Friday, December 11, 2020

Noridian Hosts January Expert Panel on Pathogen Panels / Infectious Disease

Noridian has announced it will host a public panel of experts in a four hour meeting on January 11.  The topic will be "Molecular Diagnostic Testing for Pathogens."  In this blog, we make some guesses what the backstory might be.

Find the Noridian home page for public policy meetings here.  Based on a December 8 update, there's a pending meeting on January 11, 2-6 pm CST, and registration is open.  The topic?  "Molecular Diagnostic Testing for Pathogens."  (PDF here.)  

The moderator will be Anitra Graves MD.  See her Linked In as a medical director at Noridian here.  In her earlier resume, she is listed as a pulmonologist or intensivist in Georgia. She's been associated with Medicare since 2018.  Her Linked In lists her as a Palmetto general medical director from 2018 to March 2020, and as a Noridian DME medical director since September 2020.

The registration page gives a bit of additional information, cut pasted here:

A multi-jurisdictional Contractor Advisory Committee (CAC) Meeting to discuss clinical literature related to Molecular Diagnostic Testing for Pathogens is being hosted by:
Noridian Healthcare Solutions
CGS Administrators 
Palmetto GBA
WPS Government Health Administrators

The purpose of the CAC meeting is to provide a formal mechanism for healthcare professionals to be informed of the evidence used in developing the Local Coverage Determination (LCD) and promote communications between the Medicare Administrative Contractors (MAC) and the healthcare community. 
The CAC panel will be asked to discuss the clinical literature related to "Molecular Diagnostic Testing for Pathogens" and rate their confidence in a series of Key Questions. Discussions will occur between the CAC panelists and MAC Contractor Medical Directors. The public may attend; however, questions from the public will not be entertained. 

How will the agenda be filled in?

I can only offer some guesses.  Noridian (and other MolDx MACs) have quite restrictive LCDs regarding the use of viral or pathogen panels in respiratory and GI disease.   Coverage focuses on only the minimal CPT code set, that for 3-5 pathogens, and higher-count pathogen tests are generally not covered.    See: here

Recently, of course, there's much more interest in picking up co-pathogens in COVID pneumonia, and such patients are often hospitalized, on antibiotics, and difficult to culture, bringing the focus to molecular testing.  FDA has granted EUAs for some large pathogen panels (e.g. 20-21 pathogens) to which COVID testing has newly been added.    For example, read about Biofire panels under EUA "plus COVID" -- here.

My bet is that the main topic will be the use of these large panels in COVID patients, especially outpatients, since testing for inpatients would be under a DRG anyway and not paid separately.

I do know that when MolDx initially promulgated narrow LCDs on pathogen test panels, there was public pushback from AMP, CAP, IDSA, ASM, perhaps others.  See Medicare document A56251 here.  

IDSA, CAP, AMP (April 2020)

Newer and more specific to COVID patients, see a letter from AMP, CAP, IDSA, others, to Seema Verma on 4/28/20 here, and a Genomeweb article on the topic on 4/30/20, here.

Other possible topics include COVID antigen and antibody testing, but I'm not sure if this will be an added focus or not.  

CMS Posting: All Tests With COVID Inside Get Special Ordering Rules, But Not Necessary "Coverage"

There's a pretty bizarre situation where CMS issued special emergency rules and exceptions regarding the ordering (and ordering documentation) for tests containing COVID.  These ordering rules apply equally to a test that is solely COVID (e.g. U0004), or a test that contains COVID (e.g. a large Biofire 22-pathogen test, one of which is COVID.)   However, CMS announced publicly in June 2020 that is ordering rules don't extend to coverage.  See FN1.

Additional Background on Molecular Clinical Utility

In 2019, American Society for Microbiology published a position paper on Clinical Utility of Advanced Microbiology Testing Tools, by Miller et al.  It's an important publication and worth checking out for anyone interested in clinical utility of diagnostics.  Here.  


CMS COVID ordering rules are not equal to CMS coverage of COVID testing.  

CMS says its table of COVID-containing tests is a comprehensive listing of all tests that contain COVID, and any of them may qualify for special emergency rules regarding a physician's order.   However, CMS adds the table ONLY concerns tests that fall under its physician-order-policy, and this is not a table regarding COVERAGE.    

See the CMS clarification at its (currently 165-page) guidance of COVID special rules, here:

I'm quoted from the 12/8 online version, but the particular question in the FAQ is dated back to 6/19.

11. Question: Does the CMS table “COVID-19, Influenza, and RSV Clinical Diagnostic Laboratory
Tests for which Medicare Does Not Require a Practitioner Order during the PHE” list Clinical Diagnostic Laboratory Test codes that Medicare will cover during the PHE? 

Answer: This table lists codes that, if otherwise covered by Medicare, do not require a treating practitioner’s order as a condition of Medicare payment. The table should not be interpreted as a statement of coverage for the listed codes. There may be some codes for which there are local coverage determinations that non-cover or limit coverage of certain tests. 

Practitioners and laboratories should check with their local Medicare Administrative Contractor regarding specific questions of coverage. New 6/19/20