Guardant (GH) Reveal Medicare Coverage FAQ
Following GH’s announcement this AM of Medicare coverage of its tissue-naïve Reveal test for minimal residual disease (MRD) surveillance testing, we wanted to highlight some additional salient points omitted from the company’s press release. The below FAQ addresses: (1) the payment rate ($1,644), which is on the lower-end of other covered MRD tests [e.g., NTRA’s Signatera ($3,920)], but roughly consistent with that of other tissue-naïve offerings [e.g., privately-held Naveris’ NavDx ($1,800)]; (2) prospects for rate upside through CMS designation as an Advanced Diagnostic Laboratory Test (ADLT); (3) the likely testing interval to be covered; and (4) where investors can find the relevant information.
When Will the Medicare MolDx Medicare Administrative Contractors (MACs) Incorporate Reveal Surveillance Into Their Coverage Policies?
Astute investors will observe that, GH’s press release notwithstanding, the billing and coding articles from the MAC with jurisdiction over the company’s Redwood City, CA lab (Noridian) – as well as those of other MACs in the coordinated MolDx program (Palmetto, WPS, CGS) – does not yet reflect coverage of Reveal surveillance MRD testing (i.e., “PATIENTS WITHOUT CANCER”). Instead, each only establishes that the test is only covered for post-surgical use (i.e., “PATIENTS WITH CANCER”), which has been the case since early 2024.
We would nevertheless expect these billing articles to be updated shortly, with such publications typically posted here on Thursday mornings. Investors should therefore be looking for Guardant Reveal to be newly included under the “TUMOR NAÏVE TESTING” section within the “PATIENTS WITHOUT CANCER” grouping shown above, which is how the table currently appears (Jan. 21).
We should note, however, that it is not atypical for one or more of the MolDx MACs to update their coverage policies ahead of the others. With GH’s disclosure this morning referring only to coverage from “Palmetto GBA,” that may be the case here as well. That said, all of the MolDx MACs coordinate their actions, so we would expect any delay from Noridian to last no more than several weeks.
Is There a Way to Confirm Coverage in the Interim, and When Will We Know the Payment Rate?
Coverage confirmation can be found in the MolDx DEX Diagnostics Exchange Registry, which newly lists the Guardant Reveal test as “covered,” along with a reimbursement rate of $1,644.25. Previously, this page had only listed coverage of the Guardant Reveal CRC Post-Surgery MRD Bundle, consistent with the coverage policy above, with a payment rate of $4,933.
While $1,644 is on the lower end of the listed payment rates for covered MRD tests – which range from $1,589 (Signatera Breast – Plasma Series Bundle) to $7,489 (Signatera IO Monitoring – Tumor / Normal Sequencing), it is also roughly equivalent to the only other tissue-naïve offering that MolDx covers, with a rate of $1,800 for Naveris’ NavDx. We should note, however, that NavDx is only indicated for HPV-driven oropharyngeal cancers, rather than CRC.
Is There Room for Upside in This Payment Rate?
Potentially, though we lean against it.
GH has previously discussed the possibility of CMS granting Reveal ADLT status, which would entitle it to three quarters of reimbursement at the company-set list price. While it is unclear to us exactly what that is, we would highlight a boilerplate Advance Beneficiary Notice of Non-Coverage (ABN) provided by GH [see here] – which patients are asked to sign when the test they are receiving may not be covered, acknowledging that they may need to pay out-of-pocket – that cites potential beneficiary costs of “no more than $5,000” for Reveal. It is certainly possible that this is referring only to the post-CRC surgery bundle, but this and the other MRD testing rates listed above suggest there is likely room for upside through any ADLT designation.
The reason we have remained cautious on that possibility, however, is largely as follows:
- CMS guidance on the issue states that any ADLT must “provide new clinical diagnostic information that cannot be obtained from any other test or combination of tests.”
- The agency could therefore conclude that the “clinical diagnostic information” from Reveal could already be gleaned from NTRA’s Signatera, even if the Reveal methodology is distinct by virtue of its being tissue-naïve.”
- By way of example, Signatera itself was granted ADLT status in July 2021, but following MolDx coverage of post-CRC surgery coverage for Reveal in January 2024, it has not yet received the same distinction, despite the fact that CMS reviews ADLT applications on a quarterly basis.
- If we are incorrect, however, the argument from GH would likely need to be that Reveal surveillance testing via a single plasma test provides new clinical diagnostic information beyond what Signatera can offer, or perhaps that tissue sampling may not be viable for all patients, and Reveal therefore addresses an alternative patient population.
- While it’s certainly true that a tissue-naïve approach represents a more convenient methodology for patients, and is therefore a competitive advantage, it does not necessarily follow that it provides new information that cannot otherwise be had from “any other test or combination of tests.”
- Should CMS reach that conclusion, however, the earliest we would likely hear would be ~mid-March or ~mid-June, consistent with CMS’s ADLT review schedule.
Do We Know the Likely Cadence / Interval of Covered Surveillance Testing?
The Medicare coverage policy itself merely references coverage “according to testing scheduled outlined in national (i.e., NCCN) or society guidelines.” However, per disclosures from both GH and NTRA, this has equated to once every six months beginning 24 months after curative-intent treatment.