Thursday, January 23, 2025

Brief Blog: Natera Signatera Price Changes: CMS Fee Schedule ($3500, $2919, $3920)

Header: CMS has raised the fee schedule price of the Natera Signatera test, a minimal residual disease (MDR) detection test.  But not without some hiccups.

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The Natera Signatera code is 0340U.  CMS priced it at $3500 (list price) through an ADLT pricing decision in July 2021, valid until March 2022.   

In the initial version of the CY2025 fee schedule, released a few days after January 1, 2025, CMS lowered the stated price for 0340U down to $2919. [*]

However, in a revision dated January 10, 2025, without further comment, CMS raised the price of 0340U up to $3920.   

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Most ADLT codes do not change year to year.   This suggests a balance of pricing power between ADLT labs and payers.  (But some reports on industry genetic test reimbursement are grim - here.)  

On the other hand, Natera's price rose notably, from $3500 to $3920, suggesting negotiating strength.

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Dedicated readers of the 2000-row CMS CLFS will recognize the interim price, $2919, as the price of 81455, tumor panel, 51 or more genes.

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[*] I believe if you dig hard enough, there's some location in early January where Natera mentions publicly it had been mis-priced by error, which CMS promised to correct.  It might have been a passing remark in JP Morgan Q&A.

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ADLT means Advanced Diagnostic Laborotory Test.  Qualifying tests are paid 9 months at "list price" and then annually on "median market price."  Table here.   The ADLT table above, plus annual CLFS tables for all the ADLT codes, show that the prices of ADLTs are quite stable year-to-year (but see Castle's test 0108U rising from $2350 to $4950).

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Besides this single Signatera code - The MolDx DEX REGISTRY website has elaborate code combinations, e.g. "plasma series," etc, for Signatera MRD testing.  Here.