NGS MAC Proposes Coverage or RENALYTIX KidneyIntelX and X.dkd Testing

 It's a bit of a cliche' among Medicare genomics experts that the vast majority of LCDs and articles on these topics are found in the MolDx MACs.

Here's a proprietary test with a proposed (somewhat complex) coverage status at NGS MAC.   The test is Renalytix 'KidneyIntelX" and "KidneyIntelX.dkd."  The .dkd refers to FDA nomenclature (analogous to biosimilars) for the FDA-approved version.  

I had heard at one time Renalytix would bill via Utah, a MolDx state, but the cover letter, 8 pages long, clearly lists the lab as a New York lab.  That would mean it has both NYS approval and FDA too.  FDA de novo clearance goes back to June 2023.   

The 8-page request letter provides a model to other labs, of a request letter that was successful.   The request letter does not have a printed date but the internal PDF date is October 2023, which would be consistent with a several-month review at NGS MAC.  The LCD links to a August 2023 public meeting (CAC meeting) but the link is a dead link for me.  However, Google gave me a 14-page transcript of the meeting.

The evidence review cites 9 papers, one paragraph of detailed summary for each.   This should be a heads-up to labs that plan to do one single 60 patient study of their novel test "and get coverage for 50 million Medicare patients."  See FDA label.

Business

Renalytix went public at $15 in July 2020, and reached $30 during the COVID biotech bubble.  Recently it trades at about 25 cents.   Renalytix raised $74M in 2020 and has a current market cap of $14M   Annual revenue has run circa $3M while expenses per year have been circa $40M.  Investor call here.

See my white paper on valuation of genomics companies, here. 

Coding

Code 0105U is $950.  If I am reading Part B 2022 data correctly there was 1 paid claim in 2022. 

LCD

Here's the proposed wording. Comment is open for 45 days.  DL39726.  I think the key points are patient has T2DM and eGFR 30-60 range for 1 lifetime test.

https://www.cms.gov/medicare-coverage-database/view/lcd.aspx?lcdid=39725&ver=15&stateRegion=all&contractorNumber=all&proposedStatus=C&sortBy=commentStart&bc=11

Once in a lifetime KidneylntelX or KidneyIntelX.dkd test is considered reasonable and necessary when all the following criteria are met:

• The results are used to facilitate therapeutic prognostic decision-making in the medical management of a selected patient population, and
• The results are used to assess the risk of progressive decline in kidney function in patients over the age of 21 years of age with:
• Type 2 diabetes (T2D) and existing early-stage chronic kidney disease (CKD) (stages 1-3b), and
• The test is ordered by the treating physician or qualified non-physician practitioner, and
• The test is performed in a CLIA certified laboratory qualified to perform high complexity testing, and
• The specific reason for the test must be documented by the treating practitioner in the medical documentation and demonstrate that the test is medically reasonable and necessary.

Note: Kidney function decline is defined as:

• a decline in eGFR slope of ≥: 5 ml/min/l.73m 2 /year; or
• a sustained decrease in eGFR ≥40% confirmed at least 3 months apart; or
• kidney failure, defined by sustained eGFR <15.

Limitations of Coverage

• KidneylntelX or KidneyIntelX.dkd test is not medically reasonable and necessary for:
• Patients with eGFR <30
• Patients with eGFR ≥60 ml/min/l.73m 2 without albuminuria
• Patients with ESRD or on renal recovery treatments
• Patients who are pregnant
• Patients who are currently hospitalized
• Patients taking Etanercept
• KidneylntelX or KidneyIntelX.dkd is not covered as a screening or standalone diagnostic.