Insights & Perspectives

Market Access Intelligence

Timely analysis of reimbursement policy, regulatory changes, and market access strategy for medical device and SaMD innovators.

Perspectives
Featured Policy Analysis
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Policy Analysis
July 2026  ·  By Audrey Sheeley, RN, MSN, NVRN-BC
The CY 2027 Physician Fee Schedule Proposed Rule: What Medical Device, AI, and Digital Health Companies Need to Know

CMS's 716-page proposed rule (CMS-1848-P) reshapes payment for AI-enabled software, restructures remote monitoring reimbursement, and cuts conversion factors for 2027. Comments are due September 14, 2026 — here's what our clients should be watching.

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Key Provisions
  • Conversion factor drops to $33.17 (qualifying APM), a 1.19% decrease
  • CMS introduces "Software as a Medical Service" (SaMS) payment category
  • RPM/RTM billing restricted to directly-employed clinical staff
  • Global surgical package and site-of-service differentials under review
  • Comment window closes September 14, 2026
Insights
Regulatory Alerts
01 Article
Regulatory Alert
April 2026
CMS Proposes to Eliminate the Breakthrough Device NTAP Alternative Pathway

The FY 2027 Proposed Rule introduces the most consequential reimbursement policy change in years for device and SaMD innovators. Here's what it means for your market access strategy.

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