CurrentBlue Cross Blue Shield - Rhode IslandPolicy N/A

Enhanced External Counterpulsation (EECP) Coverage Policy

Coverage guidelines for outpatient enhanced external counterpulsation (EECP) for BlueCHiP for Medicare and Commercial products issued by Blue Cross & Blue Shield of Rhode Island.

Policy Summary

PayerBlue Cross Blue Shield - Rhode Island

PolicyEnhanced External Counterpulsation (EECP) Coverage Policy

Policy CodePolicy N/A

Change TypeNo material change

Effective DateJan 12, 2014

Next Review DateN/A

Key ActionDocument the full course of therapy (typically 35 one-hour treatments) and clinical rationale when delivering EECP; follow Medicare NCD for BlueCHiP for Medicare members.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

35typical full course

G0166per-session HCPCS

Medicare/Commercialcoverage stance

510(k)FDA status

Coverage Determinations

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BlueCHiP for Medicare Coverage: EECP is covered for BlueCHiP for Medicare members when used for indications consistent with the Medicare national coverage decision for disabling angina: patients with disabling angina who, in the opinion of a cardiologist or cardiothoracic surgeon, are not readily amenable to surgical intervention because their condition is inoperable or at high operative risk; their coronary anatomy is not readily amenable to revascularization; or they have comorbid states that create excessive risk.

Medicare NCD governs specifics; BCBSRI follows CMS guidelines which may differ from Commercial products.

Commercial Products Coverage Stance: EECP used in outpatient treatment is not medically necessary for all indications (including but not limited to chronic stable angina pectoris, heart failure, erectile dysfunction, or ischemic stroke) due to insufficient peer-reviewed evidence of effectiveness.

Benefits may vary by contract; refer to the member's benefit booklet.

For Commercial products, outpatient enhanced external counterpulsation (EECP) is considered not medically necessary for all indications. Examples of excluded indications include, but are not limited to, treatment of chronic stable angina pectoris, heart failure, erectile dysfunction, and ischemic stroke. This determination is based on insufficient peer-reviewed scientific literature demonstrating the procedure’s effectiveness; benefits for these conditions have not been established and claims for payment may be denied.

The rationale for deeming EECP not medically necessary for Commercial members is that the overall evidence is insufficient to determine meaningful effects on health outcomes. Randomized controlled trials and systematic reviews report inconsistent or modest benefits for some measures (for example, selected functional tests), but methodologic limitations and mixed results limit confidence in efficacy. Observational and registry studies are subject to confounding and potential placebo effects, and available trials for noncardiac indications (for example, central retinal artery occlusion, erectile dysfunction, ischemic stroke, and type 2 diabetes) are small or have short follow-up. Taken together, the evidence does not robustly demonstrate improved survival, symptom control, or durable functional outcomes, and therefore outpatient EECP is considered not medically necessary for Commercial products.

Coding and Treatment Course

Covered HCPCS (Medicare) / Not medically necessary (Commercial)HCPCS

G0166

External counterpulsation, per treatment session

Full course of therapy — typical number and session length

Typical number of treatmentsA full course of therapy usually consists of 35 one-hour treatments.

Session lengthEach treatment session is one hour in duration.

FrequencySessions may be offered once or twice daily, usually 5 days a week.

Components documentedProcedure includes device use, finger plethysmography, continuous ECG triggering, and optional pulse oximetry.

What Providers Need to Know

Prior Authorization

Not applicable

Note

Medicare alignment

BlueCHiP for Medicare: EECP is covered for BlueCHiP for Medicare members. Blue Cross & Blue Shield of Rhode Island (BCBSRI) follows CMS national and local coverage determinations; Medicare policies may differ from Commercial products and, in some instances, benefits for BlueCHiP for Medicare may be greater than what is allowed by CMS guidance.

Documentation Required

Medicare coverage conditions

Medicare covers EECP for patients diagnosed with disabling angina who, in the opinion of a cardiologist or cardiothoracic surgeon, are not readily amenable to surgical intervention (e.g., percutaneous transluminal coronary angioplasty or cardiac bypass) because: 1) their condition is inoperable or at high risk of operative complications or post-operative failure; 2) their coronary anatomy is not readily amenable to such procedures; or 3) they have comorbid states creating excessive risk.

Denial Risk

Denial risk for Commercial products

Commercial Products: Outpatient EECP is not medically necessary for all indications (including but not limited to chronic stable angina pectoris, heart failure, erectile dysfunction, or ischemic stroke) due to insufficient peer-reviewed scientific evidence of effectiveness. Claims for outpatient EECP for Commercial members are at risk for denial.

Background and Scope

Enhanced external counterpulsation (EECP) is a noninvasive therapy that uses timed, sequential inflation of pressure cuffs on the calves, thighs, and buttocks to augment diastolic pressure, reduce left ventricular afterload, increase venous return, and improve coronary perfusion. A typical full course of therapy is 35 one-hour treatments delivered over several weeks. EECP devices used in practice have been cleared by the FDA via 510(k); clinical study results have primarily focused on chronic stable or refractory angina and heart failure, with mixed or inconclusive findings across randomized and observational studies.

Definitions

EECP — definition of enhanced external counterpulsation

DefinitionEnhanced external counterpulsation (EECP) uses timed, sequential inflation of pressure cuffs on the calves, thighs, and buttocks to augment diastolic pressure, decrease left ventricular afterload, and increase venous return.

Proposed mechanismAugmentation of diastolic pressure displaces blood backward into coronary arteries during diastole to increase coronary perfusion and potentially enhance collateral development.

Physiologic effectsMay reduce left ventricular afterload during systole and increase coronary collateral flow.

Primary indication investigatedPrimarily investigated as a treatment for chronic stable or refractory angina.

Disabling angina (Medicare NCD context) — definition used for Medicare coverage

Medicare NCD definition (disabling angina)Angina for which a cardiologist or cardiothoracic surgeon determines the patient is not readily amenable to surgical intervention (percutaneous transluminal coronary angioplasty or cardiac bypass) because the condition is inoperable or at high operative risk, coronary anatomy is not readily amenable to such procedures, or co-morbid states create excessive risk.

Decision authorityDetermination must be made by a cardiologist or cardiothoracic surgeon.

Surgical alternatives consideredIncludes consideration of percutaneous transluminal coronary angioplasty and cardiac bypass as not readily amenable.

Coverage contextThis definition is used within the Medicare national coverage decision that allows EECP for disabling angina.