Cardiac Contractility Modulation (CCM) for Heart Failure

We appreciate the opportunity to comment on this proposed Coverage with Evidence (CED) decision for cardiac contractility modulation (CCM) for Medicare beneficiaries with heart failure. Since CCM has yet to show clinically meaningful benefit in the Medicare population, we do not believe that the evidence supports Medicare coverage of CCM. If CMS proceeds with CED, we believe that the CED study requirements should be strengthened, primarily through requiring all-cause mortality as a singular primary outcome and all hospitalizations as an additional outcome and mandating a sham procedure control arm to mitigate any placebo effect.

Limitations of Existing Evidence
We agree with CMS that the existing evidence is insufficient to show that CCM is reasonable and necessary for Medicare beneficiaries. As discussed in the proposed decision memo, the randomized controlled trials investigating the safety and effectiveness of CCM suffer from issues such as short follow-up times (24 weeks for efficacy endpoints, 50 weeks for safety endpoints in FIX-HF-5) and variations in the left ventricular ejection fraction (LVEF) inclusion criteria, with only FIX-HF-5C studying patients with an LVEF between 25% and 45%, the current FDA indication and proposed Medicare coverage range.

FIX-HF-5C did find a statistically significant improvement in peak oxygen consumption (peak VO2), as well as the Minnesota Living with Heart Failure questionnaire (MLHFQ), 6-minute walk test (6MWT), and New York Heart Association (NYHA) class; however, the design of the trial limits the meaningfulness of these results. As FIX-HF-5C was unblinded, subjective measures reported or evaluated by the patients or investigators that are aware of treatment status may reflect the placebo effect. As noted in the FDA Summary of Safety and Effectiveness Data, this is particularly concerning for the 6MWT and MLHFQ results.[1] Furthermore, peak oxygen consumption is a poor predictor of mortality and hospitalizations,[2] and therefore does not provide sufficient evidence of meaningful clinical benefit to Medicare beneficiaries. Finally, as noted in the proposed decision memo, the trial population was younger and more likely to be male than the Medicare population.

Strengthening CED Study Requirements
If CMS proceeds with CED for CCM, we believe that the CED study requirements can be strengthened. For the primary outcome, CMS should require a non-composite primary outcome of all-cause mortality, as all-cause mortality is the most meaningful outcome to patients. Additionally, any hospitalization outcome (individual or in a composite) should include all hospitalizations, not a selected subgroup (such as heart failure hospitalizations).

Given the interest in determining whether CCM benefits patient quality of life and other subjective measures vulnerable to the placebo effect, any CMS-approved CED study should be blinded with a sham procedure control arm. As Impulse Dynamics, the manufacturer of the only FDA-approved CCM system, is currently conducting a quadruple-blinded randomized trial with sham procedure control,[3] there is precedent for conducting a trial with these important design features for CCM devices.

Conclusion
As CCM has not been shown to improve mortality, hospitalizations, or measures of patient function and quality of life in blinded trials, there is insufficient evidence of clinically meaningful benefit. Consequently, CCM is not reasonable nor necessary for Medicare beneficiaries. If CMS finalizes CED for CCM, the CED study criteria should be strengthened as detailed above in order to generate higher quality evidence to inform future Medicare coverage decisions.

UCSF Team for High-Value Care
Sarah Tingley, MA
Rita Redberg, MD MSc

[1] US Food and Drug Administration. Summary of Safety and Effectiveness Data (SSED): Optimizer Smart System, 2019. https://www.accessdata.fda.gov/cdrh_docs/pdf18/P180036b.pdf
[2] Ciani O, Piepoli M, Smart N, et al. Validation of Exercise Capacity as a Surrogate Endpoint in Exercise-Based Rehabilitation for Heart Failure: A Meta-Analysis of Randomized Controlled Trials. JACC Heart Fail. 2018;6(7):596-604. doi:10.1016/j.jchf.2018.03.017
[3] https://clinicaltrials.gov/study/NCT05064709

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August 8, 2025

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

RE: CAG-00469N – Proposed Decision Memo for Cardiac Contractility Modulation (CCM) for Heart Failure

Dear Ms. Syrek Jensen,

The American College of Cardiology, Heart Rhythm Society, and Heart Failure Society of America represent the physicians and healthcare professionals dedicated to the care of heart failure (HF) patients undergoing cardiac contractility modulation (CCM). We commend CMS for recognizing the growing body of clinical evidence supporting CCM’s safety and effectiveness in improving functional status, quality of life, and reducing hospitalizations in patients with HF. Our Societies support CMS encouragement of standardized shared decision-making (SDM) tools and propose the development of specific decision aids that provide clear information on CCM’s mechanism and rationale for implantation, impact on arrhythmias, interaction with other devices and long-term monitoring needs.

We appreciate that CMS has built flexibility into the proposed decision by requiring subgroup analyses that include patients with prior CRT. This suggests that CRT non-responders—patients who have received CRT but derive limited or no clinical benefit—may be eligible for CCM therapy under Coverage with Evidence Development (CED) if they meet FDA labeling criteria. These patients often have few remaining therapeutic options, and CCM may offer symptom relief and improved quality of life (Kuschyk et al., Int J Cardiol. 2019; Yuecel et al., ESC Heart Fail. 2024).

We also appreciate the flexibility in the proposed decision memo that does not rigidly define the “heart team,” allowing institutions to adapt based on available resources. At the same time, we have concerns that the lack of definition could lead to inconsistent interpretations by Medicare contractors, potentially creating barriers to access and we’ve seen how ambiguity can create confusion for institutions developing new services. With only about 1,400 board-certified advanced HF specialists nationwide—and few CCM site investigators being HF specialists—it’s important that CMS clarify that any qualified member of the cardiology care team may assess and manage guideline-directed medical therapy (GDMT) prior to CCM implantation. Additionally, any provider should be permitted to refer a patient to the cardiology care team for evaluation. This clarification would help ensure access to CCM therapy, especially in regions without board-certified HF specialists, and prevent delays in care.

It is our recommendation that Electrophysiology (EP) specialists be explicitly recognized in the physician criteria for CCM delivery. EPs have significant expertise in device implantation and management and play a pivotal role in patient selection, device programming, safe integration with other cardiac implantable electronic devices (CIEDs) and long-term follow-up. Protocols should be developed to address interactions with other CIEDs , lead-lead interactions or failures. Given the technical complexity of CCM implants the societies recommend establishing minimum training and proctoring requirements for implanting physicians.

The societies also urge CMS to emphasize that CCM therapy should be reserved for patients who are on maximally tolerated GDMT. Guidelines emphasize that advanced therapies such as CCM should only be considered after GDMT has been fully optimized (Heidenreich et al., J Am Coll Cardiol. 2022; Maddox et al., J Am Coll Cardiol. 2024). Clinical trials demonstrating the efficacy of CCM were conducted in the context of maximal GDMT, underscoring its role as a subsequent option rather than a substitute. Moreover, many patients experience meaningful recovery of cardiac function once GDMT is maximized, potentially eliminating the need for CCM altogether (Bazoukis et al., Heart Fail Rev. 2024; Cappannoli et al., Heart Fail Rev. 2021; Dulai et al., Int J Clin Pract. 2021; Letarte et al., Heart Fail Rev. 2025; Patel et al., Heart Fail Rev. 2021; Rao et al., Expert Rev Med Devices. 2021).

These clarifications are essential to ensure that CCM is used appropriately. As CCM continues to evolve as a therapeutic option, it is equally important that its use be guided by robust clinical evidence and real-world data. CED is a valuable policy tool that enables timely access to promising new technologies while ensuring that important clinical data are collected to evaluate their safety and effectiveness. CED has played a critical role in supporting the responsible introduction of innovative cardiovascular therapies into clinical practice. The NCDR EP Device Implant Registry, managed by the ACC, is currently collecting data on CCM procedures. We encourage CMS to support the use of national, audited registries maintained by professional societies to streamline data collection, promote transparency, and accelerate the development of real-world evidence for emerging technologies like CCM. EP relevant endpoints should be collected with timely publication of outcomes data allowing for guidance of procedural and other arrhythmia related safety data.

Thank you for the opportunity to comment on the proposed decision memo. The societies support Medicare coverage of CCM therapy for HF and believe the proposed framework appropriately balances access to innovative therapy with the need for continued data collection and evaluation. Please direct any questions or concerns to Amanda Stirling, Associate, Advocacy at (202) 375-6553 or astirling@acc.org.

Sincerely,

Christopher M. Kramer, MD, FACC
President, American College of Cardiology

Michael Felker, MD, FHFSA
President, Heart Failure Society of America

Mina K. Chung, MD, FHRS
President, Heart Rhythm Society

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August 7, 2025

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

Re: Proposed Decision Memo for Cardiac Contractility Modulation (CCM) for Heart Failure (CAG-00469N)

Dear Ms. Syrek-Jensen,

On behalf of the MedTech Association (AdvaMed), we appreciate the opportunity to submit comments on the Proposed Decision Memo for Cardiac Contractility Modulation (CCM) for Heart Failure (CAG-00469N). AdvaMed and CMS share a common goal – the establishment of a clear and expeditious coverage process, based on scientifically sound clinical evidence with appropriate safeguards, for emerging technologies that will benefit Medicare-eligible patients, including the 55 percent of Medicare-eligible patients enrolled in Medicare Advantage organizations in 2025(1).

AdvaMed member companies produce the 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. We are committed to ensuring patient access to lifesaving and life-enhancing devices and other advanced medical technologies in the most appropriate settings.

AdvaMed supports efforts to expand options, such as CCM, for heart failure patients. According to the Centers for Disease Control and Prevention, approximately 6.7 million adults in the United States have heart failure (2). Heart failure is the leading cause of hospitalization among adults, and Medicare beneficiaries with heart failure have the highest readmission rate of any condition (3).

Additionally, AdvaMed supports CMS’ efforts to expand access to CCM as part of the Transitional Coverage for Emerging Technologies (TCET) pilot. Pathways such as TCET are intended to facilitate faster beneficiary access to new and novel technologies and procedures, and we appreciate the agency’s ready collaboration with the submitter to review the evidence supporting CCM. Moreover, we are encouraged to see a technology from a small innovator in the TCET pilot, as such technologies may have distinct considerations from those of a larger company more versed in CMS processes. Inclusion of small innovators into the TCET pathway will help to better inform the TCET program moving forward.

We encourage CMS to work quickly in issuing a final decision memo, and subsequently approval of the CED study. AdvaMed was very pleased to see CMS approval of the CED study for the recently finalized TCET pilot for Transcatheter Tricuspid Valve Replacement (TTVR) and encourage that continue for the rest of the TCET pilot studies. We look forward to continuing our work with the Agency. If you have questions regarding these comments or if you require additional information, please contact me at tburke@advamed.org.

Sincerely,

Tara Burke, PhD
VP, Payment & Healthcare Delivery Policy
AdvaMed

References
(1) “July 2025: A Data Book: Healthcare Spending and the Medicare Program.” Medicare Payment Advisory Committee (MedPAC), Chapter 9, 17 July 2025, www.medpac.gov/document-type/data-book/. Accessed 28 July 2025.
(2) Centers for Disease Control and Prevention. https://www.cdc.gov/heart-disease/about/heart-failure.html?CDC_AAref_Val=https://www.cdc.gov/heartdisease/heart_failure.htm
(3) Jencks SF, Williams MV, Coleman EA. Rehospitalizations among patients in the Medicare fee-for-service program. N Engl J Med. 2009; 360:1418–1428. doi: 10.1056/NEJMsa0803563

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Blue Cross Blue Shield of Michigan (BCBSM) appreciates the opportunity to provide feedback on the proposal to cover Cardiac Contractility Modulation (CCM) for heart failure management.

BCBSM agrees that CCM is an evidence-backed technology with the potential to improve outcomes in patients with heart failure. CMS coverage will ensure access for high-risk populations where conventional options have failed. These recommendations, based on pivotal trial evidence and strict inclusion/exclusion criteria, aim to optimize safety, efficacy, and resource utilization.

BCBSM requests CMS expand inclusion criteria for coverage to include:

• A diagnosis of chronic Heart Failure with Reduced Ejection Fraction (HFrEF) with NYHA Class III;
• Persistent symptoms despite stable guideline-direct medical therapy (GDMT) for 90 days or more;
• Sinus rhythm; and
• Lack of eligibility for Cardiac Resynchronization Therapy.

BCBSM requests CMS expand exclusion criteria for coverage to include:

• Myocardial infarction or coronary revascularization within 3 months;
• Candidacy for Cardiac Resynchronization Therapy;
• Permanent atrial fibrilization;
• Life expectancy of less than one year due to non-cardiac causes; and
• Pregnancy or lactation.

Additionally, BCBSM requests CMS consider the following additional recommendations:

• Incentivize documentation of GDMT optimization and patient education;
• Require enrollment in national CCM registry for post-marketing surveillance;
• Ensure procedure is performed at centers with heart failure specialty services; and
• Encourage remote monitoring integration for follow-up.

Thank you for the opportunity to provide feedback on this proposal. Please feel free to reach out with any questions.

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On behalf of the Medical Device Manufacturers Association (MDMA), I am pleased to submit these comments to CMS in response to the proposed national coverage decision memo for Cardiac Contractility Modulation (CCM) for Heart Failure. MDMA supports national Medicare coverage of CCM under a National Coverage Determination (NCD) that includes Coverage with Evidence Development (CED), as outlined in the proposed decision memo.

MDMA is a national trade association that provides educational and advocacy assistance to hundreds of innovative companies in the field of medical technology. Our members, the majority of which are small to mid-sized medical device companies, have a strong record of delivering breakthrough therapies to treat chronic diseases and life-threatening conditions while lowering the cost of care. MDMA’s mission is to ensure that patients have timely access to the latest advancements of safe and e?ective medical technologies that improve health outcomes.

MDMA appreciates the Coverage and Analysis Group’s efforts to develop and implement the Transitional Coverage of Emerging Technologies (TCET) initiative. As CMS continues its development of NCDs for technologies reviewed as part of its TCET pilot work, including CCM for heart failure, we are encouraged by the potential for the TCET program to expedite access to novel lifesaving and life-enhancing technologies for Medicare-eligible patients in the future.

Chronic Heart Failure (CHF) remains a major health challenge for Medicare-eligible patients, as well as the US population in general. According to the Centers for Disease Control (CDC), nearly 6.7 million Americans over the age of 20 have CHF and CHF was mentioned on more than 450,000 death certificates in the US in 2023.(1) Specifically for the Medicare-eligible population, nearly one in eight Medicare fee-for-service enrollees has CHF. CHF is the leading cause of hospitalization among program beneficiaries and also the top cause of 30-day hospital readmissions.(2)

MDMA agrees with the conditions for coverage set forth in the draft decision memo. We have no recommendations for changes in the Coverage Criteria, Patient Criteria or CED Study Criteria. Given the high prevalence of CHF in the Medicare-eligible population, CMS should complete the policy development process for CCM as quickly as possible. Specifically, we urge CMS to work with manufacturers and study sponsors to expeditiously review and approve study protocols for CCM following the issuance of the final NCD.

Bringing innovative breakthrough devices such as CCM for heart failure to Medicare beneficiaries su?ering from debilitating disease is the intent and goal of the TCET program and the CED pathway. We appreciate the opportunity to comment on this important topic. If we can provide any additional information, please contact me at dwaldmann@medicaldevices.org or (202) 354-7171.

Sincerely,

Daniel Waldmann, JD
EVP , Health Policy & Reimbursement
Medical Device Manufacturers Association (MDMA)

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(1) https://www.cdc.gov/heart-disease/about/heart-failure.html
(2) https://www.cms.gov/about-cms/agency-information/omh/downloads/data-snapshot-heart-failure.pdf

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Re: Proposed national coverage determination (NCD) for cardiac contractility modulation (CCM) for heart failure (HF) management.

We are writing to express our support for the proposed decision memo regarding the new criteria for the implantation of cardiac devices. This proposal encompasses several essential requirements that will undoubtedly enhance patient outcomes and guide clinical practice efficiently. The proposal aligns with the available evidence from the FIX-HF-5C trial, which was designed to confirm subgroup findings of the earlier FIX-HF-5 trial.

The patient criteria essentially align with the FDA eligibility criteria that we already work with, which are: symptomatic heart failure (NYHA class III) despite medical therapy, LVEF between 25% and 45%, normal QRS duration (<130 ms) indicating patients not suitable for CRT, sinus rhythm, and age = 18 years. These criteria are integral to ensuring that only patients who meet the specific medical requirements and are most likely to benefit from the procedure are selected.

The proposed criteria also include significant contraindications as listed by the FDA labelling, such as the presence of permeant or long standing persistent atrial fibrillation or flutter, a mechanical tricuspid valve, or inadequate venous access for safe implantation of the device. These contraindications are crucial as they ensure the safety and viability of the implant procedure for eligible patients.

However, the FDA indication does not mandate a formal “heart team” determination or a defined minimum interval of “optimized” GDMT before the implant. Nonetheless, it is expected that physicians will optimize medical therapy prior to the procedure, which aligns with best practices in clinical care.

The CMS proposal features a requirement for a specific three months of GDMT and the stipulation that the patient must not have received a prior heart transplant. These additional conditions are appropriate and highly relevant as they ensure that only patients who have been adequately managed and are truly in need of the intervention are selected.

Furthermore, the proposal for future study design looks very promising. The ongoing AIM-HIGHER study for patients with HF and LVEF 40-70% reflects a robust approach to understanding the benefits and implications of this therapy. There are also hopes that the company will conduct another low EF study with larger numbers and a stronger design, facilitating the inclusion of CCM in future ACC/AHA guidelines.

We believe that the proposed decision memo is well-founded, integrating rigorous criteria that prioritize patient safety and effective clinical outcomes. We fully support this proposal and anticipate positive implications for the advancement of cardiac care.

Sincerely,

Amanda R. Vest, MBBS MPH FHFSA FAHA FACC
Section Head, Heart Failure & Transplant Cardiology
Cleveland Clinic l Heart, Vascular and Thoracic Institute
9500 Euclid Avenue l Desk J3-4 l Cleveland OH 44195
vesta2@ccf.org l P (216) 444-7646 l C (617) 368-0531

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Impulse Dynamics commends the Coverage and Analysis Group’s (CAG’s) work on TCET. We are honored to have our therapy, Cardiac Contractility Modulation (CCM) for treatment of Heart Failure included in the first set of five TCET pilot projects. The robust engagement between CAG and Impulse Dynamics led to an excellent proposed decision memo that reflects the spirit of the TCET pathway.

As a formal public comment, Impulse Dynamics would like to recommend only one change to the proposed NCD decision memo for CCM. Specifically, there is a requested sub-group analysis, Item 4., that is technically problematic to perform. Item 4. stipulates a sub-group analysis for: “No CRT, Prior CRT, or Current CRT”.

Identification of the programming status of a CRT device in a real-world evidence dataset is highly problematic. Cardiac Resynchronization Therapy devices, both pacemaker and defibrillator versions, have hundreds of programming options (therapy settings, detection algorithms, pacing protocols, defibrillator amplitude, stored electrogram settings, resynchronization settings, etc.). Unfortunately, all device programming is recorded using the same CPT procedure codes (CPTs 93281-93290). These codes document that device programming was changed, but not what element was reprogrammed. Additionally, no ICD-10-PCS code exists to explicitly describe the service of activating or deactivating CRT therapy. And finally, no ICD=10-CM diagnosis code exists to indicate whether a patient may or may not be receiving CRT at a given point in time. In summary, the use of electronic health record and claims data can identify patients who have undergone CRT implantation but cannot delineate whether CRT is currently active, nor whether it has been active in the past.

Physicians may choose to document activation, deactivation, or reactivation of CRT in a free text note in a patient’s electronic medical record. However, the verbiage by which this documentation occurs is highly inconsistent. As such, isolating this information with scientific confidence, even with the most sophisticated Natural Language Processing (NLP) model is infeasible.

For this reason, Impulse Dynamics proposes the following change to Item 4. under the subgroup analysis requirements:

Item 4. “CRT, No CRT”

With this change, patients can be compared/analyzed based on having a CRT device vs. never having had a CRT device.

Impulse Dynamics greatly appreciates the chance to participate in the TCET pilot as well as the opportunity to comment on the proposed NCD decision memo for CCM therapy. We commend CMS & the CAG team specifically for their excellent efforts in the development of the TCET pathway for important emerging therapies.

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As a patient advocate regarding the Proposed Decision to cover Cardiac Contractility Modulation (CCM) for heart failure management under Coverage with Evidence Development (CED). I appreciate CMS's commitment to ensuring access to potentially life-improving therapies for Medicare beneficiaries. I generally support the intent to provide access to CCM for patients who remain symptomatic despite optimized guideline-directed medical therapy. The potential for improved heart function, reduced symptoms, and enhanced quality of life for this vulnerable patient population is significant. Furthermore, utilizing a CED framework is a responsible approach to gather more robust data on this evolving therapy, particularly within the diverse Medicare population.

However, as an advocate for patient well-being and equitable access to care, I wish to raise several important considerations and "red flags" regarding the proposed CED criteria, particularly from a patient's perspective:

Patient Burden and Compensation for Study Participation:

The proposal mandates patient participation in CMS-approved CED studies for a minimum of 24 months. While crucial for data collection, this imposes a substantial burden on often frail heart failure patients and their caregivers, including frequent appointments, travel, and time commitments. The proposed decision does not explicitly address patient compensation for this burden, such as reimbursement for travel expenses, lost wages for caregivers, or other indirect costs associated with prolonged study participation. Lack of such provisions could create significant barriers to enrollment, particularly for low-income or geographically isolated beneficiaries, thus undermining the inclusivity goals of CED. Recommendation: CMS should require CED study protocols to include clear provisions for reasonable compensation to patients for direct and indirect costs associated with study participation, including travel, accommodation, and lost income for caregivers, ensuring financial barriers do not impede equitable access.

Mechanisms for Patient Support and Withdrawal:

While patients inherently have the right to withdraw from a clinical study, the proposal does not elaborate on the processes or support mechanisms in place should a patient choose to withdraw due to overwhelming burden, adverse events, or a lack of perceived benefit. Concerns exist regarding continued access to appropriate medical care (including device explantation if necessary) for patients who withdraw, without punitive measures or additional financial burden.

Recommendation: The CED study criteria should mandate robust informed consent processes that clearly explain a patient's right to withdraw at any time without penalty, and outline explicit pathways for ongoing medical management, including potential device removal and associated care, regardless of study participation status.

Transparency and Comprehensive Reporting of Study Outcomes:

The proposal lists primary outcomes of all-cause mortality, HF hospitalizations, or a composite thereof. While these are critical, there should be a strong emphasis on detailed and transparent reporting of all study outcomes, including all adverse events (both device-related and non-device-related), complications, and quality of life measures. The mechanism and frequency of public dissemination of this comprehensive data should be clearly defined to ensure accountability and enable informed decision-making by patients and providers.

Recommendation: CMS should establish clear guidelines for the timely, comprehensive, and publicly accessible reporting of all study data, including detailed adverse event profiles, device performance, and patient-reported outcomes, throughout and beyond the 24-month follow-up period.

Ensuring True Inclusivity in Subgroup Analyses:

The proposal outlines important subgroups for analysis (age, demographics, ischemic vs. non-ischemic, LVEF, etc.). However, simply listing these categories does not guarantee true representation. There is a risk that studies may disproportionately enroll healthier, less complex, or more easily accessible patients, potentially limiting the generalizability of findings to the full spectrum of Medicare beneficiaries living with heart failure.

Recommendation: CMS should require CED study protocols to include explicit strategies and recruitment targets to ensure robust representation of diverse patient populations, including racial and ethnic minorities, individuals from rural areas, those with multiple comorbidities, and different socioeconomic backgrounds, to ensure the evidence truly reflects the impact of CCM across all Medicare beneficiaries.

In conclusion, while the proposed coverage of CCM under CED is a positive step towards expanding treatment options for heart failure patients, addressing these concerns will be critical to ensure equitable access, minimize patient burden, and maximize the integrity and utility of the evidence gathered. I urge CMS to incorporate these recommendations into the final decision. Thank you for doing outstanding work.

Tiffiny

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