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
02 Articles
Regulatory Alert
September 2026
CMS Unveils the RAPID Coverage Pathway: What Medtech Innovators Need to Know

A new voluntary pathway aims to close the gap between FDA market authorization and Medicare coverage. Comments are due October 13, 2026. Here's what's in the proposal, who it's for, and how to weigh in before the window closes.

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Regulatory Alert
April 2026  ·  Updated September 2026
CMS Finalizes Elimination of the Breakthrough Device NTAP Alternative Pathway

CMS has finalized the FY 2027 rule, confirming the most consequential reimbursement policy change in years for device and SaMD innovators. This update includes the finalized transition timeline, the grandfather provision, and the new RAPID coverage pathway announced alongside it.

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