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July 22, 2016 - Revised: 04.11.19

Removal of Implantable Devices

Automatic Implantable Defibrillators

The National Coverage Determination (NCD) 20.4, Automatic Implantable Defibrillators, outlines coverage criteria for the insertion of these devices. The NCD was silent, however, on removal of the components of these devices until CMS released a decision memo, effective February 15, 2018, which updated the NCD. Typically, the automatic implantable defibrillators consist of a generator and a lead or leads. Removal of one or both components may be medically reasonable and necessary. In the absence of medical policy, Medicare coverage of items and services defaults to the reasonable and necessary provisions of Title XVIII, Sec 1862(a)(1)(A) of the Social Security Act.

Implantable Permanent Pacemakers

The National Coverage Determination (NCD) 20.8.3, Cardiac Pacemakers: Single Chamber and Dual Chamber Permanent Cardiac Pacemakers, outlines the coverage for the insertion of permanent cardiac pacemakers. Local Coverage Article (LCA): Single Chamber and Dual Chamber Cardiac Pacemakers – Coding and Billing (A54961), provides information on how to properly bill for these devices and related services. Typically, permanent pacemakers consist of a generator and a lead or leads. Removal of one or both components may be medically reasonable and necessary. In the absence of medical policy, Medicare coverage of items and services defaults to the reasonable and necessary provisions of Title XVIII, Sec 1862(a)(1)(A) of the Social Security Act.

Device removal may be required when there are mechanical or infectious complications of one or both components of these devices. Battery replacement may also necessitate removal. Additionally, patients who require cardiac resynchronization therapy and who have an existing device without cardiac resynchronization capabilities may require removal of one or both components of the existing device in order to facilitate implantation of a new device.

Medical record documentation should support the rationale for removal of one or both components. Claims submitted which contain a generator or lead removal procedure code should be submitted with the appropriate ICD-10 diagnosis code to indicate the medical rationale for removal of the component. The choice of code(s) is dictated by the provider, but should accurately reflect what is contained in the medical record documentation. Where device component removal is necessary to facilitate a replacement of a defibrillator or pacemaker (and its components) with a cardiac resynchronization device, the medical record must document the medical need for cardiac resynchronization. In such instances, coding should indicate an encounter for the adjustment or management of an implantable cardiac defibrillator or pacemaker.

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