National Coverage Analysis (NCA) View Public Comments

Implantable Cardioverter Defibrillators

Public Comments

Commenter Comment Information
Chari, Ravi Title: CVP, Clinica Excellence
Organization: HCA
Date: 12/20/2017
Comment:

HCA is a major hospital provider across the United States. We maintain a focus on patients and are engaged in many quality initiatives. These initiatives center on the delivery of high quality patient care, including compliance with local and national coverage determinations. It is in this spirit that we submit these comments on the proposed changes to the Implantable Cardiac Defibrillator (ICD) National Coverage Determination (NCD).

We commend CMS for the following

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Hammer, Allyson Title: Compliance Manager
Organization: Allina Health
Date: 12/20/2017
Comment:

To Whom It May Concern,

On behalf of the Allina Health (Allina) Electrophysiology sections, we appreciate the opportunity to comment on the Proposed Decision Memo Implantable Cardiac Defibrillators (CAG-00157R4). Allina Health (Allina) 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

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Simonetti, Orlando Title: Chief Executive Officer
Organization: Society for Cardiovascular Magnetic Resonance
Date: 12/20/2017
Comment:

December 20, 2017

Joseph Hutter, MD, MA
Medical Officer
Centers for Medicare and Medicaid Services
Attention: CAG-00157R4
7500 Security Boulevard
Baltimore, Maryland 21244-1850

RE: Proposed Decision Memo for Implantable Cardioverter Defibrillators (CAG-00157R4)

Dear Dr. Hutter:

The Society for Cardiovascular Magnetic Resonance (SCMR) appreciates the opportunity to comment on the proposed decision memo for ICDs (CAG-00157R4).

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Walsh, Mary Norine Title: President
Organization: American College of Cardiology
Date: 12/20/2017
Comment:

December 20, 2017

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

Re: National Coverage Analysis (NCA) for Implantable Cardioverter Defibrillators (CAG-00157R4)

Dear Ms. Syrek-Jensen:

The Heart Rhythm Society (HRS) and the American College of Cardiology (ACC) are the non-profit professional Societies representing most of the

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Grant, Marian Title: Senior Regulatory Advisor
Organization: The Coalition to Transform Advanced Care
Date: 12/20/2017
Comment:

Re: Proposed Decision Memo for Implantable Cardioverter Defibrillators (CAG-00157R4)

Thank you for the opportunity to submit comments on this proposed Decision Memo. On behalf of the Coalition to Transform Advanced Care (C-TAC), we appreciate the opportunity to provide comments with respect to those aspects that affect those living with advanced illness.

C-TAC is a national non-partisan, not-for-profit organization dedicated to ensuring that all those with

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Branham, Chandra Title: VP, Payment & Health Care Delivery Policy
Organization: AdvaMed
Date: 12/20/2017
Comment:

December 20, 2017

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

RE: Proposed National Coverage Analysis (NCA) for Implantable Cardioverter Defibrillators (CAG-00157R4)

Dear Ms. Syrek Jensen:

The Advanced Medical Technology Association (AdvaMed) offers the following

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Crawford, Thomas C. Organization: Michigan Medicine
Date: 12/20/2017
Comment:

December 20, 2017

Ms. Tamara Syrek-Jensen, JD
Director, Coverage and Analysis Group
Centers for Medicare & Medicaid Services (CMS)
7500 Security Blvd, Mail Stop 53-02-01
Baltimore, MD 21244-1850

Re: Proposed Decision Memo for Implantable Cardioverter Defibrillators (CAG-00157R4)

Dear Ms. Syrek-Jensen:

On behalf of Michigan Medicine1, the academic medical center unit of the Regents of the University of

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Hope, Patrick Title: Executive Director
Organization: MITA
Date: 12/20/2017
Comment:

December 20, 2017

BY ELECTRONIC DELIVERY

The Honorable Seema Verma
Administrator
Centers for Medicare & Medicaid Services
Department of Health and Human Services
Hubert H. Humphrey Building
200 Independence Avenue S.W.
Room 445-G
Washington, DC 20201

Re: Proposed Decision Memo for Implantable Cardioverter Defibrillators (CAG-00157R4)

Dear Administrator Verma:

As the

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Meier, MD, FACP, Diane E. Title: Director
Organization: Center to Advance Palliative Care
Date: 12/20/2017
Comment:

December 20, 2017

To: CAGinquiries@cms.hhs.gov

Re: Proposed Decision Memo for Implantable Cardioverter Defibrillators (CAG-00157R4)

Thank you for the opportunity to submit comments on this proposed Decision Memo.

The Center to Advance Palliative Care (CAPC) is a national organization dedicated to ensuring that all persons with serious illness have access to quality palliative care, regardless of diagnosis, treatment setting, or state

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Warner, MD, John J. Title: President
Organization: American Heart Association
Date: 12/20/2017
Comment:

December 20, 2017

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

Re: CAG-00157R4

Dear Ms. Syrek Jensen:

On behalf of the American Heart Association (AHA), including the American Stroke Association (ASA) and over 30 million volunteers and supporters, we appreciate the opportunity to submit comments on the proposed decision memo for

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Stewart, Maria Title: Vice President, Global Health Econ. and Mkt. Acces
Organization: Boston Scientific Corporation
Date: 12/19/2017
Comment:

December 19, 2017

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 Decision Memo for Implantable Cardioverter Defibrillators (CAG-00157R4)

Dear Ms. Syrek Jensen,

Boston Scientific appreciates the opportunity to provide comments regarding the Centers for

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Wirth, Andy Date: 12/19/2017
Comment:
I believe the shared decision making visit could cause unnecessary delay in treatment and add an additional burden on beneficiaries. For many rural patients, the shared decision making visit will require additional travel and expense. The additional physician visit will also add expense to the Medicare Trust Fund. Thank you for your consideration.
Veath, Barbara Title: Sr. Director, Reimbursement and Health Policy
Organization: Medtronic - CRHF Division
Date: 12/19/2017
Comment:

December 19, 2017

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: Proposed Decision Memo for Implantable Cardioverter Defibrillators (CAG – 00157R4)

Dear Ms. Syrek Jensen:

Medtronic is the world's leading medical technology company, specializing in implantable

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Al-Khatib, MD, MHS, FHRS, Sana M. Title: Professor of Medicine
Organization: Duke Clinical Research Institute, Duke University Medical Center
Date: 12/19/2017
Comment:

December 14, 2017

RE: Proposed Decision Memo for Implantable Cardioverter Defibrillators (CAG-00157R4)

We are writing to provide comments on the Centers for Medicare and Medicaid Services (CMS’) proposed decision memorandum on ICDs. As the co-Directors of the Duke Center for the Prevention of Sudden Cardiac Death and having conducted research on ICDs for almost 2 decades, Drs. Al-Khatib and Sanders have a deep and broad understanding of the evidence surrounding the

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Calvert, Barbara J. Title: Director, Medical Products Reimbursement
Organization: Abbott
Date: 12/19/2017
Comment:

December 18, 2017

Via Electronic Submission

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: National Coverage Analysis (NCA) for Implantable Cardioverter Defibrillators (CAG-00157R4)

Dear Ms. Syrek Jensen:

Abbott is pleased that the Centers for Medicare &

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Jacobson, Carmen Date: 12/18/2017
Comment:
My organization is requesting clarification of who is considered an "independent physician or non-physician practitioner" in regard to the shared decision making encounter requirement. We employ numerous providers of various specialties including several mid-level providers. Can the visit be with a mid-level that is employed by the EP doctor/hospital? Does it have to be a separate encounter (ex. can this be done as a consultation during the same encounter as the ICD placement)? If the

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Holloway, Patrick H. Title: President
Organization: Cardiology Advocacy Alliance
Date: 12/18/2017
Comment:

Submitted Electronically

December 18, 2017

Joseph Hutter, MD, MA
Medical Officer
Centers for Medicare and Medicaid Services
Attention: CAG-00157R4
7500 Security Boulevard
Baltimore, Maryland 21244-1850

RE: Proposed Decision Memo for Implantable Cardioverter Defibrillators (CAG-00157R4)

Dear Dr. Hutter:

Cardiology Advocacy Alliance (CAA) appreciates the opportunity to comment on the proposed

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Doshi, MD, Amit Title: Medical Director of EP Services
Organization: Mercy
Date: 12/15/2017
Comment:

Please take under consideration the recommendations from Mercy Health.

Comments to Proposed Revision to National Coverage Determination (NCD) for Implantable Automatic Defibrillators (20.4)

  • Indication 1(b):
    A documented episode of sustained VT not due to a transient or reversible cause, either spontaneous or induced by an electrophysiology (EP) study, in symptomatic patients, not associated with an Acute Myocardial Infarction (AMI), =4 days after revascularization if a

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  • Knight, Bradley Title: Professor
    Organization: Northwestern University
    Date: 12/13/2017
    Comment:
    The CMS national coverage decision on ICD Therapy should specifically address the indications for the subcutaneous implantable defibrillator.
    Cosby, Sheri Title: Compliance Manager
    Organization: Intermountain Healthcare
    Date: 12/12/2017
    Comment:

    In response to the request for comments on NCD 20.4 Implantable Cardioverter Defibrillator, Intermountain Healthcare would like to provide the following feedback on the seven proposed revisions;

    Request for clarification on the following: Requiring a patient shared decision making (SDM) interaction prior to ICD implantation for certain patients. Is the expectation similar to that of the LAAC coverage where the shared interaction must be independent of the performing physicians

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    Gidney, Brett Title: MD FHRS
    Date: 12/01/2017
    Comment:
    "Significant, irreversible brain damage" could be subjective and lead to appropriate candidates being denied this service. It should refer to "Significant, irreversible brain damage that renders the patient unable to provide informed consent or participate in shared decision making".
    Rosenwinkel, Eric Title: MD, FHRS
    Organization: Cardiology Consultants of Philadelphia
    Date: 11/22/2017
    Comment:
    The current NCD requires the NCDR registry or other IDE clinical trial for all primary prevention ICDs. The update proposes discontinuing the registry but doesn't suggest coverage for primary prevention ICDs without it.
    Sarter, Brian Title: MD, FACC, FHRS
    Organization: Cardiology Physicians , PA
    Date: 11/22/2017
    Comment:
    I am a practicing electrophysiologist with 20 years of clinical experience. I have reviewed the proposed changes to the NCD for ICD implantation. I am very concerned about the additional requirement for "shared decision making" for many of the indications for ICD implantation. Inherent to what we do as electrophysiologists is evaluating patients who are risk from sudden cardiac death and deciding if ICD implantation is appropriate. Arbitrarily requiring another practitioner to "approve" our

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    Rosenwinkel, Eric Title: MD, FHRS
    Organization: Cardiology Consultants of Philadelphia
    Date: 11/22/2017
    Comment:
    After reading through the documents, it isn't clear what is considered an "independent" physician (or PA/NP, etc.). Does that mean someone from outside the practice? Could it be me, if my partner referred the patient to me? Could it be my Physician Assistant, if the patient is my patient? One concern is that if a second opinion from outside the practice is required, it may significantly delay device implantation for many patients.