CurrentGeisinger Health PlanPolicy MP062

Transmyocardial Laser Revascularization

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This policy governs coverage criteria and definitions for transmyocardial laser revascularization (TMLR) for Geisinger Health Plan members across applicable lines of business. It affects providers submitting requests for TMLR and medical directors/management assessing medical necessity.

Policy Summary

PayerGeisinger Health Plan

PolicyTransmyocardial Laser Revascularization

Policy CodePolicy MP062

Change TypeNo material changes

Effective Date

Next Review Date

Key ActionObtain prior authorization with documentation demonstrating all coverage criteria are met, including angina class, prior maximal medical therapy, ejection fraction ≥30%, and evidence of reversible ischemia.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

All Must Be MetIndications for coverage logic

EF ≥30%EF threshold

NYHA/CCS III–IVAngina severity

PTLR & TMLR+BM cellsExcluded/experimental

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CurrentGeisinger Health PlanPolicy MP062

Transmyocardial Laser Revascularization

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Policy Summary

PayerGeisinger Health Plan

PolicyTransmyocardial Laser Revascularization

Policy CodePolicy MP062

Change TypeNo material changes

Effective Date

Next Review Date

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

All Must Be MetIndications for coverage logic

EF ≥30%EF threshold

NYHA/CCS III–IVAngina severity

PTLR & TMLR+BM cellsExcluded/experimental

Coverage Criteria for Transmyocardial Laser Revascularization (TMLR)

Indications for Coverage

Covered when ALL of the following are met

TMLR coverage criteria: Class III or IV angina (New York Heart Association or Canadian Cardiovascular Society) intractable despite maximal medical therapy.

from policy INDICATIONS FOR COVERAGE

TMLR coverage criteria: Percutaneous transluminal coronary angioplasty (PTCA) or coronary artery bypass graft (CABG) is contraindicated, or the angina symptoms are caused by an area of the heart not amenable to surgical therapies.

from policy INDICATIONS FOR COVERAGE

TMLR coverage criteria: Ejection fraction of 30% or greater.>= 30%

from policy INDICATIONS FOR COVERAGE

TMLR coverage criteria: Evidence of reversible ischemic/hibernating myocardium.

from policy INDICATIONS FOR COVERAGE

TMLR coverage criteria

Stability requirements - none present: Recent myocardial infarction (MI) or unstable angina within the last 21 days.
from policy INDICATIONS FOR COVERAGE
Stability requirements - none present: Decompensated congestive heart failure.
from policy INDICATIONS FOR COVERAGE
Stability requirements - none present: Uncontrolled ventricular or supraventricular tachyarrhythmias.
from policy INDICATIONS FOR COVERAGE
Stability requirements - none present: Severe comorbid illness (e.g., chronic obstructive pulmonary disease).
from policy INDICATIONS FOR COVERAGE

Covered or Not Covered Criteria

Coverage stance and contraindications/limitations

Not covered - experimental: Transmyocardial laser revascularization plus autologous bone marrow cell therapy is considered experimental/investigational and is NOT covered.

from policy EXCLUSIONS

Not covered - percutaneous procedure: Percutaneous transmyocardial laser revascularization (PTLR) is considered experimental/investigational and is NOT covered.

from policy EXCLUSIONS

Contraindications include ejection fraction less than 30%, peripheral vascular disease preventing intra-aortic balloon pump placement, severe comorbid illness (e.g., COPD), major fixed defects on thallium/PET, and ongoing myocardial injury.EF < 30%

from policy CONTRAINDICATIONS and EXCLUSIONS

Coverage is excluded for patients who are not clinically stable or who have specific acute cardiac or severe comorbid conditions. Specifically, coverage does not extend to patients with recent myocardial infarction (MI) or unstable angina within the last 21 days, those with decompensated congestive heart failure, or those with uncontrolled ventricular or supraventricular tachyarrhythmias. In addition, members with significant systemic disease that would compromise outcomes (for example, severe chronic obstructive pulmonary disease) are excluded until the condition has been stabilized.

The Plan considers combined procedures and alternative delivery approaches that lack sufficient peer-reviewed evidence to be experimental and not covered. Transmyocardial laser revascularization (TMLR) performed in combination with autologous bone marrow cell therapy is considered experimental/investigational and is not covered. Likewise, percutaneous transmyocardial laser revascularization (PTLR) is considered experimental/investigational and is not covered.

TMLR is intended as a late or last‑resort therapy for patients with severe refractory angina who are not candidates for standard revascularization (CABG or PTCA). The procedure is not appropriate for patients who remain candidates for conventional revascularization or for those who do not have evidence of reversible ischemia/hibernating myocardium.

Use of adjunctive or alternative TMLR approaches that lack adequate evidence is considered not medically necessary. Specifically, TMLR combined with autologous bone marrow cell therapy and percutaneous TMLR (PTLR) are determined to be experimental/investigational and therefore not medically necessary and not covered by the Plan.

Coding and Clinical Thresholds

CPT codes associated with Transmyocardial Laser RevascularizationCPT

33140	Transmyocardial laser revascularization, by thoracotomy (separate procedure)
33141	Performed at the same time of other open cardiac procedures

Ejection fraction — coverage threshold (>= 30%)

Ejection fraction threshold for coverageEjection fraction (EF) of 30% or greater

Context in coverage criteriaRequired as one of multiple ‘All Must Be Met’ indications for TMLR (with Class III/IV angina, contraindication to CABG/PTCA, evidence of reversible ischemia, and clinical stability)

Documentation requirementProvider should document EF (>=30%) as part of prior authorization and medical record submission

Ejection fraction — contraindication threshold (< 30%)

Contraindication thresholdEjection fraction less than 30% is listed as a contraindication to TMLR

Related exclusion languageEF < 30% is included among contraindications that preclude coverage (see policy contraints such as severe comorbid illness, major fixed defects, ongoing myocardial injury)

Provider Requirements and Authorization

Prior Authorization

Prior authorization required with complete documentation

Prior authorization is required for TMLR; submit documentation demonstrating that all coverage criteria are met, including angina class (NYHA/CCS), prior maximal medical therapy, ejection fraction, and evidence of reversible ischemia.

Document Class III or IV angina despite maximal medical therapy
Document EF ≥ 30%
Document evidence of reversible/hibernating myocardium
Document contraindication/ineligibility for CABG or PTCA

Note

Verify prior authorization/pre-certification requirements

Prior authorization or pre-certification requirements may apply for TMLR; verify the need for authorization using the Plan's prior authorization resources and the member's contract-specific benefit documents.

Check the Plan's prior authorization website and resources

Background

Transmyocardial laser revascularization (TMLR) is a surgical technique that attempts to improve myocardial perfusion by creating channels from the left ventricle into the ischemic myocardium. The procedure is used as a late or last‑resort option to relieve symptoms of severe refractory angina in patients with documented myocardial ischemia who are not candidates for CABG or PTCA.

Definitions

Transmyocardial — definition

DefinitionAcross or through the heart muscle

Clinical relevanceTerm used to describe the path of channels created in transmyocardial procedures such as TMLR

SourcePolicy definition: Transmyocardial

Coronary artery bypass graft (CABG) — definition

DefinitionA procedure in which a healthy blood vessel is harvested from another part of the body and grafted into the coronary artery to revascularize the heart

PurposeRestores blood flow to ischemic myocardium by providing a conduit for oxygenated blood

Context

Revision History & Related Policies

Determinations that a technology or service is experimental, investigational or unproven follow the process described in the Plan’s related policy MP015 (Experimental, Investigational or Unproven Services or Treatment). This policy is the referenced standard for exclusions of procedures such as TMLR plus cell therapy and PTLR.

This policy applies across lines of business; however, eligibility, contract‑specific benefits, limitations, and exclusions may supersede the policy language. For the PA Medicaid business segment, this policy applies as written. Providers should verify member-specific coverage and any prior authorization requirements against the member’s contract and the Plan’s authorization resources.

Policy Summary

PayerGeisinger Health Plan

PolicyTransmyocardial Laser Revascularization

Policy CodePolicy MP062

Change TypeNo material changes

Effective Date

Next Review Date

SourceLink

On This Page

Denial riskRequests may be denied if EF is below 30% per policy contraindications

Review the member's contract-specific benefit document for pre-certification lists

Step Therapy

Place in therapy: last-resort after maximal medical therapy

TMLR is a late or last-resort procedure reserved for members with severe, refractory angina after maximal medical therapy and when CABG or PTCA are contraindicated or not feasible.

Use only when patient is not a candidate for CABG or PTCA
Confirm maximal medical therapy has been attempted

Note

Provider actions: complete required authorization steps

Ensure all provider actions required by policy are completed and documented in the prior authorization submission.

Follow Plan authorization procedures and document required clinical information

Documentation Required

Required documentation to support medical necessity

Include documentation of angina severity using NYHA or CCS classification, records of prior maximal medical therapy, explicit rationale that CABG/PTCA are contraindicated or not feasible, measured ejection fraction (≥30%), and testing showing reversible ischemia or hibernating myocardium.

NYHA or CCS class documentation (Class III or IV)
Evidence of maximal medical therapy trials
Clinical notes explaining contraindication to CABG/PTCA
Ejection fraction measurement (must be ≥30%)
Objective evidence of reversible ischemia/hibernating myocardium

Note

Check member contract and Plan authorization rules

Confirm member eligibility and any contract-specific prior authorization or pre-certification requirements before submitting a request; benefits and limitations in the member's line-of-business documents supersede this policy.

Check eligibility and contract-specific benefits
Line-of-business benefit documents supersede the policy

Denial Risk

Denial risk when coverage indications are not met

Requests may be denied if the patient does not meet all coverage indications — for example, if angina is not Class III/IV, ejection fraction is less than 30%, there is no evidence of reversible ischemia, recent MI/unstable angina within 21 days, or the patient is a candidate for CABG/PTCA.

Angina not documented as NYHA/CCS Class III or IV
Ejection fraction < 30%
No evidence of reversible/hibernating myocardium
Recent MI or unstable angina within the last 21 days
Patient remains a candidate for CABG or PTCA

Denial Risk

Requests for PTLR or TMLR with bone marrow cells will be denied

Do not submit authorization requests for PTLR or for TMLR combined with autologous bone marrow cell therapy; these applications will be denied as experimental/investigational and are not covered.

Percutaneous TMLR (PTLR) is considered experimental/investigational and not covered
TMLR plus autologous bone marrow cell therapy is considered experimental/investigational and not covered

Referenced in policy as a standard revascularization option (CABG) that, if feasible, makes TMLR not indicated

Percutaneous Transluminal Coronary Angioplasty (PTCA) — definition

DefinitionA catheter-based procedure to dilate a coronary artery by inserting a catheter with a deflated balloon to the site of blockage and inflating it to enlarge the vessel

Procedure notePerformed percutaneously via a major blood vessel and used as a standard revascularization option referenced in policy

Policy relevanceIf PTCA is feasible, TMLR is not intended; PTCA contraindication is part of TMLR coverage criteria

NYHA / CCS functional classes — definitions and class descriptions

NYHA/CCS Class IIIMarked limitation of ordinary activities; comfortable at rest; less than ordinary activity causes fatigue, palpitation, dyspnea, or anginal pain

NYHA/CCS Class IVInability to carry out any physical activity without discomfort; angina may be present at rest

NYHA/CCS Class INo limitation of physical activity; ordinary activity does not cause undue fatigue, palpitation, dyspnea, or anginal pain

NYHA/CCS Class IISlight limitation of ordinary activities; comfortable at rest but ordinary activity results in symptoms