GH (US)


April 29, 2025

[EXAS] Screening Uncertainty Post-SCOTUS?

By John Leppard

Late last week the U.S. Supreme Court (SCOTUS) ordered the parties in Kennedy v Braidwood – evaluating mandatory cost-free coverage of preventive services recommended by the U.S. Preventive Services Task Force (USPSTF) – to submit…

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April 21, 2025

Diagnostics: Supreme Court Quick Takes

By John Leppard

Following oral arguments this morning, we continue to believe that the Supreme Court will preserve HHS authority to enforce mandatory cost-free coverage of U.S. Preventive Services Task Force (USPSTF) recommendations, preserving the positive status quo…

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April 21, 2025

Diagnostics & Supreme Court Expectations

By John Leppard

With the Supreme Court (SCOTUS) to hear oral arguments this morning 10-11 am ET [live stream] on the legality of mandatory cost-free coverage of U.S. Preventive Services Task Force (USPSTF) recommendations, we reiterate our long-held…

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March 21, 2025

EXAS, GH: Colorectal Cancer Coverage in Hand, Edits to Come?

By John Leppard

An update to CMS’s colorectal cancer (CRC) screening National Coverage Determination (NCD) formally establishes coverage for EXAS’ Cologuard Plus ($592) and GH’s Shield ($1,495), with claims processing likely available within 30 days. While we have…

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March 12, 2025

Guardant Health (GH): Next Steps on Shield

By John Leppard

With the Medicare rate for GH’s Shield colorectal cancer (CRC) screening test set to increase 62% on April 1 ($920 to $1,495) following designation yesterday as an Advanced Diagnostic Laboratory Test (ADLT) – in line…

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February 6, 2025

[EXAS, GH, GRAL] Multi-Cancer Coverage: Take 2

By John Leppard

Bicameral reintroduction this week of legislation to allow – not require – Medicare coverage of multi-cancer early detection (MCED) tests starting in 2028 bolsters our view of its likely inclusion in a mid-March spending bill…

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January 21, 2025

Guardant (GH) Reveal Medicare Coverage FAQ

By John Leppard

Following GH’s announcement this AM of Medicare coverage of its tissue-naïve Reveal test for minimal residual disease (MRD) surveillance testing, we wanted to highlight some additional salient points omitted from the company’s press release. The…

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January 12, 2025

Diagnostics’ New Supreme Court Risk

By John Leppard

The Supreme Court’s (SCOTUS) decision on Friday to hear oral arguments in Becerra v. Braidwood, presumably in late March / early April, will likely serve as an overhang for screening test manufacturers [EXAS, GH, MYGN,…

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January 6, 2025

Conference Policy Prep Pack: Devices, Diagnostics, & Tools

By John Leppard

With medical device, equipment, diagnostics, and life science tools (LST) companies set to descend on San Francisco next week for a key investor conference, below we provide a set of significant policy-related questions for clients…

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December 17, 2024

[GRAL, EXAS, GH] Multi-Cancer Test Coverage: Details Fall Flat

By John Leppard

While positive on its face, the inclusion of multi-cancer early detection (MCED) screening test [GRAL, EXAS, GH] coverage provisions in tonight’s continuing resolution (CR) to fund the government through March 14 leaves much to be…

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