Tuesday, August 1, 2017


On July 31 and August 1, CMS held its annual CLFS new code pricing meeting.
    CMS website here.  My earlier blog with an overview of the agenda, here.

An unofficial rapid transcript of both day one and day two is online in the cloud HERE.
     144 pages, 80,000 words.  This is a Word doc for readers to download and annotate.
     An alternate version as PDF is here.
     The CMS list of all codes to be discussed is here.

For video, CMS Youtube Links are here:
  • Monday July 31 morning session here.
  • Monday July 31 afternoon session here.
  • Tuesday August 1 morning session here.

More after the break.


While the CMS website says comments will be taken for "approximately one week," the Federal Register announcement (82 FR 27708, here) says "Written comments regarding the presentations must be received by August 11, 2017, at 5:00 pm EDT (10 days after the meeting.)"

Special Sections
In the transcript see:
  • Day One Morning (page 2)
  • Day One Afternoon (page 51)
    • Special Section on "Rarely Used Codes" (page 69)
    • AMA Presentation on PAMA implementation (page 70)
  • Day One PAMA Advisors Panel Begins (page 72)
  • Day Two PAMA Advisors Panel Morning (page 93)
    • Discussion of PLA code pricing (page 95)
    • NILA on Chemistry Panel Policy under PAMA Statute (page 132)
    • CMS Dr Chen on NCD for Hepatitis and New Screening Code (page 136)
    • ACLA on Chemistry Panel Policy under PAMA Statute (page 141)
Rarely Used Codes.  CMS proposed that perhaps rarely used codes or codes with no PAMA data could be dropped from the CMS fee schedule, to avoid difficulties such as the need to re-gapfill or re-crosswalk such codes every 3 years, by the dozens.

New 2017 Codes with 2016 Crosswalks.  See last pages of agenda, here.   CMS also proposed that codes first used in January 2017, crosswalked in the summer 2016 meeting to codes active in 1H2016, be crosswalked under PAMA in 2018 to the changed prices of those 2016 codes that they were crosswalked to.  The other option would be to leave the codes at today's dollar values of their 2016 crosswalks without further updating until the next round of PAMA.

PAMA Torpedoes Legacy Chem Panel Rules.  NILA and ACLA commented that existing chemistry panel pricing is over-ridden by PAMA statute.  CMS nonetheless asked its advisory panel to review several options through which the agency could continue its ad hoc panel pricing rules once PAMA is implemented.  About $700M per year flows through the chemistry panel codes, and they have idiosyncratic pricing rules.

NCD for G Code G0499 Confuses Panel and CMS.  Panelists were confused by a lengthy, multi component G code, G0499, proposed by CMS to implement a high risk screening benefit for hepatitis B.  This code was introduced in 9/2016, per a HCPCS website (here).  More CMS info on this code here.   This transmittal MM9859 says it will be contractor priced to 1/1/2018.  It looks like CMS may have updated G0499 on the fly with more test details, but created more confusion in doing so. Press release here, NCD here.  People have complained that the USPSTF publishes preventive services guidance that is not easily converted into coding and coverage decisions.  This appears to be a CMS NCD that is hard to convert into a coding and pricing decision.

PLA Codes.  17 PLA codes were discussed at the meeting, including those approved by the AMA in June for active use as of August 1.  In addition, in mid August, AMA released a public agenda for 8 more PLA codes, bringing the tally to about 25.   Putting both lists together, I informally tally 5 as related to drug testing, 7 as MAAA tests, 4 as novel NGS panels, 4 as unique genetic tests (other than NGS panels) and 3 as what I would call replica tests that seem very close to an existing genetic test (e.g. a PLA code for JAK2 testing.  There is a gray border between "unique" local genetic tests and "replica" genetic tests, so you might view those 7 together).

By my tally, 3 of the 25 PLA's are in the field of infectious disease.  Three relate to FDA approved IVDs (Overa and Oncomine TargetDx and LeukoStrat.)  Of those 17 PLA codes voted on by the CMS CDLT Advisory Panel, most had 7-10 recommendations for gapfill.  Some had presentations by their sponsors and data to assist the panel in price level decision-making, and others had none.