Find reimbursement resources, including coding guides, links to Medicare Coverage Determinations, on-demand webinars, and frequently asked questions for products used for carotid artery stenting.
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The Centers for Medicare and Medicaid Services (CMS) coverage of carotid artery stenting (CAS) began in July 2001 when coverage of CAS was limited to patients enrolled in an IDE trial. Since that time, CMS has published multiple related coverage policies for carotid artery stenting. Policies cover CAS in an IDE investigational trial setting, in a post-approval trial setting, in a post-approval extension trial setting, and for a subset of FDA-approved indications there is coverage outside of trials.
Effective December 9, 2009, Medicare clarified coverage for carotid artery stenting requiring the use of an FDA-approved or cleared embolic protection device. If deployment of the embolic protection device is not technically possible, and not performed, then the procedure is not covered by Medicare.
In September 2014, CMS granted approval for Percutaneous Transluminal Angioplasty (PTA) to cover carotid artery stenting through the CREST-2 trial and the CREST-2 Registry. Please view the CMS national coverage determination for additional information.
On October 11, 2023, CMS released the Final Decision Memo on NCD 20.7 that expands coverage for Carotid Artery Stenting (CAS) procedure to patients for the treatment of carotid artery stenosis.
CMS final decision is effective on October 11, 2023. Please review the CAS final decision memo for detailed information on their decision.
The Final Decision Memo is available at NCA - Percutaneous Transluminal Angioplasty (PTA) of the Carotid Artery Concurrent with Stenting (CAG-00085R8) - Decision Memo (cms.gov)
In summary, the final decision memorandum, which affects NCD 20.7 sections B4 and D, revises Medicare coverage for PTA of the carotid arteries concurrent with stenting as follows:
CMS Expands Coverage for standard surgical risk patients by removing limitation of coverage to only high surgical risk patients and patients previously only eligible for coverage in clinical trials.
CMS determines that percutaneous transluminal angioplasty (PTA) of the carotid artery concurrent with stenting is reasonable and necessary with the placement of an FDA-approved carotid stent with an FDA-approved or cleared embolic protection device for Medicare beneficiaries under the following conditions:
Patients with symptomatic carotid artery stenosis ≥50%
|Formal shared-decision making interaction|
CMS requires the provider to engage in a formal shared decision-making interaction with the patient prior to performing CAS. The shared decision-making interaction must include:
Discussion of all treatment options including carotid endarterectomy (CEA), CAS (which includes transcarotid artery revascularization (TCAR)), and optimal medical therapy (OMT)).
Explanation of risks and benefits for each option specific to the beneficiary’s clinical situation.
Integration of clinical guidelines (e.g., patient comorbidities and concomitant
Discussion and incorporation of beneficiary’s personal preferences and priorities in choosing a treatment plan.
|CMS Approved Facilities|
CMS removed all facility approval requirements.
|Carotid stenosis measurement guideline|
Neurological assessment by a neurologist or NIH stroke scale (NIHSS) certified health professional before and after carotid artery stenting (CAS) must be performed.
First-line evaluation of carotid artery stenosis must use duplex ultrasound.
Computed Tomography angiography or magnetic resonance angiography, if not contraindicated, must be used to confirm the degree of stenosis and provide additional information about the aortic arch, and extra- and intracranial circulation.
Intra-arterial digital subtraction (catheter) angiography may be used only when there is significant discrepancy between non-invasive imaging results, or in lieu of computed tomography angiography or magnetic resonance angiography if these are contraindicated.
(Carotid Revascularization and Medical Management for Asymptomatic Carotid Stenosis Trial)
CREST-2, sponsored by the National Institute of Neurological Disorders and Stroke (NINDS) of the National Institutes of Health (NIH), is intended to evaluate the best approach for managing asymptomatic patients with high-grade carotid atherosclerotic stenosis. This prospective multi-center randomized controlled trial started enrollment in 2014 and is expected to complete final data collection for primary outcome measure in 2020. CREST-2 site selection and credentialing is managed by a multi-disciplinary committee. Please visit the NIH StrokeNet web site or the CREST-2 Trial web site for additional information.
The objective of CREST-2 Registry is to promote the rapid initiation and completion of patient enrollment in the CREST-2 trial. Accreditation for Cardiovascular Excellence (ACE) was selected by CMS to accredit C2R clinical sites.
National Cardiovascular Data Registry (NCDR) Peripheral Vascular Intervention (PVI) Registry and Society for Vascular Surgery’s Vascular Quality Initiative (VQI) are the selected registries to administer C2R data collection. Each C2R participating operator/site is required to have membership for either the NCDR-PVI Registry or the SVS-VQI Registry.
Because commercial coverage varies regionally, Abbott recommends that providers verify insurance coverage prior to performing procedures.
1 Center for Medicare and Medicaid Services (CMS), Pub 100-3 Medicare National Coverage Determinations, Transmittal 115, March 5, 2010. https://www.cms.gov
Centers for Medicare and Medicaid Services at www.cms.gov
Medicare Advantage plans are managed by commercial payers who are required to provide their Medicare Advantages Beneficiaries with all services and supplies that traditional Medicare (fee-for-service) covers.
Please note there is a lag time between final memo decision effective date and implementation by medicare administrators, which may lead to coverage denials for Medicare Advantage beneficiaries. Information found in the "Carotid Stenting Prior Authorization Toolkit" provides guidance on this type of denial scenario.
For procedures or services not covered by the final decision memo, please contact your plan administrator.
This material and the information contained herein is for general information purposes only and is not intended, and does not constitute, legal, reimbursement, business, clinical, or other advice. Furthermore, it is not intended to and does not constitute a representation or guarantee of reimbursement, payment, or charge, or that reimbursement or other payment will be received. It is not intended to increase or maximize payment by any payer. Similarly, nothing in this document should be viewed as instructions for selecting any particular code, and Abbott does not advocate or warrant the appropriateness of the use of any particular code. The ultimate responsibility for coding and obtaining payment/reimbursement remains with the customer. This includes the responsibility for accuracy and veracity of all coding and claims submitted to third-party payers. In addition, the customer should note that laws, regulations, and coverage policies are complex and are updated frequently, and, therefore, the customer should check with its local carriers or intermediaries often and should consult with legal counsel or a financial, coding, or reimbursement specialist for any questions related to coding, billing, reimbursement or any related issues. This material reproduces information for reference purposes only. It is not provided or authorized for marketing use.