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NCD 20.4 Implantable Cardiac Defibrillators (ICDs)

Published on 

Tuesday, December 4, 2018

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It’s hard to believe that Thanksgiving is almost two weeks ago now and there are only nineteen shopping days left until Christmas. CMS provided what one could potentially call a gift depending on your point of view when they finally published Change Request (CR) 10865 on November 21st related to the ICD Final Decision Memo published early this year.  

Background

CMS posted a Final Decision Memo on February 15, 2018 for the National Coverage Determination (NCD) for Implantable Automatic Defibrillators (20.4). The Decision Memo finalized what CMS described as “minimal changes” to the ICD NCD from the 2005 reconsideration.

Decision Memo: Summary of the Changes

Patient Criteria

  • 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

November 21, 2018: CMS Releases Change Request (CR) 10865

Chapter 13, section 13.1.1 of the Medicare Program Integrity Manual indicates “the decision outlined in the Coverage Decision Memo will be implemented in a CMS- issued program guidance instruction within 180 days of the end of the calendar quarter in which the memo was posted on the Web site.” The end of September came and went with no program guidance.

CMS finally published CR 10865 on November 21, 2018. This CR includes updates made to the Medicare National Coverage Determinations Manual, Chapter 1, Part 1 for NCD 20.4 Implantable Cardioverter Defibrillators (ICDs).

It is important to note that “a subsequent CR will be released at a later date that contains a Pub.100-04 Claims Processing Manual update with accompanying instructions. Until that time, the Medicare Administrative Contractors (MACs) shall be responsible for implementing NCD 20.4.”

Shared Decision Making, a Deeper Dive

A significant portion of the February Decision Memo was dedicated to detailing public comments received and CMS responses. The following table highlights comments and responses specific to the new SDM criteria.   

Shared Decision Making (SDM)
Public CommentCMS Response
Disagreement with who must provide SDM and providing the SDM at all “stating informed consent would be sufficient for the patient.”“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.
Request for clarification around what is considered an “evidenced-based decision tool.”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.

Suggestion that SDM encounter be required for all ICD indications.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.”

In addition to the example SDM tool for ICDs, CMS made note of a website for patients with heart failure designed to lead them through information on ICDs to increase knowledge of their medical condition, the risks and benefits of available treatments and to empower the patient to become more involved in the decision-making process. https://patientdecisionaid.org/icd/.

Considerations Moving Forward

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 for the patient undergoing an ICD placement?

Optimal Medical Therapy, a Deeper Dive

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. The following table highlights comments and responses specific to the new OMT criteria. 

Optimal Medical Therapy (OMT)
Public CommentCMS Response
There was a comment to remove this requirement for Ischemic Dilated Cardiomyopathy“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.”
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.”“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.”

‍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?

CR Implementation Date: February 26, 2019

It is up to you to decide if the 2019 implementation date is an early gift from CMS or a potential lump of coal for those that have not begun to prepare for the changes. Either way, MMP will be on the lookout for the subsequent Change Request specific to the Medicare Claims Processing Manual and accompanying instructions and encourages key stakeholders to put processes in place now to meet the new NCD requirements.  

Article Author:

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.