Earlier this month, I covered a CMS press release that a MolDx LCD regarding transplant genomic test monitoring would not be finalized. See the August 16 blog here. Therein I noted there had been 5 or 6 WSJ Op Eds about the topic, since March 2023. Indeed, the newest WSJ Op Ed on the topic was as recent as August 21, 2024.
One of the Op Eds, on April 18, 2024, was based on FOIA documents from CMS about CareDx and its test coverage.
By coincidence, today, I got a CMS FOIA response of my own on this topic. (Oddly, my CMS letter arriving in today's email is dated 6/24/2024.)
CMS says it is responding to my FOIA request of 5/2/2024, meaning they are getting back to me in about three months (or less than two months, if you use the letterhead date of 6/24/2024).
But it's downhill from there.
They sent me:
- A letter from Noridian to the Willkie Farr law firm in New York, dated October 20, 2022, which says Noridian FOIA is responding to the law firm's September 21, 2022, letter to Noridian regarding Allosure correspondence. Noridian says it is working on it.
- A letter from CMS to the Willkie Farr law firm in New York, dated January 3, 2023, referring to another Willkie FOIA request to Noridian (written by Willkie on November 30, 2022, and received by Noridian on December 2, 2022.) Again, CMS is working on it.
- Then Noridian sends the definitive letter to Willkie Farr on November 9, 2023.
- Noridian says this pertains to Willkie Farr's September 21, 2022, letter to Noridian. Noridian completed the document search in May 2023.
- And Noridian forwarded documents found to CMS in May. Because, Noridian determined the records regarding Allosure could not be released, but it seems to have conveyed this to Willkie Farr on November 9, 2023.
- Noridian says the unreleasable documents have been forwarded under seal to Office of Program Operations and Local Engagement, and Noridian advises Willkie Farr to pursue any further questions with them (opolefoia@cms.hhs.gov).
So, it's murky, but the WSJ FOIA documents might have resulted (1) from further Willkie Farr appeals up the food chain at CMS, between November 2023 and March 2024, or (2) from a different chain of events entirely.
