Implantable Cardioverter Defibrillator Decision Memo
“Minimal Changes” to the National Coverage Determination
CMS posted a Final Decision Memo on February 15, 2018 for the National Coverage Determination (NCD) for Implantable Automatic Defibrillators (20.4). CMS finalized what they describe as “minimal changes” to the ICD NCD from the 2005 reconsideration. After you have finished reading this article I will leave it to you to decide if you agree with their definition of “minimal changes.”
DECISION SUMMARY OF THE CHANGES
- Add cardiac magnetic resonance imaging (MRI) to the list of diagnostic imaging studies that can evaluate left ventricular ejection fraction (LVEF).
- Note: Prior approved diagnostic imaging studies included echocardiography, radionuclide (nuclear medicine) imaging, and catheter angiography.
- Require patients who have severe non-ischemic dilated cardiomyopathy but no personal history of sustained ventricular tachyarrhythmia or cardiac arrest due to ventricular fibrillation to have been on optimal medical therapy (OMT) for at least 3 months.
- Require a patient shared decision making (SDM) interaction prior to ICD implementation for certain patients.
- Note: This includes all patient’s receiving an ICD for primary prevention.
Additional Patient Criteria
- Remove the Class IV heart failure requirement for cardiac resynchronization therapy (CRT)
Exceptions to Waiting Periods
- Add an exception for patients meeting CMS coverage requirements for cardiac pacemakers, and who meet the criteria for an ICD;
- Add an exception for patients with an existing ICD and qualifying replacement
- End the data collection requirement
When developing a National Coverage Determination (NCD), CMS in general “evaluates relevant clinical evidence to determine whether or not the evidence is of sufficient quality to support a findings that an item or service falling within a benefit category is reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member.”
The evidence review primarily focused “on randomized controlled trials that assess the clinical utility of defibrillators compared to optimal medical therapy, and relevant formal Technology Assessments and professional society guidelines. While reading through this part of the Decision Memo, some of the conclusions were reminiscent of statements made when Jack Handy shared “Deep Thoughts” on Saturday Night Live in the 1990’s. The following table highlights four of the studies.
|Study||Study Aim and Conclusion|
|Freeman JV1, Wang Y, Curtis JP, et al. Physician procedure volume and complications of cardioverter-defibrillator implantation. Circulation. 2012 Jan 3;125(1):57-64.||Aim: Examine the relationship between physician annual ICD implantation volume and in-hospital complications. Conclusion: “Physicians who implant more ICDs have lower rates of procedural complications and in-hospital mortality, independent of hospital procedure volume, physician’s specialty, and ICD type.” Thus, “concentrating ICD implantation in the hands of fewer physicians may improve the clinical outcomes of this increasingly common procedure.”|
|Curtis JP, Luebbert JJ, Wang Y, et al. Association of physician certification and outcomes among patients receiving an implantable cardioverter-defibrillator. JAMA. 2009 Apr 22;301(16):1661-70.||Aim: Estimate the association of implanting physician certification with in-hospital procedural complication rates following ICD implantation. Conclusion: Overall, implantations by a nonelectrophysiologist were associated with a higher risk of procedural complications and lower likelihood of receiving a CRT-D device when indicated compared with patients whose ICD was implanted by an electrophysiologist.”|
|Freeman J,Wang Y,Curtis J, et al. The relation between hospital procedure volume and complications of cardioverter-defibrillator implantation from the implantable cardioverter-defibrillator registry. J Am Coll Cardiol.2010 Sep 28;56(14):1133-9.||Aim: Assess the relationship between hospital ICD implantation volume and procedural complications. Conclusion: “Patients who have an ICD implanted at a high-volume hospital are less likely to have an adverse event associated with the procedure than patients who have an ICD implanted at a low-volume hospital.”|
|Al-Khatib S,Hellkamp M, Curtis J, et al. Non–evidence-based ICD implantations in the United States. JAMA.2011;305(1):43-49.||Aim: Determine the number, characteristics, and in-hospital outcomes of patients who receive a non-evidence-based ICD and examine the distribution of these implants by site, physician, specialty, and year of procedure. Conclusion: “A substantial number of ICDs were implanted in patients who were similar to those who either were excluded from major clinical trials of primary prevention ICDs or shown not to benefit from ICD therapy in other trials. Such patients not only have more comorbidities than patients receiving an evidence-based device, but they are at a higher risk of in-hospital death and any post-procedure complication.” They also found no clear decrease in the overall number of non–evidence-based ICD implants over time. Thus the authors conclude that more effort is needed to improve physician adherence to evidence-based practice.|
A significant portion of this Decision Memo was dedicated to detailing public comments received and CMS responses. The following table highlights comments and responses related to the “minimal changes” being made.
|CMS Responses to Public Comments|
|Shared Decision Making (SDM)||Comment: Disagreement with who must provide SDM and providing the SDM at all “stating informed consent would be sufficient for the patient.” Response: “We believe that a SDM encounter prior to initial ICD implantation is a critical step in empowering patient choice in their treatment plan….the strength of evidence for an ICD benefit is different for different patient populations. As mentioned in the Analysis section of this decision memo, the joint 2017 guidelines by AHA/ACC/HRS state that “In patients with VA [Ventricular Arrhythmia] or at increased risk for SCD, clinicians should adopt a shared decision-making approach in which treatment decisions are based not only on the best available evidence but also on the patients’ health goals, preferences, and values,” topics that are not typically covered when obtaining informed consent. The SDM interaction requires the use of an evidence-based tool to ensure topics like the patients’ health goals and preferences are covered before ICD implantation. We want to ensure that the patient receives more information than the risks and benefits of the procedure. We also recognize that requiring a SDM encounter with an “independent” physician or non-physician professional could create unnecessary burden, so we have decided to remove the word “independent” from the SDM requirement. In order to provide flexibility for this requirement, we are indicating that the SDM interaction may occur at a separate visit. Comment: Request for clarification around what is considered an “evidenced-based decision tool.” Response: CMS believes in the importance of an evidenced based tool but they are not specifying the type of tool that is required. They do provide an example of an evidence based decision aid for patients with heart failure who are at risk for sudden cardiac death and are considering an ICD. This tool was funded by the National Institutes on Aging and the Patient-Centered Outcomes Research Institute and can be found at https://patientdecisionaid.org/wp-content/uploads/2017/01/ICD-Infographic-5.23.16.pdf. CMS notes that this tool is based on published clinical research and interviews with patients and includes discussion of the option for future ICD deactivation. Comment: Suggestion that SDM encounter be required for all ICD indications. Response: CMS encourages an SDM encounter for all covered indications. However, they “only require a SDM interaction for certain patient populations to limit the added burden of this interaction.”|
|Removal of New York Heart Association (NYHA) Class IV Indication for CRT||Comment: Request for clarification of what is meant by the statement of removing the NYHA Class IV Indication for CRT and does this signify intent to create a separate coverage decision for CRT. Response: “We believe CRT is a separate therapy and should be evaluated in a distinct determination. Because there is no national coverage criteria for CRT, we have removed this section from the NCD on ICDs. At this time, CMS has not proposed to open a separate NCD on CRT.”|
|MRI for Evaluating LVEF||Comment: Several commenters supported this addition. One suggested including a Cardiac MRI for evaluation of ventricular scarring or infiltration as a finding supporting the indication for an ICD. Response: “There is strong evidence supporting the addition of cardiac MRI to our list of modalities that may be used to evaluate LVEF. Our focus here is on depressed LVEF as it is an important, trial-based risk factor for SCD in patients who have no history of documented cardiac arrest or life-threatening ventricular tachyarrhythmia. We recognize that MRI as well as other diagnostic tests may be useful in the clinical work up of such patients, but we are not mandating which tests should be used for which patients, or when in the course of their clinical evaluation.”|
|Optimal Medical Therapy (OMT)||Comment: There was a comment to remove this requirement for Ischemic Dilated Cardiomyopathy. Response: “We believe that the evidence is equivocal on whether patients with ischemic cardiomyopathy and systolic heart failure would benefit from a new requirement for at least 3 months of OMT alone prior to ICD placement, if they otherwise met criteria for an ICD. We thus accept this recommendation to split the ischemic and nonischemic categories, and to apply the 3 month OMT requirement to the nonischemic heart failure population, but not to the ischemic population.” Comment(s): Several commenters expressed concern about this being a requirement at least 3 months before implantation as this may not be possible for some patients due to not tolerating medications. One commenter suggested the wording “clinicians must have tried for at least three months to optimize medical therapy to the extent tolerated by the patient.” Response: “We understand this concern and appreciate these comments. OMT must be tailored to the patient. If a patient cannot tolerate a given medication, then that medication is not optimal medical therapy for that patient. We also note that the evidence for ICDs is based on chronic stable patients and based on the best available evidence do not believe ICDs should be implanted prior to the completion of three months of OMT for patients with non-ischemic dilated cardiomyopathy whose condition continues to worsen during that time. Therefore, we are not making any changes to the wording of the OMT requirement.”|
|Subcutaneous ICD||Comment: There was one comment suggesting the NCD specifically address indications for the subcutaneous ICD. Response: “The coverage indications in this NCD apply to subcutaneous ICDs.”|
|Covered Indications||There were several comments specific to the Covered Indications for ICD placement. Following are some of the key Responses provided in the Decision Memo: Response: We are re-wording the phrase “uncontrolled supraventricular tachycardia such as from atrial fibrillation” to “supraventricular tachycardia such as atrial fibrillation with a poorly controlled ventricular rate,” as this clarifies that a patient would not be automatically excluded if they have atrial fibrillation. Response: In response to a suggestion that discontinuing the data collection requirement would eliminate coverage for ICDs for the primary prevention of sudden cardiac death, CMS responded by noting that “ICDs for the primary prevention of sudden cardiac death will be covered under the indication for “patients who have severe ischemic and/or non-ischemic dilated cardiomyopathy but no personal history of sustained ventricular tachyarrhythmia or cardiac arrest due to ventricular fibrillation. Response: In response to a suggestion that “significant, irreversible brain damage” could be too subjective, CMS responded by noting that “the phrase “significant, irreversible brain damage” listed as part of the exclusion criteria is consistent with wording in the 2005 NCD, and with trial exclusion criteria and medical society clinical guidelines. We believe clinicians fully understand that this exclusion, for example, applies to comatose patients in a vegetative state, but may not apply to all patients with persistent speech or motor dysfunction as a result of a prior stroke, but who otherwise meet criteria and are good candidates for ICD placement. We do not believe patients or clinicians would benefit by more granular definition.”|
Patient Shared Decision Making
In addition to the example SDM tool for ICDs, CMS notes that a website was also developed “which leads patients step-by[step through some information on ICDs designed to increase patients’ knowledge of their medical condition, the risks and benefits of available treatments and to empower patients to become more involved in the decision-making process. https://patientdecisionaid.org/icd/.
CONSIDERATIONS MOVING FORWARD
Shared Decision Making
There are now 6 covered indications listed in the NCD. All patients receiving an ICD for primary prevention must be provided SDM. “For these patients…a formal shared decision making encounter must occur between the patient and a 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. The shared decision making encounter may occur at a separate visit.”
Questions to Consider:
- Who will be the healthcare provider to provide the SDM encounter?
- What tool will you utilize?
- When will this SDM be done? For example, the patient meeting Pacemaker and ICD indications that has been admitted for an AMI, Stent or CABG and placement is advised prior to the patient’s discharge.
- Since the SDM encounter can occur at a separate visit, what will be your process to make sure this information makes it into the medical record when the patient receives an ICD?
Optimal Medical Therapy
Patients who have severe non-ischemic dilated cardiomyopathy but no personal history of sustained ventricular tachyarrhythmia or cardiac arrest due to ventricular fibrillation must have been on optimal medical therapy (OMT) for at least 3 months prior to ICD placement.
Questions to Consider:
- Who is the healthcare provider providing optimal medical therapy? Is it a patient’s Internal Medicine Doctor, Cardiologist, Electrophysiologist?
- Similar to SDM, what will be your process to make sure this information makes it into the medical record when the patient receives an ICD?
MMP strongly encourages key stakeholders take the time to read the entire Decision Memo.
Article by Beth Cobb
Beth Cobb, RN, BSN, ACM, CCDS, is the Manager of Clinical Services at Medical Management Plus, Inc. Beth has over twenty-five years of experience in healthcare including eleven years in Case Management at a large multi-facility health system.
This material was compiled to share information. MMP, Inc. is not offering legal advice. Every reasonable effort has been taken to ensure the information is accurate and useful.