On March 28, 2023, PreludeDx (Laguna Hills, CA), released a press release that its DCISionRT test had received Advanced Diagnostic Laboratory Test (ADLT) status from CMS.
DCISionRT test is a gene expression test that helps women with DCIS evaluate the need for additional radiotherapy. )See also the version of Oncotype Dx which is tailored for DCIS cases.)
- A test that is rated an ADLT by CMS gets 9 months pricing at list price, followed by annual pricing at its median market price (but see FN1).
- The test must be a sole-source test, and may either be an FDA cleared or approved test, or a MAAA test with conditions.
- The conditions on the MAAA test are that it provides unique information not available from any other test (42 CFR 414.502 definition of ADLT).
- The webpage where CMS posts ADLT tests is here.
- The webpage also includes various instructions and application packets regarding ADLT rules.
The PreludeDx test Press Release is here.
CMS updated the ADLT one-pager on approved tests concurently, with a "new ADLT" price of $5435 for DCISionRT, applicable in 2Q 3Q 4Q 2023.
- Previously, such as on the 2023 CLFS, 0295U had a price of $1897.
- This was a crosswalk to 0067U, the 4-slide BBDRiskDx test from Silbiotech.
- That test had 7 Part B payments in 2021 (totaling $13,000).
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I couldn't easily find a CMS web page or MolDx article or other article specifying coverage terms and conditions for the PreludeDx test (nor the Oncotype DCIS test.) However, as an IHC test, the PreludeDx test is outside the scope of MolDx coverage decisions which only address DNA-RNA tests.
The DCISionRT test is a 7-protein immunohistochemistry test, with CPT code 0295U. Markers include Her2 and Ki67, and inputs include age, size, margin status, palpability.
As an IHC test, the test would probably be adjucated by Noridian since it is a non-MolDx, non-DNA-RNA test.
> MolDx DEX registry
The DEX web page for Oncotype DCIS says it's "covered" (a binary answer).
The similar DEX web page for DCISionRT exists, but doesn't show a tab for covered or not covered, which I learned in the past, means (1) it's being updated but also could mean (2) it is not eligible for MolDx coverage or non coverage because it is out of scope as an IHC test.
> Billing Articles at CMS
The CMS billing article for regular Oncotype DX says it is a different test than DCIS but does not point to coverage rules for Onco DCIS. A53105. Keyword searches, for me, and a code search for 0295U, didn't yield a PreludeDx article.
FN1. The cycle for ADLT price resetting is annual, but slow -- with data one year, and then data reporting next year, and then a new "annual" price in the next year after that.