Intravascular coronary brachytherapy (codes 77781-77784) is eligible in the following instances:

• to treat in-stent restenosis of a native coronary artery using gamma (photon-emitting) radioactive sources (for example, iridium-192 seeds), or beta (electron-emitting) radioactive sources (for example, strontium-90 seeds); and
• to treat in-stent restenosis in grafted coronary vessels - that is, saphenous vein grafts (SVGs).  However, coverage is limited to brachytherapy using a gamma radiation source in this instance. 

Intravascular coronary brachytherapy is considered investigational in other applications, including, but not limited to the following:

• managing initial lesions or treating restenosis in native or grafted coronary vessels without stents;
• as an alternative to stent placement to reduce the risk of or treat restenosis of native vessels or saphenous vein grafts (SVGs) at an unstented site of a prior percutaneous coronary intervention; or,
• treating in-stent restenosis in saphenous vein bypass grafts using radioactive sources other than those emitting gamma radiation. 

There is insufficient scientific evidence to permit conclusions on the efficacy of intravascular coronary brachytherapy or its impact on patient outcomes in these situations.

Intravascular brachytherapy to treat conditions of the femoropopliteal system is also considered investigational.  Current scientific evidence does not document the efficacy of intravascular brachytherapy in the peripheral arterial system at this time. 

The Food and Drug Administration (FDA) has approved devices intended for use in intracoronary brachytherapy. Examples of these devices are the Beta-Cath System (Novoste Corporation) and the Galileo Intravascular Radiotherapy System (Guidant), both of which deliver beta radiation, and the CheckMate System (Cordis) which delivers gamma radiation. There are currently no brachytherapy devices FDA approved specifically for use in the peripheral arterial system.

A participating, preferred, or network provider can bill the member for services denied as investigational.

The above information is also applicable to the transcatheter placement of the radiation delivery device used for intracoronary brachytherapy (code 92974).

Description

Patients who undergo a percutaneous coronary intervention (for example, angioplasty) for coronary artery disease are at risk for recurrence at the site of the procedure, whether or not a stent is placed at the time of the PTCA. When a re-narrowing develops within a stent, it is called an in-stent restenosis. Bypass grafting is typically the most effective intervention for revascularization.

Intracoronary brachytherapy is an alternative method that can be used to treat native coronary arteries with in-stent restenosis. (A native vessel is one that is in its natural location or unaltered from its natural state, that is, a vessel one is born with.)

NOTE:

This policy is designed to address medical guidelines that are appropriate for the majority of individuals with a particular disease, illness, or condition. Each person's unique clinical circumstances may warrant individual consideration, based on review of applicable medical records.

Under the Federal Employee Program, all services that utilize FDA-approved drugs, devices, or biological products are eligible when intended for the treatment of a serious or life-threatening condition and when medically necessary and appropriate for the patient’s condition. Intravascular brachytherapy using gamma or beta radioactive sources performed for other than restenosis are considered eligible services when determined medically necessary based on the patient’s condition.

PRN References

04/2001, Intracoronary radiation to prevent restenosis
08/2003, Coverage for intravascular brachytherapy revised

National Blue Cross Blue Shield Association TEC Bulletin, August 2002

National Blue Cross Blue Shield Association TEC Bulletin, Vol. 18, No. 1, January 2001

National Blue Cross Blue Shield Association Medical Policy 2.02.11, Intracoronary Radiation to Prevent Restenosis after Percutaneous Transluminal Coronary Angioplasty (PTCA), 7/99

Radiation Therapy to Prevent Coronary Artery Restenosis, Seminars in Radiation Oncology, Vol. 9, No. 2, April 1999

Endoluminal Beta Irradiation for the Prevention of Coronary Restenosis after Balloon Angioplasty, The Journal of the American Medical Association, Vol. 344, No. 4, January 2001

Localized Intracoronary Gamma Radiation to Inhibit Restenosis after Stenting, The Journal of the American Medical Association, Vol. 344, No. 4, January 2001

Coronary Artery Stents, The Journal of the American Medical Association, Vol. 284, No. 114, October 2000