NCD20.6 TRANSMYOCARDIAL REVASCULARIZATION (TMR)

 

 

Effective Date of this Version

7/1/1999

 

Benefit Category

• Inpatient Hospital Services.

• Physicians' Services.

• Note: This may not be an exhaustive list of all applicable Medicare benefit categories for this item or service.

 

 

Item/Service Description

 

• Transmyocardial Revascularization (TMR) is a surgical technique which uses a laser to bore holes through the myocardium of the heart in an attempt to restore perfusion to areas of the heart not being reached by diseased or clogged arteries.

o This technique is used as a late or last resort for relief of symptoms of severe angina in patients with ischemic heart disease not amenable to direct coronary revascularization interventions, such as angioplasty, stenting or open coronary bypass.

• The precise workings of this technique are not certain.

o The original theory upon which the technique was based, that the open channels would result in increased perfusion of the myocardium, does not appear to be the major or only action at work.

o Several theories have been proposed, including partial denervation of the myocardium, or the triggering of the cascade of biological reactions which encourage increased development of blood vessels.

• However, research at several facilities indicates that, despite this uncertainty, the technique does offer relief of angina symptoms for a period of time in patients for whom no other medical treatment offering relief is available.

o Studies indicate that both reduction in pain and reduction in hospitalizations are significant for most patients treated.

o Consequently, we have concluded that, for patients with severe angina (Class III or IV, Canadian Cardiovascular Society, or similar classification system) for whom all other medical therapies have been tried or evaluated and found insufficient, such therapy offers sufficient evidence of its medical effectiveness to treat the symptomatology.

o It is important to note that this technique does not provide for increased life expectancy, nor is it proven to affect the underlying cause of the angina.

o However, it appears effective in treating the symptoms of angina, and reducing hospitalizations and allowing patients to resume some of their normal activities of daily living.

 

 

Indications and Limitations of Coverage

 

• CMS therefore covers TMR as a late or last resort for patients with severe (Canadian Cardiovascular Society classification Classes III or IV) angina (stable or unstable), which has been found refractory to standard medical therapy, including drug therapy at the maximum tolerated or maximum safe dosages. In addition, the angina symptoms must be caused by areas of the heart not amenable to surgical therapies such as percutaneous transluminal coronary angioplasty, stenting, coronary atherectomy or coronary bypass.

o Coverage is further limited to those uses of the laser used in performing the procedure which have been approved by the Food and Drug Administration for the purpose for which they are being used.

• Patients would have to meet the following additional selection guidelines:

o An ejection fraction of 25% or greater.

o Have areas of viable ischemic myocardium (as demonstrated by diagnostic study) which are not capable of being revascularized by direct coronary intervention.

o Have been stabilized, or have had maximal efforts to stabilize acute conditions such as severe ventricular arrhythmias, decompensated congestive heart failure or acute myocardial infarction.

• Coverage is limited to physicians who have been properly trained in the procedure.

o Providers of this service must also document that all ancillary personnel, including physicians, nurses, operating room personnel and technicians, are trained in the procedure and the proper use of the equipment involved.

o Coverage is further limited to providers which have dedicated cardiac care units, including the diagnostic and support services necessary for care of patients undergoing this therapy.

o In addition, these providers must conform to the standards for laser safety set by the American National Standards Institute, ANSIZ1363.

 

 

Claims Processing Instructions

 

• TN B-00-31 (Program Memorandum Carriers)

 

 

National Coverage Analyses (NCAs)

 

• This NCD has been or is currently being reviewed under the National Coverage Determination process.

• The following are existing associations with NCAs, from the National Coverage Analyses database.

• Original consideration for Transmyocardial Revascularization for Severe Angina (CAG-00004N) opens in new window

 

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