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  "documentTitle": "iRhythm Technologies, Inc. (IRTC)",
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      "kind": "callout",
      "text": "The Oft-Referenced CAMELOT Study Needs to be Qualified: Excerpts From the Aetna Clinical Policy Bulletin on Cardiac Event Monitors",
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      "text": "The authors stated that these findings had several drawbacks.",
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      "text": "iRhythm frequently references research, much of which it has funded, that it claims supports its assessments of product superiority and value-add. The 2024 CAMELOT study, in particular, is heavily touted. However, we believe the objective review of that study contained in the Aetna Clinical Policy Bulletin on Cardiac Event Monitors contains important qualifications and highlights some of the limitations of that study that investors should understand.",
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      "text": "The authors stated that these findings had several drawbacks. First, the findings were observational and retrospective. This study was carried out in a sample of Medicare beneficiaries; results may not be generalizable to other populations, such as patients who are uninsured, enrolled in commercial or Medicare Advantage healthcare plans, or are aged less than 65 years. Second, the choice of ACM was decidedly not random and likely influenced by a number of patient, provider, and system factors, any of which could have served as confounders in this analysis. Although these investigators tried to account for clustering using hospital referral regions (HRRs) cross-walked from the patient's ZIP code, they did not have institutional identifiers to account for differences at the institutional level within the HRR. These researchers were unable to adjust for the duration of monitoring, as the actual wear time for monitors was not available in the claims beyond the minimum duration needed to meet the CPT code reimbursement criteria. Third, inherent limitations exist in the use of claims data. Identification of conditions was based on diagnosis codes which requires that they were actually coded. A recorded diagnosis code does not confirm the presence of disease, given that diagnosis codes may be recorded improperly or as a rule-out criterion. However, the authors would not expect disease coding or ascertainment to systematically differ across device types. Fourth, these researchers set the analytic start date using claims with CPT codes in part to facilitate the identification of device manufacturer with National Provider Identifier (NPI). The potential time-to-event bias was mitigated by examining only odds of encounter diagnosis yield and ACM re-testing through the 90- and 180-day post-index periods, respectively, rather than a time-to-event analysis. Due to different billing models, it was possible that some brand specific devices could be mis-classified as “LTCM other”, although this was expected to be far less common in Medicare or other fee-for-service claims than in a managed care population. Fifth, although a difference-in-difference analysis could identify relative differences in utilization and cost trajectories, which was the objective of this analysis, the healthcare resource utilization (HCRU) and cost outcomes were unadjusted. Sixth, this study was not designed to examine the mechanism (mediator or moderator) of outcomes. For example, the authors did not examine non-ACM testing (e.g., electrocardiogram, cardiac imaging, stress test) on diagnostic yield, ACM retesting, or utilization. This area is ripe for further investigations.",
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      "text": "The authors stated that these findings had several drawbacks. First, the findings were observational and retrospective. Second, the choice of ACM was decidedly not random and likely influenced by a number of patient, provider, and system factors. Third, inherent limitations exist in the use of claims data. Fourth, these researchers set the analytic start date using claims with CPT codes in part to facilitate the identification of device manufacturer with National Provider Identifier (NPI). Fifth, although a difference-in-difference analysis could identify relative differences in utilization and cost trajectories, which was the objective of this analysis, the healthcare resource utilization (HCRU) and cost outcomes were unadjusted. Sixth, this study was not designed to examine the mechanism (mediator or regulator) of outcomes. — Aetna Clinical Policy Bulletin on Cardiac Event Monitors",
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      "text": "Red text for Spruce Point emphasis. Source: Aetna Clinical Policy Bulletin on Cardiac Event Monitors (last reviewed 7/22/2025)",
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      "text": "iRhythm’s References To Studies Such As CAMELOT Need To Be Qualified",
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