Credentialing Guidelines Meant to Be Fluid
Whether the ACC’s proposals will be adopted or what difference they would make to device access remains to be seen. Neither STS nor SCAI officials proposed the same changes in their public comments on the CMS proposal.
But Dr. Carl Tommaso, chair of the document’s writing committee and medical director of the cardiac catheterization lab at North Shore University Health System’s Skokie (Ill.) Hospital, said the guidelines were established with the knowledge that near-term adjustments might be necessary.
"Part of the problem stated up front is that [there are] no data that says what experience makes you a good TAVR center medically or surgically," Dr. Tommaso said in an interview. "We were hoping to write, basically, a fluid document. We wanted to take the stance that we can change those numbers as data became available."
Dr. Tommaso acknowledges that having the requirements locked into a national Medicare coverage determination so early in the lifespan of the technology will make such a fluid process more difficult, "but if the numbers are too restrictive, we hope we can impress upon CMS that Americans are not getting appropriate-enough therapy, and that this be expanded."
Still, he underscored, the goal of the societies was to be considerably restrictive in the early stages of the technique. "We did not want it to be in every interventionalist’s hands," Dr. Tommaso explained. "We think that would have been too much. We were hoping that somewhere in the range of 250-300 centers would qualify under those numbers."
Elsevier Global Medical News and "The Gray Sheet" are owned by Elsevier.