Implantable Cardioverter Defibrillators

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 changes:

• removing the registry reporting requirement,
• addition of cardiac MRI as an LVEF measurement study,
• exceptions to the waiting periods specified in sections B2 and B3 for patients needing pacing therapy who also meet ICD criteria and for ICD replacements,
• additional coverage for patients with prior personal history of cardiac arrest or sustained VT to include patients within four or more days of a revascularization procedure when there is no evidence of ongoing ischemia.

I. Addition of “symptomatic” to Section B1
We are concerned that the addition of “symptomatic” to the coverage indication below will exclude ICDs implanted in patients with asymptomatic non-sustained VT who have EP-inducible sustained VT.

Covered Indication 1, second bullet:
“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 revascularization procedure is performed, and with no evidence of ongoing ischemia.”

In the Multicenter Automatic Defibrillator Implantation Trial (MADIT)¹ a significant reduction in overall mortality was found associated with the implantation of a defibrillator in high-risk patients with coronary disease and left ventricular dysfunction, asymptomatic unsustained ventricular tachycardia, and inducible sustained ventricular tachycardia. Prescribed medications, including beta-blockers, had no discernible effect on the survival benefit derived from the defibrillator in this population. Patients randomly assigned to receive the defibrillator had a much lower rate of death from primary arrhythmia than patients assigned to conventional therapy.

By requiring patients to be symptomatic prior to ICD placement, patients that were identified in the MADIT1 trial who were asymptomatic (NYHA Class I) with sustained ventricular tachycardia would be excluded from coverage. We request that “in symptomatic patients” be removed from this indication to allow for coverage of these high-risk patients that showed a significant reduction in overall mortality with the implantation of a defibrillator.

II. Participation of “independent” physician in Shared Decision Making Encounter (Section B2)
We request the word “independent” be removed from the physician description to minimize confusion on who can participate in this encounter.

We recognize the importance of the patient shared decision making encounter to promote patient safety and understanding and assist patients in making informed decisions that reflect their preferences. We believe this encounter can be performed by any physician or non-physician practitioner, recognizing that the EP physician will have the most experience with the cardiac defibrillator device especially in areas such as patients with familial or genetic disorders with high risk of life-threatening tachyarrhythmias.

Thank you for your consideration of our comments. Please feel free to contact me with any questions.

References:
1 http://www.nejm.org/doi/full/10.1056/NEJM199612263352601#t=article

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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 beginning to end-of-life through its 90+ clinics, 13 hospitals, 15 pharmacies, specialty care centers and specialty medical services that provide home care, senior transitions, hospice care, home oxygen and medical equipment, and emergency medical transportation services.

Allina generally supports the changes proposed within this memo however we are concerned with two of the elements: 1) The shared decision making requirement and 2) the class IV heart failure requirement for CRT.

CMS includes the following language regarding shared decision making:

For these patients, a formal shared decision making encounter must occur between the patient and an independent physician (as defined in Section 1861(r)(1)) or qualified non-physician practitioner (meaning a physician assistant, nurse practitioner, or clinical nurse specialist as defined in §1861(aa)(5)) using an evidence-based decision tool on ICDs prior to initial ICD implantation.

Allina supports that there should be a formal discussion, including an informed consent process prior to the implantation of any ICD (primary, secondary, or any surgical procedure, for that matter). However, the following elements of the proposal are unclear:

Secondly, we seek clarification regarding what is mean by the following statement: “Removing the Class IV heart failure requirement for CRT,’ under Additional Patient Criteria. Is CMS proposing to create a separate coverage decision for CRT? If so, we would recommend revising the statement to read as follows: “Remove the specific indication for CRT and Class IV heart failure. CMS plans to create a separate coverage decision for CRT.”

We thank the Centers for Medicare & Medicaid Services for the opportunity to share our comments on this Proposed Decision Memo. We hope to see a revised Decision Memo for Implantable Cardiac Defibrillators that is inclusive of the change we’ve recommended in this comment letter.

If you have any questions regarding these remarks, please feel free to contact me at 612-262-4908.

Sincerely,

Allyson Hammer
Manager, Organization Integrity & Regulatory Affairs
Allina Health

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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). SCMR represents over 2,700 cardiologists, radiologists, and scientists with a mission to improve cardiovascular health by advancing the field of cardiovascular magnetic resonance (CMR), and a vision that recognition and utilization of CMR will improve cardiovascular health and outcomes. CMR has unique capabilities to characterize myocardial tissue and identify potential arrhythmic substrate. We offer the following comments on CMS’ proposed changes to the ICD NCD.

First, CMS is proposing to add CMR to the list of diagnostic imaging studies that can be used to evaluate LVEF. CMR arguably provides the most accurate and precise measurement of LVEF and we strongly agree with CMS’ proposal to include CMR for the measurement of LVEF.

In addition, we recommend that CMS also consider including CMR for the evaluation of ventricular scarring or infiltration as a finding supporting the indication for ICD implantation. There exists a robust body of recent literature supporting the use of the CMR technique of late gadolinium enhancement as an independent predictor of appropriate ICD therapy in both ischemic and non-ischemic cardiomyopathy patients:

Literature:

1. Jablonowski R, Chaudhry U, van der Pals J, Engblom H, Arheden H, Heiberg E, Wu KC, Borgquist R, Carlsson M. Cardiovascular Magnetic Resonance to Predict Appropriate Implantable Cardioverter Defibrillator Therapy in Ischemic and Nonischemic Cardiomyopathy Patients Using Late Gadolinium Enhancement Border Zone: Comparison of Four Analysis Methods. Circ Cardiovasc Imaging. 2017;10:e006105.
2. Pontone G, Guaricci AI, Andreini D, Solbiati A, Guglielmo M, Mushtaq S, Baggiano A, Beltrama V, Fusini L, Rota C, Segurini C, Conte E, Gripari P, Russo Dello A, Moltrasio M, Tundo F, Lombardi F, Muscogiuri G, Lorenzoni V, Tondo C, Agostoni P, Bartorelli AL, Pepi M. Prognostic Benefit of Cardiac Magnetic Resonance Over Transthoracic Echocardiography for the Assessment of Ischemic and Nonischemic Dilated Cardiomyopathy Patients Referred for the Evaluation of Primary Prevention Implantable Cardioverter-Defibrillator Therapy. Circ Cardiovasc Imaging. 2016;9:e004956.
3. Disertori M, Rigoni M, Pace N, Casolo G, Masè M, Gonzini L, Lucci D, Nollo G, Ravelli F. Myocardial Fibrosis Assessment by LGE Is a Powerful Predictor of Ventricular Tachyarrhythmias in Ischemic and Nonischemic LV Dysfunction: A Meta-Analysis. JACC: Cardiovasc Img. 2016;9:1046–1055.
4. Neilan TG, Farhad H, Mayrhofer T, Shah RV, Dodson JA, Abbasi SA, Danik SB, Verdini DJ, Tokuda M, Tedrow UB, Jerosch-Herold M, Hoffmann U, Ghoshhajra BB, Stevenson WG, Kwong RY. Late Gadolinium Enhancement Among Survivors of Sudden Cardiac Arrest. JACC: Cardiovasc Img. 2015;8:414–423.
5. Chan RH, Maron BJ, Olivotto I, Pencina MJ, Assenza GE, Haas T, Lesser JR, Gruner C, Crean AM, Rakowski H, Udelson JE, Rowin E, Lombardi M, Cecchi F, Tomberli B, Spirito P, Formisano F, Biagini E, Rapezzi C, De Cecco CN, Autore C, Cook EF, Hong SN, Gibson CM, Manning WJ, Appelbaum E, Maron MS. Prognostic Value of Quantitative Contrast-Enhanced Cardiovascular Magnetic Resonance for the Evaluation of Sudden Death Risk in Patients With Hypertrophic Cardiomyopathy. Circulation. 2014;130:484–495.

CMR provides advanced, non-invasive imaging technology that can directly evaluate the myocardium and the potential for arrhythmic substrate, moving beyond a simple measure of left ventricular ejection fraction. SCMR believes the literature supports the use of CMR to determine the presence and extent of ventricular scarring as an additional indication for ICD implantation.

We suggest modifications to the following section of the NCD to incorporate the use of CMR prior to initial ICD implantation:

4. Patients with documented familial, or genetic disorders with a high risk of life-threatening tachyarrhythmias (sustained VT or VF), to include, but not limited to, long QT syndrome, hypertrophic cardiomyopathy, arrhythmogenic cardiomyopathy, post-inflammatory cardiomyopathy, infiltrative heart disease such as amyloidosis or sarcoidosis, or primary electrical diseases:

• Presence of structural abnormalities of the myocardium (severe global dilatation, scar, infiltration, diffuse fibrosis) as verified by appropriate CMR imaging (cine imaging, Late Gadolinium Enhancement/LGE, or CMR mapping).

Thank you for your consideration of these comments. If you have questions or require additional information, please contact me at Orlando.simonetti@osumc.edu.

Sincerely,

Orlando P. Simonetti, PhD
Chief Executive Officer, Society for Cardiovascular Magnetic Resonance
John W. Wolfe Professor in Cardiovascular Research
Professor of Internal Medicine and Radiology
The Ohio State University

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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 practicing electrophysiologists in the United States. The discipline of electrophysiology has undergone significant change in recent years, crossing clinical frontiers in the treatment of sudden cardiac death. HRS and ACC are committed to ensuring access to evidence-based patient care.

HRS and ACC appreciate the opportunity to submit joint comments on the Centers for Medicare and Medicaid Services’ (CMS) request for comments on the proposed national coverage determination (NCD) for implantable cardioverter defibrillators (CAG-00157R4). This comment letter represents the two Societies’ consensus on recommendations to the Agency to update the policy in a manner that reflects current, evidence-based medicine.

Shared Decision Making (SDM) Interaction Criteria

The Societies are providing comments on CMS’s changes requiring a patient SDM encounter prior to ICD implantation for patients who qualify for a primary prevention ICD. We support the Agency’s efforts to facilitate patients’ understanding of their individual risk of sudden cardiac death and the potential benefits and risks of receiving of an ICD.

The Societies recommend that CMS strongly consider the following when determining mechanisms to promote shared decision making for patients who qualify for a primary prevention ICD:

• Shared decision making is inherent in a referral to an electrophysiologist for an evaluation for a primary prevention ICD. For the most part, a primary prevention ICD patient is a patient referred by another physician to an electrophysiologist.
• The principle of shared decision making has long been an integral component of patient care in electrophysiology programs across the country. During an evaluation for an ICD, the physician and the patient discuss the scientific data regarding benefits, risks and indications of a primary prevention ICD implant as it pertains to his or her individual health goals, preferences and values. This well-established workflow, predicated on evidence-based medicine, occurs in a similar fashion to the informed consent discussion and is documented in the medial record by the implanting physician.
• Requiring an additional and separate SDM encounter with another clinician would be redundant to the current work flow and could delay potentially lifesaving ICD treatment while the additional SDM is being arranged.
• Validated SDM tools employed by the arrhythmia care team will continue to enhance and support quality and patient satisfaction. The profession has developed decision aids in a number of areas, including rhythm management. However, the effectiveness of implementing SDM tools in this patient population is only now being evaluated in a multicenter randomized clinical trial.¹

For these reasons, the Societies view a requirement for a formal SDM encounter between the patient and an independent clinician to be unnecessary. If CMS determines that the SDM encounter is a requirement of coverage, the Societies provide the following recommendations to maximize the benefits of SDM for patients who are presenting for evaluation and consideration of a primary prevention ICD implant.

Personal History

The Societies recommend that CMS clarify the intent of the term “personal history” used throughout the policy. This term likely will be unfamiliar to the clinical community and could inadvertently cause confusion in decision making and documentation in the medical record and ultimately to patient care. It seems CMS simply means “medical history.” Regardless, there are several instances in the draft NCD where additional information would be helpful. In some instances, the phrase “personal history of cardiac arrest” is used, while in others the type of “personal history” is not defined.

Clinical Indications

The Societies seek clarification or modification to the following clinical indications:

Syncope Presumed to be caused by Ventricular Fibrillation (VT) Or Ventricular Tachycardia (VF)

One of the Societies’ recommendations for coverage during the initial comment period in June was to include a waiting period exception for “patients with syncope thought to be due to VT or VF.” This recommendation draws on guideline recommendations and supporting evidence regarding evaluation of patients with documented or suspected arrhythmias to diagnose VT or VF in Section 4 of the 2017 guideline. Diagnosis can be made through: a history and physical exam that provides information about medication regimen, coronary artery disease, valve disease, congenital heart disease, or other causes of cardiomyopathy, a 12-lead ECG, exercise treadmill testing, ambulatory electrocardiographic monitoring, implanted cardiac monitors, echocardiography, MRI, CT, electrophysiological study, or angiography.

The Societies seek confirmation that for patients who present with syncope in the setting of an ischemic cardiomyopathy, non-ischemic cardiomyopathy or congenital heart disease, VT or VF can be diagnosed using any of the tests/methods discussed in the guideline to diagnose the likely mechanism of syncope as VT or VF. Our interpretation of the indications covered in Section B.1. of the draft NCD would allow each of those options to document VT or VF. If that is not the case, the Societies recommend that the following language is added to section B.1.

A documented episode of syncope in the setting of structural heart disease and VF or VT.

Waiting Period For Ischemic Cardiomyopathy Changed From 40 Days to 3 Months

The draft policy extends the waiting period from 40 days to 3 months for patients with newly diagnosed ischemic cardiomyopathy beginning guideline-directed medical therapy who do not undergo revascularization. This indication does not align with the clinical trial data and the 2017 ACC/HRS Guidelines for Management of Patients with Ventricular Arrhythmias and Prevention of Sudden Cardiac Death.^2,3,4 The NCD should be aligned with the following primary prevention indications for ICD implant that are Class I recommendations and have level of evidence A:

• In patients with LVEF of 35% or less that is due to ischemic heart disease who are at least 40 days’ post-MI and at least 90 days post-revascularization, and with NYHA class II or III HF despite GDMT, an ICD is recommended if meaningful survival of greater than 1 year is expected. (Level 1 Recommendation, Level of Evidence A, Guideline Recommendation 7.1.2)
• In patients with LVEF of 30% or less that is due to ischemic heart disease who are at least 40 days’ post-MI and at least 90 days post-revascularization, and with NYHA class I HF despite GDMT, an ICD is recommended if meaningful survival of greater than 1 year is expected. (Level 1 Recommendation, Level of Evidence A, Guideline Recommendation 7.1.2)

As such, we recommend the indications for severe ischemic and/or non-ischemic dilated cardiomyopathy, NYHA Class II or III heart failure patients with LVEF less than or equal to 35% in covered indication B.3. be separated as follows:

Class IV heart failure patients awaiting transplant

To further clarify the criteria for patients with Class IV heart failure awaiting transplant, the Societies recommend that the following language is added to section B.3.

• Patients who qualify for ICD under criterion #3 but have NYHA Class IV heart failure and are awaiting heart transplantation.^5-7

Exception to waiting period for primary prevention ICDs: Cardiac Pacemakers:

To further clarify the criteria for cardiac pacemaker implantation during the primary prevention waiting period, the Societies recommend that the following added language to section C.

Data Collection

In the 2005 coverage policy, CMS outlined the ten hypotheses necessary to determine that the ICD is reasonable and necessary. Since 2005, the National Cardiovascular Data Registry (NCDR) ICD Registry has collected data to address these ten hypotheses and eight related studies. With these hypotheses addressed, the remaining questions can be addressed by randomized clinical trials and enhanced mechanisms to evaluate device safety and effectiveness.

We appreciate that CMS recognizes the contributions of the ICD Registry and “encourages the continuation and improvement of voluntary registry participation for the purposes of quality improvement, safety, and appropriate use verification.” Voluntary registry participation can continue to create value for future patients, clinicians, and facilities as a mechanism of quality improvement, safety, and appropriate use verification. Furthermore, the registry model will remain critical as an essential tool for real world evidence data collection for programs like the National Evaluation System for Health Technology (NEST), new EP devices, and new iterations of current technologies to support evaluation of device safety and effectiveness.

Ongoing collaboration and coordination among CMS, the Food and Drug Administration, the National Institutes of Health, the Agency for Healthcare Quality and Research, and other federal agencies presents an opportunity to ensure funding and timely completion of well-designed studies to answer outstanding questions. The Societies support the coverage with evidence development paradigm to expedite earlier access to innovative technologies that are likely to show benefit for the Medicare population where there is incomplete evidence.

We appreciate the Agency’s action to update the coverage policy in a manner that reflects current, evidence-based medicine and clinical practice. If you have questions about the Societies’ recommendations, please contact Laura Blum at lblum@hrsonline.org or James Vavricek at jvavricek@acc.org.

Sincerely,

George F. Van Hare, MD, FHRS, FACC
President, Heart Rhythm Society

Mary Norine Walsh, MD, FACC
President, American College of Cardiology

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Citations

1. Matlock D, A Multicenter Trial of a Shared Decision Support Interventiona for Patients Offered Implantable Cardioverter-Defibrillators: DECIDE - ICD Trial. NIH RePORTER - NIH Research Portfolio Online Reporting Tools Expenditures and Results. 2017; https://projectreporter.nih.gov/project_info_description.cfm?aid=9282816&icde=37324464.
2. Al-Khatib SM, Stevenson WG, Ackerman MJ, et al. AHA/ACC/HRS Guideline for Management of Patients With Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines and the Heart Rhythm Society [published online ahead of print October 30, 2017]. Circulation. doi: 10.1161/CIR. 0000000000000548. Circulation. doi. 2017;10.
3. Moss AJ, Zareba W, Hall WJ, et al. Prophylactic implantation of a defibrillator in patients with myocardial infarction and reduced ejection fraction. New England Journal of Medicine. 2002;346(12):877-883.
4. Bardy GH, Lee KL, Mark DB, et al. Amiodarone or an implantable cardioverter–defibrillator for congestive heart failure. New England Journal of Medicine. 2005;352(3):225-237.
5. Fröhlich GM, Holzmeister J, Hübler M, et al. Prophylactic implantable cardioverter defibrillator treatment in patients with end-stage heart failure awaiting heart transplantation. Heart. 2013;99(16):1158-1165.
6. Sandner SE, Wieselthaler G, Zuckermann A, et al. Survival benefit of the implantable cardioverter-defibrillator in patients on the waiting list for cardiac transplantation. Circulation. 2001;104(suppl 1):I-171.
7. Vakil K, Duval S, Cogswell R, et al. Impact of implantable cardioverter-defibrillators on waitlist mortality among patients awaiting heart transplantation: an UNOS/OPTN analysis. JACC: Clinical Electrophysiology. 2016:253.

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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 advanced illness, especially the sickest and most vulnerable, receive comprehensive, high- quality, person- and family-centered care that is consistent with their goals and values and honors their dignity. C-TAC is made up of over 140 national and regional organizations including patient and consumer advocacy groups, providers, health plans, faith-based and community organizations, and others who share a common vision of improving advanced illness care in the U.S.

C-TAC’s definition of advanced illness is when one or more conditions becomes serious enough that general health and functioning begin to decline, treatment may no longer lead to preferred outcomes, and care oriented toward comfort may take precedence over attempts to cure – a process that extends to the end of life and that for some patients and their families may lead to transition to hospice. It is with that population in mind that we comment on the following aspects of this decision memo.

We applaud requiring a patient shared decision-making (SDM) interaction prior to ICD implantation for certain patients. This is important as patients are often confusedⁱ about the purpose and nature of these devices. However, we would go further and recommend that any decision aid tool used to facilitate SDM for these devices also include information about when and how they might be deactivated at a future time. Many patientsⁱⁱ are unaware of this option, which is unfortunate as some suffer shocks from these devices at the end of life, which are painful and may be counter to their goals of care at that time. Including information about deactivation in the SDM at the time of insertion will help patients make a more truly informed decision about these devices.

Thank you for the opportunity to comment on this decision memo. If you have any questions, please contact Marian Grant, Senior Regulatory Advisor at C-TAC, at 443-742-8872 or mgrant@thectac.org.

Sincerely,

Marian Grant

Marian Grant, DNP, CRNP, ACHPN, FPCN
Senior Regulatory Advisor
Coalition to Transform Advanced Care (C-TAC)
1299 Pennsylvania Ave, Suite 1175
Washington, DC 20004

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i https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4675745/
ii https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5114828/

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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 comments on the Centers for Medicare & Medicaid Services’ (CMS) proposed National Coverage Determination (NCD) for implantable cardioverter defibrillators (ICDs).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.

AdvaMed appreciates this opportunity to comment on the ICD NCD, which was last reconsidered in 2005. First, AdvaMed is pleased with the proposal, and the direction in which CMS has gone to align coverage with currently available evidence. In particular, AdvaMed applauds CMS’ decision to propose removing the mandatory registry requirements, based on its finding that additional data collection is no longer needed. AdvaMed also supports the addition of reasonable exceptions to waiting periods, and the recognition in the NCD of disparities and underuse in some cases. We do offer some feedback with respect to the proposal for shared decision-making. Our comments are discussed in greater detail below.

Registry Requirement
AdvaMed is pleased that CMS has proposed to eliminate the mandatory registry data collection, citing the Agency’s review of the peer-reviewed literature and findings that the ten initial hypotheses have been answered and additional data collection for the Medicare covered indications and populations is no longer needed. We support this proposal. AdvaMed agrees with CMS’ assertion that data collected through the registry over the past decade has served the purpose of improving the evidence base. We also support the proposal to continue registry data collection on a voluntary basis for the purposes of quality improvement, safety and appropriate use verification.

Exceptions to Waiting Periods
AdvaMed supports CMS’ proposal to make certain exceptions to the waiting periods for certain patients, in alignment with standard medical practice and the recommendations in the 2014 HRS/ACC/AHA consensus statement.²

Patient Shared Decision-Making
CMS is proposing to require a patient shared decision-making (SDM) interaction for certain patients, noting that, by adding shared decision-making, CMS is empowering patients to be more active in their health treatment decisions. AdvaMed agrees that shared decision-making can be important for patients making complex health care decisions. It is also important to recognize individual patient values and preferences. Shared decision-making can serve to engage patients in their own care and treatment decisions.

However, AdvaMed does have concerns that, without additional clarification, this proposal could result in significant confusion.

For example, the proposed coverage determination states that “[i]deally, SDM integrates the use of evidence-based decision tools including treatment pictograms to characterize benefits and harms.” The draft decision does not specify any particular tool, nor would we support such specificity. However, it is unclear whether an encounter that is documented in the medical record, without the use of a specific decision tool, would meet the requirements as defined.

In addition, it is unclear who would be required to carry out and document the shared decision-making encounter. The draft coverage decision states that for certain patients – primarily those for whom implantation is for primary prevention of sudden cardiac death – a formal shared decision-making encounter must occur between the patient and an “independent physician or qualified non-physician practitioner, using an evidence-based decision tool on ICDs prior to initial ICD implantation.” After discussions with our member companies and physician groups, AdvaMed recommends that CMS revise the language to remove the word “independent” and to clarify that the physician involved in the shared decision-making interaction could be the implanting physician, or a physician assistant or nurse practitioner member of the physician’s practice. It is important to ensure that shared decision-making, a concept that seems patient-centric in theory, does not actually become a barrier to access for certain patients.

Eligibility Criteria
While AdvaMed supports the concept of waiting periods and the addition of a waiting period requirement for patients who have severe ischemic and/or non-ischemic dilated cardiomyopathy but no prior personal history, we are concerned that it may be impossible for some patients to meet the requirement of having been on optimal medical therapy (OMT) for three months prior to implantation. For example, if a patient is unable to tolerate beta blockers and does not take them, that patient may not be viewed as having completed three months of OMT. Therefore, we propose that CMS amend the “optimal medical therapy” requirement wherever it appears to say that “clinicians must have tried for at least 3 months to optimize medical therapy to the extent tolerated by the patient.”

For example, for the new requirement for patients who have ischemic and / or non-ischemic dilated cardiomyopathy but no prior personal history, we would recommend the following language:

Health Disparities
AdvaMed was pleased that CMS recognized in the proposed NCD that health disparities relating to ICD implantation in African Americans as compared to Caucasians have not been addressed, and that African Americans and women have been underrepresented in health research. We agree that these findings regarding disparities illuminate a need for future research. We encourage CMS to work with specialty societies and industry representatives to explore new ways to reach these underserved populations.

Summary
In conclusion, AdvaMed is pleased that CMS’ proposed revisions align with the clinical evidence and guidelines that have been issued in the years since the last reconsideration of the ICD NCD in 2005. Our goal has been to assure access to ICDs for all appropriate patient populations consistent with the findings of the evidence and guidelines.

Thank you once again for the opportunity to comment on this important proposed coverage determination. If you have questions regarding these comments or if you require additional information, please contact me or Chandra Branham, JD, Vice President, Payment and Health Care Delivery Policy, at (202) 434-7219 or cbranham@AdvaMed.org.

Sincerely,

/s/

Donald May
Executive Vice President
Payment and Health Care Delivery Policy

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1Proposed Decision Memo for Implantable Cardioverter Defibrillators (CAG-00157R4) https://www.cms.gov/medicare-coverage-database/details/nca-proposed-decisionmemo.aspx?NCAId=288&type=Open&bc=ACAAAAAACAAAAA%3d%3d& (accessed November 27, 2017).
2 HRS/ACC/AHA Expert Consensus Statement on the Use of Implantable Cardioverter-Defibrillator Therapy in Patients Who Are Not Included or Not Well Represented in Clinical Trials, Journal of the American College of Cardiology, Vol. 64, No.11, 2014.

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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 Michigan, we respectfully submit comments on the Proposed Decision Memo for Implantable Cardioverter Defibrillators (CAG-00517R4). In preparation, we reviewed Michigan Medicine's own recent ICD cases as well as the HRS/ACC public comment dated June 29, 2017 and the HRS/ACC/AHA expert consensus statement on the use of implantable cardioverter-defibrillator therapy in patients who are not included or well represented in clinical trials. We have the following comments/recommendations:

For covered indications B 3, we recommend that the first sentence be clarified by adding the italicized text:

Patients who have severe ischemic and/or non-ischemic dilated cardiomyopathy but no prior personal history of cardiac arrest or sustained ventricular tachyarrhythmia, NYHA Class II or III heart failure, left ventricular ejection fraction (LVEF) ≤ 35%, been on optimal medical therapy for at least 3 months. Additionally, patients who have severe ischemic and/or non-ischemic dilated cardiomyopathy but no prior personal history must not have:

For covered indications B 2 and B 3, we recommend that CMS consider modifying the third bullet to include the italicized text regarding MI type. This modification would remove any lack of clarity regarding whether demand ischemia, troponin leaks, etc. are subject to the MI waiting period:

Had a Type I MI within the past 40 days

We strongly support the exceptions to the waiting period for patients requiring pacemakers and ICD replacements. We would recommend that the pacemaker exception include specific language for CRT pacing indications as follows:

Cardiac Pacemakers: Patients who meet all CMS coverage requirements for cardiac pacemakers, including those requiring Cardiac Resynchronization Therapy or CRT, and who meet the criteria in this national coverage determination for an ICD, may receive the combined devices in one procedure, at the time the pacemaker is clinically indicated;

We also recommend the following additional exceptions to the waiting period based on clinical experience at Michigan Medicine:

Patients who previously met primary prevention criteria defined in sections B 2 or B 3 before an MI or revascularization event occurred.

Patients who are status post Left Ventricular Assist Device (LV AD) placement.

We appreciate the opportunity to provide comment on the Proposed Decision Memo and your consideration of our observations. We believe the changes proposed in the Proposed Decision Memo are important and necessary to allow us the opportunity to furnish high-value, high quality of care to the patients that we serve. If you have questions about our comments, please contact me.

Sincerely,

/s/
Thomas C. Crawford
Internal Medicine, Medical School

Haka Oral
Frederick G L Huetwell Research Professor of Cardiovascular Medicine and Professor of Internal Medicine,
Medical School

cc: Jeff Desmond, M.D.
Himanshu Patel, M.D.
Linda Larin
Leslie Kamil
David Pinsky, M.D.
Richard Prager, M.D.
Jamie Beach
Colleen McClorey, Esq.

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1 Michigan Medicine is a preeminent health system and academic medical center based in Ann Arbor, Michigan. Consistently ranked as one of the leading health systems in the nation, Michigan Medicine provides healthcare services to millions of patients each year in its 3 hospitals, 40 outpatient locations, and many other facilities. In the field of cardiovascular medicine, the Samuel & Jean Frankel Cardiovascular Center at Michigan Medicine is recognized as one of the country's best programs for cardiology and heart surgery. The Center performs more than 2,000 electrophysiology procedures and over 1,400 cardiac surgeries every year, including cutting-edge treatments such as heart transplant and, recently, the insertion of the world's smallest pacemaker directly into the heart. Because of its exceptional staff and reputation, the Frankel Cardiovascular Center often treats patients with multiple, complex, life-threatening medical conditions.

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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 premier trade association representing the manufacturers of medical imaging equipment and radiopharmaceuticals, the Medical Imaging & Technology Alliance (MITA) is submitting the following comments on the referenced Proposed Decision Memo for Implantable Cardioverter Defibrillators (CAG-00157R4).

Significant advances have been made in implantable cardioverter defibrillator (ICDs) technology as well as in associated imaging technologies over the past several years, so it is commendable that CMS is updating its coverage policy to reflect the latest research. In particular, we are pleased to see that CMS is adding cardiac magnetic resonance imaging (MRI) to the list of list of diagnostic imaging studies that can evaluate left ventricular ejection fraction (LVEF). The list of acceptable LVEF assessment technologies now includes echocardiography, radionuclide (nuclear medicine) imaging, cardiac MRI, and catheter angiography. These imaging exams provide health care providers with a robust toolkit for assessing patients.

Recently, a number of MRI-compatible ICDs have come to market. This is an important development since cardiac MRI is very important for diagnosis of certain heart diseases. It is our hope that cardiac MRI will grow in importance and benefit to healthcare providers and their patients as utilization of MRI-compatible ICDs increases.

If you have any questions, please contact Peter Weems at 703-389-1614 or by email at pweems@medicalimaging.org.

Sincerely,

Patrick Hope
Executive Director, MITA

MITA is the collective voice of medical imaging equipment and radiopharmaceutical manufacturers, innovators and product developers. It represents companies whose sales comprise more than 90 percent of the global market for medical imaging technology. These technologies include: magnetic resonance imaging (MRI), medical X-Ray equipment, computed tomography (CT) scanners, ultrasound, nuclear imaging, radiopharmaceuticals, and imaging information systems. Advancements in medical imaging are transforming health care through earlier disease detection, less invasive procedures and more effective treatments. The industry is extremely important to American healthcare and noted for its continual drive for innovation, fast-as-possible product introduction cycles, complex technologies, and multifaceted supply chains. Individually and collectively, these attributes result in unique concerns as the industry strives toward the goal of providing patients with the safest, most advanced medical imaging currently available.

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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 of the disease. Palliative care focuses on providing patients with relief from the pain, symptoms and stress of a serious illness, and can be provided along with curative treatment. By definition, it is patient-centered care that emphasizes the value of shared decision making (SDM) between the patient, family and/or caregiver(s), and the interdisciplinary palliative care team. A recent randomized controlled trial demonstrated that patients with advanced heart failure who received palliative care had better outcomes for quality of life, anxiety, depression, and spiritual well-being when compared to patients who did not receive palliative care.ⁱ

We are pleased to see that the proposed Decision Memo includes the requirement of a SDM interaction prior to ICD implantation for certain patients. For patients with advanced cardiovascular disease and heart failure, the unpredictable nature of acute exacerbations, the increasing availability of expensive advanced therapies, the limited number of heart donors, the uncertainty of outcomes from invasive and intensive therapies, and a bias towards full cure versus end-of-life makes the integration of palliative care more challenging. Even though the evidence base for the role of palliative care for patients with advanced cardiovascular disease lags behind that for other serious and chronic illnesses, the American College of Cardiology (ACC), American Heart Association (AHA), International Society for Heart and Lung Transplantation (ISHLT), Heart Failure Society of America (HFSA) and Canadian Cardiovascular Society (CCS), all encourage the incorporation of palliative care into the care of patients with advanced heart disease.

Therefore, we agree that the inclusion of an SDM interaction is important, as research has shown that patients are often confused about the purpose and nature of these devices.^ii,iii In addition, we recommend that any decision aid tool used to facilitate SDM for these devices also include information about when and how such devices might be deactivated at a future time. A 2016 systematic review showed that a high proportion of patients were unaware of this option,^iv despite the fact that ICDs can cause painful shocks at the end of a serious illness and do not meaningfully prolong survival. Including information about deactivation at the time of insertion will help patients make a more informed decision about these devices.

Thank you for the opportunity to submit these comments. Please do not hesitate to contact myself or Stacie Sinclair, Senior Policy Manager at Stacie.Sinclair@mssm.edu if we can provide any further assistance.

Sincerely,

/s/
Diane E. Meier, MD, FACP
Director
Center to Advance Palliative Care
Diane.Meier@mssm.edu
(212) 201-2675

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i Rogers JG, Patel CB, Mentz RJ, Granger BB, Steinhauser KE, Fiuzat M, Tulsky JA, et al. Palliative care in heart failure: The PAL-HF randomized, controlled clinical trial. J Am Coll Cardiol. 2017; 70(3):331-341. Retrieved from https://www.ncbi.nlm.nih.gov/pubmed/28705314
ii Balci KG, Balci MM, Akboða MK, Sen F, Açar B, Yilmaz S, Aydoðdu S, et al. Perceived benefits of implantable cardioverter defibrillator implantation among heart failure patients and its relation to quality of life: A crosssectional study. Cardiol Ther. 2015; 4(2):155-165. Retrieved from https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4675745/
iii Kramer DB, Matlock DD, Buxton AE, Goldstein NE, Goodwin C, Green AR, Mitchell SL, et al. Implantable Cardioverter-Defibrillator use in older adults. Circulation: Cardiovascular Quality and Outcomes (AHA). 2015; 8:437-446. Retrieved from http://circoutcomes.ahajournals.org/content/8/4/437.full
iv Ooi SL, He H, Dong Y, Wang W. Perceptions and experiences of patients living with implantable cardioverter defibrillators: a systematic review and meta-synthesis. Health Qual Life Outcomes. 2016; 14:160-189. Retrieved from https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5114828/

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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 implantable cardioverter defibrillators (ICDs).

According to the decision memo, the Centers for Medicare and Medicaid Services (CMS) intends to make minimal changes to the current coverage policy. We provide feedback below on the proposed modifications to the patient criteria and the addition of two exceptions to the waiting period.

Patient Criteria
AHA appreciates the Agency's careful reexamination of the covered indications for ICDs. ICDs are an important treatment option for Medicare beneficiaries with life threatening arrhythmias or an underlying condition such as heart failure or a genetic predisposition that increases the risk of sudden cardiac death. In general, AHA is comfortable with the covered indications included in the proposed decision memo; however, we believe three changes are warranted.

First, CMS should add a new covered indication for patients with a New York Heart Association (NYHA) classification IV who are candidates for heart transplantation. This is a Class IIa, Level of Evidence B-NR recommendation from the 2017 AHA/ACC/HRS Guideline for Management of Patients with Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death.¹

The AHA/ACC/HRS Guideline based this recommendation on studies that indicate that an ICD can reduce mortality among patients waiting for a heart transplant. As described in the Guideline, one retrospective analysis of 32,599 patients listed on the United Network for Organ Sharing registry found that the 'presence of an ICD at listing was associated with an adjusted 13% relative risk reduction in mortality.' This finding was supported by another retrospective study of 1,089 patients listed for heart transplantation, which showed that an 'ICD was associated with a reduction in all-cause mortality in the primary and secondary prevention cohorts (estimated 1-year: 88±3% versus 77±3% versus 67±3%; p=0.0001).' Another study of 380 patients who received an ICD before or within 3 months after being listed for heart transplantation, also found that patients without an ICD were more likely to die.

Second, CMS should clarify the requirement that "patients who have severe ischemic and/or non-ischemic dilated cardiomyopathy but no prior personal history, NYHA Class II or III heart failure, left ventricular ejection fraction ≤35%" must first try optimal medical therapy for at least 3 months before ICD implantation. It is unclear what the Agency means by 'no prior personal history' in this context. Does this mean that the patient has never experienced ventricular fibrillation, ventricular tachycardia, syncope, or something else?

In addition, while we agree that patients should be treated according to guideline-directed management and therapy, clinical guidelines - and coverage policies - should provide some flexibility to account for each individual patient's characteristics and disease progression. For example, if a patient's condition deteriorates while on medical therapy, the patient may require an ICD before the 90-day waiting period ends. We encourage CMS to modify the optimal medical therapy requirement to provide patients and providers with needed flexibility.

Third, AHA strongly supports the requirement that patients participate in a shared decisionmaking encounter before receiving an ICD. This requirement, however, should not be limited to certain covered indications as currently proposed. Instead, we recommend that CMS extend this requirement to all ICD candidates regardless of the covered indication. This change would align Medicare's coverage policy with the 2017 AHA/ACC/HRS Guideline, which recommends:

Such a change is also supported by AHA's 2016 Policy Statement on Palliative Care and Cardiovascular Disease and Stroke. That statement highlights the need for patients and providers to "share information and work together to make decisions about care and treatment options from medically reasonable options that are aligned with the patient's values, goals, and preferences."³

However, we must note that while we support a shared decision-making approach, we do not agree with the Agency's proposal that the shared decision-making encounter must occur between the patient and an independent physician or qualified non-physician practitioner. Requiring the patient to visit another clinician impedes the efficiency of patient care. It will be challenging to identify a qualified, independent clinician in every clinical care environment who must be well-informed about the indications, risks and benefits of ICD therapy, and available to see the patient in a timely manner. Requiring another mandatory consultation is likely to delay implementation of therapy when the patient is at risk of sudden death, as well as result in additional costs to both the patient and the Medicare program. In addition, requiring the patient to consult with an independent clinician could disrupt the relationship between the patient and the treating medical team by eliminating the treating physician(s) from the shared decision-making encounter; having the patient and the treating physician participate in shared decision-making is fundamental to providing good medical care. While all patients should have the option to seek a second opinion, we do not believe it should be mandatory.

We are also concerned that the proposed decision memo would require the use of an evidence-based decision tool as part of the shared decision-making encounter. We are not aware of a validated evidence-based shared decision-making tool for ICDs that is widely available. Requiring a tool to be used, when insufficient tools are available, is premature.

Therefore, we recommend that CMS modify the shared decision-making requirement to eliminate the need for an "independent" physician or qualified non-physician practitioner and the use of an evidence-based decision tool.

Exceptions to the Waiting Periods
AHA supports the Agency's proposed addition of two exemptions to the waiting periods for patients who need a combined pacemaker and ICD, or patients with an existing ICD that needs replacement due to a low battery or device malfunction.

In closing, we reiterate our appreciation for the Agency's decision to reexamine Medicare coverage of ICDs. To further improve the benefit, CMS should: 1) add coverage for NYHA Class IV patients who are candidates for heart transplantation; 2) revise the optimal medical therapy requirement to provide flexibility; and 3) expand the shared decision-making requirement to all covered indications, while eliminating the need for an independent physician or nonphysician practitioner and the use of an evidence-based tool.

Thank you for your consideration of our comments.

Sincerely,

/s/
John J. Warner, MD
President
American Heart Association

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1 Al-Khatib SM, Stevenson WG, Ackerman MJ, Bryant WJ, Callans DJ, Curtis AB, Deal BJ, Dickfeld T, Field ME, Fonarow GC, Gillis AM, Hlatky MA, Granger CB, Hammill SC, Joglar JA, Kay GN, Matlock DD, Myerburg RJ, Page RL. 2017 AHA/ACC/HRS guideline for management of patients with ventricular arrhythmias and the prevention of sudden cardiac death: a report of the American College of Cardiology Foundation/American Heart Association Task Force on Clinical Practice Guidelines and the Heart Rhythm Society. Circulation. 2017. DOI: 10.1161/CIR.0000000000000549. Pages 69-70.
2 Ibid.
3 Palliative Care and Cardiovascular Disease and Stroke: A Policy Statement from the American Heart Association/American Stroke Association. Circulation. 2016. http://circ.ahajournals.org/content/early/2016/08/08/CIR.0000000000000438

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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 Medicare & Medicaid Services’ (CMS) Proposed Decision Memo for Implantable Cardioverter Defibrillators¹ (ICDs).

As a company dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world, Boston Scientific supplies medical devices in Rhythm Management, among other clinical areas, which are used to treat Medicare beneficiaries.

We applaud CMS for updating the ICD NCD to be aligned with most recent clinical guidelines, and we are supportive of the main concepts of the proposed NCD. We offer some more detailed comments on specific sections of the proposed NCD in the following paragraphs.

Shared Decision Making
Boston Scientific strongly supports the concept of involving patients in their care through Shared Decision Making (SDM), and we appreciate CMS’ efforts to encourage greater patient engagement in decisions related to implantation of ICDs. However, we believe there are opportunities for CMS to clarify its proposed requirements so as to avoid the unintended consequence of creating administrative and procedural difficulties that may impact patient access, timely care, and, potentially, outcomes.

Shared decision making (SDM) is currently a CMS requirement under the National Coverage Determination for left atrial appendage closure (LAAC). As the manufacturer of the WATCHMAN™ Left Atrial Appendage Closure Implant, the only FDA approved LAAC device available in the United States, Boston Scientific has had a unique opportunity to identify areas for improvement or clarification in the execution of SDM requirements. We are also in a unique position, as manufactures of both LAAC devices and ICDs, to observe and comment on areas of difference in the application of SDM requirements. We offer the following recommendations:

Remove the Word “Independent” from the SDM Requirement for ICDs
In the LAAC NCD, CMS states that a patient must have “a formal shared decision making interaction with an independent non-interventional physician using an evidence-based decision tool on oral anticoagulation in patients with NVAF prior to LAAC. Additionally, the shared decision making interaction must be documented in the medical record.”²

In the period since publication of the LAAC NCD, Boston Scientific has encountered extensive confusion among providers due to a variety of interpretations regarding the meaning of “independent” in this coverage provision. Boston Scientific recommends not including the word “independent” in the final ICD NCD in order to avoid causing additional confusion. In particular, for ICDs, the only non-implant alternative for patients at risk for sudden cardiac death is non-treatment. Patients are not choosing between medical and surgical therapy, therefore it is not necessary to require an independent physician to conduct SDM. In fact, the clinicians most appropriate to provide SDM for patients at risk for sudden cardiac death are those who know most about devices: implanting physicians and their teams.

Clarify that SDM May Be Provided by the Implanting Physician or His / Her Team Members
It is important for the implanting physician or a member of his or her team to directly engage with the patient to assess the patient’s needs and to explain key features and differences in devices. Specifically, the implanting physician or his or her team member is best able to discuss options such as (but not limited to) the risks and benefits of not implanting an ICD, implantation of a subcutaneous versus transvenous device, programming needs, device placement, diagnostics, battery longevity, and single vs. dual chamber.

Rather than requiring an “independent physician (as defined in §1861(r)(1)) or qualified non-physician practitioner (meaning a physician assistant, nurse practitioner, or clinical nurse specialist as defined in §1861(aa)(5)),” Boston Scientific recommends that CMS clarify that SDM should be provided by “a physician (as defined in §1861(r)(1)) who has experience implanting ICDs, including the implanting physician or a qualified non-physician practitioner (meaning a physician assistant, nurse practitioner, or clinical nurse specialist as defined in §1861(aa)(5)).”

From a technical standpoint, section 1861 (r)(1), referenced in the NCD, states: “(r) The term “physician”, when used in connection with the performance of any function or action, means (1) a doctor of medicine or osteopathy legally authorized to practice medicine and surgery by the State in which he performs such function or action (including a physician within the meaning of section 1101(a)(7)).”³ There is no mention of the word “independent” in this language, therefore, CMS should be able to remove the word without impacting the definition of physician.

Clarify that SDM Does Not Have to be Provided by Someone Outside the Implanter’s Practice
Another important difference between LAAC and ICD decision-making is that the decision regarding whether to have a LAAC procedure or be treated with oral anticoagulants for atrial fibrillation, while critical, is not as time-sensitive as the decision regarding whether and what type of ICD to implant to prevent sudden cardiac death. Requiring patients to seek SDM support from a clinician outside of their implanting doctors’ practice may take significant time (possibly even weeks) and may result in inappropriate delays in access to care. A delay may be tolerable in the case of an elective procedure such as LAAC, however delaying an ICD implant could leave patients unprotected from potentially life-threatening arrhythmias.

Based on these important differences between LAAC and ICD implantation, Boston Scientific recommends that CMS remove the word “independent” from the SDM requirement, clarify that implanting physicians or their team members can provide SDM, and confirm that patients are not required to seek SDM in a separate practice.

Specify a Minimum Set of Elements to be Included in SDM Discussions
In the proposed NCD, CMS requires SDM to be conducted “using an evidence-based decision tool on ICDs prior to initial ICD implantation.” Boston Scientific is not aware of a validated evidence-based decision tool for ICDs. Thus, rather than inadvertently creating a scenario where a variety of tools with inconsistent requirements are used, Boston Scientific recommends that CMS specify a minimum set of elements that must be incorporated into any SDM discussion for ICDs. Specifically, Boston Scientific recommends that, at a minimum, any SDM tool for ICDs must address:

• Risks and benefits of not implanting an ICD
• Risks and benefits of single versus dual chamber
• Risks and benefits of subcutaneous (S-ICD) and transvenous (T-ICD) defibrillators (i.e., because the 2017 ACC/AHA/HRS guidelines for the management of ventricular arrhythmias included S-ICD as a viable alternative to T-ICDs for appropriate patients)
• Options for device shape and size
• Options for device placement
• Device diagnostics
• Lead reliability of various devices
• Difference in outcomes and adverse events for relevant device options
• Battery longevity of various devices

Specify that SDM Must be Documented in Patient Records
As currently written, the requirement that certain groups of patients participate in SDM prior to ICD implantation is not auditable. As proposed, some populations would be covered without SDM while others would only be covered after having a SDM encounter. Therefore, CMS must have some way to determine whether providers are adhering to the proposed requirement and to assess the impact of SDM on outcomes and device selection. The simplest way to accomplish these goals is for CMS to require, as it did in the LAAC NCD, that the SDM interaction be documented in the medical record.

To summarize, based on Boston Scientific’s experience with shared decision making, we would make the following recommendations for improvement:

Additional Patient Eligibility Criteria
Boston Scientific is largely in agreement with the changes to clinical eligibility criteria specified in the proposed NCD, however we believe there are a few areas that could be clarified to minimize confusion and misinterpretation of the NCD. Specifically, we ask that CMS clarify its discussion of coverage for patients with severe ischemic and / or non-ischemic dilated cardiomyopathy.

Clarify Patient Groups (i.e., Ischemic Cardiomyopathy vs. Non-Ischemic Dilated Cardiomyopathy)
As currently written, paragraphs B (2) and B (3) are somewhat confusing because they appear to overlap. In paragraph B (2), CMS describes “Patients with a prior MI and a measured LVEF ≤ 0.30” as a having a covered indication for an ICD. CMS goes on to state that these patients must not have:

• New York Heart Association (NYHA) classification IV;
• Had a coronary artery bypass graft (CABG), or percutaneous coronary intervention (PCI) with angioplasty and/or stenting, within the past 3 months; or
• Had a MI within the past 40 days; or
• Clinical symptoms and findings that would make them a candidate for coronary revascularization.

In Paragraph B (3), CMS describes “Patients who have severe ischemic and/or non-ischemic dilated cardiomyopathy but no prior personal history, NYHA Class II or III heart failure, left ventricular ejection fraction (LVEF) ≤ 35%, been on optimal medical therapy for at least 3 months” as having a covered indication for ICD. CMS goes on to state that these patients must not have:

• Had a coronary artery bypass graft (CABG), or percutaneous coronary intervention (PCI) with angioplasty and/or stenting, within the past 3 months; or
• Had a MI within the past 40 days; or
• Clinical symptoms and findings that would make them a candidate for coronary revascularization.

Boston Scientific finds these groups confusing for the following reasons:

Revise Optimal Medical Therapy Language and Requirement
Boston Scientific is also concerned about the addition of the requirement that patients in B (3) have “been on optimal medical therapy for at least 3 months.” We ask that CMS clarify its rationale for the addition of this language, which presents a number of potential issues. For example: (1) What is optimal medical therapy? and (2) Some patients cannot tolerate certain medications, have adverse events to medications, are unable to tolerate high doses of certain medications, and/or, are non-compliant. Thus, optimal medical therapy will be patient specific and will present compliance issues and, in the case of audits, could result in inappropriate claims denials.

Finally, in some cases, patients are unable to tolerate medications considered part of optimal medical therapy, and therefore would not ever be deemed to be receiving optimal medical therapy. As the NCD is currently written, these patients would be unable to access ICDs, as they would never complete the three month waiting requirement. Boston Scientific therefore recommends that CMS revise the phrase “optimal medical therapy” wherever referenced to state “providers have attempted to optimize medical therapy to the extent tolerated by the patient for at least three months.”

Registry Requirement
We agree with CMS’ proposal to end the data collection requirement associated with Medicare coverage of ICDs. The requirement provided critical information regarding the outcomes of ICD therapy, however the most pressing questions the requirement was intended to answer have been addressed, and we support the effort to minimize administrative burdens for providers.

In the event that CMS recommends the coverage with evidence determination (CED) process to assess coverage for additional indications for ICDs in the future, we urge the Agency to again clearly and concisely identify research questions and endpoints and to cease data collection requirements once questions are answered, in the same manner as it is proposing to do for ICDs at this point.

Waiting Periods
We appreciate CMS providing exceptions to waiting periods for patients who meet CMS coverage requirements for cardiac pacemakers and who meet the criteria for an ICD and for patients with an existing ICD who qualify for a replacement. We believe it is important for patients to access the care they need in a timely manner.

Health Disparities
Boston Scientific applauds CMS for recognizing in the proposed NCD that health disparities relating to ICD implantation in African Americans as compared to Caucasians have not been addressed, and African Americans and women have been underrepresented in health research. We agree that there is a need for future research and other activities. Our efforts in this area include Close the Gap, a health equity initiative which aims to eliminate cardiovascular care disparities and help ensure that all patients receive optimal cardiac care regardless of age, gender, race, ethnicity or primary language. Additionally, in partnership with physician investigators, we have incorporated the WIN-HER Initiative (Women opt IN for HEaRt Research) into the MADIT S-ICD clinical trial. The objectives of WIN-HER are to develop a robust in-study process for recruitment and retention of women in MADIT S-ICD and to provide a foundational knowledge base that can be applied across multiple trials going forward. We encourage CMS to work with physician specialty societies and industry representatives to explore other new ways like Close the Gap and WIN-HER to reach these underserved populations.

We appreciate your consideration of our comments.

Sincerely,

/s/
Maria Stewart
Vice-President, Global Health Economics and Market Access

Kenneth Stein, MD
Senior Vice President, Chief Medical Officer, Rhythm Management and Global Health Policy

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1 Proposed Decision Memo for Implantable Cardioverter Defibrillators (CAG-00157R4), https://www.cms.gov/medicare-coverage-database/details/nca-proposed-decision-memo.aspx?NCAId=288&CoverageSelection=Both&ArticleType=All&PolicyType=Final&s=All&KeyWord=icd&KeyWordLookUp=Title&KeyWordSearchType=And&bc=gAAAACAACAAAAA%3d%3d& (accessed December 7, 2017)
2 National Coverage Determination (NCD) for Percutaneous Left Atrial Appendage Closure (LAAC) (20.34), https://www.cms.gov/medicare-coverage-database/details/ncd-details.aspx?NCDId=367&ncdver=1&CoverageSelection=Both&ArticleType=All&PolicyType=Final&s=All&KeyWord=LAAC&KeyWordLookUp=Title&KeyWordSearchType=And&bc=gAAAACAAAAAAAA%3d%3d& (accessed December 13, 2017)
3 https://www.ssa.gov/OP_Home/ssact/title18/1861.htm (accessed December 13, 2017)

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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 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' health outcomes.

We appreciate the opportunity to comment on the Proposed Decision Memo for Implantable Cardioverter Defibrillators (CAG – 00157R4). As the leading manufacturer of implantable cardioverter defibrillators (ICDs), we wish to thank CMS for the many proposed revisions that simplify the ICD policy and remove burden from providers, while ensuring coverage for indicated patients. In this letter we provide our perspective on the draft NCD and offer comments to refine and clarify the ICD policy in the final NCD.

General Comments

Overall, Medtronic believes the proposed decision memo comprehensively and accurately addresses considerations around the application of ICD therapy. ICD therapy has long been supported by a strong and growing body of evidence, and we believe the memo appropriately recognizes that the “evidence is sufficient to consider ICDs as reasonable and necessary”. We also commend CMS for creating streamlined, clear language for the covered indications, and for the alignment of these indications with the evidence base and physician society guidelines.

We very much appreciate that the proposed decision memo is responsive to many core components of the public comments made during the June 2017 public comment period, especially as it pertains to feedback that was consistent among multiple commenters. First, there was a clear message in the public comments that the preponderance of evidence supports the efficacy of ICD therapy in indicated patients with both ischemic and non-ischemic cardiomyopathy. The proposed memo reflects this by reaffirming the previously existing coverage for these indications. Second, the comments also were aligned in asking CMS to reevaluate the CED requirement, noting that data generated from the ICD Registry have been employed to address the research questions posed when CED was initially established. The proposed memo contains a comprehensive summary of the evidence generated via the registry, how the evidence pertains to the research questions posed when the registry was established, and appropriately concludes that that the data collection requirement can be removed. Finally, multiple stakeholders requested that CMS consider reasonable exceptions to the post CABG/PCI/MI waiting periods, and the memo allows exceptions for those with a pacing indication or those needing a device replacement.

Medtronic also appreciates the consideration given to issues of importance to ICD therapy that go beyond simple covered indications. Given the importance of continued advancement of the knowledge base in areas such as risk stratification, it is commendable that CMS will support ongoing research by covering devices under Category B Investigational Device Exemption (IDE) trials. As recognized in the memo, Medicare beneficiaries could potentially be impacted by disparities in the application of ICD therapy, which may lead to lower rates of appropriate ICD use among African Americans and women. Support from CMS on this issue could serve to propel the healthcare system to address these disparities and further improve health outcomes of all Medicare beneficiaries.

There is one editorial detail we suggest be addressed. The proposed memo uses the phrase “no prior personal history” in multiple parts of the document, which we believe has the potential to be misunderstood or misinterpreted. It is our understanding that when this phrase is used, the authors intend it to mean “no prior personal history of sudden cardiac arrest (SCA).” In other words, the statement is intended to refer to patients with a primary prevention indication. Medtronic recommends that the full context of the phrase be used throughout the document. For example, under “Patient Criteria” in section A of the decision summary, we request it be updated from “Requiring patients who have severe ischemic and/or non-ischemic dilated cardiomyopathy but no prior personal history to have been on optimal medical therapy…” to “Requiring patients who have severe ischemic and/or non-ischemic dilated cardiomyopathy but no prior personal history of SCA to have been on optimal medical therapy…”.

Shared Decision Making

Medtronic understands and supports the intent of shared decision making (SDM), particularly for new medical technologies where understanding of appropriate application is still evolving. However, we believe that ICD therapy is a well understood and established therapy, and doctors are already well equipped to continue to have meaningful, collaborative discussions with their patients to reach treatment decisions aligned with the patient’s goals without new administrative requirements. We are also concerned that extraneous requirements could unnecessarily delay appropriate use of ICDs, which have a high acuity as a lifesaving therapy.

If despite the above comments CMS chooses to include the SDM requirement in the final NCD, we request that some adjustments be made to ensure that there is adequate flexibility in implementation detail, that it is done in alignment with physician society guidelines, and that the requirement for an “independent” clinician be removed. The following comments only apply should the SDM requirement be retained in the final NCD:

• Providers should have the flexibility to choose methods that are effective for their specific organization and personnel, and that are reflective of specific patient needs. Therefore, the goal of the final NCD should be to accommodate for this needed variability.


• At the same time, CMS should provide clear guidance for minimum standards of documentation that demonstrate that the overall aims of SDM were accomplished. Medtronic suggests that the memo be updated to be consistent with the four essential components of SDM laid out in the 2017 AHA/ACC/HRS Guideline for Management of Patients with Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death :
  • At least 2 participants, the clinician and patient, be involved;
  • Both parties share information;
  • Both parties take steps to build a consensus about the preferred treatment; and
  • An agreement is reached on the treatment to implement.
• We propose that CMS reconsider the language regarding SDM requiring the encounter to occur between the patient and an “independent” physician. While the shared decision needs to incorporate patient desires and expectations, the healthcare provider engaging in the conversation must have adequate training to understand device capabilities, function, risks and the nuances of ICD therapy. We believe this would be most efficiently and effectively implemented by allowing SDM to occur between the patient and clinicians involved in the referral or implant. We note that this approach is consistent with the AHA/ACC/HRS guidelines noted above, which do not reference the independence of clinicians involved in SDM but instead place overall weight implicitly on the value of a collaborative SDM process between the clinician and patient.

We also ask that the final NCD provide an example clarifying expectations on how to operationalize this process in the medical record so that it is appropriately documented.

Conclusion

Medtronic greatly appreciates the proposed NCD, which is clearly stated and in alignment with published evidence and physician society guidelines. We hope you will re-consider the shared decision-making requirement in order to minimize administrative requirements and simplify program requirements for patients and providers for this well-established therapy. If CMS proceeds with SDM in the final rule, we respectfully request that the process and documentation requirements be clear and consistent with the society guidelines, and most importantly, that the final policy not specify the involvement of an “independent” physician.

Thank you for your consideration of these recommendations. We look forward to the publication of the final NCD and providing any additional information that may be of assistance to CMS. Please feel free to contact me at barbara.kay.veath@medtronic.com should you have any questions or wish to discuss our comments in further detail.

Sincerely,

Barbara K. Veath
Sr. Director, Reimbursement and Health Policy

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Al-Khatib SM, Stevenson WG, Ackerman MJ, et al. 2017 AHA/ACC/HRS Guideline for Management of Patients With Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death: Executive Summary: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines and the Heart Rhythm Society. Heart Rhythm. 2017 Oct 30. pii: S1547-5271(17)31249-3.

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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 efficacy, effectiveness, and safety of ICDs. As Past Presidents of the Heart Rhythm Society, the world’s leading organization for heart rhythm specialists, Drs. Curtis and Gillis are leaders in the field of electrophysiology; they have also led research on ICDs. Drs. Al-Khatib, Curtis and Gillis are practicing electrophysiologists who take care of patients with ICDs and are therefore keenly aware of the needs and preferences of patients with ICDs and those who are eligible for this device. Dr. Al-Khatib recently chaired the 2017 American Heart Association (AHA)/ American College of Cardiology (ACC)/Heart Rhythm Society (HRS) Guideline for Management of Patients with Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death that covers indications for ICDs. Drs. Curtis and Gillis both served on this writing committee.

We commend CMS for issuing a well-balanced and evidence-based proposed decision regarding ICDs. Based on the available evidence, CMS concluded that the use of ICDs is reasonable and necessary for the treatment of illness or injury or to improve the functioning of a malformed body member under section 1862(a)(1)(A) of the Social Security Act. CMS stated that based on the 2017 AHA/ACC/HRS Guideline for Management of Patients with Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death, they made no changes to the requirements that should be met by eligible clinically stable patients. CMS clearly put the patients’ well-being first when they made exceptions to the waiting periods of 40 days after a myocardial infarction and 90 days after revascularization and while optimizing medical therapy related to patients meeting CMS coverage requirements for cardiac pacemakers, and who meet the criteria for an ICD and those with an existing ICD qualifying for a replacement. To reduce provider burden and documentation, CMS discontinued the registry data collection requirement acknowledging that the ICD Registry has served its purpose and has substantially contributed to the evidence base and supported their proposal to end the registry data collection requirements from the 2005 National Coverage Decision (NCD).

We are thrilled to see great alignment between CMS’ proposed decision on ICDs and the 2017 AHA/ACC/HRS Guideline for Management of Patients with Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death. The misalignment between CMS’ 2005 NCD and the prior guidelines created challenges and confusion for healthcare providers and patients and may have had a negative impact on patient care. The alignment between CMS’ proposed decision on ICDs and the 2017 AHA/ACC/HRS guideline will streamline clinical decision making and will likely lead to better patient outcomes.

CMS’ proposed decision on ICDs requires a shared decision making (SDM) interaction prior to ICD implantation for certain patients. They stated that a formal SDM encounter must occur between the patient and an independent physician or qualified non-physician practitioner using an evidence-based decision tool on ICDs prior to initial ICD implantation. While such an interaction is undoubtedly already taking place in many clinical settings, it is great to see CMS emphasize the value of SDM and elevate its importance. In fact, the 2017 AHA/ACC/HRS guideline for the first time includes 2 Class I recommendations on SDM. However, several aspects of CMS’ requirement of an SDM interaction prior to ICD implantation deserve further clarification. What is meant by an “independent physician or non-physician practitioner” should be spelled out in this document. Such a physician or nonphysician practitioner should be expected to have expertise in ICDs, the implantation procedure, and patient follow-up after the procedure. It is also important for the physician who will be implanting the device to partake in this SDM process as she/he is better positioned to answer questions about her/his skills and patient outcomes. Also, the definition of an “evidence-based decision tool” should be provided. Is it enough to use a tool that has been shown to be feasible and able to facilitate SDM or should the evidence on the tool be related to improved patient satisfaction and outcomes? We are not aware of any existing tools that have been linked with better patient outcomes.

Another aspect of CMS’ proposed decision that is in need of further clarification is the definition of “uncontrolled supraventricular tachycardia such as from atrial fibrillation”. We suspect that the basis for this exclusion is to reduce the risk of inappropriate shocks. If so, it would be helpful to modify the phrase to “persistent supraventricular tachycardia such as atrial fibrillation with a poorly controlled ventricular rate”.

We propose a few additional revisions. The CMS proposed decision states that: “At the same time, defibrillators never actually “fire” in the majority of patients who receive them for primary prevention.” For this statement, they cite a review paper by Merchant et al and the European Society of Cardiology’s guideline on ICDs. Neither reference provides primary data on this issue. In addition, the number of patients who receive shocks during follow-up is not only dependent on the patients’ characteristics and their management, but it also depends on the duration of followup. Arguably, studies of ICD shocks have not exceeded a few years of follow-up, and more shocks are expected to be observed with longer follow-up. Also, CMS’ reference to the ICD battery life being 5-7 years is not accurate. With much improved battery technology, ICDs are now lasting 7-10 years.

In summary, CMS’ proposed decision on ICDs is well-balanced, evidence-based, and well-aligned with the latest AHA/ACC/HRS guidelines on ICDs. While a few clarifications of some of the requirements are needed, the proposed decision will eliminate the confusion that resulted from the misalignment between CMS’ 2005 NCD and the prior guidelines and will help save many lives.

If you have questions about our letter or seek clarification, please do not hesitate to contact Sana Al-Khatib at alkha001@mc.duke.edu.

Sincerely,

Sana M. Al-Khatib, MD, MHS, FHRS, FAHA, FACC
Professor of Medicine
Cardiology- Electrophysiology
Duke University Medical Center

Gillian D. Sanders, PhD
Professor of Medicine
Duke Evidence Synthesis Group, Director
Duke University Medical Center

Anne M Gillis, MD, FRCPC, FHRS
Professor of Medicine
University of Calgary,
Deputy Director Libin Cardiovascular Institute of Alberta,
Calgary, Alberta, Canada

Anne B. Curtis, MD, MACP, FACC, FHRS, FAHA
SUNY Distinguished Professor
Charles and Mary Bauer Professor and Chair
Department of Medicine
Jacobs School of Medicine & Biomedical Sciences
University at Buffalo
Buffalo, NY

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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 & Medicaid Services' (CMS) has proposed changes to the National Coverage Decision for implantable cardiac defibrillators (ICDs) and welcomes the opportunity to provide comments. Abbott is committed to helping people live their best possible life through the power of health. For more than 125 years, we've brought new products and technologies to the world in nutrition, diagnostics, medical devices and branded generic pharmaceuticals that create more possibilities for more people at all stages of life. Today, 94,000 Abbott employees are working to help people live not just longer, but better, in the more than 150 countries we serve.

As a leading medical technology manufacturer of implantable cardiac devices, we seek to ensure that Medicare coverage policies promote beneficiary access to high-quality healthcare innovations that both address unmet medical needs and improve health outcomes. We believe the changes proposed to the ICD NCD are important steps to expand coverage to patients who will benefit from ICD therapy.

Discontinuation of the registry mandate
Abbott commends CMS for proposing to end the data collection (registry) requirement for coverage of ICDs. Abbott supports and encourages the development of clinical evidence for ICDs and acknowledges the importance of CED in certain circumstances where sufficient evidence is lacking to develop a coverage policy. We appreciate that CMS recognizes that the registry has collected sufficient data to meet the criteria for CED completion.

Requiring a shared decision-making (SDM) interaction before ICD implantation for certain patients
Abbott supports CMS's proposal to cover ICDs "for patients who have documented familial or genetic disorders with a high risk of life-threatening tachyarrhythmias (sustained VT or VF), to include, but not limited to, long QT syndrome or hypertrophic cardiomyopathy or patients with severe ischemic and/or non-ischemic dilated cardiomyopathy but no prior personal history, NYHA Class II or III heart failure, left ventricular ejection fraction (LVEF) ≤ 35%, been on optimal medical therapy for at least 3 months. Additionally, patients who have severe ischemic and/or non-ischemic dilated cardiomyopathy but no prior personal history that have not:

• Had a coronary artery bypass graft (CABG), or percutaneous coronary intervention (PCI) with angioplasty and/or stenting, within the past 3 months; or
• Had a MI within the past 40 days; or
• Clinical symptoms and findings that would make them a candidate for coronary revascularization"

We request clarification regarding CMS's plan to implement the required formal shared decision making encounter that must occur between these patients and an independent physician or qualified nonphysician practitioner using an ICD evidence-based decision tool prior to initial ICD implantation. Additional information on SDM specifics such as the tool required, timeframe of encounter prior to implant, and documentation/reporting would be helpful in understanding this requirement.

The addition of two exceptions to waiting periods
Abbott supports CMS's proposal to eliminate the 40-day waiting period after acute MI for patients who 1) meet all CMS coverage requirements for cardiac pacemakers, and who meet the criteria in this national coverage determination for an ICD, which will allow coverage for the combined devices in one procedure, at the time the pacemaker is clinically indicated or 2) have an existing ICD that requires an ICD replacement due to the end of battery life, elective replacement indicator (ERI), or device malfunction, with documentation that the device is at ERI level, or that there is a device/lead malfunction. These changes to the policy will ensure alignment with clinical guidelines and the recommendations of physician societies for the appropriate use of ICDs.

In summary, Abbott commends Medicare for updating the ICD coverage policy to align with published guidelines and clinical evidence. We request that Medicare provide guidance on the implementation of the required shared decision making interaction as it relates to ICDs for certain populations.

We appreciate your consideration of our comments. Please feel free to contact me if you have any questions or if you need additional information.

Sincerely,
Barbara J. Calvert
Director, Medical Products Reimbursement

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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 mid-level is not appropriate, would a Cardiologist/Electrophysiologist from the same group/practice be allowed to complete this requirement? Also, what "evidence based tool" is CMS proposing we utilize?

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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 decision memo for ICDs. CAA represents more than 5,000 cardiologists in private practice and within integrated organizations who provide care to our nation’s Medicare population. CAA’s mission is to educate the professional cardiovascular community about regulatory and legislative issues that affect their ability to provide high-quality patient care, to represent the common interests of the cardiovascular patient and professional on such issues, and to encourage its members to advocate for their patients and their practices. Our comments on various aspects of the proposed decision memo are listed below.

Registry Requirement
CMS is proposing to remove mandatory participation the NCDR, and instead encourage continuation and improvement of a voluntary registry. We agree with this proposal. Since the inception of the NCDR, we agree with CMS that key questions have been answered regarding the impact on health outcomes for certain Medicare beneficiaries. Eliminating mandatory participation is warranted, and reduces administrative burden and cost for providers and patients.

Shared Decision Making (SDM)
CMS is proposing to add a SDM requirement for certain Medicare patients that are indicated for an ICD. We agree with CMS’ assertion that SDM is important in treatments where there are complex considerations on benefits, harms, indications and existing effective treatments, and agree with the potential IDE patients identified that require SDM.

However, we are concerned with the language CMS provides regarding SDM as it relates to, “For these patients, a formal shared decision-making encounter must occur between the patient and an independent physician…”. It is not clear based on this language what CMS means by “independent.” While we agree that SDM tools are appropriate, we contend that these tools can be best implemented between the prescribing physician and patient, and that a separate encounter with another “independent” physician is not necessary. If the Medicare beneficiary requests a second opinion, that will be provided. But, requiring another physician encounter creates unnecessary administrative and economic burden on providers and patients. We believe that appropriate SDM tools, like that suggested in the proposed decision memo, will facilitate the necessary interaction between the prescribing physician and patient to ensure appropriate decision making.

We recommend that CMS eliminate the term “independent” in describing the SDM requirement. Should CMS retain this term, we urge CMS to provide additional details on what constitutes an independent physician encounter. For example, would another physician in the same clinical group or practice suffice, or does the encounter need to be with a physician completely unaffiliated with the prescribing physician? Again, we reiterate we believe an additional physician encounter beyond the prescribing physician is not warranted. However, more clarification is required if CMS retains this language.

Cardiac MRI
CMS is proposing to add cardiac MRI to measure LVEF. We agree with adding this modality to evaluate LVEF. In addition, we recommend that CMS consider excluding cardiac MRI for measuring LVEF from the requirements of the forthcoming Appropriate Use Criteria (AUC) for advanced imaging services. Given the NDC will include cardiac MRI as an approved method of measure LVEF, we believe it to be redundant for providers to refer and include the necessary modifiers to indicate they reviewed AUC for this service when identifying Medicare beneficiaries eligible for an ICD.

Exceptions to Waiting Periods
CMS is proposing two exceptions to waiting periods for certain ICD-eligible Medicare patients. We agree with these proposed exceptions and recommend that CMS implement them as proposed.

*********

Thank you for the opportunity to provide our comments on this proposed rule. If you have any questions or require additional information, please do not hesitate to contact me directly at (405) 608-3772 or at pholloway@okheart.com.

Sincerely,

Patrick H. Holloway
President, Cardiology Advocacy Alliance

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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 revascularization procedure is performed, and with no evidence of ongoing ischemia.

Comment 1: “not associated with an Acute Myocardial Infarction (AMI)” needs to be defined with a timeframe, for example within 48 hours per DOJ Resoltion Model for ICD Investigation. After revascularization, the time should be revised to “after 12 hours,” not =4 days. “Ongoing ischemia” needs clarification. Lesions unable to be revascularized should not be included in the “ongoing ischemia” definition.

Language under indication 2, 3, and 4:
For these patients, a formal shared decision making encounter must occur between the patient and an independent physician (as defined in Section 1861(r)(1)) or qualified non-physician practitioner (meaning a physician assistant, nurse practitioner, or clinical nurse specialist as defined in §1861(aa)(5)) using an evidence-based decision tool on ICDs prior to initial ICD implantation.

Comment 2: The "formal shared decision making encounter” requirement will not improve patient care and it will delay therapy when practicing along published guidelines. As long as an informed consent is signed by the patient discussing the surgical risk and alternatives, another formal shared decision making encounter will confuse the patient and will be redundant.

If final decision is to keep the proposed language, CMS needs to provide a formal shared decision making template and specifics on the proposed evidence-based decision tool.

For each of these groups listed above, the following additional criteria must also be met:

3. Patients must not have:

• Significant, irreversible brain damage; or
• Any disease, other than cardiac disease (e.g., cancer, renal failure, liver failure) associated with a likelihood of survival less than 1 year; or
• Uncontrolled supraventricular tachycardia such as from atrial fibrillation.

Comment 3: Remove “Uncontrolled supraventricular tachycardia such as from atrial fibrillation” as requirement. Uncontrolled atrial fibrillation patients may undergo ICD placement and AV node ablation at the same time if they meet criteria. This statement would not allow these patients to get adequate therapy. It should be revised to say “patients with suspected typical atrial flutter, reentrant SVT that may be readily ablatable, should have their arrhythmia addressed prior to consideration for ICD therapy.”

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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 practice? Would the referral from primary care, cardiologist, or other referral source be considered a valid shared decision making source? We also believe that this extra layer would not add value to the decision process. The detailed knowledge that is very prescriptive in the NCD is sufficient. Requiring the implanting physician to document evidence-based shared decision making would be sufficient.

We agree with the remaining 6 proposed revisions.

Thank you

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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 decision is not only unnecessary but represents an impediment to patient care. Electrophysiologists are highly trained and should have the final opinion/decision on implantation of an ICD. Further burdening patients with additional timely and costly evaluations by practitioners who are less qualified and trained is unfair and inefficient. I hope that CMS strongly considers removing the shared decision requirement from the NCD. This will not improve care and may in fact increase the cost of healthcare as patients are forced to see additional practitioners unnecessarily.

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