Friday, July 10, 2020

Brief Blog: AMA Posts Lab Codes for Comment for October 1 AMA CPT Meeting

It seems like every time I turn around, AMA is posting for comment either lab codes for a PLA cycle (four times a year) or lab CPT codes for comment (3 times a year).

On July 8, AMA posted for comment lab CPT codes which will be voted on at the October 1-2, 2020 fall virtual CPT editorial meeting.  The home page for the meeting is here.

The codes are here:

According to the CPT process calendar here, interested stakeholders can request a copy of the CPT applications by July 24, and must turnaround comments by July 31.  (For non lab codes, the comment starts July 31 and ends September 10).

There aren't too many codes in play this summer.  
  • 001XM - MAAA code for lymphoma, profiling 20 genes
  • 0564T elevated to Cat I code 88XX0 - cancer cytotoxicity assay
  • 815X0 - MAAA code for small bowel transplantation rejection
  • 81XX1 - Category 1 code for periprosthetic joint infection detection
  • Delete 0067U and elevate to 81XX0, a category I code for breast cancer risk
  • 815X1 - a MAAA code for oncology RNA sequencing (breast)
  • Deletion of legacy codes 80500, 80502 for clin path consults, and replace with a quartet of 4 codes (moderately complex, highly complex, prolonged, etc).
The deletion of a PLA code 0067U (Silbiotech 4-biomarker breast cancer risk test) in favor of a Cat I code caught my attention.  I thought AMA CPT had determined that PLA codes would remain PLA series codes (same code) and not be elevated to Category I codes.   Possibly some game is afoot here.  Or possibly, the application is erroneous.   






Thursday, July 9, 2020

Flurry of Reviews: Pharmacogenetics, Liquid Biopsy, TMB, Infectious Disease Dx Stewardship

The last week has brought a landslide of interesting review articles on fast-changing topics.  I'll highlight several below.

Overview:  Economics of Molecular Testing from AMP

Let's start with a 19-page review in the new J Molec Dx by Sireci et al, entitled:  "Molecular Pathology Economics 101: An Overview of Molecular Diagnostics Coding, Coverage and Reimbursement."  See the main article here, and a one-page supportive Op Ed, by Zehnbauer, here.


Pharmacogenomics and Clinical Utility

The Pharmacogenomics Action and Reimbursement Coalition (PARC) has produced a 12-page review article in the journal Pharmacogenomics on the state of play for PGx, clinical utility, and reimbursement.  

They provide a thorough review that includes, but is not limited to, the activities of CPIC (the Clinical Pharmacogenetics Implementation Consortium), which has published 21 guidelines spanning 46 drugs and 19 genes.  CPIC is especially important because it is officially recognized as authoritative for Medicare coverage under a new MolDx LCD (here).

Find Eichmeyer et al. here (subscription).


Liquid Biopsy - Payor Review; CRC Review

UCSF's Transpers institute studies the translational medicine processs around precision medicine, including payor behavior.  Douglas et al. have a brand-new publication on private payer, and Medicare, coverage of circulating tumor DNA testing (e.g. liquid biopsy for tumor oncogenes).   They are willing to dive into the details - for example, they note that MolDx brought out an LCD last year for the Guardant test alone, but finalized it as a potential "umbrella" policy including other tests "with similar performance."  (They don't note that Noridian declined to finalize that LCD, a puzzle for MolDx watchers (here).)

See Douglas, Gray, & Philips here.  See trade journal coverage of their findings at Genomeweb here.  This same group published an excellent review of the lab benefit manager (LBM) industry last fall in Health Affairs (here; see also Cahan at STAT, here).

At Nature Reviews Clinical Oncology, see an open access new review of ctDNA applications in colorectal cancer (Dasari et al., here).  This one spans the clinical utility spectrum, from screening tests, to minimal residual disease detection after surgery, to "regular" liquid biopsy for tumor oncogenes.


TMB and Controversy

A few months ago, Friends of Cancer Research published its Phase I review on harmonization of tumor mutational burden (TMB); see Merino et al, here.  And see trade press from April here.  

But there's more.  In June, FDA approves Keytruda with the FMI CDx test newly reporting TMB (with a 10% cut off) as an FDA-endorsed companion diagnostic (here).   Previously, Keytruda was approved for high-MSI tumors, which are quite uncommon (and there's no FDA-approved MSI test, either, although Promega and Biocartis are trying to achieve FDA endorsement, here).   

"Ignited Controversy."  See an article at Precision Oncology News that the Keytruda/FMI/TMB approval has "ignited controversy" among TMB experts - here.  In part, there's still debate about the least burdensome cutoff acceptable to the FDA (10 mutations per Mb) and a higher cutoff that would select patients with bigger clinical response (perhaps 30 - see article).   


Infectious Disease - COVID Review, Diagnostic Stewardship

The new listings for in-press articles at J Molec Diagnostics include:
  • A review article by Nolte et al. on molecular testing for COVID - here.   Focuses on the policy and operations perspective as seen by molecular lab directors in the grip of major social, regulatory, and supply chain forces.
  • Similarly, AMP, ASM, CAP, others ask White House to address testing supply shortages on July 8; here.   Genomeweb here.
  • A review article on diagnostic stewardship in the field of infectious disease, focused on new rapid molecular test methods - by Morjaria & Chapin - here.  Their essay is informal and built around a case study; for a deeper dive they refer readers to Messacar et al. 2017 - here.













Thursday, July 2, 2020

AMA Updates its PLA Code List for July 1: Reaches PLA Code #224

AMA publishes PLA codes in its annual codebook, and all codes that are more recent than the published codes, appear on a PDF on the AMA website which is updated quarterly.

On June 25, 2020, AMA released some off-cycle "stat" CPT codes for a couple new COVID PLA tests.

On July 1, 2020, AMA released the full set of new PLA codes for July 1.

The code list is online  here.   Because the 2020 code book runs to 0138U, most of the codes published in the online AMA PDF are from 0139U forward.   However, some earlier codes appear as well, due to the actions of deletion or revision. 

The new PLA codes run from 0202U to 0224U.   Generally, these are "published July 1 and effective October 1."  However, COVID PLA codes (for example, 0223U, Qiagen) are effective on the same day the AMA publishes them.

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The codes published by AMA on July 1 were transmitted to CMS by around June 1 and included in the current summer CLFS pricing process at CMS.  This year, CMS broadcast the CLFS public meeting as a webinar rather than via YouTube streaming, and the webinar so far has NOT been video archived at the CMS YouTube channel.  However, I provided an unofficial transcript at the link just given.

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Figure below: Note that most PLA codes are published July 1, effective October 1, but the lower two codes, the COVID codes, are published off-cycle ASAP and effective immediately when published.