GH (US)


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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December 13, 2024

[PBMs, Hospitals, Docs] Healthcare Extenders: State of Play

By Beth Steindecker

While Republicans and Democrats are trying to hash out a healthcare extenders package to add to a short-term government funding measure that needs to be taken up and passed by next Friday, we ascribe just…

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November 26, 2024

Exact Sciences: Cologuard Plus Gets 16% Bump, Coverage Questions Remain

By John Leppard

In a positive surprise relative to our initial expectations, CMS’s CY25 payment rate of $592 for EXAS’s Cologuard Plus represents a 16% premium to the legacy test’s $509. While this falls slightly shy of the…

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November 13, 2024

EXAS, GH: Next Steps on Next Gen Test Rates

By John Leppard

Key Takeaways: Following the split market reaction to EXAS [-29%] and GH [+25%] 3Q24 earnings reports last week, and investors looking to the opportunities associated with next generation colorectal cancer (CRC) screening tests Cologuard Plus…

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