Yhis year, for example, 18 live active codes are in the "gapfill" process for CMS, because they didn't get crosswalked last fall.
Under "gapfill," MACs are supposed to send their proposed pricing decisions on the new codes to CMS by March, CMS post in March or April for public comment. This year, the whole process was radio silent in April...May....June...July. Today, August 21, 2019, CMS posted the proposed prices for 60 days of public comment. Whew.
- The home page for pricing postings is here.
- The cloud file for August 2019 Gapfill is here.
- It's called "2019 CLFS Gapfill Preliminary Determinations."
- I've put my own cloud copy, slightly modified for clarity, directly in the cloud here.
Summaries web-posted below. For the full range of prices and MAC rationales see the cloud Excel spreadsheets.
CMS tells us:
Accounting Rationales
If you see the accounting rationales (see cloud Excel files) the MACs have some confusion about accounting principles.
CMS *definitely* pays for overhead - whether DME, hospital outpatient, RVU Part B calculations, inpatient, hospice, anything.
Here, the MACs seem to sometimes take a position "CMS doesn't pay for overhead" and subtract it out as a line item in costs provided. Well, if you don't "pay" for overhead, then overhead has to be baked into the direct costs. If you have $100 direct cost A, $100 direct cost B, $100 direct cost C, and $200 overhead, the correct CMS price may be $500. If you say "no overhead is paid separately," then that only makes sense if overhead is already baked into the listed build up of direct prices, which aren't really direct prices anymore.
My point, it's similar to e.g. CMS rules for controls in immunohistochemistry, where CMS doesn't pay for "controls" separately - true - but the costs of control slides are very clearly and explicitly baked into (listed among) the public tables of CMS RVU direct costs of the tests in the first place, which are then also multiplied by CMS for overhead.
Infectious Codes and High Multiple Crosswalks
Codes 0041U-0044U in infectious disease by a specialty lab are an interesting case. As I recall from June 2018, the lab wanted high crosswalk multiples (e.g. 10X). CMS proposed very low crosswalk multiples in September 2018 (e.g. 1X or 2X) and the codes ended up in gapfill. However, the MACs under gapfill have proposed very low prices again. I suspect these codes will get some aggressive public comment in the next weeks.
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- There were about 10 codes where the multiple between the highest and lowest rationale was 1.6X or less.
- There were only 3 codes with 100% agreement.
- There were four infectious disease codes where the high/low multiple was over 4x, but the absolute dollars small ($15, $68).
- The wildest multiple was 11X, from $328 to $3675. For 19U, Columbia OncoTarget, Columbia/DarwinHealth, the MACs said "their was a lack of direct resource requirements" or "data was not received." One rationale pulled out of this vacuum was the median of several four-figure 815xx codes, the other was crosswalk to 81445 for $600 or less.
- 0053U, a Mayo prostate test, had a multiple of 2.7X with rationales from "Similar to ConfirmMDx" to "data not received."
CMS tells us:
"Preliminary 2019 Gapfill recommendations have been posted. Public comments will be accepted for 60 days, until Monday October 21, 2019. Please submit comments to Glenn McGuirk; glenn.mcguirk@cms.hhs.gov."CMS will post final decisions after circulating the above comments to MACs, who will "consider" the comments, and potentially "revise" the prices. My best bet is, allow a minimum of a month, suggesting CMS final gapfill prices will be posted sometime after November 21, 2019 (TBD).
Accounting Rationales
If you see the accounting rationales (see cloud Excel files) the MACs have some confusion about accounting principles.
CMS *definitely* pays for overhead - whether DME, hospital outpatient, RVU Part B calculations, inpatient, hospice, anything.
Here, the MACs seem to sometimes take a position "CMS doesn't pay for overhead" and subtract it out as a line item in costs provided. Well, if you don't "pay" for overhead, then overhead has to be baked into the direct costs. If you have $100 direct cost A, $100 direct cost B, $100 direct cost C, and $200 overhead, the correct CMS price may be $500. If you say "no overhead is paid separately," then that only makes sense if overhead is already baked into the listed build up of direct prices, which aren't really direct prices anymore.
My point, it's similar to e.g. CMS rules for controls in immunohistochemistry, where CMS doesn't pay for "controls" separately - true - but the costs of control slides are very clearly and explicitly baked into (listed among) the public tables of CMS RVU direct costs of the tests in the first place, which are then also multiplied by CMS for overhead.
Infectious Codes and High Multiple Crosswalks
Codes 0041U-0044U in infectious disease by a specialty lab are an interesting case. As I recall from June 2018, the lab wanted high crosswalk multiples (e.g. 10X). CMS proposed very low crosswalk multiples in September 2018 (e.g. 1X or 2X) and the codes ended up in gapfill. However, the MACs under gapfill have proposed very low prices again. I suspect these codes will get some aggressive public comment in the next weeks.
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| 0018U | Oncology (thyroid), microRNA profiling by RT-PCR of 10 microRNA sequences, utilizing fine needle aspirate, algorithm reported as a positive or negative result for moderate to high risk of malignancy A3 | $ 3,002 | ThyraMIR (Interpace) |
| 0019U | Oncology, RNA, gene expression by whole transcriptome sequencing, formalinfixed paraffin embedded tissue or fresh frozen tissue, predictive algorithm reported as potential targets for therapeutic agents. | $ 3,675 | OncoTarget/Columbia |
| 0021U | Oncology (prostate), detection of 8 autoantibodies (ARF 6, NKX3-1, 5’-UTRBMI1, CEP 164, 3’-UTR-Ropporin, Desmocollin, AURKAIP-1, CSNK2A2), multiplexed immunoassay and flow cytometry serum, algorithm reported as risk score. | $ 760 | Apifiny, Armune |
| 0022U | Targeted genomic sequence analysis panel, non-small cell lung neoplasia, DNA and RNA analysis, 23 genes, interrogation for sequence variants and rearrangements, reported as presence/absence of variants and associated therapy(ies) to consider. | $ 1,950 | Oncomine /Dx Target (FDA),Thermo Fisher |
| 0023U | Oncology (acute myelogenous leukemia), DNA, genotyping of internal tandem duplication, p.D835, p.I836, using mononuclear cells, reported as detection or non-detection of FLT3 mutation and indication for or against the use of midostaurin. | $ 249 | LeukoStrat, Invivoscribe |
| 0029U | Drug metabolism (adverse drug reactions and drug response), targeted sequence analysis (ie, CYP1A2, CYP2C19, CYP2C9, CYP2D6, CYP3A4, CYP3A5, CYP4F2, SLCO1B1, VKORC1 and rs12777823). | $ 451 | PGx Panel, Mayo |
| 0030U | Drug metabolism (warfarin drug response), targeted sequence analysis (ie, CYP2C9, CYP4F2, VKORC1, rs12777823). | $ 134 | Warfarin Resp, Mayo |
| 0035U | Neurology (prion disease), cerebrospinal fluid, detection of prion protein by quaking-induced conformational conversion, qualitative | $ 541 | Prion, National Prion Ctr |
| 0041U | Borrelia burgdorferi, antibody detection of 5 recombinant protein groups, by immunoblot, IgM. | $ 17 | Lyme, IGeneX |
| 0042U | Borrelia burgdorferi, antibody detection of 12 recombinant protein groups, by immunoblot, IgG. | $ 17 | Lyme, IGeneX |
| 0043U | Tick-borne relapsing fever Borrelia group, antibody detection to 4 recombinant protein groups, by immunoblot, IgM. | $ 15 | Tick, IGeneX |
| 0044U | Tick-borne relapsing fever Borrelia group, antibody detection to 4 recombinant protein groups, by immunoblot, IgG. | $ 15 | Tick, IGeneX |
| 0048U | Oncology (solid organ neoplasia), DNA, targeted sequencing of protein-coding exons of 468 cancer-associated genes, including interrogation for somatic mutations and microsatellite instability, matched with normal specimens, utilizing formalin-fixed paraffin-embedded tumor tissue, report of clinically significant mutation(s) | $ 2,920 | MSK IMPACT |
| 0050U | Targeted genomic sequence analysis panel, acute myelogenous leukemia, DNA analysis, 194 genes, interrogation for sequence variants, copy number variants or rearrangements | $ 2,279 | MyAML, Invivoscribe |
| 0053U | Oncology (prostate cancer), FISH analysis of 4 genes (ASAP1, HDAC9, CHD1 and PTEN), needle biopsy specimen, algorithm reported as probability of higher tumor grade | $ 2,030 | Prostate Risk, Mayo |
| 0055U | Cardiology (heart transplant), cell-free DNA, PCR assay of 96 DNA target sequences (94 single nucleotide polymorphism targets and two control targets), plasma | $ 3,240 | MyTaiHeart, TAI |
| 0056U | Hematology (acute myelogenous leukemia), DNA, whole genome next generation sequencing to detect gene rearrangement(s), blood or bone marrow, report of specific gene rearrangement(s). | $ 2,516 | MatePair, Mayo |
| 0057U | Oncology (solid organ neoplasia), mRNA, gene expression profiling by massively parallel sequencing for analysis of 51 genes, utilizing formalin-fixed paraffin embedded tissue, algorithm reported as a normalized percentile rank. | deleted | RNA, NGS, OmniSEeq, Life Tech |
