On February 2018 CMS released a Final Decision Memo making some “minimal” changes to the National Coverage Determination for ICD’s (20.4).
CMS added magnetic resonance imaging (MRI) to the list of approved diagnostic imaging studies that can be used to evaluate left ventricular ejection fraction (LVEF).
- The prior list of approved diagnostic studies was echocardiography, radionuclide (nuclear) imaging, and catheter-based angiography studies.
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. A question to consider is:
- What healthcare provider is providing the OMT (Cardiologist, Electrophysiologist or PCP)?
A shared decision making (SDM) interaction prior to implant for certain patients is required (defined in Section 1861(r)(1)). There are now 6 covered indications listed in the NCD and all patient’s receiving an ICD for primary prevention must be provided an SDM. Questions to ask are:
- What SDM tool will you be utilizing, who will be providing the SDM encounter, and when will it be performed? Additionally, how will this record be stored in the patient’s medical record?
- The patient may also be referred to a website developed to help them understand their medical condition, treatments available, and how to become more involved in the decision-making process – https://patientdecisionaid.org/icd/.
The Class IV heart failure requirement for cardiac resynchronization therapy (CRT) was removed.
An exception was added for patients that meet CMS coverage requirements for cardiac pacemakers, and who meet the criteria for an ICD.
Additionally, an exception was added for patients with an existing ICD and qualifying replacement.
Lastly, after a decade, the data collection requirement (registry) was ended.
Read the full Decision Memo for Implantable Cardioverter Defibrillators here:
https://www.cms.gov/medicare-coverage-database/details/nca-decision-memo.aspx?NCAId=288
