory support for at least 7 days.

Cleveland Clinic Response: We agree with this change.

CMS Proposal:
CMS Facility criteria

• The facility criteria remain unchanged from the current NCD. The removal of therapeutic intent is not expected to decrease appropriate patient access to LVADs.

Below is the 20.9.1 NCD (Ventricular Assist Devices). All proposed changes are in italics. Any part of 20.9.1 that is not italicized is not proposed to be revised.

B. Covered Indications
1. Advanced Heart Faihtre
Left ventricular assist devices (L V ADs) are covered if thry are FDA approved for short-term (e.g., bridge-to-recovery and bridge-to-transplant) or long-term (e.g., destination therapy) mechanical circulatory support for heart failure patients who meet the following criteria:

Have New York Heart Association (NYHA) Class IV heart failure;

Have a left ventricular ejection fraction (L VEF) ≤ 25%;

OR
have a Cardiac Index (CI) < 2.2 L/ min/ m2, while not on inotropes, and also meet one of the following:

Are on optimal medical management (OMM), based on current heart failure practice guidelines for at least 4 5 out of the last 60 days and are f(li/iHg to respond; or

Have advanced heart failure for at least 14 days and are dependent on an intra-aortic balloon pump (IABP) or similar temporary mechanical circulatory support for at least 7 days.

Cleveland Clinic Response: We agree with this change. The provided criteria define an advanced heart profile associated with a poor prognosis and ensure the use of optimal medical management in this patient population. The chosen hemodynamic marker (cardiac index and cut off), optimal medical management criteria, and IABP or similar temporary MCS use criteria are consistent with landmark LVAD related trials including the more recent MOMENTUM trial.

Thank you for conducting a thoughtful process that allows us to provide input on such important issues. Should you need any further information, please don't hesitate to contact me.

Sincerely,

Edward G. Soltesz, MD, MPH
Surgical Director of the Kaufman Center for Heart Failure

Jerry D. Estep,MD,FACC,FASE
Section Head, Heart Failure and Transplantation

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As the chief of a very busy transplant and MCS program, I care for these advanced heart failure patients on a daily basis. While I appreciate some aspects of the proposal, I disagree with others.

1. I do not support elimination of the NCD for artificial hearts. I believe that the lack of a national coverage determination will impede the use of the artificial heart due to the complex critical nature of the patient population in need of these devices. These patients are critically ill and decisions need to be made in matter of days, sometimes hours. That is impossible without NCD. It would also create fragmented access to this life saving technology based on the area of the country the patient lived and the fickle nature of their particular MAC. THis is NOT an experimental device but rather the only durable biventricular support device currently on the market. We must not go backward at a time. In addition, the national transplant system has moved to giving priority to patients supported on mechanical devices. Thus patients should not be penalized access to this device based on where they live. This is against the OPTN Final Rule.

2. WHile I heartily support elimination of the BTT and DT label since it is no longer applicable in today's world of durable VADs, I DO NOT support the elimination of a VAD only center not getting a written statement that the patient is not a transplant candidate. Many VAD only centers open with little understanding about transplant candidacy in their area or further away. The patient should always be made aware of the potential for transplant and thus a VAD only center should maintain a formal relationship with a transplant center and present the patient to the transplant group to confirm that patient could not go directly to transplant and skip a durable VAD. Without this step, many patients would get a VAD and then, if develops a complication or desires to pursue transplant, would be at a disadvantage due to the changes in the allocation policy. The shift in heart transplant patients has resulted in a marked decline in durable VAD patients getting heart transplant and left unchecked, may ultimately become dichotomized so that a patient who gets a VAD will rarely get a heart transplant. Thus the oversight or communal relationship with a transplant center should continue.

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August 31, 2020

VIA EMAIL

Tamara Syrek Jensen, Director
Coverage and Analysis Group
Centers for Medicare & Medicaid Services
Mailstop 53-02-01
7500 Security Boulevard
Baltimore, MD 21244

RE: Comments on CMS proposed national coverage determination on artificial hearts

Dear Ms. Jensen:

As a practicing Heart Failure/Transplant Cardiologist at the University of Wisconsin School of Medicine and Public Health, I care for patients who would be affected by the proposed CMS National Coverage Determination on artificial hearts and the proposal to defer coverage decisions to Medicare intermediaries. I have been involved in the care of such patients over the past 30 years and have taken care of numerous patients on the total artificial heart and other ventricular support devices. Although the total artificial heart is not frequently needed as a bridge to transplantation or, in the future, destination therapy, when it is the device that is required it can be life saving. Indeed, it may be the only thing that can save a life. While I appreciate the proposal to end evidence development, I believe that the lack of a national coverage determination will impede the use of the artificial heart and thus ask for coverage to be determined at the national level, for reasons I will explain.

By its nature, end stage heart failure, particularly the type for which total artificial heart implantation may be considered or needed, can require rapid decisions to be made and with no prior approval being assured by Medicare, this will serve as a disincentive for centers to implant an artificial heart if coverage is determined by the MAC on a case by case basis. This means that the coverage may need to be determined after the fact and artificial heart implantation will depend on the hospital taking a financial risk, as the implant may need to occur prior to the time the MAC may be able to provide a coverage decision. In addition, with this being a very specialized form of care, whether individual MACs would have the expertise to make such a complex and infrequent determination is uncertain. Unfortunately, any delays in decision making concerning the coverage for implantation of the artificial heart in an individual patient will most negatively affect those who have not had long term access to medical care who arrive at the hospital in a more severe clinical condition and require even more rapid decision making. This would include patients who are socially and financially disadvantaged and, in particular, the growing population of adults with congenital heart disease.

In light of the above, I propose that CMS continue to have a national coverage determination for the use of artificial hearts as a bridge to transplant. This could be pursued either by continuing coverage with the evidence development requirement or proceeding to a national coverage determination for artificial heart implantation with close monitoring of utilization and outcome. Given the modest number of artificial heart implants annually, the fiscal risk of the latter to CMS would be modest, while the morbidity and mortality of patients who need timely access to artificial hearts in the light of any delays occurring because of time for MAC deliberations could be catastrophic.

Thank you for your consideration of these comments. An artificial heart is an important option for our advanced heart failure patients and the current proposal could be problematic in terms of patient access, timing, and eventual outcomes.

Sincerely yours,

/s/
Maryl Johnson, MD
Professor of Medicine
Heart Failure and Transplant Cardiology

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Our institution applauds the removal of the arbitrary labels placed on patients prior to LVAD implantation that have no clinical meaning. In fact, as mentioned in comments earlier this year, we have clinical evidence supporting the lack of utility in this labeling. https://jamanetwork.com/journals/jamacardiology/fullarticle/2758869

However, we do not support removing total artificial heart from the NCD. While this uptake of this technology may not be as high as conventional LVADs, it fits a unique population of cardiomyopathy patients (e.g. congenital, right heart failure, arrhythmia, restrictive, etc) that will be underserved by such a decision.

We appreciate your thoughtful consideration of these comments and others.

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Whether Bridge to transplant. Bridge to decision or Destination therapy, for many patients with acute decompensation of chronic heart failuire these "intents" are just an artificial labeling with minimal clinical relevance. These patients all have advanced heart failure that have failed medical therapy. Thus, requiring and "intent" is unnecessary and and potentially confuses future evaluation and clinical research as ultimate designation will change in many patients after receiving support.

Similarly, we need a national coverage decision for total artificial hearts or else there will be potential variations in coverage putting certain groups of patients at risk depending on which region the country they reside.

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I have concerns regarding CMS' proposed changes re to TAH implants. As the financial manager of our transplant and mechanical heart program, I am responsible for ensuring that our program operates at a positive margin to help ensure that we are able to care for this vulnerable subset of patients.

If we ultimately end up leaving the decision on coverage to local Medicare contractors on a case by case basis (Local MACs) , we will not have insurance authorization prior to the implant. This is not acceptable within our program (and others across the nation)

Without this clarity of coverage / reimbursement, we have serious concerns of our ability to ensure that every patient needing this care would receive it.

Hospitals need immediate response re clarity of coverage for our patients, which we know is not feasible. This delay in acquiring insurance authorization will ultimately impact our ability to ensure these patients receive timely and appropriate care.

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I congratulate CMS on revising and honing the coverage for ventricular assist devices. These devices are life saving and needed. The coverage determination sets the standard that most commercial payors follow. Thank you for recognizing the need for these life saving devices for circulatory support as a physiologic need, not as a pre-determined therapeutic destination.

While I applaud the determination of VAD, I am seriously concerned about the elimination of coverage for the total artificial hearts. This important technology, while less applicable than VADs per se, the devices are the ONLY devices that support grown congenital heart patients, patients with right and left heart failure, restrictive cardiomyopathies and other less frequent patient populations. In removing the coverage, CMS sets into motion uneven access throughout the country to these important therapies. Having implanted twenty or so devices, everyone of these patients would have died without these devices. Everyone of these patients would have suffered had the devices not been available in a timely fashion. Leaving these decisions to MACs and commercial payers individually creates an inconsistent and incongruent decisions and access issues that could leave patients without options. Further these devices do not have the population that allows large randomized clinical trials to be conducted, leaving many payers to put these devices in a perpetual investigational/experimental category to deny payment.

In closing while the allocation for heart transplant has changed, the need for durable circulatory support for this very sick patients remains more than ever. Please maintain the coverage determination.

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LVAD outcomes have improved tremendously over time. Although there used to be a clear survival advantage of transplant over LVAD, this difference has decreased significantly. Given current selection biases, short term LVAD survival is likely equivalent to transplant and may even be superior. Additionally, many patients implanted as a bridge to transplant ultimately end up as destination therapy and vice versa. Therefore, we agree that the distinction between bridge to transplant and destination therapy is artificial, not predictive of outcomes, and often not even predictive of future therapies. Given this improvement in outcomes and the artificial nature of the distinction, we agree that the distinction should be removed and patients should be able to be implanted with an LVAD without necessitating a transplant evaluation or transplant denial.

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