Cardiology Coding Alert

Hint: Make sure you include modifier Q0.

This summer, CMS released MLN Matters® MM10117 Change Request (CR) 10117 where it outlined the specifics you must include on your leadless pacemaker claims so they will not be denied.

At the beginning of the year, CMS issued a National Coverage Determination (NCD) to cover leadless pacemakers through Coverage with Evidence Development (CED). Before Jan. 18, 2017, there was no NCD in effect.

Don't miss: The implementation date for CR 10117 was Aug. 29, 2017 for local MAC system edits and Jan. 2, 2018 for shared system edits.

Review ABCs of Leadless Pacemakers

Leadless pacemakers are self-contained, enclosed capsules that include the pacemaker electronics and battery. Leadless pacemakers work similarly to traditional single-chamber ventricular pacemakers without requiring transvenous leads or a surgical pocket - the major components of a traditional pacing system.

For most patients, there are fewer medical complications and fewer post-implant activity restrictions with leadless pacemakers, according to Rebecca Sanzone, CPC, CPMA, compliance administrator at St. Vincent Medical Group/Ascension Health in Indianapolis, Indiana.

Jim Pawloski, BS, MSA, CIRCC, R.T. (R)(CV),  interventional radiology technologist/coder at William Beaumont Hospital in Royal Oak, Michigan, and coder at Adreima in Phoenix, Arizona, explains why a leadless pacemaker could be beneficial for a patient over a traditional pacemaker.

The following complications can occur with traditional pacemakers, according to Pawloski:

• A blood clot could develop in the patient's arm where the cardiologist inserted the pacer.
• Since a part of the body was opened, infection of the pacemaker and/or the leads could occur.
• In achieving venous access, the lung could be accidently punctured, resulting in a pneumothorax.

As for potential problems with traditional pacemakers, the lead could get pulled out of position, the battery could fail, the circuit could become damaged from going into an MRI machine (strong magnetic fields), or the pacemaker may not be properly programmed, Pawloski adds.

In contrast, leadless pacemakers are smaller and do not have to be tunneled or placed in a pocket, Pawloski says. The cardiologist then implants a leadless pacemaker via venous access in the groin or neck, and the pacemaker is inserted through a catheter into the right ventricle, right atrium, or both.

Additional benefits of leadless pacemakers include that since they are less invasive, there is no chest incision, scar, or bump like would result from a conventional pacemaker, says Mari Robinson, A.A.S, CPC, CRC, CCC, compliance analyst of chronic conditions at Riverside Medical Group in Newport News, Virginia. Also, leadless pacemakers adjust the patient's heart rate automatically by sensing changes in his body related to his activity level.

Include These Components to Safeguard Your Claims

According to its policy, CMS will cover leadless pacemakers when the cardiologist performs the procedures in FDA-approved studies.

Also, according to the policy, CMS will cover, in prospective longitudinal studies, "leadless pacemakers used in accordance with the FDA-approved label for devices that have either: an associated ongoing FDA-approved post-approval study or completed an FDA post-approval study."

Make sure you're aware of the following important codes to include on your leadless pacemaker claims:

CPT^® codes: Medicare will pay leadless pacemaker claims through CED when you bill them with the following procedure codes:

• 0387T, Transcatheter insertion or replacement of permanent leadless pacemaker, ventricular
• 0389T, Programming device evaluation (in person) with iterative adjustment of the implantable device to test the function of the device and select optimal permanent programmed values with analysis, review and report, leadless pacemaker system
• 0390T, Peri-procedural device evaluation (in person) and programming of device system parameters before or after surgery, procedure or test with analysis, review and report, leadless pacemaker system
• 0391T, Interrogation device evaluation (in person) with analysis, review and report, includes connection, recording and disconnection per patient encounter, leadless pacemaker system.

The procedure is considered experimental, so that's why your CPT^® choices are T-codes, according to Pawloski. This means you may not get reimbursed for the procedure and equipment for the procedure.

Caution: If you do not include the following elements on your leadless pacemaker claims, Medicare will deny or reject them:

• Z00.6 (Encounter for examination for normal comparison and control in clinical research program)
• Modifier Q0 (Investigational clinical service provided in a clinical research study that is an approved clinical research study)
• The 8-digit clinical trial identifier in item 23 of the CMS-1500 form or the electronic equivalent
• The cardiologist must also provide the leadless pacemaker service in one of the following Places of Service (POS):

            o POS 06, Indian Health Service Provider-based Facility
            o POS 21, Inpatient Hospital
            o POS 22, On Campus-Outpatient Hospital
            o POS 26, Military Treatment Facility.

Want to Submit Cleaner Claims? Remember These Details

To submit clean leadless pacemaker claims, heed the following:

• Leadless pacemakers are not covered outside of CMS-approved studies.
• Although MACs will not search their files for claims you submit for leadless pacemakers with dates of service between Jan. 18, 2017 and the CR10117 implementation date, they may adjust claims you bring to their attention.
• All clinical research study protocols must address pre-specified research questions, adhere to standards of scientific integrity, and CMS must review and approve them.