Friday, September 25, 2015

2016 CLFS PRICING: CMS posts proposed pricing for new CY2016 tests including CY2016 Genome, MAAA, and Drug Tests

Having held the July 2015 summer CLFS comment meeting on new codes, and having held a special PAMA advisory panel on lab test in late August, on September 25, 2015 CMS released its proposed pricing for new lab tests for 1/1/2016.  Details after the break.

Genomeweb's article here. Fierce Diagnostics here.  San Francisco Business Journal here.

Find the CMS PDF of its proposed positions on the new 2016 codes: Here.

The assignment of new codes into the crosswalk and the gapfill categories can be appealed in writing for 60 days (until about November 24, here).  However, no action will be taken until next summer's July CLFS meeting.

Regarding presumptive (aka screening) testing for drugs of abuse, CMS proposes 3 codes.  For definitive testing, CMS proposes 4 codes.  For any code, specimen validity testing (e.g. for malicious overdilution) is a bundled cost.

These correspond to giving up on CMS's July proposal to create only 1 code for presumptive and 1 code for definitive testing.  The three presumptive codes are to be paid at 0.5X, 1X, and 3X code G0434 [$19.79].   The four definitive codes are to be paid at (2x82542 + 5x82542x.1), (2x82542 + 12x82542x.1), (2x82542 + 32x82542x.1) and at (2x82542 + 48x82542x.1).  82542 is $24.58.

This gives the three Presumptive code prices as: $9.89, $19.79, $59.37 and the four Definitive code prices as: $61.46, $78.68, $127.88, $167.24.

A table of the drug class pricing codes is presented at the bottom of this blog.  For a recent trade journal article, here.

The Cologuard test G0464, priced last year, was under appeal for a lower price (an appeal lodged by an unusual stakeholder).  CMS deleted G0464 and applied the same price to new CPT code 81528 for Cologuard.

A new BRCA code 81162 is crosswalked to (81211 + 81213) X 90%, to allow for "economies of scale" when sequencing (current 81211) is combined with large dup/del analysis (current 81213).  The new price would be about ($2178 + $581) * 90%, or $2759 discounted to $2483.

For a range of new single gene codes, such as 81311 NRAS, CMS agreed with straightforward crosswalks recommend by the August advisory panel.  In one dramatic moment among the single-gene codes, July commenters and August panelists all recommended crosswalking 81314 PDGFRA to 81235, but CMS disagreed with everybody, and crosswalked to 81245, citing a better exon number match.

Gapfill recommended for:
81312, 9 or more Ashkenazi associated disorders.
81432, 14 or more breast cancer associated genes.
  (For an article on the shift from BRCA only testing to gene panel testing in breast cancer, see Nature Biotechnology, September 2015, here.)   Note there is a separate code for dup/del analysis panel of at least 5 of the 14 genes (81433).
81434, 15 or more retinal disorders.
81437, 6 or more hereditary neuroendocrine disorders.  Also gapfill the add-on dup/del code.
81442, Noonan spectrum disorders, 12 or more.

CMS provided a surprising range of decisions for MAAA codes created by AMA CPT in early 2015 and thus entering the summer gapfill meeting prior to use in 2016.  In separate rulemaking on PAMA published the same day, CMS apparently offered to publish prices of MACs on these sole-source codes rather than (or concomitant with????) putting them into the gapfill process.

For MAAA 81490, 12 rheumatoid arthritis biomarkers, crosswalk to 12x 83520 (the unlisted immunoassay code, about $20).

For MAAA 81493, 23 genes, coronary artery disease, risk profile, crosswalk to 81292 (about $600).

For MAAA 81525, colon cancer, prognostic, 7 genes, crosswalk to 81292.

For MAAA 81535 and 81536 (oncology cell culture chemotherapy response), crosswalk to 87903 (HIV phenotype with drug resistance phenotype) and 87904 (additional test).

For MAAA 81538, lung mass spec 8 protein signature, crosswalk to 8 x 83789 (mass spec single analyte).

For 81540, 92 genes, oncology tumor of unknown origin, crosswalk to 81214.

For 81545, thyroid mass, analysis of 142 genes, crosswalk to 1.5 x 81214.

81595, cardiology, heart transplant, 20 genes, cardiac rejection, crosswalk to 81292.

CMS jumped from crosswalk to gapfill for the last two MAAA tests:

0009M, fetal aneuploidy, trisomy 18/21, gapfill.

0010M, oncology, high grade prostate cancer, 4 kallikreins, Gapfill.


AMP last winter requested that CMS reconsider a range of genomic procedure codes that are under gapfill in 2015 (now), and reclassify them as crosswalks, and then price them at (fairly reasonable) crosswalks proposed by AMP.    AMP presented on this both in July and August.

In the PDF released by CMS today, I don't see any reference to this reconsideration docket.   In contrast, the reconsideration docket for Cologuard was discussed and dealt with by CMS.


DEFINITIVE defined as:
 Drug test(s), definitive, utilizing drug identification methods able to identify
individual drugs and distinguish between structural isomers (but not necessarily stereoisomers),
including, but not limited to GC/MS (any type, single or tandem) and LC/MS (any type, single or
tandem and excluding immunoassays (eg, IA, EIA, ELISA, EMIT, FPIA) and enzymatic methods
(eg, alcohol dehydrogenase)); qualitative or quantitative, all sources(s), includes specimen
validity testing, per day, #X to #Y drug class(es), including metabolite(s) if performed).

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