Dated 11 October 2023, the US Centers for Medicare & Medicaid Services (CMS) recently finalised its decision regarding National Coverage Determination (NCD) 20.7 for carotid artery stenting (CAS), confirming coverage expansion. Previously, patients were only eligible for CAS through clinical trials or if they were high-surgical-risk individuals. The decision made by the CMS removes several facility standards and approval requirements, as well as leaving coverage for any CAS procedure not described in the NCD to Medicare Administrative Contractor (MAC) discretion.
Previously, the CMS required facilities to hold an accreditation certification as a condition of reimbursement for CAS procedures. This meant that centres must meet a minimum standard for a range of criteria, self-attesting quality in areas such as staffing, equipment status, device inventory and facility infrastructure. Sceptical about the scope and diligence of the CMS’ accreditation requirements, David Sacks (Reading Hospital, West Reading, USA), past president of the Intersocietal Accreditation Commission (IAC) CAS board and a representative of the Society of Interventional Radiology (SIR), worked with stakeholders from professional societies to develop the IAC Carotid Artery Stenting accreditation programme, which began accrediting CAS facilities in 2011.
“Accreditation has two main purposes,” said Sacks, “one is that it provides guidelines for facilities to do a good job, know what best practices are, and fulfil recommendations. Second, it provides some degree of assurance to patients and insurance companies that patients are getting care that meets a particular benchmark—both of those have value”. Yet, he noted that some facilities see accreditation personified as “a policeman”, viewing the process as “unpleasant and usually not well-accepted”, rather than seeing accreditation as a means to provide “tools” to help organisations achieve better patient outcomes.
In the early days of CAS—around 2007—Sacks detailed that there was concern among specialties and societies that the procedure may be “abused” by providers with “unbridled enthusiasm” despite poor outcomes at that time. “Many of us felt that accreditation could be a useful tool for reigning in some of this enthusiasm and allow patients to get good care. There was no accrediting organisation that focused on [CAS], so I organised multiple conference calls among various societies to see how we could move forward.”
Engaging multiple societies, Sacks and colleagues agreed that a multispecialty, multisociety accreditation programme would be effective. Representatives from the American Academy of Neurology (AAN), American Association of Neurological Surgeons/Congress of Neurological Surgeons (AANS/ CNS) Cerebrovascular Section, American Association of Physics in Medicine (AAPM), Neurocritical Care Society (NCS), Society for Vascular Medicine (SVM), Society for Vascular Surgery (SVS), the SIR, Society of NeuroInterventional Surgery (SNIS), and the Society of Vascular and Interventional Neurology (SVIN), and later joined by the Society of Cardiovascular Angiography and Interventions (SCAI) “took off their societal hats to work together” to create the programme. Sacks averred that their end product—the IAC CAS accreditation programme— upholds “good processes of care via a thorough history”, requiring facilities to provide detailed logs of CAS procedures and periodical case reviews.
Following the launch of the IAC CAS programme, Sacks stated how they had hoped the CMS would defer to them for CAS accreditation. “Medicare in the USA requires facilities to be accredited to be reimbursed for CAS, but their accreditation system was pretty much just attestation, stating ‘we do good work’ and Medicare saying ‘OK’. We were hopeful that they would defer to us, but they never did.”
Aimed to reveal the distinction between IAC-accredited and non-accredited facilities certified by the CMS with CAS best practices, Sacks et al conducted an exploratory study in 2019. Their results demonstrated that IAC-accredited facilities are more likely to “follow best-practices, use quantitative tools to select appropriate patients, and quantitatively measure patient-centred clinical outcomes”, although the authors acknowledge the limitation of the study’s small sample size.
In Sacks et al’s discussion of their results, they aver that CMS-certified facilities “may not necessarily comply with process measures”, determining the value indicated by having an “external entity audit facilities” and provide “oversight to ensure best practices”. In a separate article analysing cases submitted for accreditation 90% of CAS asymptomatic cases and 28% of symptomatic stenosis did not meet CMS requirements for stenosis severity. Accredited facilities were found to have had significantly better compliance. Sacks and colleagues subsequently communicated these results with the CMS, however CMS decided to remove several training requirements and quality assurance measures, allowing centres to self-monitor procedural standards for CAS.
Casting a realistic eye toward the near future, Sacks stated that he is uncertain of whether facilities will choose to become accredited for CAS: “There could be many facilities who say ‘we are going to get into this and we want to be the best—what tools are available?’ Those folks might seek us out and apply for accreditation the same way people hire consultants to help them do a better job. Consultants aren’t mandatory, but they are a resource. We are hoping with the expected increase in the number of carotid artery stenting procedures and the number of facilities offering [CAS], that there will be an interest in using the IAC as a resource to improve and maintain quality of care.”
The IAC CAS accreditation is available both in the USA and internationally.
