Thursday, June 13, 2024

CMS Updates ADLT Application Instructions - Just Slightly

The 2014  PAMA Medicare legislation updated the lab test pricing system as a whole.  It also created a novel test category, "ADLT," Advanced Diagnostic Laboratory Test, which has special pricing rules.

In June 2024, CMS made a minor update to its application instructions.   CMS continues to state (as per statute) the test must be "covered by Medicare."  However, CMS continues to take as little as "a paid claim" as proof of coverage.

Here's the update.  

  • CMS adds a sentence stating that while "proof" of coverage (such as a paid claim) is needed for ADLT approval, this is NOT the same as "establishment of coverage."  
  • Ongoing future coverage, if any, is dependent on ongoing future LCDs or NCDs.   
    • Creation of an ADLT code is not in itself evidence of any ongoing coverage.

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The CMS web page for ADLT information is here:

https://www.cms.gov/medicare/payment/fee-schedules/clinical-laboratory-fee-schedule-clfs/adlt-information

This includes a list of ADLTs (about 15 since 2014), a 17-page application form, and a 30-page info document.   Both the 17-page application form and 30-page info document have the new inserted text (that ADLT creation isn't "proof" of ongoing coverage.)   Both PDFs have been updated and given a new issue date (6/2024).   Other changes are minor (like changing the issue date everywhere it appeared, to 2024).

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I compared the documents with "Draftable.com" which offers some free online resources for PDF comparisons.

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I've put the old and new documents in a cloud zip file.

https://drive.google.com/file/d/1gxOK5NqLc2uIsmyfi3PyOrbB_X1wbKIg/view?usp=sharing

click to enlarge
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What's an ADLT?

The ADLT list is here:

In brief, omitting some details, an ADLT test is priced first at the test's list price (it mostly avoids a local pricing or national crosswalk process).  Thereafter the ADLT test is repriced annually at its commercial payor median rate.