Summary Of Evidence

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Analysis of Evidence

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Since Gruentzig’s 1979 report of coronary balloon angioplasty, percutaneous transluminal coronary interventions have substantively altered the management of patients with symptomatic arteriosclerotic heart disease. Balloon angioplasty rapidly expanded from single to multiple vessels and from simple to complex anatomic substrates. Transluminal interventions now encompass balloon dilation (PTCA), a variety of atherectomy devices, high pressure and biologic/polymer coated stents as well as transluminal thrombectomy. Additionally, intracoronary ultrasound is often employed to assess the efficacy of these interventions. In addition to medical therapy and coronary bypass surgery, percutaneous coronary intervention has emerged as a primary option for the management of patients with acute coronary syndromes and selected patients with chronic angina.

Indications:

Percutaneous coronary intervention (PCI) may be indicated in the management of :

• patients with acute coronary syndrome (eg acute myocardial infarction, unstable angina)
• patients with a history of significant obstructive atherosclerotic disease
• patients with restenosis of a coronary artery previously treated with intracoronary stent or other revascularization procedure
• patients with chronic angina
• patients with silent ischemia

Intracoronary ultrasound may be separately covered when needed to assess the extent of coronary stenosis if equivocal on angiography, or when needed to assess the patency and integrity of a coronary artery post-intervention. Alternatively, intravascular Doppler velocity and/or pressure derived coronary flow reserve measurement may be performed to assess the degree of stenosis within a vessel.

Limitations:

A diagnostic cardiac catheterization to assess the nature of the lesion(s) prior to the intervention is a covered service. The diagnostic cardiac catheterization may be performed at any time prior to the PCI, including the same day as the PCI.

Performance of a diagnostic cardiac catheterization and interventional procedure on the same day is increasingly the standard of practice. While there may be reasons for delaying the interventional procedure (e.g., transfer from a community hospital to a tertiary center, excessive dye load, further treatment planning or evaluation of angiography, etc.), it is recommended that both procedures be performed during the same encounter when medically appropriate. Separation of these procedures for the purpose of circumventing the multiple surgery pricing, or for the convenience of physician or hospital scheduling, is considered an inappropriate practice and may subject the services to review and denial for medical necessity. The decision to stage these procedures is deferred to the judgment of the interventional cardiologist, and individualized only to the clinical needs of the patient. (e.g., dye load already received, need to correlate findings with other test results, etc). Reasons for delaying indicated intervention should be documented in the medical record. Unless there is a new clinical event or change in symptomatology, examination or other test results, a repeat diagnostic catheterization service within three months of a previous diagnostic catheterization, and prior to completion of the staged intervention is generally not reimbursable and is considered not to be reasonable and necessary.

Angiography during the procedure, used to monitor the course of the intervention, is considered part of the PCI and is not separately billable to Medicare. Diagnostic angiography may be separately payable in situations where no previous catheter-based coronary angiography study is available, or a previous study is no longer adequate due to changes in the patient’s condition.

The deployment of a device for distal embolic protection during an interventional procedure is considered part of the more complex procedure and is not separately billable.

Prophylactic insertion of a temporary transvenous pacemaker, repositioning or replacement of catheters and administration of medications during the procedure are included in the procedure and are not separately billable. Right heart catheterization and insertion of a Swan-Ganz catheter are not generally medically necessary for a PCI and will be denied, unless medically necessary when performed incident to a diagnostic catheterization prior to the intervention. Standby services of a surgeon or anesthesiologist are not covered services.

Intracoronary injections of drugs during diagnostic or therapeutic procedures are considered to be part of the procedure and are not separately reimbursable.

Percutaneous vascular closure devices (PVCD) may be used to facilitate closure of an arterial puncture site after angiography, cardiac catheterization and interventional cardiology procedures in addition to or in place of manual compression, use of a mechanical clamp or a sandbag, or a combination of these methods. These services are inherent to the invasive procedure and are not separately payable.