Medicare will soon begin reimbursing physicians for inserting leadless pacemakers, provided the patient is enrolled in a CMS-approved clinical trial.
Leadless pacemakers are tiny capsules that include both the battery and generator in one self-contained unit. They are implanted directly into the right ventricle. That’s in contrast to standard pacemakers, which require a generator to be implanted in a skin pocket on the upper portion of the chest, from which leads are tunneled into the heart chambers.
Physicians should use the following CPT Category III codes to bill for implant, replacement, interrogation and programming of the new leadless pacemakers, CMS announced in
Transmittal 3815, issued July 28:
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0387T (Transcatheter insertion or replacement of permanent leadless pacemaker, ventricular)
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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)
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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)
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0391T (Interrogation device evaluation [in person] with analysis, review and report, includes connection, recording and disconnection per patient encounter, leadless pacemaker system)
In addition, CMS directs you to append modifier Q0 (Investigational clinical service provided in a clinical research study that is an approved clinical research study) to the appropriate procedure code, and report ICD-10-CM code Z00.6 (Encounter for examination for normal comparison and control in clinical research program).
The implants are payable in the following places of service (POS):
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POS 06 – Indian Health Service Provider Based Facility
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POS 21 – Inpatient Hospital
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POS 22 - On Campus-Outpatient Hospital
Notably absent from that list are POS 11 (physician’s office) and POS 19 (Off-campus provider-based department). That means physicians will need to bring the patient to an on-campus hospital for services such as device interrogation and programming in order to be paid for the service.
At the moment, there are
two CMS-approved clinical studies for leadless pacemakers, both set up earlier this year by device manufacturer Medtronic Inc. For more details about the clinical trial requirements for these procedures, see
Transmittal 201, issued July 28.
The new pacemakers are technically covered nationally effective Jan. 18 this year. However, it appears that Medicare will not be prepared to process claims for the devices until somewhat later than that. CMS is requiring Medicare administrative contractors to have local coverage determinations ready to go by Aug. 29, while the agency’s multi-carrier system (MCS) -- used by the MACs to process professional claims -- will not be prepared to deal with the codes until Jan. 2, 2018, the agency states in Transmittal 3815.