Exact Sciences (EXAS): Cologuard Plus Coverage Questions
A Jan. 1 update to CMS’s colorectal cancer (CRC) screening guide appears to support our view that Medicare coverage of EXAS’ Cologuard Plus (0464U: $592) and its 16% rate premium over the legacy version (81528: $509) risks delay until YE25 or 1H26. In short, we have been waiting for an explicit indication that code 0464U is covered under the established National Coverage Determination (NCD), and though the updated screening guide now includes CT colonography code 74263 ($700), the Cologuard Plus code remains omitted. In the absence of an explicit directive to Medicare Administrative Contractors (MACs), it is unclear whether / how Cologuard Plus claims can be processed, and we suspect a full NCD reconsideration may be required.
Note: With the JP Morgan Healthcare Conference coming up next week, please see our recently-published CPP Conference Policy Prep Pack for key questions on this and other issues that we would like to see management address.
To be clear, the above CRC screening guide is not the final word on which codes are covered under a given NCD, which is instead derived from transmittal / change requests (CRs) sent from CMS to the local MACs responsible for claims administration. These are posted at the bottom of each NCD [see here for CRC], with the most recent (zip) for CRC screening updated on Oct. 24.
We should note that these coding instructions from Oct. 24 also do not include the Jan. 1, 2025, update highlighted in the CRC screening guide indicating coverage for CT colonography code 74263, which was finalized as part of the CY25 Physician Fee Schedule (PFS) published on Nov. 1. This suggests that a formal NCD coding update will be released in the near future, if only to formalize the status of CT colonography, which in our view allows for two possible interpretations:
- Glass Half Full: If coverage of Cologuard Plus code 0464U is self-evident under the existing NCD, we would expect it to be included in updated instructions, or at the very least a directive that the MACs may use their own discretion to cover additional multi-target stool DNA tests beyond the legacy “Cologuard™” test billed under CPT 81528.
- Glass Half Empty: The fact that this screening guide update seems to be preceding a formal NCD coding revision, Cologuard Plus code 0464U would likely remain absent as well, indicating that CMS views the current NCD language – which refers only to “Cologuard™” – as limiting its ability to cover “Cologuard Plus™” absent a full reconsideration.
Between these options we increasingly take the half empty view, particularly with CMS already signaling its intention to reopen the CRC NCD for reconsideration via its inclusion on the published wait list of accepted requests that will be addressed once there is sufficient staff capacity. Unfortunately, NCD reconsiderations typically take ~9 months to complete once they are formally opened, suggesting that even an announcement from CMS today would imply an implementation date in 4Q25.
This is particularly the case when one considers the cadence of recent events for the Cologuard Plus code that would seem to allow ample time for NCD inclusion, with an update applicable to 1Q25 at the very latest:
- Apr. 1, 2024: Code 0464U is created for Cologuard Plus™
- July 1, 2024: Code 0464U takes effect
- Sept. 1, 2024: Code 0464U is published in the CPT code book
- Oct. 3, 2024: Cologuard Plus™ is approved by FDA
- Nov. 1, 2024: CMS finalizes coverage of CT colonography (CPT 74263) in CY25 PFS
- Nov. 25, 2024: CMS finalizes CY25 payment rate for Cologuard Plus™ code 0464U
- Jan. 1, 2025: (A) Cologuard Plus™ payment rate takes effect; (B) CMS updates CRC screening guide to include coverage of CT colonography code 74263 but makes no reference of Cologuard Plus™ code 0464U
For code 0464U to be covered under the current NCD, in the absence of any directive to that effect, the assumption would like have to be that: (A) CMS is merely disregarding the direct language of the NCD itself, as well as the fact that there are two different tests described under two distinct billing codes; (B) decisions on which tests are to be covered under the NCD will be left up to each individual MAC; and / or (C) the agency believes this is self-evident, and does not require any explicit clarification.
Under option (A) we would still expect CMS to include the billing code itself in some manner of NCD coding directive, given that reliance on their own discretion strikes us as improbable given the statutory prohibition against coverage of CRC screening tests outside of those “established by a national coverage determination.”
