Thursday, October 19, 2023

CMS Gives NCD STI Coverage to New Abbott STI PCR Test

In a transmittal released October 19, 2023 (T12318/CR13390), CMS gives coverage to PLA code 0402U, under NCD 210.10, Screening for STI's.   There are a few interesting policy nuances.

What is Code 0402U?

0402U is the Abbot ALINITY (TM) STI assay, which was released by AMA on June 30, 2023, effective October 1, 2023, a few weeks ago.  The code text is:   

  • Infectious agent (sexually transmitted infection), Chlamydia trachomatis, Neisseria gonorrhoeae, Trichomonas vaginalis, Mycoplasma genitalium, 
  • multiplex amplified probe technique, 
  • vaginal, endocervical, or male urine, 
  • each pathogen reported as detected or not detected. 

CMS recently issued a crosswalk price for this code (under placeholder X072U) at $143, crosswalk to 87631, 3-5 respiratory viruses.  0402U has 4 (chlamydia, gonorrhoeae, trich, mycoplasma).  The code is gapfilled from its effective date (October 1) to the date of the new annual fee schedule (January 1), although this NCD release is titled the "April 2024" update.

What Happened?

CMS regulates coding and processing for most NCDs through national (uniform) instructioons.  In CR13390, code 0402U is added to the instructions for NCD 210.10.  These instructions apply to Part A (outpatient), Part B, and Medicare Advantage.

What is NCD 210.10?

Dating back to November 2012, this is one of a number of NCDs that are the Medicare implementation of preventive USPSTF coverage (endorsement).  

The text is fairly long - here.  It covers laboratory screening for chlamydia, gonorrhea, syphilis, and HBV, plus an STI counseling session, but there are bug-specific rules.  

The NCD covers the same screening conditions for chlamydia and gonorrhea. But it has different rules for syphilis, and different rules for hepatitis B.  The NCD doesn't mention mycloplasma.

How does CMS Handle Differing Rules per Bug?

I'm not sure.  The CR13390 contains a link to an online zip file with granular Excel claims processing instructions.  The link worked when I tried it on a second day. 

This zip file holds about a dozen Excels, each for one NCD, and the relevant one is titled:  210.10 Screening STI  and HIBC eag 100323 v2 pmbs 101323.xlsx.  Looks like it was signed-off Oct 13, 2023.

The rules are very complicated, spanning 37 row of Excel.  It was last updated to add PLA 0353U, a Cepheid chlamydia and gonnorhea test.   It is now updated to add 0402U, the Abbott test, to those parts of the NCD that govern chlamydia or gonnorhea.   As I read the Transmittal, the implementation date (required last date to program computer) is 4/1/2024, with an effective date (for claims of the date) 10/1/2023.  A few requests have faster implementation, but not STI Item 12.

For example (click to enlarge) see 0402U added in "red" to lines 24 for chlamydia and 25 for gonorrhea:

PLA Codes and NCDs

Generally, CMS doesn't add LDT tests to NCD's.  Most PLA codes are LDT tests.  However, PLA codes can also represent national IVD kits, as in this case for Abbott.