Thursday, June 15, 2017

CMS CLFS: Public Pricing Meeting July 31, PAMA Advisory Board August 1

CMS has announced the dates of the annual summer Clinical Laboratory Fee Schedule pricing meeting, as well as the PAMA Laboratory Advisory Panel Meeting.   Historically, these meetings have been held in mid-July, but this summer they fall on Monday July 31 and Tuesday August 1, respectively.

The CMS lab public meeting page will be updated soon (it's here).   You can already see the advance posting of the Federal Register notices online as follows:
  • CLFS Pricing Meeting ("Crosswalk/Gapfill Meeting"), here - July 31.
    • Agenda for the Pricing Meeting, here.
    • The agenda is 8 pages long, 31 regular Tier 1 codes, 1 GSP code, 4 MAAA codes, 4 immunology/microbiology codes (including Zika IgM),  and 16 PLA codes.
    • CMS requires a specific template for PPT presentations (see discussion below).
  • CLFS PAMA Lab Policy Advisory Panel Meeeting, here - August 1.
  • Update: Transcript Here.
CMS requires registration in advance; instructions to follow.  Registration will opened on June 19 and closed on July 14.

Details after the break.

Pricing Meeting

For the pricing meeting, Presenters will need to register and also submit electronic presentations by July 14.

In a major twist, CMS states that presenters will need to use a standard template available online at CMS. See the CMS homepage for the meeting (here).

CMS has posted the pricing meeting agenda with 55 new codes and several reconsidered codes, here.  See summary of the new codes, further below in this blog.   Given 55 codes in a 6 hour or 360 minute meeting, that's 6 minutes per code all day long.

After the public meeting, CMS will take additional, post-meeting comment until August 11.   They will release preliminary decisions in early September, and final decisions in early October.  At that time, gapfill decisions can be appealed immediately for internal review at CMS.  Crosswalk decisions can be appealed, but will only be reviewed the following summer.

Advisory Panel Meeting

For the Advisory Panel Meeting on August 1, a detailed agenda will be published at least 2 weeks prior to the meeting (e.g. circa July 15, at the PAMA advisory panel website, here.)

What Are The New Codes?

Molecular Codes.  Most of the sequencing codes have been lifted from Tier 2 to Tier 1:

ASXL1, myeloproliferative disorders: 2 codes, full sequencing, targeted sequencing eg exon 12
CYP3A4, common variants
CYP3A5, common variants
DPYD, dihyrdopyrimidine dihydrogenase, e.g. 5-FU metabolism, common variants
F9, coagulation, full sequence
G6PD: 3 codes, common variants; known familial variant; full sequence.
HBA1/HBA2: alpha globin 1 and 2; 3 codes:  known variant; full sequence; DupDel analysis.
Human Platelet Antigen,  8 codes: individual variant codes for variants 1,2,3,4,5,6,9,15.
IDH1 and IDH2, common variants (2 codes)
IFNL3, interferon lambda 3, drug response, 1 variant
RUNX1, e.g. AML, targeted sequencing, e.g. exons 3-8.
SCLO1B1, e.g. adverse drug reactions in anion drug transporter, common variants
TPMT, thiopurine 5-methyltransferase, drug metabolism, common variants
TYMS, thymidylate synthetase, 5FU, common variants eg tandem repeat
HBB, hemoglobin beta, 4 codes: common variants, familial variant, dull sequencing, DupDel analysis.

GSP:  Hereditary peripheral neuropathy, e.g. Charcot-Marie-Tooth, sequencing at least 5 genes.

Oncology, breast mRNA, 58 genes, FFPE, recurrence score.
Oncology,  breast mRNA, 70 content and 465 housekeeping genes, risk of distant metastasis
Oncology, prostate mRNA, 31 content 15 housekeeping, mortality risk score.
Oncology, prostate promoter methylation, 3 genes, likelihood of cancer on repeat biopsy.

Allergen-specific IgE; recombinant or purified component.
Zika Virus, IgM

Infectious agent, DNA or RNA, RSV virus, amplified probe.
Infectious agent, DNA or RNA, ZIKA virus, amplified probe.

PLA Codes:
0001U, RBC Typing, 35 antigens
0002U, Oncology, CRC, 3 urine metabolites
0003U, Oncology, ovarian, biochemical assays of 5 proteins
0004U, Infectious disease, 27 resistance genes, PCR/microarray, AmpC, carbapeenemase, ESBL
0005U, Oncology, prostate, 3 genes, urine, risk score
0006U, Prescription drug monitoring, 120 or more drugs and substances, tandem mass spec, definitive.
0007U, Drug tests, presumptive, with confirmation of positives, with specimen ID via buccal DNA, per DOS
0008U, Helicobacter pylori detection & resistance, DNA.
0009U, Oncology, breast cancer, HER2 copy number by FISH, DEP sorting
0010U, Infectious, bacterial, strain typing by whole genome sequencing
0011U, Rx drug monitoring, LC/MS, oral fluid, including all drug compounds, metabolites
0012U, Germline disorders, whole genome NGS, DNA, whole blood, report of specific gene rearrangements.
0013U, Oncology, gene rearrangement detection by whole genome NGS. fresh or frozen tissue or cells.
0014U, Oncology, gene rearrangement detection by whole genome NGS. whole blood or bone marrow.
0015U, Drug metabolism, adverse drug reactions, blood or buccal, 22 genes, with therapeutic decision support/report.
0016U, Oncology, hematolymphoid, RNA, BCR/ABL1 breakpoint, major, minor. qPCR.
0017U  Oncology, hematolymphoid, JAK2 mutation, exons 12-14.

Category III and G Codes:
02X1T, infectious agent detection, HPV, five or more separately reported high risk types, genotyping.
G0499, Hepatitis B screening in non pregnant, high risk individual, with HBsAg, neutralizing confirmatory test, Ab to HBsAg, Anti HBc.

83127: SEPT 9
G0480: Drug tests, definitive, 1 ID method, including but not limited to GC/MS (etc etc), 1-7 drug classes, including metabolites if performed.


[*]  We are standardizing the presentation format for the CLFS public meeting. As a result, this year we are requiring presenters to submit all presentations using a standard PowerPoint template that is available on the CMS website, at,
under the “Meeting Notice and Agenda” heading