Friday, May 8, 2020

CMS Schedules Annual New Lab Codes Meeting: June 22, 2020

Update: Around May 29, CMS added some 30 new codes to the agenda.  Here.


Each summer, CMS holds two types of meetings for pricing new clinical laboratory tests.  The first is a public comment meeting, held in the second half of June.   Generally, CMS accepts new codes passed by the AMA CPT as recently as the early May CPT meeting the month prior.   This year's public comment meeting is June 22, 2020. 

CMS holds a second type of meeting, typically in July, of its advisory panel on how the new codes should be priced.  They consider public comment from the June meeting as well as their own expertise.  In the last several years, this meeting has lasted two days.  This year, it will be July 29-30, 2020 (see page 26466).

Federal Register 86 FR 26475-77 (here)

CMS will hold a VIRTUAL public meeting on Monday, June 22.  (No need to fly anywhere on Sunday, June 21).   The meeting will be 830 am to 500 pm (ET).

Sumissions of presenters must be made by June 4, 2020, 5 pm ET.   What is the agenda of the meeting?   CMS is supposed to publish it 30 days in advance, e.g. by May 22, 2020.  You can submit commenters as a presenter (e.g. asking for a speaking slot) or as written comments only.   For presenters, comments must be brief and if there are time limitations, CMS may use a first-come, first-serve approach. 

CMS will publish its draft price proposals in early September and take comments on those until early October.

Nerd Notes


I've seen it written that CMS must post the agenda 30 days in advance, letting it add mid-May AMA CPT PLA codes in time for a late-June meeting.   This year's Fed Reg announcement says that CMS will announce the meeting and post the agenda (of codes) on the same day - e.g. that day was May 8. 

CMS has posted a Zip file agenda online updated as of May 4 - here. (It's on this webpage as CY 2021 Clin Lab Fee Schedule Test  The PLA codes on the list run up to 0201U, which was the last PLA code released by AMA on April 1, 2020.   CMS may or may not update the last for the PLA codes being approved by AMA CPT now in 1H May.   In past years, CMS has updated the list with PLA codes approved by AMA CPT in 1H May.

I've put my cloud copy of the May 4 excel code list agenda in the cloud here.

Agenda Breakdown

Six codes are "Reconsiderations," a larger number than I've ever seen,  These are 81307 (PALB2 breast cancer gene, full sequence), 0071U (CYP2D6), 0101U-0103U, 0129U (HBOC and Lynch panel codes). 

Based on past experience, while reconsidered codes were requested in December 2019, I recommend companies with reconsidered codes to resubmit their pricing arguments for the June meeting, lest CMS say "no arguments were received."

28 codes are new CPT codes (not of the PLA type).  These include new single-drug drug tests codes, some microbiology codes, some single-gene codes, and a few others.  CMS also lists 0001U and 0002U, which are CMS-created U codes for COVID testing.  These codes have been priced so far by MACs uniformly at around $35 (0001U) and around $50 (0002U) so it would be interesting if CMS chose a different administrative price.  High volume COVID codes 0003U and 0004U were both priced at $100 even, based on a CMS Administrator's Ruling (here).

62 Codes are PLA Codes.   These are codes released by AMA on October 1, January 1, April 1. 

As I mentioned earlier, CMS usually has included PLA (and CPT) codes approved in the early May AMA CPT cycle; we'll see if that occurs this year.  AMA had 26 PLA codes its April/May 2020 review cycle (here).

In short, there are 6+28+62 codes, or 96 codes so far, about the same number as last year.  Whether this grows even further depends on whether CMS updates the code list for early May AMA CPT decisions as it did in the past.

CMS's PPT Template

Note: CMS "requires" a standard PPT template to be used (see announcement and links therein); however, I can say that, in every recent past year, CMS has also allowed additional slides (though your time is brief) in addition to the template slide.