LCD Reference Article Billing and Coding Article

Billing and Coding: Leadless Pacemakers

A59819

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Draft Article
Draft Articles are works in progress and not necessarily a reflection of the current billing and coding practices. Revisions to codes are carefully and thoroughly reviewed and are not intended to change the original intent of the LCD.
NOT AN LCD REFERENCE ARTICLE
This article is not in direct support of an LCD.

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General Information

Source Article ID
N/A
Article ID
A59819
Original ICD-9 Article ID
Not Applicable
Article Title
Billing and Coding: Leadless Pacemakers
Article Type
Billing and Coding
Original Effective Date
06/06/2024
Revision Effective Date
06/06/2024
Revision Ending Date
N/A
Retirement Date
N/A

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CMS National Coverage Policy

Social Security Act SSA 1862(a)(1)(A)

Social Security Act SSA 1862(a)(1)(e)

National Coverage Determination (NCD) 20.8.4, Leadless Pacemakers

Internet Only Manual Pub 100-8; Medicare Program Integrity Manual Chapter 3, Section 3.6.2.2-Reasonable and Necessary Criteria

Article Guidance

Article Text

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. 

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Coding Information

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Bill Type Codes

Contractors may specify Bill Types to help providers identify those Bill Types typically used to report this service. Absence of a Bill Type does not guarantee that the article does not apply to that Bill Type. Complete absence of all Bill Types indicates that coverage is not influenced by Bill Type and the article should be assumed to apply equally to all claims.

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Revenue Codes

Contractors may specify Revenue Codes to help providers identify those Revenue Codes typically used to report this service. In most instances Revenue Codes are purely advisory. Unless specified in the article, services reported under other Revenue Codes are equally subject to this coverage determination. Complete absence of all Revenue Codes indicates that coverage is not influenced by Revenue Code and the article should be assumed to apply equally to all Revenue Codes.

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Other Coding Information

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Coding Table Information

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Revision History Information

Revision History Date Revision History Number Revision History Explanation
06/06/2024 R1

CLARIFICATION/CORRECTION: Billing and Coding article for NCD 20.8.4 pertains to the placement or replacement of a Leadless Pacemaker. Codes representing removal only (without replacement) and programming/device evaluation are not relevant to this article and will be removed from this list.

Codes removed from Group 1: 33275, 0824T and 0826T

Codes removed from Group 2: 0798T, 0799T and 0800T

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Associated Documents

Medicare BPM Ch 15.50.2 SAD Determinations
Medicare BPM Ch 15.50.2
Related Local Coverage Documents
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Related National Coverage Documents
NCDs
20.8.4 - Leadless Pacemakers
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Public Versions
Updated On Effective Dates Status
06/14/2024 06/06/2024 - N/A Currently in Effect You are here
05/31/2024 06/06/2024 - N/A Superseded View

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