Thursday, October 10, 2024

Multiple MACs Quickly Finalize New LCD for AI Assisted Coronary Angiography

HEADER: On October 10, 2024, several MACS - NGS MAC, Palmetto, CGS, and WPS MACs - all finalized a new complex LCD for AI-assisted coronary angiography.  Several take-home lessons.

Chat GPT could have made the convoluted coverage rules far more clear.

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  • Here's the proposed LCD, DL39840.
  • Here's the final LCD, L39840.
  • Here's the request letter, from CLEERLY, 2/2/2023, 12pp.
  • Here's the response to comments A59928.
  • Here's the billing and coding A59716.
    • Note the billing and coding for these AI CCTA codes 0623T-0626T, only make sense in light of separate LCDs for CCT and CCTA (L33947) and computer-assisted fractional flow reserve FFR (L38771).
  • Get all the documents PLUS the redline in a zip file.

Some take home lessons.

  • REQUEST TO DRAFT
    • The time from request letter to draft LCD was 15 months (Feb 2023, May 2024).
  • LONG
    • The LCD is long, 14000 words and 80 citations in the final version.
  • REDLINES
    • There were extensive comments and extensive redlining of the final LCD 
    • (I made a redline in Word, but I didn't attempt to decipher all the changes.)
  • DRAFT TO FINAL: FIVE MONTHS
    • The multiple MACs (some inside and some outside of "MolDx") were able to issue the LCD, take complex comments, add numerous citations, and finalize it from May to October.
  • CONTEXT: 
    • The LCD's value only makes sense in the context of other codes.  There is traditional "invasive" coronary angiography, then, computer-assisted (non invasive, CT based) coronary angiography, to which can be added FFR fractional flow reserve.  The RVU valuation of that has been a hot potatoe for CMS Part B for years.   Finally, there is the newest layer, AI-assisted CCTA.
    • The AI CCTA codes 0623T forward, are probably unpriced by CMS RVUs, so the "delta" the AI captures is not easily visible but is a key outcome.
  • TERMINOLOGY
    • The LCD has a good terms & definitions & abbreviations section.

Convoluted Coverage Rules: Can AI Help?

The coverage rules start out simple with 3 rules, but then have multiple asterisk-based complexities.  I'm just cutting and pasting, note the asterisks.  The bracketed numbers [1] refer to 2021 and 2022 national guidelines [3 is a correction to [2]).

AI-QCT/AI-CPA using CCTA* is considered reasonable and medically necessary as a diagnostic study when:


ONE
The patient has acute or stable chest pain with no known CAD1 and is eligible for CCTA*, AND

TWO
CCTA classifies patient as:
Intermediate risk ** OR  CAD-RADs [1], CAD-RADS [2] or CAD-RADS [3] *** category on CCTA [1,2]  AND

THREE

Cardiac evaluation is negative or inconclusive for acute coronary syndrome (ACS) [1]
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ALSO NOTE ASTERISKS:

*    See L33947 for criteria for CCTA. AI-QCT/AI-CPA should not be performed until after the base study (CCTA) has been completed and interpreted. Software to perform AI-QCT/AI-CPA must be FDA cleared or approved.

**     Intermediate and high-risk as defined in the 2021 AHA/ACC/ASE/CHEST/SAEM/SCCT/SCMR Guideline for the Evaluation and Diagnosis of Chest Pain [1]


***     CAD-RADS 1-CAD-RADS 3 category as defined by CAD-RADS™ 2.0–2022 Coronary Artery Disease Reporting and Data System (CAD-RADS): an Expert Consensus document of the Society of Cardiovascular Computed Tomography (SCCT), the American College of Cardiology (ACC), the American College of Radiology (ACR), and the North America Society of Cardiovascular Imaging (NASCI).  [2 ,3]

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I asked CHAT GPT to read the whole LCD, then, to focus on the top-line coverage rules and explain them in English if possible.  I do not guarantee that the Chat GPT re-writing exactly captures the Medicare rules.   However, I do guarantee, that if an LCD author wrote his confusing rules, then, started again with the CHAT GPT rules, and then, did any final editing to be sure the AI English exactly matched his maze-like coverage plan in his head, the end result would be a lot more clear than the published final rules in the LCD.

Here's Chat GPT 4o:

Coverage Conditions:

  1. Patient Eligibility:

    • The patient must have either acute or stable chest pain.
    • The patient should have no history of coronary artery disease (CAD).
    • The patient must be eligible for a Coronary CT Angiography (CCTA).

  2. CCTA Results:

    • The CCTA should show the patient as intermediate risk (based on specific guidelines).
    • Alternatively, the CCTA may classify the patient under CAD-RADS 1, 2, or 3, indicating varying levels of non-obstructive to moderate stenosis.

  3. Cardiac Evaluation Outcome:

    • A prior cardiac evaluation must show no signs of acute coronary syndrome (ACS) or have inconclusive results.

Additional Notes:

  • The CCTA must be done and interpreted before using AI-QCT/AI-CPA.
  • The software used for AI-QCT/AI-CPA must have FDA clearance or approval.

This summary simplifies the rules while retaining the essential coverage criteria for clarity. Let me know if any further details are needed!

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SIDEBAR

For curious readers, I include as a sidebar, a Chat GPT 4o comparison of the draft and final LCDs.  I have labeled this clearly as FYI only, because I have not verified the AI comparison of the two long  documents.   No doubt, it's directionally correct and it shows an approach to strucutring the comparison.  Sidebar HERE.