National Coverage Analysis (NCA) View Public Comments

Ventricular Assist Devices as Destination Therapy

Public Comments

Commenter Comment Information
Crumbley, Arthur Title: Assoc. Prof. of Surg., Dir. of Thor. Org. Transpl.
Organization: Medical University of South Carolina
Date: 01/26/2007
Comment:

Shortly, the Center for Medicare and Medicaid Services must decide the appropriate criteria for Ventricular Assist Device (VAD) teams. As proposed, the selection criteria will apply only to the use of VADs for destination therapy, VAD placement as a final therapy for congestive heart failure patients. Specifically, these are patients have who have end stage disease and who would be viable candidates for heart transplantation if not for one or more contraindications or other medically

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Blum, Laura Title: Associate Director, Federal Relations
Organization: The Joint Commission
Date: 01/26/2007
Comment:

The Joint Commission believes that its Disease-Specific Care Certification for Ventricular Assist Device as Destination Therapy can contribute to the quality of care that Medicare beneficiaries receive. Certification by the Joint Commission means a facility is complying with the most state-of –the-art national standards for safety and quality of care. The Joint Commission standards focus on essential performance improvement strategies that help organizations continuously improve the safety

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Mayes, Gwen Title: Director of Reimbursement and Government Relations
Organization: Abiomed, Inc.
Date: 01/26/2007
Comment:

To Whom it Concerns:

ABIOMED welcomes the opportunity to provide the following comments on the Centers for Medicare and Medicaid Services (CMS) proposed decision memo on ventricular assist devices (VADs) as destination therapy (DT). Our comments refer to the proposed modified criteria for CMS eligibility criteria and the VAD DT Certification requirements adopted in October, 2006, by the Joint Commission on Accreditation of Healthcare Organizations (JCAHO) (herein “JCAHO

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Crist, Katrina Title: Executive Director
Organization: American Society of Transplant Surgeons
Date: 01/26/2007
Comment:

January 24, 2007

Steve E. Phurrough, MD, MPA
Director, Coverage and Analysis Group
Centers for Medicare and Medicaid Services
U.S. Department of Health and Human Services
7500 Security Blvd., Mailstop: C1-09-06
Baltimore, MD 21244-8016

Attention: CAG 00119R

Dear Dr. Phurrough:

On behalf of the American Society of Transplant Surgeons (ASTS), we are delighted to have the opportunity to comment on the proposed facility criteria for Ventricular

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Kormos, MD, Robert L. Organization: The Society of Thoracic Surgeons
Date: 01/25/2007
Comment:

January 25, 2007

Steve E. Phurrough, MD, MPA
Director, Coverage and Analysis Group
Centers for Medicare and Medicaid Services
U.S. Department of Health and Human Services
7500 Security Blvd.
Mailstop: C1-09-06
Baltimore, MD 21244-8016

Attention: CAG 00119R

Dear Dr. Phurrough:
On behalf of The Society of Thoracic Surgeons, representing the vast majority of board certified cardiac and thoracic surgeons nationally; we would like to comment on

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Morris, Rohinton Title: Surgical Director - Cardiac Transplantation
Organization: University of Pennsylvania
Date: 01/24/2007
Comment:

1. VAD implant volume should not be the only criteria. Survival (short and long-term), complications, crossover to transplant, QOL surveys, etc. should all be included. All centers should be required to join INTERMACS registry, for documentation, policing and outcomes. Programs that only do 10 patients with superior outcomes are much more preferable to 20 with poorly selected patients and worse outcomes.

2. All non-transplant centers should be required to have a formal,

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Bostic, Robin Title: VP of Reimbursement
Organization: Thoratec.
Date: 01/22/2007
Comment:

Thoratec Corporation is pleased to submit comments on the proposed Left Ventricular Assist Device Certification Requirements recently proposed by the Joint Commission on Accreditation of HealthCare Organizations (“JCAHO”). Thoratec Corporation is a world leader in left ventricular devices to treat cardiovascular disease. Our Thoratec® VAD and HeartMate® have been implanted in more than 10,000 patients suffering from heart failure, and the HeartMate is the only left ventricular

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Entwistle, John Title: Assistant Professor of Cardiothoracic Surgery
Organization: Hahnemann Hospital/Drexel College of Medicine
Date: 01/17/2007
Comment:

The members of our transplant and LVAD teams have discussed the proposed changes. The following reflects the consensus opinion of our team members:

1) Reducing the volume standard from 15 to 10 over a three-year period: We are neutral in regards to this change, but realize that the decrease in required numbers may limit the temptation of some centers to implant devices to meet the lower minimum numbers. However, we would like some clarification of the requirements regarding an individual

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Icenogle MD, Tim Title: Director of Thoracic Transplantation, Mechanical H
Organization: Sacred Heart Medical Center
Date: 01/09/2007
Comment:

I believe that a destination VAD center should be at least a trasnplant center. Destination therapy is more difficult than heart transplantation. I've been involved in heart transplantation since 1982 and involved with VADs since 1985. It requires a TEAM of dedicated VAD engineers and nurses and full commitment from the hospital. We are a Medicare approved VAD and heart transplant center in Spokane, WA and I have seen what happens when facilities that are not committed to this implant

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Loebe, Matthias Date: 01/08/2007
Comment:

The changes are reasonable. However, I would like to stress the fact that many of the present programs in VAD in the US rely on foreign trained surgeons, who have wast experience with devices but no US board certification. I dont think that board certification is in any way of importance when being ceritified for a nouvell treatment strategy. I would wellcome a broader definition of board certification in this context.

ravichandran, pasala Title: Director, Heart TX and Assist Device program
Organization: Oregon Health Sciences University
Date: 01/06/2007
Comment:

The language for the requirement for VAD surgeon still need to be changed. It should read " Board certified or its foreign equivalent degree or training and experience". Please note the similar language used in the UNOS requirement for Transplant surgeons and it is very specific.This suggestion was made during the initial 30day period as well. Many of the best VAD surgeons (Dr.Naka at Columbia presbytarian for example) are not American Board Certified.

Hallinan, William Title: Clinical Director
Organization: Strong Memorial Hospital
Date: 12/28/2006
Comment:

The requirement for 10 VADS over three years is to broad. Since VAD program require a similar infrastructure as transplant, the requirement should be 10 per year,5 of which should be long term or Destination Therapy VADS. Centers that perform less then that would not be able to attain the level of proficeieny required to generate good outcomes within a resonable time. There is a clear difference in outcomes and costs per patients related to volume and the ability to select patients.