Thursday, June 13, 2024

Medicare MACs Finalized LCDs for KidneyIntelX (NGS MAC) and Thyroid Nodule Stratification (MolDx)

 Two new final LCDs have been posted on June 13, 2024.


NGS MAC posts final version of L39726, "KidneyIntelX and KidneyIntelX.dkd Testing."  The process reflects a public meeting (CAC meeting) on August 24, 2023 (17pp; see link within LCD). NGS MAC writes,

  • “The current evidence concerning KidneyIntelX or KidneyIntelX.dkd as a test to identify and stratify patients with T2D and early-stage CKD into low, intermediate, and high risk for near-term rapid progressive decline in kidney function, suggests that the early identification of high-risk patients by the test allows for more intensive patient management, selection of appropriate medications, and appropriate specialty referral or consultation.”
  • “Also, the clinical principles, that more proactive care leads to better health outcomes and improved quality of life for patients, including slowed disease progression, avoidance or delay of kidney failure and need for hemodialysis, were supported by our CAC Subject Matter Experts.”

See LCD L39726 here.  Response to comments A59758 here.  Coding article A59595 here.

The LDT form of the test is "Kidney Intel X" while the FDA-cleared form of the text has the FDA-provided suffix ".dkd".   The text is coded as 0407U, $950.   

  • The code text is, "Nephrology (diabetic chronic kidney disease [ckd]), multiplex electrochemiluminescent immunoassay (eclia) of soluble tumor necrosis factor receptor 1 (stnfr1), soluble tumor necrosis receptor 2 (stnfr2), and kidney injury molecule 1 (kim-1) combined with clinical data, plasma, algorithm reported as risk for progressive decline in kidney function."
Share price for Renalytix has been as high as $32 (2021) and is currently trading around 45 cents, for a market cap of $35M. For the fiscal year ending June 2023, per Yahoo Finance, revenue was $3.4M and operating income negative $44M.  


Palmetto and other MolDx MACs post the final version of L39646, a foundational (general) LCD for thyroid nodule risk stratification,

Find LCD L39646 here.  Response to comments A59734 here.   Coding article A59470 here.

The LCD, effective in August 2024, is based on a request letter from Veracyte dated January 12, 2022.

Updates to the coverage bullet points were minor.  The LCD states somewhat obliquely that "if the patient has multiple nodules, concurrent or reflex testing may be medically necessary."  The Q&A document clarifies that if a nodule is positive for potential malignancy, indicating surgery, then testing of additional nodules on that side are not necessary (which makes sense).


I believe that the Veracyte Afirma test had previously been covered under a general-purpose LCD ("Molecular Diagnostic Tests L35160") and a short billing and coding article which will soon be retired (A54356).   Veracyte's request letter (2022) had been to include the Afirma MTC test as well as creating a broader (open ended or foundational) LCD.  MTC is a test version for medullary thyroid cancer.  In early trading on Thursday, Veracyte (VCYT) was down 2% at $21.62.  Its five-year high was $73 in 2021, low at $15 in late 2022.




It can be difficult to predict a consensus for market demand and market response in diagnostics (e.g. the share price of Renalytix ranges from $32 to <$1 in a couple years, during which, they hit progressive benchmarks like FDA approval).   I found the book "Heart of Innovation" helpful in thinking about utility cases and market response.


AI Corner.

Here is a Chat GPT 4 summary of the 17-page NGS MAC renal transcript.

The CMS transcript presents a detailed Contractor Advisory Committee (CAC) meeting conducted by Dr. Gina Mullen on August 24, 2023, focusing on the KidneyIntelX test, an AI-enabled prognostic testing platform. This test is intended to guide care management for adults with type 2 diabetes and chronic diabetic kidney disease. Key points discussed include:

  1. Overview and Purpose: Dr. Gina Mullen outlined the meeting's purpose—to evaluate medical evidence regarding the KidneyIntelX test as outlined in CMS IOM Publication 100-08, Chapter 13, Section Renalytix introduced two versions of the test, KidneyIntelX and KidneyIntelX.dkd, with the latter distinguished by a suffix and targeted for different CKD-EPI equations used in clinical practice.

  2. Expert Panel: A panel of five experts—Dr. Maryam Gondal, Dr. Jeffrey Rimmer, Dr. Mike Ross, Dr. Charles Jacobs, and Dr. Catherine Kimball—introduced themselves and confirmed no conflicts of interest. They represent diverse institutions and bring significant expertise in nephrology and family practice.

  3. Scientific and Clinical Evaluation: The panel engaged in a structured discussion based on 12 key questions addressing the scientific basis, clinical utility, and potential impact of the KidneyIntelX test. Topics included the adequacy of published evidence, the prognostic capability of the test, and its role in improving health outcomes and clinical management practices.

  4. Evidence Review and Discussion: Highlights from the discussion include:

    • Prognostic Utility: Dr. Gondal supported the test's integration into current practice, highlighting its ability to stratify patients into low, intermediate, and high-risk categories but noted that it should not be used as the sole method for predicting disease progression.
    • Clinical Impact and Utility: Dr. Ross detailed a study indicating that the test led to increased referrals and medication adjustments, suggesting improvements in clinical management but not necessarily in direct health outcomes.
    • Integration Challenges: Concerns were raised about the test’s integration into electronic health records and its dependency on specific clinical variables, which might limit its applicability across diverse health systems.
  5. Future Directions and Considerations: There was a consensus on the need for more randomized controlled trials to conclusively demonstrate the test’s efficacy in improving health outcomes. The discussion also touched upon the test's potential to reduce socioeconomic disparities in CKD management, provided its broader integration into healthcare systems.

  6. Concluding Remarks: Dr. Mullen appreciated the expert inputs, indicating that these would be considered in future deliberations and potential guidelines.

This transcript provides a comprehensive account of expert opinions and discussions regarding the KidneyIntelX test, illustrating the complexity and interdisciplinary approach required to evaluate and potentially integrate new medical technologies into clinical practice.   [ /end ChatGPT4 ]