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A.7.01.97
Drug-coated balloons (DCBs) deliver antiproliferative agents directly to the coronary vessel wall via a semicompliant balloon coated with drugs (typically paclitaxel, sirolimus, or everolimus) embedded in a carrier matrix that rapidly diffuses into the vessel wall during inflation, without requiring permanent stent implantation. This approach provides localized drug delivery to inhibit neointimal hyperplasia while avoiding additional metallic layers.
In-Stent Restenosis
Coronary artery disease (CAD) is the leading cause of death worldwide and commonly presents as either chronic coronary syndrome with exertional angina or acute coronary syndromes due to plaque rupture or erosion with thrombotic occlusion. Percutaneous coronary intervention (PCI) with drug-eluting stent (DES) implantation has become the standard of care for coronary revascularization because it provides an immediate and stable result, which reduces the risk of major adverse cardiac events (MACE) compared with balloon angioplasty alone. Earlier generations of bare-metal stents were associated with neointimal hyperplasia and in-stent restenosis (ISR) in approximately 15% to 30% of treated lesions at mid- to long-term follow-up. Although second-generation DES substantially lowered ISR and stent thrombosis compared with BMS, a non-negligible risk of ISR and late thrombotic events persists. ISR reflects a combination of smooth muscle cell proliferation, inflammatory response to stent-related vessel injury, and later neoatherosclerosis and vessel remodeling, and is more frequent in patients with long stents, diabetes, or complex lesion anatomy. Patients who develop ISR may experience recurrent angina and ischemia and require repeat revascularization. ISR in multilayer or small-vessel segments can be particularly challenging to manage because additional stent layers may compromise lumen diameter, impair future surgical options, and increase the risk of recurrent restenosis or thrombosis.
Treatment
For patients with coronary in-stent restenosis (ISR), the standard evidence-based approach is repeat stenting using drug-eluting stents (DES), while drug-coated balloons (DCBs) are under active investigation as an alternative therapy. DCBs are angioplasty balloons coated with an antiproliferative drug and an excipient, enabling rapid drug delivery and retention within the vessel wall during balloon inflation. This technique aims to prevent neointimal hyperplasia without requiring a permanent implant. DCB angioplasty purports several advantages over additional DES implantation, including: preservation of coronary vasomotion, avoidance of multiple stent layers and polymer-related inflammation, the potential for positive vessel remodeling and late luminal enlargement, avoidance of side branch jailing and carina shift in bifurcation lesions, and does not constrain future reinterventions with additional metallic scaffolds.
In February 2024, the AGENT™ Paclitaxel-Coated Balloon Catheter (Boston Scientific) was approved by the U.S. Food and Drug Administration (FDA) through the premarket approval (PMA) process (P230035) for use “after appropriate vessel preparation in adult patients undergoing percutaneous coronary intervention (PCI) in coronary arteries 2.0 mm to 4.0 mm in diameter and lesions up to 26 mm in length for the purpose of improving myocardial perfusion when treating in-stent restenosis (ISR).” The device had previously been granted FDA Breakthrough Device designation in January 2021.
Several additional DCBs remain as investigational devices in the United States and have not yet received FDA premarket approval for commercial use:
In October 2024, the FDA granted Medtronic an investigational device exemption (IDE) approval for the Prevail™ paclitaxel-coated drug-coated balloon (DCB) coronary pivotal trial (Prevail Global), designed to evaluate the safety and effectiveness of Prevail for the treatment of coronary ISR and de novo small-vessel coronary disease.
In October 2022 and January 2023, the FDA granted investigational device exemption (IDE) approvals for the SELUTION SLR™ sustained limus-release sirolimus-eluting balloon (MedAlliance, now Cordis) to evaluate sirolimus-coated balloon angioplasty for coronary ISR in October 2022 and for de novo small-vessel coronary lesions in January 2023.
In April 2019, the FDA granted Breakthrough Device designation to the Virtue™ sirolimus-eluting balloon (Orchestra BioMed) for the treatment of coronary ISR. Virtue SAB has subsequently been granted Breakthrough Device designation for the treatment of coronary ISR and coronary small-vessel disease.
In April 2019, the MagicTouch™ sirolimus-coated balloon (Concept Medical) received FDA Breakthrough Device designation for the treatment of coronary artery disease in patients with ISR, and the MagicTouch SCB platform has since obtained IDE approvals for multiple indications, including de novo or small-vessel coronary disease.
No DCBs have been approved by the FDA for the treatment of de novo coronary lesions or small coronary vessel disease.
The use of percutaneous coronary intervention (PCI) with a drug-coated balloon (DCB) in adult individuals for treating coronary in-stent restenosis (ISR) is considered investigational.
Federal Employee Program (FEP) may dictate that all FDA-approved devices, drugs or biologics may not be considered investigational and thus these devices may be assessed only on the basis of their medical necessity.
The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.
Investigative is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized as a generally accepted standard of good medical practice for the treatment of the condition being treated and; therefore, is not considered medically necessary. For the definition of Investigative, “generally accepted standards of medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. In order for equipment, devices, drugs or supplies [i.e, technologies], to be considered not investigative, the technology must have final approval from the appropriate governmental bodies, and scientific evidence must permit conclusions concerning the effect of the technology on health outcomes, and the technology must improve the net health outcome, and the technology must be as beneficial as any established alternative and the improvement must be attainable outside the testing/investigational setting.
04/01/2026: New policy added. Approved by the Medical Policy Advisory Committee.
Blue Cross Blue Shield Association policy # 7.01.97
This may not be a comprehensive list of procedure codes applicable to this policy.
Investigational Codes
Code Number | Description |
CPT-4 | |
0913T | Percutaneous transcatheter therapeutic drug delivery by intracoronary drug-delivery balloon (eg, drug-coated, drug-eluting), including mechanical dilation by nondrug-delivery balloon angioplasty, endoluminal imaging using intravascular ultrasound (IVUS) or optical coherence tomography (OCT) when performed, imaging supervision, interpretation, and report, single major coronary artery or branch |
0914T | Percutaneous transcatheter therapeutic drug delivery by intracoronary drug-delivery balloon (eg, drug-coated, drug-eluting) performed on a separate target lesion from the target lesion treated with balloon angioplasty, coronary stent placement or coronary atherectomy, including mechanical dilation by nondrug-delivery balloon angioplasty, endoluminal imaging using intravascular ultrasound (IVUS) or optical coherence tomography (OCT) when performed, imaging supervision, interpretation, and report, single major coronary artery or branch (List separately in addition to code for percutaneous coronary stent or atherectomy intervention) |
HCPCS | |
C9610 | Catheter, transluminal drug delivery with or without angioplasty, coronary, non-laser (insertable) |
ICD-10 Procedure | |
XW0J3HA | Introduction of Paclitaxel-Coated Balloon Technology, One Balloon into Coronary Artery, One Artery, Percutaneous Approach, New Technology Group 10 |
XW0J3JA | Introduction of Paclitaxel-Coated Balloon Technology, Two Balloons into Coronary Artery, One Artery, Percutaneous Approach, New Technology Group 10 |
XW0J3KA | Introduction of Paclitaxel-Coated Balloon Technology, Three Balloons into Coronary Artery, One Artery, Percutaneous Approach, New Technology Group 10 |
XW0J3LA | Introduction of Paclitaxel-Coated Balloon Technology, Four or More Balloons into Coronary Artery, One Artery, Percutaneous Approach, New Technology Group 10 |
XW0K3HA | Introduction of Paclitaxel-Coated Balloon Technology, One Balloon into Coronary Artery, Two Arteries, Percutaneous Approach, New Technology Group 10 |
XW0K3JA | Introduction of Paclitaxel-Coated Balloon Technology, Two Balloons into Coronary Artery, Two Arteries, Percutaneous Approach, New Technology Group 10 |
XW0K3KA | Introduction of Paclitaxel-Coated Balloon Technology, Three Balloons into Coronary Artery, Two Arteries, Percutaneous Approach, New Technology Group 10 |
XW0K3LA | Introduction of Paclitaxel-Coated Balloon Technology, Four or More Balloons into Coronary Artery, Two Arteries, Percutaneous Approach, New Technology Group 10 |
XW0L3HA | Introduction of Paclitaxel-Coated Balloon Technology, One Balloon into Coronary Artery, Three Arteries, Percutaneous Approach, New Technology Group 10 |
XW0L3JA | Introduction of Paclitaxel-Coated Balloon Technology, Two Balloons into Coronary Artery, Three Arteries, Percutaneous Approach, New Technology Group 10 |
XW0L3KA | Introduction of Paclitaxel-Coated Balloon Technology, Three Balloons into Coronary Artery, Three Arteries, Percutaneous Approach, New Technology Group 10 |
XW0L3LA | Introduction of Paclitaxel-Coated Balloon Technology, Four or More Balloons into Coronary Artery, Three Arteries, Percutaneous Approach, New Technology Group 10 |
XW0M3HA | Introduction of Paclitaxel-Coated Balloon Technology, One Balloon into Coronary Artery, Four or More Arteries, Percutaneous Approach, New Technology Group 10 |
XW0M3JA | Introduction of Paclitaxel-Coated Balloon Technology, Two Balloons into Coronary Artery, Four or More Arteries, Percutaneous Approach, New Technology Group 10 |
XW0M3KA | Introduction of Paclitaxel-Coated Balloon Technology, Three Balloons into Coronary Artery, Four or More Arteries, Percutaneous Approach, New Technology Group 10 |
XW0M3LA | Introduction of Paclitaxel-Coated Balloon Technology, Four or More Balloons into Coronary Artery, Four or More Arteries, Percutaneous Approach, New Technology Group 10 |
ICD-10 Diagnosis | |
T82.855A | Stenosis of coronary artery stent, initial encounter |
T82.855D | Stenosis of coronary artery stent, subsequent encounter |
T82.855S | Stenosis of coronary artery stent, sequela |
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