April 29, 2025
[EXAS] Screening Uncertainty Post-SCOTUS?
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…
April 21, 2025
Diagnostics: Supreme Court Quick Takes
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…
April 21, 2025
Diagnostics & Supreme Court Expectations
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…
March 21, 2025
EXAS, GH: Colorectal Cancer Coverage in Hand, Edits to Come?
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…
February 6, 2025
[EXAS, GH, GRAL] Multi-Cancer Coverage: Take 2
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…
January 12, 2025
Diagnostics’ New Supreme Court Risk
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,…
January 8, 2025
Exact Sciences (EXAS): Cologuard Plus Coverage Questions
A Jan. 1 update to CMS’s colorectal cancer (CRC) screening guide appears to support our view that Medicare coverage of EXAS’ Cologuard Plus (0464U: $592) and its 16% rate premium over the legacy version (81528:…
January 6, 2025
Conference Policy Prep Pack: Devices, Diagnostics, & Tools
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…
December 18, 2024
[PBMs, Cancer Screening, Medicare Advantage] A Few Surprises in the Healthcare Spending Package but Otherwise Mirroring Prior Compromise
Following Tuesday night’s release of a short-term continuing resolution (CR) funding the government through March 14, we outline some key differences from previously-reported iterations of the healthcare extenders package, involving PBMs [CI, CVS, UNH, ELV],…
December 17, 2024
[GRAL, EXAS, GH] Multi-Cancer Test Coverage: Details Fall Flat
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…