National Coverage Analysis (NCA) View Public Comments

Leadless Pacemakers

Public Comments

Commenter Comment Information
Nordahl, Karen Title: Director, Health Economics and Market Access
Organization: Boston Scientific Corporation
Date: 12/14/2016
Comment:

December 14, 2016

Tamara Syrek Jensen, JD
Director, Coverage & Analysis Group
Office of Clinical Standards and Quality
Centers for Medicare & Medicaid Services
Mailstop C1-09-06
7500 Security Blvd
Baltimore MD 21244

RE: Medicare Proposed National Coverage Determination for Leadless Pacemakers

Dear Ms. Syrek Jensen:

On behalf of Boston Scientific, we appreciate the opportunity to provide input on the

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Reynolds, MD, Dwight Title: Regents Professor and Chief
Organization: Cardiovascular Section, The University of Oklahoma HSC
Date: 12/14/2016
Comment:

Thank you for the opportunity to comment on the NCD proposal re leadless pacemakers. I have read the entirety of the proposal. I am a cardiologist involved in pacemaker implantation and follow-up (for 36+years)and am involved in the clinical leadership of the Micra Transcatheter Pacemaker Global Clinical Trial since its earliest development.

My specific comments follow:

1)It is important to reiterate that the 2 leadless pacemakers that have been studied in pivotal

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Veath, Barbara Title: Sr. Director, Economics and Reimbursement
Organization: Medtronic - CRHF Division
Date: 12/14/2016
Comment:

December 14, 2016

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

RE: Comments on Proposed National Coverage Determination (NCD) for Leadless Pacemakers (CAG-00448N)

Dear Ms. Syrek Jensen:

Medtronic is the world's leading medical technology company,

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Mittal, Suneet Title: Director, EP
Organization: The Valley Hospital
Date: 12/14/2016
Comment:

Leadless pacing is now suppord by scientific data. This has led the US FDA to approve the technology. We have many patients who are eagerly awaiting this technology - avoids a surgical incision, no upoper vascular access issues, very low risk of dislodgment, and importantly seemingly no risk of infection.

We were very diasspointed by what CMS proposed as the basis for coverage of payment. If payment is restricted to just a few sites who have already been selected to participate in

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Ellis, Christopher Title: Associate Professor of Medicine- Cardiac EP
Organization: Vanderbilt Heart and Vascular Institute
Date: 12/14/2016
Comment:

To CMS,

I am Christopher R. Ellis, MD, FACC, FHRS, Associate Professor and Director of the Vanderbilt University Cardiac Electrophysiology Laboratory. I have followed and implanted 45 patients with transcatheter pacing systems (MICRA) and believe this is both the future of pacing therapy, and a critical, cost reducing and risk reducing invasive therapy.

Using the catheter delivered MICRA rather thank traditional pacemaker, we have (at Vanderbilt) dramatically

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Bostic, Robin Title: Vice President, Global Reimbursement and Health Ca
Organization: St. Jude Medical, Inc.
Date: 12/14/2016
Comment:

December 14, 2016

Tamara Syrek Jensen, JD
Director, Coverage & Analysis Group
Office of Clinical Standards and Quality
Centers for Medicare & Medicaid Services
Mailstop C1-09-06
7500 Security Blvd
Baltimore MD 21244

RE: Proposed Medicare Coverage Decision Memorandum for Leadless Pacemakers (CAG-00448N)

Dear Ms. Syrek Jensen:

St. Jude Medical (SJM) is writing to provide comments related to the

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Hammer, Allyson Title: Compliance Manager
Organization: Allina Health
Date: 12/14/2016
Comment:

To whom it may concern,

On behalf of Allina Health (Allina), I appreciate the opportunity to comment on the National Coverage Analysis for Leadless Pacemakers (CAG-00448N). Allina Health is dedicated to the prevention and treatment of illness and enhancing the greater health of individuals, families and communities throughout Minnesota and western Wisconsin. A not-for-profit health care system, Allina Health cares for patients from beginning to end-of-life through its 90+

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Bowers, Mark Title: MD
Organization: Mercy Medical Group, Sacramento, CA
Date: 12/14/2016
Comment:
I have implanted several Nanostim devices, and when my patients have not qualified for the investigational study I have transferred several patients to other hospitals to get the Micra device when I think they would benefit. Although I think the data supports implanting these devices in any patient with a single chamber indication, we have had several patients with vascular issues that truly have no other good option without surgery. Leadless pacemakers are truly a breakthrough innovation for

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Prutkin, Jordan Title: Medical Director, Electrophysiology Lab
Organization: Regional Heart Center, University of Washington
Date: 12/13/2016
Comment:

At the Regional Heart Center of the UW Medicine, we think leadless pacing is a breakthrough treatment for bradyarrhythmias. We have implanted the Micra Leadless Pacemaker at our institution in patients who meet FDA labelling for this device. One of our initial patients who lacked appropriate vascular access would have needed an epicardial pacemaker system if this device were not available. Another patient had a history of a pacemaker infection and underwent a lead extraction, but then

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Saleem, Moeen Title: MD
Organization: Advocate Medical Group
Date: 12/13/2016
Comment:
I would like to strongly encourage CMS approval for access for patients who are indicated for leadless pacemaker have the opportunity to have access and coverage for this device therapy. Leadless pacemakers have been studied extensively in international clinical trials demonstrating both procedural safety and long term benefits including safety of device therapy and decreased risk of infection. As compared to transvenous devices, leadless pacemakers address a common concern and challenge that

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Rivera, DeeAnn Date: 12/13/2016
Comment:
I see this technology as the next wave of what pacemakers will become. While currently I think leadless pacemakers are for a small subset of patients, I think the technology will continue to advance and may be how most pacemakers will be placed in the future. I think it is important that implanters begin to learn the techniques involved in implanting these devices on a wider scale than those involved with the studies. I would hope that I do not have to outsource my patients from my care to

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Kowal, Robert Title: MD/PhD
Date: 12/13/2016
Comment:

The Micra leadless pacemaker represents a transformation in care for patients requiring single chamber pacing. The trial leading to its FDA approval was robust and showed outstanding performance, excellent implantation success and a dramatic reduction in overall complications relative to a control derived from similarly rigorous trials of traditional transvenous pacemakers.

While I strongly appreciate the decision by CMS to consider National Coverage for Leadless Pacing, I do

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Aleong, Ryan Title: MD
Organization: University Of Colorado
Date: 12/13/2016
Comment:

Approval of this technology needs to account for a few special considerations:

  1. It should be available not just sites that were part of the initial study. This is especially true at sites like the University of Colorado which service a large area of the U.S., none of which were part of the initial study. Patients who often need this technology are older and frail. So approving this technology at sites that were only part of the study would basically exclude many patients who

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Manshadi, Ramin Title: MD
Organization: MANSHADI Heart Institute
Date: 12/13/2016
Comment:
My position supports the leadless pacemaker technology because of the absence of pocket formation with risk of infection.
For many patients the leadless pacemaker for indications of RV backup pacing , is a much better approach especially for compromises venous access, and having the ability to be MRI compatible is even better.
Buhari, Cyrus Title: DO
Organization: SAN Joaquin Cardiology Medical Group
Date: 12/13/2016
Comment:
I feel that the need for leadless pacemaker is very important due to access issues, and it satisfies the minimalist approach to backup RV pacing which may minimize the risk of POCKET and cardiac device infection. Provides for minimal interruption in ADLs and quicker recovery.
Lowery, Christopher Title: Physician (Cardiology)
Organization: Kaiser Permanente Colorado
Date: 12/13/2016
Comment:
I feel strongly that CMS should approve payment for leadless pacemakers. I have provided care for several patients, and so have my colleagues, for whom these devices would have been an ideal solution to issues with vascular access and concern for infection. Unfortunately, patients have required a thoracotomy to place an epicardial pacing system. Specific instances included bilateral upper extremity venous occlusion and high concern about intravascular infection with immunosuppression and

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Branham, Chandra Title: VP, Payment & Health Care Delivery Policy
Organization: AdvaMed
Date: 12/13/2016
Comment:

December 13, 2016

Tamara Syrek Jensen, JD
Director, Coverage & Analysis Group
Office of Clinical Standards and Quality
Centers for Medicare & Medicaid Services
Mailstop C1-09-06
7500 Security Blvd
Baltimore MD 21244

RE: Proposed Medicare Coverage Decision Memorandum for Leadless Pacemakers (CAG-00448N)

Dear Ms. Syrek Jensen:

The Advanced Medical Technology Association (AdvaMed) offers the following

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Zipse, Matthew Title: Assistance Professor of Medicine, Attending EP
Organization: University of Colorado
Date: 12/13/2016
Comment:
Leadless pacing is an important and disruptive technological development and improves upon the current design of the traditional transvenous system. Large, randomized trials have demonstrated the safety and efficacy of the procedure. I have many patients who would have benefited from this technology to a greater extent than a transvenous system (particularly, hemodialysis patients without vascular access options) in whom we have had to 'settle' for a transvenous device while awaiting a

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Nichols, Allan Organization: OhioHealth
Date: 12/13/2016
Comment:

I feel very strongly that coverage for leadless pacemaker should be approved . This an extremely valuable addition allowing physicians involved in cardiac care to provide much needed therapy for a select group of patients . Patient access should not be limited to those involved in research studies nor should there be any restrictions placed on the patient population meeting the needs for this type of device when other alternatives are less favorable.

Patients who meet the

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Chazal, MD, FACC, Richard A. Title: President
Organization: The American College of Cardiology (ACC)
Date: 12/13/2016
Comment:

December 13, 2016

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

RE: Draft National Coverage Decision (NCD) for Leadless Pacemakers (CAG-00448N) Dear Ms. Syrek-Jenson:

The American College of Cardiology (ACC), Heart Rhythm Society (HRS), and Society for Cardiovascular Angiography and Interventions (SCAI) are the non-profit professional

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Houser, Steven R. Organization: American Heart Association (AHA)
Date: 12/13/2016
Comment:

December 14, 2016

Mr. Andrew Slavitt
Acting Administrator
Centers for Medicare and Medicaid Services
200 Independence Ave SW
Washington, DC 20201

RE: CAG-00448N

Dear Acting Administrator Slavitt:

On behalf of the American Heart Association (AHA), including its American Stroke Association (ASA) division and over 30 million volunteers, we appreciate this opportunity to submit comments on the Centers for Medicare and Medicaid

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Springer, Michael Title: MD
Organization: Norton Healthcare
Date: 12/12/2016
Comment:
I was initially very skeptical about leadless pacemakers but I must say that having learned more about them I believe they are the future of pacing. Implantation is certainly a little more challenging and there is a learning curve but there are multiple benefits to the patients and the healthcare system. The elimination of pacemaker pocket and lead complications will be a big savings to the healthcare system over time. There is also the likelihood that after the first year or two these devices

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ElChami, Mikhael Title: MD
Date: 12/12/2016
Comment:

Than you for the opportunity to provide comments to CMS regarding the NCD for Leadless pacemakers.
I would like first to disclose that i am one of the principal investigator of the Micra Post approval study.
I am a cardiac Electrophysiologist in Atlanta, GA. I would like to report my positive experience with the Micra pacemaker. I have had the opportunity to implant Micra in more than 30 patients during clinical trials. This device as proven by the IDE trial and data from the

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Lloyd, Michael Title: md
Organization: emory
Date: 12/12/2016
Comment:
This is a proven device that represents a long-awaited pacing option for many patients. I am hopeful for a fair decision on behalf of my patients.
Sovari, Ali Date: 12/12/2016
Comment:
As an implanter of Micra leadless pacemaker I have witnessed its tremendous advantage in certain cases such as those with h/o endocarditis who need pacemaker. This technology has been developed in the US and I believe it should become widely available for improving patient care in this country. It won't be fair to our patients to see that this US born technology will become available abroad more than in the US because of limited coverage.
Wilkoff, Bruce Title: Director Cardiac Pacing and Tachyarrhythmia Device
Organization: Cleveland Clinic
Date: 12/12/2016
Comment:
Limiting the access of MICRA to 1000 patients and waiting for an extended period of time of follow-up will result in effectively removing the device from access for an extended period of time. The post approval study will intensively collect data and will provide the needed information as approved by the FDA. CED is not required in this case. Personally I would have access, as I was an investigator of MICRA, but we need more broad release to understand the performance in the general

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Khairallah, Farhat Organization: Tallahassee Memorial Healthcar3
Date: 12/12/2016
Comment:

Leadless pacemakers are a significant breakthrough in patients who require pacemaker support. The benefits over transvenous pacemakers include but are not limited to reduction of infection rates, absence of wound complications and elimination of lead related issues that might require extractions placing the patient at a significant risk.

I believe that these devices should be approved immediately without waiting period. They are a game changer and would improve patient outcomes.

Higgins, MD, Steven Title: Chairman, Cardiology; Director, Cardiac EP
Organization: Scripps Memorial Hospital, La Jolla, CA
Date: 12/09/2016
Comment:

Thank you for the opportunity to provide feedback regarding the proposed Medicare coverage decision for Leadless pacemakers (CAG-00448N).
Under protocol, I have implanted approximately 25 St. Jude Nanostim leadless pacemakers and colleagues at Scripps have implanted a similar number of Medtronic Micra devices. Scripps Health is one of the top 20 cardiac EP programs in the country in both volume and reputational score.
Leadless pacemakers are a revolutionary advance in pacing

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Giedrimas, Arnoldas Title: MD
Organization: Southcoast
Date: 12/06/2016
Comment:
The leadless pacemaker offers a new option to many patients that are at higher risk for complications related to traditional pacemakers. It has gone through appropriate testing prior to FDA approval and will continue to do so in the registry run by Medtronic. I am concerned that a requirement tying payment to clinical studies, will limit it's availability in community hospitals such as the one I practice in. I don't believe it's the place of CMS to limit patient's access to care, and I

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Nguyen, Ngai Title: MD/ Medical Director
Organization: Regional Medical Center San Jose California
Date: 12/06/2016
Comment:
Very important advanced technology which help in patients with difficult vascular access, less risks of infection, bleeding, pocket issues, leads fracture... Ideal device for high risk patients including advanced age, multiple comorbidities
Daoud, Emile Title: Section Chief, Electrophysiology Ohio State Univ.
Organization: The Ohio State University Wexner Medical Center
Date: 12/05/2016
Comment:

I would like to provide a comment re access to leadless pacemakers. The have been 2 US trials. The Medtronic trial was a well designed trial with appropriate data collection and follow up confirming excellent outcomes, at least comparable to current pacemaker technology that utilizes leads. The fact that the second device (ST jude) has had some problems should bot be a consideration since the devices have differing technology and hence the results are different.

Considering

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Richter, Katie Date: 11/17/2016
Comment:
What happens to the current leadless pacemaker trials that are currently approved by the local MAC? How to handle those has not been addressed and would be very helpful to know whether they are still covered under the MAC or they have to be listed as a CED trial