Percutaneous coronary intervention with drug-coated balloon for coronary in-stent restenosis
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This policy governs coverage and authorization requirements for percutaneous coronary intervention (PCI) using drug-coated balloons (DCBs) to treat coronary in-stent restenosis (ISR) in adult members of Blue Cross Blue Shield - Massachusetts.
No material clinical or coverage changes in this revision.
Coverage Determination
Investigational — General
Policy coverage determination
Applies to Commercial and Medicare product lines; outpatient DCB for ISR is not a covered outpatient service for listed products.
For adult members, the use of percutaneous coronary intervention (PCI) with a drug-coated balloon (DCB) to treat coronary in-stent restenosis (ISR) is considered investigational. As a result, outpatient PCI with a DCB for ISR is not a covered service for Commercial Managed Care (HMO and POS), Commercial PPO and Indemnity, Medicare HMO Blue SM, and Medicare PPO Blue SM.
This intervention is designated investigational because current evidence does not establish that DCB therapy for ISR improves the net health outcome compared with available alternatives. Although DCBs have demonstrated benefit versus plain balloon angioplasty, there remain unresolved questions about their comparative effectiveness against current-generation drug-eluting stents (DES), limited durability data for the FDA-approved AGENT device, and an overall need for additional well-conducted studies to define which patients, if any, derive superior or durable benefit from DCB versus DES.
Coding and Billing
| 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). |
| C9610 | Catheter, transluminal drug delivery with or without angioplasty, coronary, non-laser |
Provider Requirements and Actions
Prior Authorization Required
For services described in this policy, precertification/preauthorization is REQUIRED when the procedure is performed inpatient for all product lines.
- Applies to all products when performed inpatient
Outpatient Use Not Covered
Outpatient use of PCI with a drug-coated balloon (DCB) for coronary in-stent restenosis (ISR) is not a covered service for Commercial Managed Care (HMO and POS), Commercial PPO and Indemnity, Medicare HMO Blue SM, and Medicare PPO Blue SM.
- Commercial Managed Care (HMO and POS), Outpatient = Not a covered service
- Commercial PPO and Indemnity, Outpatient = Not a covered service
- Medicare HMO Blue SM, Outpatient = Not a covered service
- Medicare PPO Blue SM, Outpatient = Not a covered service
Investigational Therapy / Coverage Restrictions
Percutaneous coronary intervention (PCI) using a drug-coated balloon (DCB) for coronary ISR is considered investigational. As such, DCB angioplasty for ISR is subject to coverage restrictions and is not considered medically necessary based on current evidence.
- DCB for coronary ISR is investigational for Commercial and Medicare product lines
- Ongoing studies (e.g., AGENT IDE) are insufficient to establish net health benefit or durability
Preferred Therapy (DES) over Investigational DCB
The standard, evidence-based treatment for coronary in-stent restenosis (ISR) remains repeat stenting with drug-eluting stents (DES). DCBs are under investigation as an alternative but are not preferred over DES given current evidence.
- Preferred therapy for ISR: repeat PCI with drug-eluting stents (DES)
- DCB angioplasty remains investigational and is not preferred over DES
Clinical Background
In-stent restenosis (ISR) results from biological processes occurring within a previously implanted coronary stent, including neointimal hyperplasia, inflammation, neoatherosclerosis, and vessel remodeling. These processes produce recurrent narrowing of the stented segment and can lead to recurrent angina and the need for repeat revascularization.
Management of ISR has important clinical implications because treatment choices affect both short-term symptom relief and long-term vessel integrity. Standard therapy is repeat stenting with a drug-eluting stent (DES), which delivers antiproliferative medication via a new implant. Drug-coated balloons (DCBs) are an alternative approach that deliver antiproliferative drug to the vessel wall during angioplasty without leaving an additional metal layer, a potential advantage in select scenarios under active investigation.
Definitions
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