Thursday, June 22, 2023

CMS Outlines Alzheimer Drug Registries; Blog #1: Require Amyloid Tests - But Which and What Price?

 CMS famously is requiring some level of registries - maybe Registry Lite - for all patients who imminently will start getting the new FDA-approved Alzheimer beta amyloid drugs.

CMS has released template information for the registries.  Specific registries will have their own management and focus and will be set up in the near future.

Information here and here.  See Blog #2 about the registry itself here.

The information or minimum data set will include among other things, the patient's diagnosis (mild MCI or mild Alzheimer), plus the prescription of any antiplatelet drugs, plus the results of an amyloid PET scan, or CSF test, or "other amyloid test."

What does this mean?   

PET tests will have FDA approved tracers, like Lilly's Amyvid and others.  There's an approved FDA CSF test (Fujirebio), which is in the current coding & pricing process at CMS.   What what about non-FDA tests?  Or blood tests?   There may be good ones, or over-hyped bad ones.   Do MACs have to cover all of them?   Could a MAC limit to FDA-approved tests?   When you consider an instruction like this, and the wild west of sometimes scuzzy LDTs, you have to wonder about implementation.

Possibly, it simply means that the registry will require the physician to report which amyloid test the patient has had, and how to get it, or who pays for it, or whether one is available, is up to other parts of CMS, not the registry managers.