National Coverage Analysis (NCA) View Public Comments

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

Public Comments

Commenter Comment Information
Daneshmand, Mani Title: Director of Heart & Lung Transplant, MCS, and ECMO
Organization: Emory Healthcare
Date: 09/11/2020
Comment:

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

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Palatiello, Amy Title: Director, CRHF Reimbursement
Organization: Medtronic
Date: 09/11/2020
Comment:

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

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Horstmanshof, Douglas Title: Co-Director, INTEGRIS Advanced Cardiac Care
Organization: INTEGRIS Health
Date: 09/11/2020
Comment:

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

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McCone, Kelly Title: Government Relations Coordinator
Organization: The Society of Thoracic Surgeons
Date: 09/11/2020
Comment:

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

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McCone, Kelly Title: Government Relations Coordinator
Organization: The Society of Thoracic Surgeons
Date: 09/11/2020
Comment:

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

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Rallis, Kim Title: Executive Director
Organization: UofL Health - Jewish Hosptial
Date: 09/11/2020
Comment:

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

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Mokadam, Nahush Title: Professor and Director of Cardiac Surgery
Organization: The Ohio State University
Date: 09/11/2020
Comment:

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

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Whitson, Bryan Date: 09/11/2020
Comment:

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

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Kormos, Robert Title: Division VP Global Medical Affairs, Heart Failure
Organization: Abbott
Date: 09/11/2020
Comment:

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.

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Kooistra, DO, Joshua Title: SVP, Chief Medical Officer
Organization: Spectrum Health West Michigan
Date: 09/11/2020
Comment:

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

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Moriguchi, MD, Jaime D. Title: Medical Director, MCS Program
Organization: Cedars-Sinai Smidt Heart Institute
Date: 09/11/2020
Comment:

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.

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Skroback, CIP, CRCP, Judy Title: Director of Clinical Research
Organization: SynCardia Systems, LLC
Date: 09/11/2020
Comment:

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

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Branham, Chandra Title: VP, Payment & Health Care Delivery Policy
Organization: AdvaMed
Date: 09/10/2020
Comment:

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

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Copeland, MD, Hannah Organization: Lutheran Hospital
Date: 09/10/2020
Comment:

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

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Ganapathi M.D., Asvin M. Title: Assistant Professor, Division of Cardiac Surgery
Organization: Ohio State University Medical Center
Date: 09/10/2020
Comment:

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

More

Henn, MD, Matthew C. Title: Assistant Professor, Division of Cardiac Surgery
Organization: THE OHIO STATE UNIVERSITY
Date: 09/10/2020
Comment:

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

More

Morales, David L.S. Title: Professor of Surgery & Pediatrics
Organization: The University of Cincinnati College of Medicine
Date: 09/10/2020
Comment:

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

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Cowger, MD, MS, Jennifer Title: Med. Director of Mech Circulatory Support
Organization: Henry Ford Hospital
Date: 09/09/2020
Comment:

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:

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Arabía, MD MBA, Francisco A. Title: Professor of Surgery and Medicine
Organization: Banner-University Arizona University Medical Center
Date: 09/09/2020
Comment:

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

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Benza, MD, FACC, Raymond L. Title: Professor and Director
Organization: The Ohio State University Wexner Medical Center
Date: 09/09/2020
Comment:

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

More

Hoblitzell, Tyler Title: Regulatory Affairs Manager
Organization: American Heart Association
Date: 09/09/2020
Comment:

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

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Joyce MD, PhD, Lyle D. Title: Section Chief, Adult Cardiac Surgery
Organization: Medical College of Wisconsin
Date: 09/09/2020
Comment:

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

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Marra, Kristine Title: Advocacy Committee Chair
Organization: American Association of Heart Failure Nurses
Date: 09/08/2020
Comment:

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

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Stillion, Laura Title: Administrator
Organization: The Ohio State University Wexner Medical Center
Date: 09/07/2020
Comment:
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

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Shafii, Alexis Title: MD
Organization: Baylor St Lukes Medical Center, Common Spirit Health
Date: 09/07/2020
Comment:
I agree and support the proposed NCD changes.
Allen, Larry Title: Professor of Medicine, Medical Director
Organization: University of Colorado, School of Medicine
Date: 09/04/2020
Comment:

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

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Lampert, DO, FACC, Brent C. Title: Associate Professor of Clinical Medicine
Organization: The Ohio State University Wexner Medical Center
Date: 09/04/2020
Comment:

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

More

Boyce, Steven Title: Surgical Dir., Advanced Heart Failure
Organization: Adventist Healthcare
Date: 09/01/2020
Comment:
I agree and support the NCD proposed changes
Tedford, MD, Ryan Title: Professor; Chief, Heart Failure and Transplant
Organization: MUSC
Date: 09/01/2020
Comment:
Agree this is an important step forward and support the changes
Sauer, Andrew Title: Medical Director, Heart Transplant Program
Organization: The University of Kansas Health System
Date: 09/01/2020
Comment:
We need to move toward eliminating the BTT and DT designations and authorize use of durable MCS for patients who meet clinical criteria for selection based on current standards of care as it relates to patient characteristics. The terms BTT and DT no longer apply to contemporary population.
barnhart-hinkle, blair Organization: Cleveland Clinic
Date: 09/01/2020
Comment:

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

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Hall, Shelley Title: Chief, Transplant Cardiology and MCS
Organization: Baylor University MEdical Center
Date: 08/31/2020
Comment:

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

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Johnson, MD, Mary Title: Professor of Medicine
Organization: UNIVERSITY OF WISCONSIN-MADISON
Date: 08/31/2020
Comment:

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

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Ravichandran, Ashwin Title: Medical Director, Mechanical Circulatory Support
Organization: Ascension St. Vincent, Indianapolis, Indiana
Date: 08/29/2020
Comment:

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,

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Slaughter, Mark Title: MD
Organization: University of Louisville
Date: 08/26/2020
Comment:

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

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Seiger, Todd Title: Transplant Business Manager
Organization: Providence Sacred Heart Medical Center
Date: 08/21/2020
Comment:

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

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Silvestry, Scott Title: Surgical Director Thoracic Transplant Programs
Organization: Advent Health Orlando
Date: 08/19/2020
Comment:

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

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Alhosaini, Hassan Title: Medical Director- Advanced HF & LVAD Program
Organization: Vidant Heart & Vascular Care
Date: 08/19/2020
Comment:
Our program delivers advanced heart failure care to an undeserved rural population. Our center is the only facility delivering surgical heart failure care to ~ 1.5 million patients in a 29 counties area in eastern North Carolina. Removing LVAD NCD /bridging requirement and adopting "short and long-term" designations would expedite advanced heart failure care and mend an important health disparity gap in Eastern NC.
Velez, Mauricio Title: MD
Organization: Cleveland Clinic
Date: 08/18/2020
Comment:
I support this NCA and the revisions to the NCD pertaining to durable LVADs to reflect evidence-based patient selection criteria and the most recent clinical trial data regarding the benefit of durable LVAD support for patients with advanced heart failure.
George, Timothy Title: MD
Date: 08/17/2020
Comment:
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

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Siemeck, Roxanne Title: Manager Heart and Vascular Institute
Organization: Advocate Aurora Christ Medical Center
Date: 08/17/2020
Comment:
I believe the designation of the intent to treat should be removed and patients should be implanted based on their candidacy for implant, not the strategy or intention such as bridge to transplant or destination therapy. I feel this way mainly because the indications are fluid and can change throughout the course of pump support.
Coats, Kirk E Title: Mr.
Organization: Home
Date: 08/12/2020
Comment:
We hope this is not a change which will eliminate the elderly from transplant consideration.
Hirsch, Ronald Date: 08/12/2020
Comment:
It is unclear to me why you would eliminate 20.9 and relinquish control to the MACs. Allowing the MACs to set coverage means that a patient in Illinois may have access to a treatment but a 15 minute car ride to Wisconsin where another MAC is in control will deprive that patient of the same treatment. Medicare is a national program and allowing separate decisions based on the varying analyses by the MACs is counterintuitive. The OIG has pointed out the flaws of such a system yet it persists.