TCAR Surveillance Project https://clinicaltrials.gov/ct2/show/study/NCT02850588
Effective September 1, 2016, hospitals participating in the Society for Vascular Surgery (SVS) Vascular Quality Initiative (VQI) receive CMS coverage for Transcarotid Artery Revascularization (TCAR) procedures entered into the VQI Carotid Artery Stenting module. According to the National Coverage Determination (NCD) 20.7 for Percutaneous Transluminal Angioplasty, the TCAR Surveillance Project is an FDA-approved post approval carotid stenting study. CMS will reimburse hospitals and physicians for symptomatic and asymptomatic patients at high risk for traditional carotid artery surgery who participate in the TCAR Surveillance Project.
The Patient Safety Organization (PSO) for the SVS has made public the CMS letter detailing the approval of the TCAR Surveillance Project. The Project Coverage Letter can now be found on the VQI website with the following link: http://www.vascularqualityinitiative.org/vqi-resource-library/tcar-surveillance-project/
Under NCD 20.7, the TCAR Surveillance Project does not require the study sites to get approval from the Medicare Administrative Contractors. For billing purposes, facilities and providers will submit claims for the TCAR Surveillance Project using National Clinical Trial (NCT) identifier NCT02850588.
Post-Approval Study # / PMA #:
The TCAR Surveillance Project
Transcarotid Artery Revascularization (TCAR)
Direct implantation of a stent into the carotid artery via surgical incision in the neck combined with blood flow reversal in the carotid artery during stent placement.
ENROUTE® Transcarotid Neuroprotection System
ENROUTE® Transcarotid Stent System
Any FDA-cleared proximal embolic protection device and FDA-approved carotid artery stent system indicated for the transcarotid approach
ROADSTER 2 is an FDA-approved Post Approval Study. Patients who meet the inclusion/exclusion criteria for ROADSTER 2 may be eligible for Medicare coverage per Section 3 of NCD Manual Section 20.7 and as highlighted on the CMS website of approved studies:
Providers must bill the Pre-Market Approval (PMA) number assigned to the stent system by the FDA (P140026).
Post-Approval Study # / PMA #:
The ROADSTER 2 Registry
Registry of Transcarotid Carotid Artery Revascularization in Patients with Significant Carotid Artery Disease
ENROUTE ™ Transcarotid Stent System
Silk Road Medical, Inc.
Detailed billing instructions can be found here.
CREST-2 Registry https://clinicaltrials.gov/ct2/show/NCT02240862
TCAR and the ENROUTE Neuroprotection and Stent System are included in the CREST-2 Registry. Providers can bill Medicare for TCAR patients enrolled in this registry using NCT02240862.
CREST-2 Randomized Trial https://clinicaltrials.gov/ct2/show/NCT02089217
TCAR and the ENROUTE Neuroprotection and Stent System are excluded from the CREST-2 randomized trial.
8 See CMS, Medicare Claims Processing Manual Ch. 32 §§ 68.2, 69.6, 160.2 available at https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/Downloads/clm104c32.pdf
Silk Road Medical provides this content for informational purposes only. The information contained herein is gathered from various publicly available sources and is subject to change without notice. Silk Road Medical cannot guarantee (either implicitly or explicitly) success in obtaining coverage or payment. Reimbursement for medical products and services is affected by numerous factors. It is always the provider’s responsibility to determine and submit appropriate codes, charges, and modifiers for services that are rendered. Actual codes and/or modifiers used are at the sole discretion of the treating physician and/or facility. Providers should contact their third-party payers for specific information on their coding, coverage, and payment policies. This guide is in no way intended to promote the off‐label use of any medical device. Information last reviewed January 15, 2019.