Cardiology Coding Alert

Hint: For all patient indications, the patient must be clinically stable.

Your cardiologist replaces an existing single chamber implantable defibrillator pulse generator with a new dual chamber defibrillator, new RV lead, and existing RA lead for a Medicare patient. It seems like this should be a fairly straightforward service to report, so you submit 33241and 33249 on your claim.

But, Medicare rejects your claim. What went wrong?

First, Understand Background of ICDs

If you bill for implantable cardioverter defibrillators (ICDs), you must be aware of new change request (CR) 10865 and Publication (Pub.) 100-03 from the Medicare national coverage determination (NCD) Manual, which details CMS’s final decision about the reconsideration of NCD 20.4, ICDs. In this NCD, CMS very specifically outlines six patient indications where it will cover ICDs.

ICDs will be covered, effective for claims with dates of service on or after February 15, 2018, according to MLN Matters®. The implementation date is February 26, 2019.

ICDs defined: Cardiologists use ICDs to diagnose and treat life-threatening ventricular tachyarrhythmias (VTs). Implantable defibrillator systems include a pulse generator and electrodes, like a pacemaker system, according to the CPT^® guidelines.

“This therapy has been shown in trials to improve survival and reduce sudden cardiac death in patients with certain clinical characteristics,” according to MLN Matters®.

CMS first issued an NCD in 1986 that provided limited coverage of ICDs. Over the past 32 years, CMS has expanded its original ICD policy, and the last time this NCD was reconsidered was 2005.

Observe First Patient Indication for ICDs

For the first indication, Medicare will cover ICDs for patients who have a personal history of sustained VT or cardiac arrest because of a ventricular fibrillation (VF). As part of this condition, the patient must have also experienced:

• A sustained VT episode, which can be either spontaneous or the cardiologist can induce the episode with an electrophysiology (EP) study. However, the patient’s VT episode cannot be associated with an acute myocardial infarction (MI). Additionally, the patient’s VT episode cannot be because of a transient or reversible cause; or
• A cardiac arrest episode caused by VF. However, this type of episode does not qualify for coverage if it was due to a transient or reversible cause.

Catch These Additional 5 Conditions for Coverage

Medicare will also cover ICDs for the following five types of patient indications:

• For the second indication, ICDs will be covered for patients who have experienced a prior MI and a measured left ventricular ejection fraction (LVEF) ≤ 0.30. Also, this type of patient must not have New York Heart Association (NYHA) classification type IV heart failure.
• To meet the third condition, patients who have severe, ischemic dilated cardiomyopathy, but no personal history of sustained VT or cardiac arrest caused by VF, qualify for coverage. Additionally, patients must have NYHA Class II or III heart failure, LVEF < 35%.
• To meet the fourth condition, 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%, qualify for coverage. In addition, these patients must have been on optimal medical therapy for at least three months.

Additional criteria: For the patients who meet the criteria listed in conditions two through four, “a formal shared decision-making encounter must occur between the patient and a physician (as defined in Section 1861(r)(1) of the Act) or qualified non-physician practitioner (meaning a physician assistant, nurse practitioner, or clinical nurse specialist as defined in Section 1861(aa)(5) of the Act) using an evidence-based decision tool on ICDs prior to initial ICD implantation,” according to MLN Matters^®. “The shared decision-making encounter may occur at a separate visit.”

Don’t miss: Also, for the above patient indications, two, three, and four, in addition to the above mentioned conditions, to qualify for ICD coverage, patients must not have experienced the following:

• A coronary artery bypass graft (CABG) or percutaneous coronary intervention (PCI) with angioplasty and/or stenting within the past three months; or,
• An MI within the past 40 days; or,
• Clinical symptoms and findings that make them a coronary revascularization candidate.

Exceptions to the rule: There are several exceptions for the waiting periods for patients who have experienced a CABG or PCI with angioplasty and/or stenting within the past three months, or who have experienced an MI within the past 40 days, according to MLN Matters®:

• Cardiac Pacemakers: If a patient meets all of the coverage requirements for cardiac pacemakers, and he also meets the ICD NCD 20.4 criteria, he may receive the combined devices in one procedure, when the pacemaker is clinically indicated.
• Replacement of ICDs: Patients with an existing ICD may receive an ICD replacement if it is mandatory because its battery life ended, an elective replacement indicator (ERI), or device/lead malfunction.

Condition 5: For the fifth condition, ICDs are covered for patients who have documented familial or genetic disorders with a high risk of life-threatening tachyarrhythmias. These disorders include but are not limited to long QT syndrome or hypertrophic cardiomyopathy. Similar to patient indications two through four, this fifth condition also requires a formal shared decision-making encounter between the patient and physician or qualified non-physician practitioner.

Condition 6: Lastly, patients with an existing ICD may receive an ICD replacement if it is required because its battery life ended, an elective replacement indicator (ERI), or device/lead malfunction.

Make Sure All Six Types of Patients Meet These Additional Criteria

Along with the already mentioned indications, all of the six patient indications must also meet the following additional criteria to qualify for ICD coverage, according to MLN Matters®:

• The patient must be clinically stable.
• The cardiologist must measure the patient’s LVEF using echocardiography, radionuclide imaging, cardiac magnetic resonance imaging (MRI), or catheter angiography.
• The patient cannot have significant, irreversible brain damage; any disease, other than cardiac disease associated with a likelihood of survival rate less than one year; or supraventricular tachycardia with a poorly controlled ventricular rate.

Putting it All Together

Now, let’s look at the example where the cardiologist performed a 33241-XU (Removal of implantable defibrillator pulse generator only) and 33249 (Insertion or replacement of permanent implantable defibrillator system with transvenous lead(s), single or dual chamber) service.

Unlike the original patient, for this new patient, you read in the medical documentation that the patient has hypertrophic cardiomyopathy. You also see that the cardiologist engaged in a formal shared decision-making encounter with the patient where he used an evidence-based decision tool on the ICD before the initial implantation.

Also, the cardiologist documented that the patient is clinically stable, and he does not have significant, irreversible brain damage; any disease, other than cardiac disease associated with a likelihood of survival rate less than one year; or supraventricular tachycardia with a poorly controlled ventricular rate.

Additionally, the cardiologist has measured the patient’s LVEF with catheter angiography.

As you can see, this patient falls under the fifth patient condition for ICD coverage under NCD 20.4, so your claim should not be denied.

Reminder: Always keep in consideration the primary (Modifier Q0 or Q1, ICD-10-CM Z00.6, and CMS ICD registry) vs. secondary prevention coding rules and regulations, explains Christina Neighbors, MA, CPC, CCC, Coding Quality Auditor for Conifer Health Solutions, Coding Quality & Education Department, and member of AAPC’s Certified Cardiology Coder steering committee.

Keep in mind the ERI replacement first listed Z45.02 (Encounter for adjustment and management of automatic implantable cardiac defibrillator) doesn’t require the primary prevention modifier, Neighbors continues. However, it’s still recommended to append modifier Q0 or Q1 when primary prevention is documented. Also, it’s not uncommon that a patient receives a defibrillator initially for primary prevention. Then, many years later, the patient’s medical conditions worsen, and the device now falls under the secondary prevention criteria.