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CMS Comments Close on a Rule That Retires the Small Biotech Exemption and Shuts the Hyaluronidase Route

CMS Comments Close on a Rule That Retires the Small Biotech Exemption and Shuts the Hyaluronidase Route

QuickAccess read/Oncology/Antibody CMS Comments Close on a Rule That Retires the Small Biotech Exemption and Shuts the Hyaluronidase Route Athithi Verma· 19 August 2026· 2 min read· Synopulse The 60-day comment period on CMS-4215-P closed at 5pm on 17 August 2026. The proposed rule, published in the Federal Register on 16 June 2026, would codify … Read more

Weekly Pulse: Policy & Access Rules Rewritten for 2026

Weekly Pulse: Policy & Access Rules Rewritten for 2026

The past week delivered a coordinated sequence of moves that, taken together, quietly reset expectations for how global systems will price, approve, pay for, and ultimately adopt innovation in 2026. What distinguished this week was not the volume of news but its consistency: across borders and agencies, decision-makers leaned into a shared posture, broadened access … Read more

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CMS Sets $1,352 Payment Rate for Pillar’s oncoReveal CDx

CMS Sets $1,352 Payment Rate for Pillar’s oncoReveal CDx

CMS has issued its final payment determination for Pillar Biosciences’ oncoReveal CDx, confirming a crosswalk-based national rate of $1,352.09, service beginning January 1, 2026. The decision, which aligns with CMS’ preliminary ruling from August, marks a meaningful advance for Medicare beneficiaries and reinforces oncoReveal CDx’s position as a front-line, multi-cancer NGS testing kit in the … Read more

Weekly Pulse: Access Decisions, Regulatory Events & Market Dynamics, Week of Nov 24, 2025

Weekly Pulse Access Decisions, Regulatory Events & Market Dynamics, Week of Nov 24, 2025

The Reimbursement Landscape Recalibrates As we pause for the Thanksgiving holiday, a sincere thank-you to our readers and partners for your continued engagement. This week’s update reflects a period of meaningful policymaking momentum across major global agencies. Across the U.S., UK, France, Canada and Thailand, agencies delivered firm, directional decisions that shape how hospitals, clinics … Read more