DRG 226 and 227 Cardiac Defibrillator Implant without Cardiac Catheterization with/without MCC

An implantable cardioverter defibrillator (ICD) is an electronic device designed to diagnose and treat life-threatening ventricular tachyarrhythmias. 

Medicare defines the requirements for coverage of an ICD insertion in National Coverage Determination (NCD) 20.4, Implantable Automatic Defibrillators. The use of ICDs may be considered reasonable and necessary for patients meeting the criteria below. (This list is not all-inclusive. Please refer to NCD 20.4 for complete guidance.)

1. Patients with a personal history of sustained Ventricular Tachyarrhythmia (VT) or cardiac arrest due to Ventricular Fibrillation (VF)
2. Patients with a prior MI and a measured Left Ventricular Ejection Fraction (LVEF) ≤ 0.30
3. Patients who have severe, ischemic, dilated cardiomyopathy but no personal history of sustained VT or cardiac arrest due to VF, and have NYHA Class II or III heart failure, LVEF ≤ 35%
4. Patients who have severe, non-ischemic, dilated cardiomyopathy but no personal history of cardiac arrest or sustained VT, NYHA Class II or III heart failure, LVEF ≤ 35%, been on optimal medical therapy for at least three (3) months
5. Patients with documented, familial, or genetic disorders with a high risk of life-threatening tachyarrhythmias (sustained VT or VF, to include, but not limited to, long QT syndrome or hypertrophic cardiomyopathy
6. Patients with an existing ICD may receive an ICD replacement if it is required due to the end of battery life, Elective Replacement Indicator (ERI), or device/lead malfunction

For these patients identified in items 2 through 5 above, a face-to-face encounter between the beneficiary and a physician using an evidence-based formal ICD decision tool to support the implanted ICD must be performed prior to implantation of the device. Providers should maintain record of the shared decision making (SDM) tool used within the patient’s medical record when these services are performed. The tool used should be named and results of tool noted within documentation. 

Shared decision-making (SDM) involves the following:

•  An encounter must occur between the patient and a physician or qualified nonphysician practitioner
  • Physician assistant
  • Nurse practitioner
  • Clinical nurse specialist
• Evidence-based decision tool
  • Anticoagulant Care Planning (ACP) AF Management Guide
  • National Institute for Clinical Excellence (NICE) Patient Decision Aid on AF Treatment Options, American College of Cardiology (ACC) Cardiosmart’s AF Treatment Options
  • SPARC — Stroke Prevention in Atrial Fibrillation Risk Tool
  • Healthwise Decision Tool

Keep in mind SDM is not just informed consent. “SDM has the patient at the center and is much more structured, evidence-based and importantly interactive with bilateral exchange of information compared to informed consent.” 

Medical record documentation maintained by the physician must substantiate the medical need for services provided and must include the following (this list is not all inclusive):

• Records of patient's condition before, during and after submitted billing period to support medical necessity and reason services were provided
  • History and physical, progress notes, office visit notes, cardiology consultations and all other pertinent medical records
• Documentation to support patient does not have irreversible brain damage from preexisting cerebral disease
• Documentation of the history and duration of unsuccessful medical management
• Diagnostic test results/reports to support any applicable cardiac findings such as ventricular arrhythmia, the LVEF, a prior MI or prior cardiac intervention
• Complete legible operative report outlining operative approach used and all the procedure components performed that includes sufficient detail to
  allow reconstruction of ICD insertion
• Signature log or signature attestation for any missing or illegible signatures within the medical record (all personnel providing services)

Resources

• Decision Memo for Implantable Cardioverter Defibrillators (CAG-00157R4)
• National Coverage Determination (NCD) for Implantable Automatic Defibrillators (20.4)
• Medicare Learning Network (MLN) Matters MM 10865 — NCD 20.4 Implantable Cardiac Defibrillators (ICDs) (PDF)
• Medicare Learning Network (MLN) Matters SE 2006 — NCD 20.4 Implantable Cardiac Defibrillators (ICDs) (PDF)
• Local Coverage Article: Billing and Coding: Implantable Automatic Defibrillators (A56343)