Sunday, December 27, 2020

PerkinElmer and ARUP as Reference Labs vis-a-vis MOLDX

It's well known that ARUP, in Utah, is a reference laboratory that does not directly bill Medicare.   (I'm not sure how that will be affected by new rules in the last year requiring labs that perform tests on Medicare hospital outpatients to bill Medicare directly - a change that sole source labs like Genomic Health generally like, but a change that would be a new practice for ARUP).

Recently, PerkinElmer Genetics was in the news as a reference lab for labs allegedly being investigated by the DOJ.  PerkinElmer on May 18, 2020, "denies Reuters report that it is being investigated."  Here.  This was in response to a Reuters report that is still online here.  Also with a date of May 18.

NPI

Even if you never bill Medicare, if other labs bill your tests, the other lab will list -90 (modifier 90, reference test) and the NPI of the performing laboratory.   So the lab, not billing Medicare, will still have to have an NPI.  ARUP has an NPI of 1982694931 and Perkin Elmer has two, 1781585067 in Pittsburgh and 1033520028 in New York.

I checked all three NPI's against the CMS 2018 provider billing database, and there were no claims for any codes under any of the NPIs.   Here

MolDx Public Database

MolDx and Palmetto have a public website database that amounts to tests with registered Z-codes, although the Z codes are not shown.   Here.   If a lab in a MolDx (e.g. Palmetto) MAC bills Medicare, it is supposed to list the Z code of the lab that performed the test (e.g. ARUP).   Accordingly, ARUP, though it never bills Medicare and certainly not Palmetto, has 392 registered tests.   PerkinElmer (Pittsburgh) ahs 53 registered tests.   A person could click on all 392 and 53 tests, and see if they are listed as covered or not covered by Palmetto MolDx.   The several PerkinElmer tests I clicked on werre listed as "not covered" but I did not take the time to click on all 53.  A person who was interested in which tests PerkinElmer had listed with Palmetto, could see them enumerated in a list of 53.

PerkinElmer Website

You can also look up offered tests directly on the PerkinElmer Genomics website.  For one example, if you look up gene TUBGCP4, you get several Autism and Intellectual Disability Panels (which seem to be listed as having 2436 to 3439 genes).  This panel doesn't seem to be listed with MolDx, but Perkin Elmer's Exome test is listed (WES, Proband, Not Covered).   

Summary

If a lab in the MolDx jurisdictions were to use PerkinElmer as a reference lab, it would be able to use the corresponding Z codes in its submissions to the MACs (along with the nationally required -90 modifier).  



Footnote.

The 70/30 law at SSA 1834(h)(5)(C) stems from OBRA 1989 6111b as slightly modified by OBRA 1990 4154.   


 

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