Pathologist Ordering Diagnostic Tests: The "Pathology Exception" - and Lung Cancer Papers

Periodically, questions arise whether pathologists can order genomic tests (e.g. lung cancer gene panels).

My reading of Medicare regulations, is "NO."  There are two sources.  In 42 CFR 410.32, CMS regulations state that diagnostic tests must be ordered by the treating physician who uses the test in the management of the patient's disease.   For me, the only natural reading is that this was intended to excluded pathologists and radiologists (by intention, not by accident.) 

Further, the origin of the rules is 62 Fed Reg 59048, 1997, where they discuss for example an IDTF physician cannot order tests, but the primary physician "treating the patient" can. (59071).  This despite the fact the IDTF radiologist is "managing" the patient to the extent of reading out the imaging. (See also 410.33(d).) See also p. 59058.  CMS remarks that, "[in a radiology example,] provision could be made for an emergency situation. We are trying to address situations in which there is a pattern of the testing entity’s adding procedures [tests] to those ordered by the patient’s personal physician."

Second, the Benefits Policy Manual, Chapter 15, 80.6.4, has several pages about when a pathologist or radiologist can order or alter a diagnostic test.   They carefully distinguish not just between diagnostic and interventional radiologists, but between "therapeutic" and "diagnostic" interventional radiology procedures.   (I assume they didn't mention pathologists here because the term "therapeutic interventional pathologist" isn't even availalble.)   

In short, my reading of 410.32 and 80.6.4 is that the only natural reading of the author's intent was to exclude pathologists. '

Admittedly, there is a bit of gray area.  A pathologist can order tests required to complete a case, such as a gram stain when bacteria are seen.   

See my 2022 discussion here:

https://www.discoveriesinhealthpolicy.com/2022/04/the-exception-for-pathologists-ordering.html

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While attending a March 2024 meeting where this was discussed, I ran across some further citations.

See LOSK 2017

https://ascopubs.org/doi/10.1200/JOP.2017.023788

Losk et al  (2017) Implementation of Surgeon-Initiated Gene Expression Profile Testing (Oncotype DX) Among Patients With Early-Stage Breast Cancer to Reduce Delays in Chemotherapy Initiation.  J Onco Pract 13:e815.  PMID 28858535

Finding:

The introduction of standardized criteria and workflows reduced time between surgery and Onco type DX ordering, and time from surgery to receipt of result, by 7.3 days ( P < .001) and 6.3 days ( P < .001), respectively. The mean number of days between surgery and initiation of chemotherapy was also reduced by 6.4 days ( P = .004).

The authors open with a number of citations to Oncotype causing downstream delays in decision-making.   The authors do not discuss CMS rules.

I used a subscription data resource, SCITE, to pull later papers citing LOSK.  It had been cited 14 times.  These include:

Natsuhara (& Losk), 2018, The Ooncologist.  Impact of genomic assay testing and clinical factors on chemotherapy use after implementation of standardized testing criteria.  

https://academic.oup.com/oncolo/article/24/5/595/6439227

Zipkin 2021  Cancer Med.  Surgeon and medical oncologist peer network effects on the uptake of the 21‐gene breast cancer recurrence score assay.  

https://onlinelibrary.wiley.com/doi/10.1002/cam4.3720

Trapani 2023  JCO  Identifying Patterns and Barriers in OncotypeDX Recurrence Score Testing in Older Patients With Early-Stage, Estrogen Receptor–Positive Breast Cancer: Implications for Guidance and Reimbursement.

https://ascopubs.org/doi/10.1200/OP.22.00731 [not open access]

Gregg 2019.  Tranl Lung Ca Res.   Molecular testing strategies in non-small cell lung cancer: optimizing the diagnostic journey.   

https://tlcr.amegroups.org/article/view/29030/21559

Pruneri 2023  NPJ Breast Cancer.  The central role of pathology labs in breast cancer precision oncology: a call for action

https://www.nature.com/articles/s41523-023-00506-5

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A Linked In Post and a new "Oncology & Therapy" article by Nesline et al.

The Impact of Prior Single-Gene Testing on Comprehensive Genomic Profiling Results for Patients with Non-Small Cell Lung Cancer, NESLINE et al., March 2024.

https://link.springer.com/article/10.1007/s40487-024-00270-x

See a cover note at Linked In by Rebecca Previs MD of LabCorp..

https://www.linkedin.com/posts/rebecca-previs-190bb422b_experts-sound-the-alarm-on-lack-of-comprehensive-activity-7180567156835651584-6MPw/?utm_source=share&utm_medium=member_ios

See J Clin ONcol, March 17, 2024, Subbiah et al.   See section, "Where is the evidence" with a number of timely major links.  Universal Germline and Tumor Genomic Testing Needed to Win the War Against Cancer: Genomics Is the Diagnosis.

https://ascopubs.org/doi/full/10.1200/JCO.22.02833

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See also news  from PMC about lung cancer and health equity,

https://www.msm.edu/RSSFeedArticles/2024/March/Lung-Cancer-Inequity.php

https://www.ajc.com/opinion/from-diagnosis-to-denial-breaking-chains-of-lung-cancer-inequity/GIUYCEKONVA35A7BOWL6LFE44Y/

Original source (2nd link) is firewaled, top source (MSM.edu) is not.

ALso mirrored:  https://www.personalizedmedicinecoalition.org/op-ed-from-diagnosis-to-denial-breaking-the-chains-of-lung-cancer-inequity-for-black-men/

PMC Report, 41pp, on disparities in personalized medicine and underserved communities

https://www.personalizedmedicinecoalition.org/wp-content/uploads/2024/02/report-1.pdf

See also Turna Ray April 3, Lung cancer EGFR treated with PDL1

https://www.precisionmedicineonline.com/precision-oncology/nsclc-patients-who-should-get-first-line-egfr-inhibitors-are-immunotherapy

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CA Blue Shield rolls back MRD coverage in cancer, via Laura Housman,

https://www.linkedin.com/feed/update/urn:li:activity:7178526955921715200?commentUrn=urn%3Ali%3Acomment%3A%28activity%3A7178526955921715200%2C7178764131209007105%29&replyUrn=urn%3Ali%3Acomment%3A%28activity%3A7178526955921715200%2C7179473466461450240%29&dashCommentUrn=urn%3Ali%3Afsd_comment%3A%287178764131209007105%2Curn%3Ali%3Aactivity%3A7178526955921715200%29&dashReplyUrn=urn%3Ali%3Afsd_comment%3A%287179473466461450240%2Curn%3Ali%3Aactivity%3A7178526955921715200%29

Genomeweb - pro's con's of MRD

https://www.precisionmedicineonline.com/liquid-biopsy/failed-trial-suggests-circulating-tumor-dna-monitoring-not-universally-applicable

Another pivotal article was:

Roberts MC et al. (2016) Int J Tech Assmt HealthCare 32:355.  PMID 27958190.  ONCOLOGISTS' BARRIERS AND FACILITATORS FOR ONCOTYPE DX USE: QUALITATIVE STUDY

https://pubmed.ncbi.nlm.nih.gov/27958190/

According to SCITE, this has been cited 10 times.

Citations included

Roberts, 2015, Racial variations in adjuvant chemotherapy initiation among breast cancer patients receiving oncotype Dx testing. Br Ca Res Tx.  (No diff found).

https://link.springer.com/article/10.1007/s10549-015-3518-9

McVeigh 2016, CLinical use of the Oncotype Dx genomic test...  Br Ca  Targets & Therapy.  Primarily a review up to 2016.    https://www.dovepress.com/clinical-use-of-the-oncotype-dx-genomic-test-to-guide-treatment-decisi-peer-reviewed-fulltext-article-BCTT

A small study, appearing in Cancers, looked at machine learning with clinical variables for recurrence risk..   Sukhadia et al, 2023, open access.  https://www.mdpi.com/2072-6694/15/15/3960 

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Medicare, as I recall, has public cloud databases that include ordering physicians for DME, but not for other services.  To get the type of physicians ordering, say, a Foundation Medicine or an Oncotype Dx test, I don't think FOIA would work, since FOIA releases only available documents and precludes any filtering or research work.  But one could do a work order for CMS data on ordering physician for key diagnostic codes like Foundation or Oncotype.  I suspect it would show none or next-to-none are ordered by radiologists or pathologists.   Whether this is good or bad is a policy issue to debate or revise.