The CMS A/B Medicare Administrative Contractor's (MAC's) responsibility is to ensure compliance with Medicare National Coverage Determinations (NCDs) at the local jurisdictional level. Upon review of claim sampling, Noridian has observed errors in billing and coding for items/services discussed in NCD 20.8.4 Leadless Pacemakers, which became effective January 18, 2017. While most providers are following NCD coverage requirements, at the time of this instruction, Noridian has identified CPT/HCPCs codes that require updating as well as a few new CPT/HCPCs codes representing leadless pacemakers that would fall under the same NCD requirements. As a result, Noridian is providing the following billing and coding guidance to assist in meeting the requirements set forth by this NCD as well as to supplement information provided in the Medicare Claims Processing Manual (MCPM), Chapter 32, Section 380. This guidance will be reviewed periodically for any further CPT/HCPCs coding information that may become available.
As per NCD 20.8.4, “Effective for dates of service on or after January 18, 2017, contractors shall cover leadless pacemakers through Coverage with Evidence Development (CED) when procedures are performed in CMS-approved CED studies.”
The list of CMS-approved CED studies can be found on this link: Leadless Pacemakers | CMS
In addition, all items/services provided to Medicare beneficiaries must also meet Reasonable and Necessary Requirements as per the Social Security Act 1862 (a)(1)(A) and Medicare Program Integrity Manual Chapter 3, Section 3.6.2.2; as well as any other pertinent Medicare rules and regulation.
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 clinical trial identifier in item 23 of the CMS-1500 form or the electronic equivalent
If the required billing and coding elements are not found on the claim, the claim is subject to rejection as unprocessible or as a denial.
Reminder: the 8-digit clinical trial identifier must be on the list of CMS-approved CED studies to meet the NCD requirement.
Coding Information
This billing and coding article pertains to the initial placement or replacement of a leadless pacemaker. CPT/HCPCS codes representing removal only (without replacement) as well as programming/device evaluation codes are not relevant to this article.
