The Centers for Medicare and Medicaid Services (CMS) has published a draft decision memo on carotid-artery stenting (CAS) that would expand Medicare coverage of the procedure and remove certain requirements for CAS facilities and operators.
The new memo follows a national coverage analysis for CAS that was initiated in January 2023 and considers 193 public comments received in the ensuing month.
That analysis followed a request from the Multispecialty Carotid Alliance (MSCA) to make the existing guidelines less restrictive.
The decision proposal would expand coverage for CAS "to standard surgical risk patients by removing the limitation of coverage to only high-surgical risk patients." It would limit it to patients for whom CAS is considered "reasonable and necessary" and who are either symptomatic with carotid stenosis of 50% or greater or asymptomatic with carotid stenosis of at least 70%.
The proposal would require practitioners to "engage in a formal shared decision-making interaction with the beneficiary" that involves use of a "validated decision-making tool." The conversation must include discussion of all treatment options and their risks and benefits and cover information from the clinical guidelines, as well as "incorporate the patient's personal preferences and priorities."
Much of the proposed coverage criteria resemble recommendations from several societies that offered comments in response to the January 12 CMS statement that led to the current draft proposal. They include, along with MSCA, the American Association of Neurological Surgeons and the Congress of Neurological Surgeons, and jointly the American College of Cardiology (ACC) and the American Heart Association (AHA).
Carotid stenting, commented the ACC/AHA, "was first introduced in 1994, and the field has matured in the last three decades." The procedure "is a well-established treatment option." The groups declared support for "removal of the facility and operator requirement for CAS consistent with the current state of the published literature and standard clinical practice."
The current CMS draft proposal acknowledges the publication of five major randomized controlled trials and a number of "large, prospective registry-based studies" since 2009 that support its proposed coverage criteria.
Collectively, it states, the evidence "suffices to demonstrate that CAS and [carotid endarterectomy] are similarly effective" with respect to the clinical primary endpoints of recent trials "in patients with either standard or high surgical risk and who are symptomatic with carotid artery stenosis ≥ 50% or asymptomatic with stenosis ≥ 70%."
Batya Swift Yasgur MA, LSW, is a freelance writer with a counseling practice in Teaneck, NJ. She is a regular contributor to numerous medical publications, including Medscape and WebMD, and is the author of several consumer-oriented health books as well as Behind the Burqa: Our Lives in Afghanistan and How We Escaped to Freedom (the memoir of two brave Afghan sisters who told her their story).