CurrentAetnaPolicy 0163

Transmyocardial and Endovascular Laser Revascularization

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.

Policy Summary

PayerAetna

PolicyTransmyocardial and Endovascular Laser Revascularization

Policy CodePolicy 0163

Change TypeNo material changes

Effective DateJun 4, 1997

Next Review DateFeb 8, 2024

Key ActionObtain prior authorization and document that the patient has refractory severe angina despite maximal medical therapy and is not a candidate for conventional revascularization.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

medically necessaryOpen chest/thoracoscopic TMLR

investigationalPercutaneous TMLR / ELCA

15–30Typical laser channels

n=298Largest PTMR RCT

03/28/2023Last review

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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

CPT codes covered if selection criteria are metCPTCovered

33140	Transmyocardial laser revascularization, by thoracotomy
33141	Transmyocardial laser revascularization

CPT codes listed with cell therapy / harvesting (not covered for listed indications)CPTNot Covered

38206	Blood-derived hematopoietic progenitor cell harvesting for transplantation, per collection; autologous
38232	Bone marrow harvesting for transplantation; autologous
38241	Hematopoietic progenitor cell (HPC); autologous transplantation

ICD-10 codes covered when selection criteria are metICD-10

I20.1	Angina pectoris
I20.9	Angina pectoris, unspecified

ICD-10 codes listed as not covered for indications in CPBICD-10Not Covered

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

Codesmixed

No codes listed

Typical number of laser channels

Typical number of transmural channels15–30 channels

Procedure approach describedChannels bored from epicardial to endocardial surfaces in the left ventricular myocardium

Intended effectAttempt to improve local perfusion to ischemic myocardial territories

Provider Requirements, Prior Authorization, and Documentation

Prior Authorization

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.

Prior Authorization

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.

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

Refractory angina

DefinitionPersistence of severe anginal symptoms despite maximal conventional anti-anginal combination therapy

Exclusion for revascularizationInvasive revascularization (PCI or CABG) must be excluded on the basis of a recent coronary angiogram

Clinical contextRepresents end-stage coronary artery disease with severe coronary insufficiency and only moderately impaired LV function

Transmyocardial laser revascularization (TMLR)

DefinitionSurgical creation of multiple transmural channels through the myocardium (epicardial to endocardial) often via left thoracotomy

PurposeAttempt to improve perfusion in ischemic myocardial territories not reached by diseased arteries

Policy Summary

PayerAetna

PolicyTransmyocardial and Endovascular Laser Revascularization

Policy CodePolicy 0163

Change TypeNo material changes

Effective DateJun 4, 1997

Next Review DateFeb 8, 2024

Key ActionObtain prior authorization and document that the patient has refractory severe angina despite maximal medical therapy and is not a candidate for conventional revascularization.

SourceLink

On This Page

State New York Heart Association (NYHA) angina class (III or IV) and supporting clinical notes.

Note

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.

Documentation Required

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).

Prior Authorization

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).

Documentation Required

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 Required

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

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.

Alternative approaches notedThoracoscopic and pilot percutaneous catheter-based approaches have been reported

Transmyocardial laser revascularization (TMR)

DefinitionSurgical or percutaneous laser technique creating transmural channels and investigated for refractory angina and end-stage coronary artery disease

Investigational statusEvaluated in multiple clinical studies and trials; percutaneous methods have randomized trial data with no clear benefit

Variants describedCO2 and holmium laser techniques and catheter-based systems reported in the literature

Excimer laser coronary angioplasty (ELCA)

DefinitionEndovascular laser technique applied in complex percutaneous coronary interventions, including treatment of in-stent restenosis and lesion modification

Clinical evidenceMultiple registries and cohort reports describe use for ISR and lesion modification; outcomes vs standard PCI are mixed

Contemporary useReported for modification of calcified or underexpanded stents and in select acute coronary syndrome cases

NYHA functional classification

Class IPatients with cardiac disease but without resulting limitation of physical activity (ordinary activity does not cause symptoms)

Class IISlight limitation of physical activity; comfortable at rest; ordinary activity causes symptoms

Class IIIMarked limitation of physical activity; less than ordinary activity causes symptoms

Class IVInability to carry on any physical activity without discomfort; symptoms may be present at rest