Tuesday, August 7, 2018

NGS MAC Updates Hematolymphoid Sequencing LCD - Not Ready for CPT 81455 (51+ genes)

This year, NGS MAC consolidates two LCDs into one LCD for sequencing in hematolymphoid diseases.  

They cover various applications for 5-50 genes, but that Medicare code pays only $600, which may be below costs for many fully-loaded tests with overhead, etc.  NGS MAC notes there are no guidelines that name and require 51+ genes.

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As of early August 2018, the draft LCD DL37606 was online here  and the final online here.  Comments from AMP/CAP were online here.  Responses to comments were online here (A55974).

The LCD doesn't specifically refer to the recent NCD on next generation sequencing, which places different rules and restrictions on NGS based testing as opposed to other technologies for gene testing.  (In addition, the NGS NCD applies to "advanced cancers" which some borderline blood disorders may not be, while advanced blood cancers are "advanced cancers.")

81450 versus 81455
Coverage is based on code 81450, 5-50 genes in hematolymphoid disorders. 

AMP/CAP requested, but NGS MAC didn't seem to provide, coverage for 81455 (51+ genes in any cancer).   81450 pays only about $600, whereas the latter code 81455 pays about $2900.  The CMS NCD covers all FDA approved gene panels (where <50 or >50 genes) in advanced cancer, so it might provide coverage whereas this LCD does not, and the reader would have to figure out the difference. Or the MAC would have to process claims for 81455 one way under the NCD and another way under the LCD.  (FDA approved tests could, but might not, have PLA codes).

Other Notes
NGS MAC added some ICD-10 codes to describe unusual or borderline clinical states, as suggested by AMP/CAP.

An informal redline test didn't show any other differences between draft and final LCDs.

I've put the key documents in a cloud zip file.  Here.



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As a bonus, the zip file includes comments on NGS MAC LCD L35000, their catch-all MDX LCD.  AMP/CAP provide 12 pages of comment (mostly ICD10 codes by length) and then attach a 7 page comment written by the IGNITE consortium, which is funded by NHGRI for translational research on genomics.   The IGNITE consortium supported a range of additions including pharmacogenetic ones.   NGS right now lists the relevant LCD L35000 as "RFT" or released to final (see pic above), but hasn't seemed to actually post the final version (see "NA" in pic) or its Q&A response.



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