Monday, July 17, 2023

CMS to Cancel Amyloid PET NCD, Leave Issue to MACs; plus JAMA

For decades, CMS has tightly controlled access to PET scans, through a series of complex and topic-specific NCDs.  Today, CMS announced a proposal to terminate its beta-amyloid PET scan NCD, which allowed access only within clinical trials.  If the change is carried out, beta-amyloid PET scans will be subject to MAC discretion.

Concurrently, JAMA published a large clinical RCT for donanemab (Lilly drug), along with 4 Op Eds.


What Happened

The proposed NCD decision is here.  NCD 220.6.20 would be removed, making amyloid PET coverage up to each MAC.   CMS includes a lengthy topical discussion, a history of its PET coverage, and a rationale for local management.


CMS took up this topic early in June 2022, but deferred a decision from December 2022 (expected) to July 2023 (actual).  

What happens next?  

CMS must take public comment to August 16, 2023.  CMS has 60 days to finalize, but could do so faster (on or possibly earlier than October 16, 2023).   Then, a little weirdness.  Legally, the decision is effective on that day (October 16, or earlier).  But CMS typically issues a transmittal effectuating the change with MACs in a few months (say, December 2023) typically "effective" on some future date (say, March 1, 2024), but retroactive to October 16.   Whew.

Nerd Note 1 - Removal

CMS could have used the "expedited NCD removal process," since this is simply a cancellation of the NCD and not a revision of it.

Nerd Note 2 - Tau

I don't think CMS has ever regulated tau PET scans, if FDA versions are approved, I think they would be covered by MACs   Lots about TAU in JAMA.

Nerd Note 3 - Packaging

CMS has a "packaging" policy that is highly adverse to using special tracers (tracers other than FDG) in the hospital outpatient PET scanner setting, special tracers are used only in the "freestanding” or non-hospital PET scanner setting.   CMS is discussing this in current rulemaking (see ACR here).

Nerd Note 4: CED?

CMS summarizes several PET amyloid CED studies conducted in the past decade, but it's unclear they were contributory to the decision.  

Nerd Note 5: Alz Biomarkers

An international body has upgraded the need for biomarkers in managing Alzheimer's; article here. Links and entry points here. 39 page draft position here, figures here.

JAMA Donanemab

Sims et al. is a 1700 patient 72 week RCT showing that donanemab slowed AD progression by about 30%, and may have preferentially helped earlier-stage patients with less tau pathology.

There are 4 Op Eds.


AI Versions of JAMA Op Eds

I provide an AI mini summary of each op ed (Manly, Widera, Rabinovici, Rosenthal), and then, an AI generated composite op ed of 250 words.