LCD L34761

Coverage Guidance

Italicized font represents CMS national language/wording copied directly from CMS Manuals or CMS transmittals. Contractors are prohibited from changing national language.

CMS Pub 100-03, Medicare National Coverage Determination (NCD) Manual, Chapter 1- Coverage Determinations, Section 20.7 - Percutaneous Transluminal Angioplasty (PTA).

CMS Pub 100-04 Medicare Claims Processing Manual, Chapter 4 – Part B Hospital (Including Inpatient Hospital Part B and OPPS), Section 61.5 - Billing for Intracoronary Stent Placement.

CMS Pub 100-04 Medicare Claims Processing Manual, Chapter 13 – Radiology Services and Other Diagnosis Procedures, Section 20 - Payment Conditions for Radiology Services.

Indications and Limitations of Coverage

Overview

Percutaneous coronary intervention (PCI), commonly known as coronary angioplasty or simply angioplasty, is a non-surgical procedure used to treat the stenotic (narrowed) coronary arteries of the heart found in coronary heart disease. These stenotic segments are due to the buildup of the cholesterol-laden plaques that form due to atherosclerosis. During PCI, a cardiologist feeds a deflated balloon or other device on a catheter from the inguinal femoral artery or radial artery up through blood vessels until they reach the site of blockage in the heart. X-ray imaging is used to guide the catheter threading. At the blockage, the balloon is inflated to open the artery, allowing blood to flow. A stent is often placed at the site of blockage to permanently open the artery.

Percutaneous transluminal coronary angioplasty (PTCA) is a minimally invasive procedure to open blocked coronary arteries, allowing blood to circulate unobstructed to the heart muscle.

Indications:

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

• acute coronary syndrome (e.g., acute myocardial infarction, unstable angina);

• a history of significant obstructive atherosclerotic disease;

• restenosis of a coronary artery previously treated with intracoronary stent or another revascularization procedure;

• chronic angina; or

• silent ischemia

Intracoronary ultrasound (IVUS) 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 during percutaneous coronary 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. Intracoronary ultrasound or fractional flow reserve measurement should be performed on an individual artery as clinically indicated. Both procedures are not considered medically necessary unless written documentation is submitted to support medical necessity. Intracoronary ultrasound and Doppler fractional flow reserve studies can be required in multivessel coronary artery disease (CAD).

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. If the diagnostic catheterization is done within 30 days of the PCI, it is usually not necessary to repeat the catheterization unless there is a documented change in the patient’s condition. 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, with detailed discussion of benefits and risks of PCI. 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 an indicated percutaneous coronary intervention should be documented in the medical record. Unless there is a new clinical event, a change in symptomatology, abnormal examination or other test results, a repeat diagnostic catheterization within 3 months of the last diagnostic catheterization and prior to the percutaneous coronary intervention is generally not reimbursable and is considered not reasonable and necessary.

Limitations:

Generally, PCI is not indicated for:

• Patients that can be managed medically.

• 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.

• Patient with stable CAD.

Summary of Evidence

N/A

Analysis of Evidence

N/A

Associated Information

Documentation Requirements

The patient’s medical record must contain documentation that fully supports the medical necessity for coverage as stated in the Indications, Limitations, and/or Medical Necessity section of the policy. This documentation includes but is not limited to relevant medical history, physical examination, and results of pertinent diagnostic tests or procedures. There should be a permanent record of the procedure. The documentation should include a description of the procedure(s) performed and any contrast media, medications, catheters, stents, or devices used. Any known significant patient reaction or complication should be recorded. Comparison with prior relevant studies or procedure(s) needs to be addressed in the documentation. The report should address or answer any specific clinical questions or findings. If there are factors that prevent answering the clinical questions, this should be explained in the documentation. If there are factors that prevent the completion of the procedure, this should be explained in the documentation. Retention of angiographic documentation (film or digital) as well as intravascular sonographic recording(s) should be consistent both with clinical need and with relevant legal and local health care facility requirements.

If the provider performing the procedure is other than the ordering/referring physician/nonphysician practitioner, that provider must maintain a copy of the procedure report and interpretation, along with copies of the ordering/referring physician/nonphysician practitioner’s order for the procedure. The physician/nonphysician practitioner must state the clinical indication/medical necessity for the procedure in his/her order for the procedure. Results of all procedures must be shared with the referring physician.

Each claim must be submitted with diagnosis codes that reflect the condition of the patient and indicate the reason(s) for which the test was performed. Note: A payable diagnosis alone does not support medical necessity of ANY service.

The medical record must include documentation of the need for repeat diagnostic angiography when previously performed, in the absence of any new clinical symptoms or signs of disease progression, within the preceding 3 months.

All documentation must be maintained in the patient’s medical record and made available to Medicare upon request.

The HCPCS/CPT code(s) may be subject to Correct Coding Initiative (CCI) edits. This policy does not take precedence over CCI edits. Please refer to the CCI for correct coding guidelines and specific applicable code combinations prior to billing Medicare.

When the documentation does not meet the criteria for the service rendered or the documentation does not establish the medical necessity for the services, such services will be denied as “not reasonable and necessary” under Section 1862(a)(1) of the Social Security Act.

Utilization Guidelines

It is expected that these services would be performed as indicated by current medical literature and/or standards of practice for the patient’s condition. PCI testing which exceeds the frequency or duration indicated by the accepted standards of medical practice are not covered unless there are special circumstances which justify the medical necessity for the additional PCI. The routine and repetitive monitoring of patients in the absence of a documented change in condition (i.e., new symptoms or progression of existing symptoms) is not considered medically necessary.

An overnight inpatient stay is not anticipated for routine recovery of a PCI procedure and should not be billed as inpatient services. The routine recovery period should not be billed as observation hours in addition to the PCI unless the patient has sustained untoward complications necessitating the continued monitoring. An inpatient stay following a routine PCI would not be considered medically necessary. It is important to submit written documentation of complications or additional concerns about risk factors for those who have inpatient admission or observation after PCI.

Preventive and/or screening services unless covered in Statute are not covered by Medicare.

Bibliography

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