When it comes to coverage and reimbursement, there are gatekeepers all over the place, but some keep bigger gates than others. Following are two stories about the Centers for Medicare & Medicaid Services and how it has kept its gate in recent weeks.
CMS not wild about MILD
CMS recently took it upon itself to review percutaneous, image-guided lumbar decompression for stenosis, proposing on Oct. 17 that it sees the evidence as insufficient to prompt coverage.
Among the references found in the coverage proposal is one addressing the MILD procedure by Vertos Medical, a company that is no doubt pulling out all the stops to get CMS on board. The agency said most of the evidence in support was provided by case series, and the only randomized, controlled trial “had a small enrollment and major design flaws.”
CMS also said it has “questions about missing information, questions about adverse events and conflicts of interest,” concluding that the evidence “does not support a conclusion of improved health outcomes.”
So it doesn’t look good. Still, we might bear in mind that more than 100 people sounded off on the treatment, the vast majority of which were supportive. Even if CMS passes, this won’t be the last we hear of MILD and PILD.
Heart failure? VAD you asked
CMS also recently published a coverage memo for ventricular assist devices, which among other things declared the Intermacs registry a dinosaur. The problem here is that the age of mammals has yet to arrive where a replacement registry is concerned, so T. Rex reigns until further notice.
Perhaps the most significant aspect of this coverage memo is that CMS seems to have pried open enough space for those bridge-to-decision patients with a passage stating that the agency has removed the word “permanent” from the language dealing with VAD for destination therapy.
Doctors seem to be of the view that CMS left a lot of ambiguity in its rewrite of the coverage manual, and the term “destination therapy” will now include a much more varied population. Still, where there’s fuzziness, there’s latitude, and what was a bad state of limbo for some heart failure patients now becomes a haven, and the docs have to deal with limbo, which frankly is a task they’re paid to handle.
All in all, it sounds like an improvement for heart failure patients, and an especially welcome bit of news for a patient population that is in desperate straits.