MDC 05 Update: Clarified MCT/ILR and CardioMEMS Criteria; Added References

Effective 03/01/2026, Baylor Scott & White Health Plan updated MDC 05 (Cardiology & Vascular) to add references and document ongoing annual review with next review due 02/26/2027. The policy clarifies coverage criteria: external loop recorders and MCT (e.g., Ziopatch®, CardioNet MCOT) are medically necessary for specified arrhythmia evaluations after nondiagnostic Holter or when symptoms are infrequent, and MCT is required to document absence of atrial fibrillation before stopping anticoagulation. Implantable loop recorders are covered when noninvasive monitoring (MCT or two 30‑day ELRs) fails and a dysrhythmia is suspected; CardioMEMS™ PAP monitoring is covered for select NYHA class III patients meeting strict clinical and anatomical criteria. Multiple consumer ECG products, alternative implantable HF monitors, pulse tachometers, and several named devices are designated investigational or not covered. The policy cites systematic reviews, trials, guideline statements, and HTAs to support coverage distinctions between CardioMEMS and other telemonitoring or consumer devices.

Summary of changes in the 02/26/2026 review

This revision (effective 03/01/2026) documents updates made 02/26/2026 and lists the next review date of 02/26/2027. The policy history shows iterative updates since the policy's inception in 2010, with the most recent entry indicating that additional references were added on 02/26/2026. The header reiterates that medical policies apply to all lines of business unless otherwise indicated and that plan documents supersede this policy when discrepancies exist.

No single consolidated change list is printed in the policy text beyond the history entry stating "Added additional references." However, the document's revision history highlights prior substantive edits such as: addition of Ziopatch ®, inclusion and later removal of retired CPT codes, added CardioMEMS criteria (02/23/2023), and alignment with CMS/TMPPM resources in prior years.

Covered ambulatory external monitors and clinical indications

Baylor Scott & White Health Plan (BSWHP) considers external intermittent cardiac event monitors (external loop recorders) medically necessary for specified clinical situations: when a dysrhythmia must be documented instead of or after a failed Holter monitor; to document response to initiation or discontinuation of antiarrhythmic drug therapy; to assess results after ablation; and to evaluate syncope, palpitations, or lightheadedness suspected to be arrhythmic when other methods have failed. External loop recorders are explicitly listed as investigational for indications outside these enumerated uses.

The policy also addresses Mobile Cardiovascular Telemetry (MCT) devices (examples include Ziopatch ® and CardioNet MCOT): MCT is considered medically necessary for ensuring absence of atrial fibrillation prior to discontinuing anticoagulation and for recurrent unexplained pre-syncope, syncope, palpitations, or dizziness when (1) dysrhythmia is suspected, (2) the member has a non-diagnostic Holter or symptoms are infrequent, and (3) other methods failed to find etiology.

Implantable loop recorder and CardioMEMS coverage criteria

BSWHP may consider an implantable loop recorder (ILR) medically necessary for recurrent unexplained pre-syncope, syncope, palpitations, or dizziness when (A) a cardiac dysrhythmia is suspected, (B) noninvasive ambulatory monitoring (either MCT or two 30‑day external loop recordings) failed to establish a diagnosis because symptoms are too infrequent/unpredictable, and (C) all other methods failed to illuminate the etiology. ILRs are considered experimental/investigational for other indications.

Separately, the policy specifies criteria for the CardioMEMS ™ implantable pulmonary artery pressure (PAP) monitor to be considered medically necessary: NYHA class III symptoms despite maximally tolerated therapy; at least one HF hospitalization in prior 12 months; ability to take dual antiplatelet or anticoagulant for one month post‑implant; age ≥ 18; HF diagnosis ≥ 3 months; PA branch diameter between 7–15 mm; BMI ≤ 35 (or chest circumference ≤ 165 cm if BMI > 35); and monitoring at least weekly. Other implantable HF monitors (e.g., Chronicle IHM, HeartPOD™, Promote® LAP) are labeled investigational/unproven.

Devices and technologies explicitly considered investigational or not covered

BSWHP identifies several specific devices and technologies as experimental, investigational, or not covered. The policy lists the Biotronik BioMonitor, Kardia Mobile (AliveCor), mobile patient management systems (e.g., BodyGuardian, iHEART), self‑monitoring ECG technologies including ViSi Mobile, and CardioPatch as investigational. Implantable loop recorders and MCT/ELR are limited to defined indications; otherwise they are investigational for other uses.

Additionally, the policy states that pulse tachometers (heart rate monitors such as Exersentry, Insta‑Pulse, MacLevy Omni Pulse) are not covered because they do not meet the plan's definition of durable medical equipment and are primarily for non‑medical or fitness use. Self‑contained pacemaker monitors and a telephone attachment for trans‑telephonic pacemaker monitoring (e.g., Pace Trac) are considered medically necessary for members with pacemakers.

Evidence base and guideline references cited in the policy

The policy cites systematic reviews, randomized trials, guideline statements, and health‑technology assessments to support coverage distinctions. For MCT versus external loop recorders the policy references an AHRQ‑commissioned review and a multicenter study (Rothman et al.) concluding that realtime continuous attended monitoring can change disease management in more patients than some ELRs, though overall evidence strength was described as weak due to limited studies. For invasive PAP monitoring, the policy references meta‑analyses (Thakker et al., 2021), NICE Interventional Procedures guidance (IPG711, 2021), ESC 2021 HF guideline remarks (strength IIb, level B for PAP monitoring), and multiple clinical studies and HTAs supporting CardioMEMS outcomes and adoption in selected patients.

The reference list spans older telemonitoring trials (TEN‑HMS, COMPASS‑HF) and multiple systematic reviews/meta‑analyses addressing telemonitoring in heart failure, reflecting the plan's differentiation between CardioMEMS (with a defined evidence base and specific device criteria) and other implantable or consumer ECG products judged investigational due to insufficient evidence of clinical outcome benefit.

OpenPayer

February 2026 Revision: Added References and Ongoing Updates

Summary of changes in the 02/26/2026 review

External Event Monitors and Mobile Cardiovascular Telemetry (`Ziopatch ®`, MCT) Coverage Criteria

Covered ambulatory external monitors and clinical indications

Implantable Devices: `Insertable Loop Recorder` and `CardioMEMS ™` Eligibility

Implantable loop recorder and CardioMEMS coverage criteria

Excluded Devices, Investigational Technologies, and Pacemaker Monitor Coverage

Devices and technologies explicitly considered investigational or not covered

Clinical Evidence and Guideline Basis Referenced in the Policy

Evidence base and guideline references cited in the policy