XL2 Lung Cancer Test 2022: "First Four Private Payers;" Other Delay Case Studies

 See a December 19 2022 press release, Biodesix "First Four Private Payer Coverage Policies."

https://www.businesswire.com/news/home/20221219005228/en/Biodesix-Announces-First-Four-Private-Payer-Coverage-Policies-for-the-Nodify-XL2%C2%AE-Test

See a June 2022 notice regarding coverage of "Nodify CDT" lung nodule test.

https://www.biodesix.com/newsroom/press-releases/biodesix-obtains-medicare-coverage-for-nodify-cdt-lung-nodule-test

BOULDER, Colo.— (BUSINESS WIRE)— June 7, 2022— Biodesix, Inc. (Nasdaq: BDSX), a leading data-driven diagnostic solutions company with a focus in lung disease, announced that WPS Government Health Administrators, the Medicare Administrative Contractor with jurisdiction for Biodesix’s De Soto, Kansas laboratory, has provided coverage for the Nodify CDT® lung nodule test.

The Nodify CDT test is a part of the Biodesix’s blood-based Nodify Lung® Nodule Risk Assessment testing strategy consisting of two tests to aid physicians in stratifying patients into distinct nodule management treatment pathways: diagnostic procedure or imaging surveillance. The Nodify CDT test helps identify patients with lung nodules that are likely malignant or higher risk of cancer, and the Nodify XL2® test conversely helps identify those that are likely benign or lower risk of cancer.

Interestingly, there doesn't seem to be a PLA code for NODIFY CDT yet.   

And WPS MAC has no mention of Biodesix or NODIFY on a web search.

WPS MAC has an LCD for XL2 37216

https://www.cms.gov/medicare-coverage-database/view/lcd.aspx?lcdid=37216

And a billing article 57558

https://www.cms.gov/medicare-coverage-database/view/article.aspx?articleid=57558

But neither mentions NODIFY CDT.

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The original MEDICARE coverage from Dr Jeter MOLDX was 2017.

My file:

2017 MOLDX A55557 QA on Original L37031 XL2 No Comments Recd.pdf

The Palmetto version of LCD is retired since they stopped managing proteomic tests and have no Biodesix claims either.   L37031 was originally active 7 10 2017.

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Iin other news about Medicare-covered tests getting outside coverage, a January 2023 press release that the DermTech test has TriCare coverage:

https://finance.yahoo.com/news/dermtech-announces-foundational-assay-dermtech-133000036.html

The PLA test got its initial Medicare coverage in January 2020, three years earlier.

https://investors.dermtech.com/news-releases/news-release-details/dermtechs-pigmented-lesion-assay-pla-receives-medicare-coverage

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Guidelines are also slow.  At JP Morgan, Natera noted that in December 2022, the ACMG endorsed wider use of NIPS (NIPT) in general, and specifically, added 22Q11.2 deletions as a recommended test.   Regarding the time delay, CEO Steve Chapman remarked,'

Last month the American College of Medical Genetics and Genomics conditionally recommended that noninvasive prenatal screening for 22q11.2 deletions be offered to all patients. Natera is also awaiting action from the American College of Obstetricians and Gynecologists.   "A lot of the ACMG guideline members in women's health are also ACOG members," he said. "If you go back and look at the fundamentals … [it checks] all the boxes. The reason we did the [SMART] study eight years ago is, we know it takes this type of study to move the needle," Chapman said. 

I'm not sure the connection between "8 years ago" and 2021/2022 announcements and publications, but the pivotal study appears to be here in May 2022 AJOG Dar et al.

https://www.natera.com/resource-library/publications/smart-22q-1-2022-fully-published

Press release January 2022

https://www.businesswire.com/news/home/20220120005436/en/Landmark-SMART-Study-Demonstrates-High-Accuracy-of-Natera%E2%80%99s-Panorama%C2%AE-NIPT-for-22q11.2-Deletion-Screening#:~:text=These%20findings%20demonstrate%20that%20routine,1%2C524%20pregnancies%20in%20this%20cohort.

While press releases on SMART and 22q11date back to February 2021

https://www.prnewswire.com/news-releases/smart-study-finds-22q11-2-microdeletion-prevalence-much-higher-than-expected-301218829.html

This 2021 press release remarks, "The SMART study sets a new standard as the largest prospective NIPT study to date (N = 20,927 enrolled from 21 medical centers), and the only large-scale study to collect genetic outcomes in most of the subjects. The study includes the validation of a new artificial intelligence-based algorithm for Panorama® called Panorama AI, which utilizes information from over 2 million cfDNA tests performed by Natera."