Tuesday, July 17, 2018

July 16-17, 2018: CMS Panel Debates New Test Pricing; Value of R&D?; Transcripts

CMS is pricing almost 100 new CPT codes (including PLA codes) for CY2019.  After a public comment meeting on June 25, 2018, on July 16-17, CMS is holding two all day sessions of its laboratory advisory panel to debate the crosswalk/gapfill issues.
  • For the CMS new test price webpage see here.
  • For the CMS youtube channel (both streaming) see here.

  • Unofficial Transcripts:
  • Monday Morning HERE
  • Monday Afternoon HERE
  • Tuesday Morning & Afternoon HERE.
In 2016 and 2017, CMS both streamed and archived video of these lab policy sessions.  This year in 2018, CMS has not posted archive video of the June 25 session and it is to-be-seen if they will archive post the current live-stream advisory sessions.

Crosswalk Valuation and R&D?

CMS's statute for crosswalk and gapfill of new tests is at SSA 1834A, as created by the PAMA law of 2014.  

Payment for the test shall be determined—
(A) using cross-walking (as described in section 414.508(a) of title 42, Code of Federal Regulations, or any successor regulation) to the most appropriate existing test under the fee schedule under this section during that period; or
(B) if no existing test is comparable to the new test, according to the gapfilling process described in paragraph (2).
(2) Gapfilling process described.— The gapfilling process described in this paragraph shall take into account the following sources of information to determine gapfill amounts, if available:
(A) Charges for the test and routine discounts to charges.
(B) Resources required to perform the test.
(C) Payment amounts determined by other payors.
(D) Charges, payment amounts, and resources required for other tests that may be comparable or otherwise relevant.
(E) Other criteria the Secretary determines appropriate.

42 CFR 414.508 states that crosswalking is used "if it is determined that a new CDLT is comparable to an existing test, multiple existing test codes, or a portion of an existing test code."   

Neither statute nor regulation, then, describe what "comparable" means.   (For example, is one new car the most comparable to any one of ten existing cars when they are the same brand; or the same color; or the same body style; etc.  Which of these things is most like the other?)

At 81 FR 41039, CMS remarked that crosswalking "is used when a new test is comparable in terms of test methods and resources."  Elsewhere, CMS has also stated to the public what information CMS requires from the public to make a crosswalk decision, which is fairly detailed and broader (clinical purpose of the test, etc.; see 71 FR 69703) and it wouldn't make sense to request and require that type of information if it were not germane to its crosswalk decision.  [I believe this was in prior but fairly recent rulemaking on the crosswalk/gapfill processes].

Resources to Perform a Test Include Marketing and R&D 

In regard to ADLT pricing (81FR41-56), CMS writes that "we view the statute as intending to award special payment status to the one laboratory that is expending the resources for all aspects of the test - developing it, marketing it to the public, performing it, and selling it."   Even without this confirmation, it would be clear to me in plain English that for any test "resources required to perform a test" included having a lab to put it in (some amount of overhead) and having developed it (you have a test to do in the first place, whether protocol and reagents assembled and developed to implementation by one lab or by the kit manufacturer.)

CMS is obligated to provide an explanation of how it chooses either crosswalk or gapfill rates (81FR41086).  However, this explanation is sometimes telegraphic ("We determined that Code A is most similar to Code B.")   

Footnote 1

PLA codes are easily created and sometimes the lab is not even around by the next summer when the crosswalk meetings arise.  For examlpe, Armune Bioscience got PLA code 0021U in October 2017, but the lab closed in January 2018.  Expert panelists carefully debated how to price this no longer existing test.

Footnote 2

Statute requires crosswalking to "the most" appropriate test.  This suggests that if CMS chooses B of choices A,B,C, you could argue that A is "the most" appropriate.   Regulation only requires CMS to crosswalk to "an" appropriate test.  Here's the difference.  This suggests that if A, B, C are all potentially appropriate, and if CMS chooses "B", it has chosen "an" appropriate test of several, and you can't argue that A or C was most appropriate.   (If push came to shove, the statute should overrule the regulation.)

Footnote 3

Audio transcript from Youtube streaming conference, commissioned from REV.COM by Bruce Quinn Associates LLC