My Comment: Using Gapfill Codes as Crosswalk Targets

Sent: Monday, October 24, 2022 at 11:20:04 AM PDT

Subject: CLFS: Request comment on "Gapfill codes as Crosswalk codes"

I have attended many past CLFS pricing meetings, and nearly every year, CMS has remarked that a code currently in gapfill may not be used as a crosswalk target.

This topic arose again during the July 2022 expert advisory panel meetings, and CMS announced provisionally that gapfill codes could, now, be used as crosswalk codes.   However, verbally, CMS also requested public comment.

The index case seemed like a rational example of using a gapfill code as a new crosswalk code.   The Kiatek company had its code 0248U in current gapfill, and had very similar tests 0324U and 0325U up for pricing.  Here, the crosswalk-to-gapfill seemed like a "hand in glove" fit.   The expert panel also recommended that at least two other gapfill codes (0264U and 0267U) be used as crosswalk targets for other tests.

However, there are several reasons why a gapfill code should NOT be used as a crosswalk target.

1.  NOT PRICED ON FEE SCHEDULE

In the past, CMS stated that a gapfill code not priced on the fee schedule should not be a target for crosswalk.   This fits the most reasonable reading of statute and regulation, that prices be assigned to a new code by assigning the price of a code "on the fee schedule."  

An unpriced code is not really "on the fee schedule" - it may appear in a table of all code numbers, but it doesn't have a "fee" on a "fee schedule."  To argue it is "on the fee schedule" of fees, because it appears there with no price, is a stretch.

2.  LACK OF INFORMATION THAT IS PUBLICLY REQUIRED BY CMS IN FED REG

In the Federal Register, CMS lists the information requested when making proposals for pricing, such as test resources, method, purpose, etc., and the price of crosswalk targets.   

For gapfill codes, the price of the crosswalk target cannot be submitted by the requester.   In addition, while some new codes are well-known tests (with publications, etc), other new PLA codes may have essentially no publications or information about them.   Therefore, they can't be discussed and supported as rational crosswalk targets.

3.  SOME PLA CODES IN GAPFILL ARE THERE DUE TO "NO INFORMATION"

Let's say a new PLA code appears, 0999U.  The company makes no public presentation.  There are not any publications and no helpful website.   Therefore, the panel and CMS assign the code to gapfill.   

The next spring, this repeats.  The company either no longer exists, or fails to submit information to the MACs, or submits "goofy" unhelpful information to the MACs.   The pricing of this code in gapfill could be very erratic.   

Therefore, it is unfair to assign a useful new code, which may be the lifeblood of a new company that is working hard on clinical utility and pricing, to crosswalk it to this mystery and perhaps very capriciously priced gapfill code 0999U.

Bruce Quinn MD
Pathologist

Policy Consultant