Whenever there is a high-cost item, CMS has historically evaluated usage to determine appropriateness of billing and this is another example. A Decision Memo was released on February 15, 2018 which included the following changes:
- Changes to who qualifies for a device and the required waiting periods
- Patient registry no longer required
- Cardiac magnetic resonance imaging (MRI) added as an acceptable measure for determining the left ventricular ejection fraction
- Patients who are having ICD placed for prevention, must have a "Shared Decision-Making" encounter
While removing the requirement for patient registries will reduce some administrative burden, the addition of the shared decision-making encounter requirement does present a significant change which will require changes to procedural processes. The memo states:
“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.” - Decision Memo for Implantable Cardioverter Defibrillators (CAG-00157R4)
Watch for payer policy changes relating to this decision memo and take this time to begin reviewing policies and procedures. Review the shared decision-making requirements and review evidence-based decision tools to determine which will be used by your organization. Be sure your organization implements new procedures to ensure that all required elements are met to ensure continued reimbursement.