In a move that surprised some physicians, CMS officials last week decided not to follow through on a previous plan to expand Medicare coverage of carotid artery stenting.
The decision is an about-face from an announcement in February in which the CMS appeared poised to expand coverage of carotid artery stenting, a minimally invasive procedure that clears plaque blockages.
In an April 30 memo the CMS officials cited objections by medical profession groups—many representing surgeons—as well as a lack of clinical trial evidence showing an acceptable level of patient-risk factors as the reasons for their turnabout. According to the memo, Medicare officials reviewed 17 clinical trials and studies on carotid artery stenting conducted since 2005, the year the CMS issued its current policy on covering the procedure. “The studies didn’t change, but our interpretation of them was modified after we heard all the (public) comments and concerns,” said Marcel Salive, director of the CMS’ Medical and Surgical Services Division.
Under the decision, Medicare’s carotid artery stenting coverage will remain unchanged, with the agency providing direct coverage only to patients who are at high risk for life-threatening complication using endarterectomy surgery (surgical removal of fatty deposits from the carotid artery); have symptoms of blood-flow restriction; and have at least a 70% artery blockage. Low-risk surgical patients and high-risk ones who are asymptomatic would have to qualify for a clinical trial.
Proponents of the procedure disagreed with the reversal. “My feeling is Medicare made what I think is an unfortunate decision, because they put us in a position of not being able to offer an alternative to endarterectomy,” said Nick Hopkins, a neurosurgeon who is a principal investigator for carotid artery stenting clinical trials financed by Abbott Laboratories, one of four firms approved by the Food and Drug Administration to manufacture the stents.