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FUTURE LCD Reference Article Response To Comments Article

Response to Comments: Temporary Nontherapeutic Ambulatory Cardiac Monitoring Devices

A60428

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Article ID
A60428
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Article Title
Response to Comments: Temporary Nontherapeutic Ambulatory Cardiac Monitoring Devices
Article Type
Response to Comments
Original Effective Date
06/21/2026
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The comment period for Temporary Nontherapeutic Ambulatory Cardiac Monitoring Devices (DL40255) Local Coverage Determination (LCD) began on 09/25/2025 and ended on 11/08/2025. The notice period for L40255 begins on 05/07/2026 and will become effective 06/21/2026.

This article addresses comments received by Noridian Healthcare Solutions, CGS Administrators, and Palmetto GBA during the open comment period for this LCD. The comments below were received from the provider community.

Response To Comments

Number Comment Response
1

Nearly all commenters urge explicit coverage for a broader set of clinical indications, including dizziness, syncope, bradycardia, nocturnal arrhythmias, heart block (especially post-valve), device reprogramming, silent myocardial ischemia, post-ablation/ACS monitoring, and cryptogenic stroke. They recommend alignment with FDA-cleared uses and professional society guidelines.

Our coverage indications were based on careful review of available evidence. The covered indications and associated diagnosis codes with adequate evidence where patients would be expected to be symptomatic are already included in the policy’s coverage criteria. The LCD is intentionally structured around the clinical purpose of monitoring (e.g., diagnosis or management of arrhythmia), rather than listing every specific management scenario. Monitoring to regulate medication management encompasses assessment of heart rate control in atrial fibrillation when clinically indicated. Indications addressed within the National Coverage Determination (NCD) 20.15 take precedence over Local Coverage Determinations (LCDs), as the NCD establishes uniform coverage standards at the national level. If an indication—such as post-myocardial infarction monitoring—is included within the scope of the NCD, it is inherently a covered indication within our jurisdiction as well. Routine monitoring in the absence of treatable symptoms is considered screening and is not medically necessary. Several suggested codes inadvertently missed in the Billing & Coding article have been added to the Group 1 diagnosis codes.
2

Multiple stakeholders request the addition of omitted ICD-10-CM codes, especially for chronic ischemic heart disease (I25.x), cardiomyopathies (I42.x, I43.x), conduction disorders/arrhythmias (I44.x, I45.x, I47.x, I49.x), congenital/structural heart disease (Q20.x, Q21.x, Q24.x), symptom-only findings (R00.8, R06.01, R10.13), sleep apnea (G47.33), stroke (I63.9), and unspecified codes. Many urge harmonization with the Novitas LCD and coding article.

Additional diagnosis codes which fit with established coverage outlined in the policy, and with adequate supporting evidence have been added to the policy and Billing & Coding article. Sleep apnea diagnoses (e.g., G47.33) were considered; however, obstructive sleep apnea alone is not a covered indication under this LCD. TNACMD coverage requires an arrhythmia-related clinical indication consistent with the coverage criteria, and routine monitoring absent such indication is considered screening and not medically necessary.
Please also see Response 1.
Coverage is based on statutory requirements and the reasonable and necessary standard as outlined in §1862(a)(1)(A) of the Act.

The Novitas policy (at the time of this publication) addresses some implantable device codes which is beyond the scope of this policy therefore some variations are to be expected.
3

Commenters requested clarification and opposed 24-hour monitoring station and emergency notification requirements to all device types. Commenters recommend limiting these requirements to mobile cardiac telemetry (MCT/MCOT) devices, not to Holter or extended-wear patch monitors. Many requests clarification that monitoring stations are typically staffed by ECG technicians or non-physician staff, not critical care nurses or paramedics, and that technicians should have access to physicians for review, not direct patient management.

The intention is not to apply MCT-specific requirements to all device types. Editorial changes clarify that devices must meet applicable FDA and CPT definitions for their type.
Device requirements have been clarified to require devices meet their applicable CPT coding requirements and FDA device type requirements as applicable.
Emergency notification requirements only apply where clinically and technically appropriate, consistent with FDA clearance and CPT coding.
Language has been revised to accurately reflect device capabilities and FDA-cleared indications.
Receiving station definition and technician staffing have been clarified in the LCD.
4

Commenters object to strict limits on repeat testing (e.g., only one test per year or 30-day packaged service), arguing for physician discretion and allowance for repeat or extended monitoring when clinically justified. There are also requests for clarification on when standard ECG versus ambulatory monitoring is appropriate, and for moving some limitations to the coverage section.

As acknowledged by the policy and commenters, repeat testing is expected to be rare. Repeat or extended testing must be justified by the treating physician; policy language reflects this.
Language has been edited to clarify that overlapping billing is not permitted.
The policy does not define use cases for standard ECG; it focuses on coverage for TNACMD based on evidence.
Limitation 3 (receiving station) has been clarified to apply only where appropriate.
Documentation requirements have been clarified and expanded in the Billing & Coding article.
5

Multiple commenters recommend aligning device type descriptions with CPT code definitions, to avoid confusion and ensure clarity for providers.

Edits have been made for clarity, and a table has been added to the Billing & Coding article to appropriately list device types with their codes and descriptions.
Device type language has been clarified in the LCD.
6

Requests to clarify documentation requirements and coding practices, especially for outpatient diagnostic services and use of unspecified codes during diagnostic workup.

Documentation requirements as listed in the Billing & Coding article are based on the coverage criteria as outlined in the policy and applicable general guidance for documentation requirements.
More extensive documentation requirements were added to the Billing & Coding article to clarify required documentation for TNACMD services.
7

One commenter raised several unique requests in their comment letter. They advocated for the inclusion of “evidence of systemic emboli” as a covered indication, emphasizing its clinical relevance for arrhythmia monitoring. Additionally, ACC requested explicit coverage for the “assessment of rate control in atrial fibrillation,” monitoring before and after reprogramming of implantable cardioverter defibrillators (ICDs), and evaluation of asymptomatic premature ventricular contractions (PVCs) in patients at risk for PVC-mediated cardiomyopathy. These requests reflect nuanced clinical scenarios that may not have been highlighted by other commenters.

Policy expanded to include systemic emboli, with arterial embolism codes (I74.*) added. Direct evidence specifically for ambulatory cardiac monitoring in non-stroke systemic emboli is limited, as most published trials and guidelines focus on cryptogenic stroke or transient ischemic attack. However, the underlying rationale—detecting occult atrial fibrillation as a cardioembolic source—applies to other systemic embolic events.
Assessment of rate control in AF is already included in coverage criteria, supported by guidelines and evidence.
Routine use of external monitors after ICD reprogramming is not generally indicated, but is covered when device data are insufficient or symptoms persist; relevant codes are included.
PVC-mediated cardiomyopathy is already included in coverage criteria.
8

One commenter made specific recommendations to broaden the policy’s scope. They requested coverage for “obstructive sleep apnea” as an indication for cardiac monitoring, and suggested reclassifying certain channelopathies (such as long QT syndrome, Brugada syndrome, Catecholaminergic Polymorphic VT, Early Repolarization Syndrome, Short QT Syndrome, Idiopathic Ventricular Fibrillation, and Isolated Progressive Cardiac Conduction Disease) to ensure comprehensive coverage. Additionally, they advocated for the inclusion of “abnormal electrocardiogram” (R94.31) as a covered diagnosis code, recognizing its importance in the diagnostic workup for arrhythmias.

Please see Responses 1 and 2. Policy and coding have been updated where evidence supports inclusion.
9

One comment letter included several unique coding requests. They recommended coverage for “personal history of corrected congenital malformations of heart and circulatory system” (Z87.74), “repeated falls” (R29.6), “personal history of sudden cardiac arrest” (Z86.74), “long term (current) use of anticoagulants” (Z79.01), and “postoperative state without active complications” (Z98.890). These codes reflect scenarios where cardiac monitoring may be clinically justified but are not universally addressed in other stakeholder comments.

Please see Response 1. Policy and coding have been updated where evidence supports inclusion.
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Associated Documents

Medicare BPM Ch 15.50.2 SAD Determinations
Medicare BPM Ch 15.50.2
Related National Coverage Documents
NCDs
20.15 - Electrocardiographic Services
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