Tuesday, May 21, 2024

TEMPUS Files for IPO; Actual SEC Document; Focus on Reimbursement Tactics

As widely noted in the biotech media, TEMPUS filed for an IPO on May 20, 2024.   The IPO value may be up to $100M.  Prior funding rounds had raised over $1B in total.  

News at Genomeweb, BloombergChicago Business, Fierce Healthcare.

Most of the articles don't link to the actual IPO document; it's online here:

https://www.sec.gov/Archives/edgar/data/1717115/000119312524142956/d221145ds1.htm


As a PDF, it weighs in at 169 pages.

Per Fierce Healthcare, accumulated losses are $1.5B, with $530M in 2023 revenue and about a $200M burn rate.  There are currently 2,300 employees (p 220, paginated 212).  Their Chicago space is 180,000 sq ft.

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The Word "Reimbursement" Occurs 120 Times

Reimbursement occurs about 120 times, Medicare about 70 times.

MACs.  There's substantial discussion of their "local MAC, NGS [MAC]" on PDF page 44 [paginated 40].  They recite steps towards coverage with NGS MAC (e.g. "March 25, 2021...July 29, 2021...").   They then pivot to discussing the MolDx Palmetto jurisdiction, which processes claims that come from their alternate labs in Raleigh and Atlanta.  They note they submitted a tech assessment to MolDx for their xT assay in 2022, receiving approval in October 2023.  They note they submitted a tech assessment for the xF assay in 2023, but are still awaiting response as of May 2024.

14 Day Rule.  The same part of the S-1, PDF page 44 [paginated 40], also discusses situations where "we cannot bill Medicare directly for tests provided for Medicare beneficiaries."  This hinges on a discussion of Date of Service aka 14 Day Rule considerations.  Memdicare policies are also discussed at 217-219 [paginated 209-211].

Also tied to 14-day rule, they discuss a Civil Investigative Demand (CID) regarding compliance with 14-day rule and other issues (72-73, paginated 67-68; March 2024).

See also this remark:  "Our status as both a healthcare company and a technology company presents unique complexities when attempting to comply with these myriad laws and regulations. For example, certain data services we provide as a technology company may result in compensating other healthcare providers for access to data or the right to commercialize de-identified data. While such services, standing alone, appear routine, the compliance issues become more complex when considering our status as a healthcare provider that performs clinical diagnostic testing on behalf of healthcare providers."  (72, paginated 68). 

CPT Codes. There is a discussion of new AMA CPT codes for some tests in their genomics line of business, and how these tests are in gapfill (preliminary prices May 1), because "CMS rejected the recommendations from experts" in 2023.

There is a discussion of new capabilities to bill DNA and RNA studies under separate CPT codes (PDF 44, paginated p 40).

LBMs.  Reimbursement discussion continues, into page 45 [paginated 41], discussing "third party benefit managers" and "laboratory benefit management programs" and how these can cause "additional pricing pressure" and "substantial administrative burden."   (See an article on the same topic in 360Dx on May 16.)

Payment.   Average reimbursement was $916 in 2022 and $1452 in 2023; CY2021-CY22 payments were 50% of cases  (PDF 202, paginated 194).


Cohort Lifetime Value

There's an interesting discussion of recurrent testing and "cohort lifetime value" on pages 11-12 (paginated 8ff).

Addressable markets (TAM) are discussed at 190ff [paginated 182].


Artificial Intelligence

Risks and mitigations. TEMPUS frequently discusses the critical role of AI in its future services; legal risks and mitigations regarding the use of AI are discussed on page 46ff [paginated 42].

Vision.  See an extensive discussion of  Tempus proprietary advanced informatics services at page 153ff (paginated 147ff).  This lengthy discussion (with multiple screenshots) could almost comprise a review article on their vision for AI in diagnostics.

Tempus: The Cell Culture Company

Tempus press releases about organoid tests go back to 2021, and they have a 2024 abstract on the topic at ASCO.  In the S-1, the term "organoid" occurs 25 times, reflecting various product or process acquisitions, pharma collaborations, and plans.