Transmyocardial and Endovascular Laser Revascularization
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This clinical policy governs coverage and medical necessity for transmyocardial laser revascularization (TMLR), percutaneous/transcatheter laser revascularization, and excimer laser coronary angioplasty for Aetna members; it identifies which approaches are considered medically necessary versus experimental/investigational.
No material clinical or coverage changes in this revision.
Coverage and Medical Necessity Criteria
Coverage criteria
Covered when ALL of the following are met:
ALL of the following
- Anginal symptoms are caused by viable ischemic myocardium (as demonstrated by diagnostic study) not amenable to surgical revascularization therapies such as PTCA, stenting, coronary atherectomy or coronary bypass.
- Member has had maximal efforts to stabilize acute conditions such as severe ventricular arrhythmia, decompensated congestive heart failure or acute myocardial infarction.
- Severe New York Heart Association functional classification of angina pectoris – Class III or IV.
- Symptoms of angina refractory to standard medical therapy, including drug therapy at the maximum tolerated or maximum safe dosages.
- The physician has been properly trained in the procedure and the laser used in performing the procedure has been approved by the FDA for the purpose for which it is being used.
Coding and Procedure Codes
| I20.1 | Angina pectoris |
| I20.9 | Angina pectoris, unspecified |
| I21.01 | STEMI involving left main coronary artery (example grouping present in document) |
| I25.9 | Chronic ischemic heart disease |
| I21.A1 | Myocardial infarction type 2 |
| I21.A9 | Other myocardial infarction type |
| No codes listed |
Provider Requirements, Prior Authorization, and Documentation
Prior Authorization Required
Prior authorization is required for TMLR procedures. Prior authorization requests should confirm that patient selection criteria are met before scheduling or performing transmyocardial laser revascularization.
- Aetna considers open chest and thoracoscopic approaches to TMLR medically necessary only when selection criteria are met (see Appendix).
- Percutaneous TMLR and other listed percutaneous laser approaches for experimental indications will be denied.
Selection Criteria Confirmation
Prior authorization requests must include documentation confirming that the patient has viable ischemic myocardium not amenable to conventional revascularization and has refractory angina despite maximal therapy.
- Document diagnostic studies demonstrating viable ischemic myocardium (e.g., imaging, stress testing).
- Provide coronary angiography evidence that percutaneous or surgical revascularization (PTCA, stent, atherectomy, CABG) is not feasible.
- State New York Heart Association (NYHA) angina class (III or IV) and supporting clinical notes.
Prior Authorization Submission Details Not Specified in Excerpt
The excerpt does not list a plan-specific prior authorization number, electronic portal, or step-by-step authorization workflow. Providers should follow their Aetna plan's standard prior authorization process and submit clinical documentation as described.
- If unsure, contact the member's plan or provider relations for plan-specific prior authorization submission details.
- Treat the Clinical Policy Bulletin as a coverage guidance document; it is not a substitute for plan-specific authorization requirements.
Training and Device Approval Requirement
The physician performing TMLR must be properly trained in the procedure and the specific laser device used must have FDA approval for the intended use. Lack of documented surgeon training or device approval may affect coverage.
- Include documentation of physician training/credentialing for TMLR in the prior authorization or medical record.
- Provide documentation of FDA approval/status for the laser device used, or rationale if using an FDA-cleared device for an off-label purpose (coverage may be affected).
Therapy Failure Prerequisite
Patient must have failed maximal conventional anti-anginal combination therapy prior to consideration for TMLR. Document medication trials and intolerances or contraindications.
- List anti-anginal medications tried (doses and duration) and reasons for discontinuation if applicable.
- Document any adjunctive therapies attempted and response (e.g., risk factor modification, revascularization attempts).
Required Selection and Clinical Documentation
Clinical documentation should demonstrate that angina is medically refractory and that invasive revascularization is not feasible. Provide operative notes, consultation reports, and diagnostic testing as applicable.
- Clinical notes showing persistent severe, intractable angina despite maximal therapy.
- Recent coronary angiogram report documenting anatomy not amenable to revascularization.
- Objective evidence of viable ischemic myocardium (imaging/stress tests).
- NYHA classification documentation.
Documentation Guidance and Limitations
Clinical Policy Bulletins are a partial description of plan benefits. Providers must follow plan-specific documentation and prior authorization procedures; include all requested records with the authorization to avoid delays or denials.
- The CPB does not replace the full benefit contract — include plan-specific forms, authorization numbers, and any additional requested documentation.
- Retain complete records of training, device approval, and clinical selection criteria in the medical record for audit.
Step Therapy Not Described in Excerpt
No step therapy requirements are described in the supplied excerpt. If a plan-level step therapy applies, providers must follow that plan's requirements in addition to the CPB selection criteria.
- Verify member's benefit plan for any step therapy or prior conservative therapy mandates beyond the CPB.
- If step therapy is required by plan, document completion of required steps in authorization submission.
Background and Rationale
Refractory angina is defined in the policy as persistent, severe anginal symptoms despite maximal conventional anti‑anginal combination therapy, occurring when invasive revascularization options are excluded by a recent coronary angiogram. Transmyocardial laser revascularization (TMLR) is a surgical technique that creates multiple transmural channels in the left ventricular myocardium (typically approximately 15–30 channels) to attempt symptom relief in selected patients with viable ischemic myocardium not amenable to conventional revascularization. The policy restricts coverage to open chest or thoracoscopic TMLR meeting specific selection criteria (NYHA Class III–IV, refractory symptoms despite maximal therapy, documented non‑revascularizable viable myocardium, stabilized acute conditions, and appropriately trained physicians using FDA‑approved lasers).
Definitions
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