Leadless Pacemaker - JF Part B

CMS National Coverage Determination (NCD) 20.8.4 - Leadless Pacemakers includes coverage for leadless pacemakers and placement of the device when performed in CMS approved studies under Coverage with Evidence Development (CED) with certain conditions.

Locate the CMS approved CED studies and National Clinical Trials (NCT) numbers: CMS Leadless Pacemakers

The NCT indicated on the claim needs to correspond with the leadless pacemaker implanted product and correct CPT code. Refer to the Billing and Coding Article for Leadless Pacemakers for CPT codes.

Billing and Coding

The elements below are required on any claim submitted for Medicare reimbursement that falls under Coverage with Evidence Development:

• ICD-10 diagnosis code - 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
• 8-digit NCT identifier in item 19 (preceded by 'CT') on CMS-1500 claim form; or 837 P-Loop 2300, REF02, REF01 = P4 (do not use 'CT' on electronic claim)

Resources

• NCD - Leadless Pacemakers (20.8.4)
• Article - Billing and Coding: Leadless Pacemakers (A59828)