2026-04-30 - CMS & FDA Announce RAPID Coverage Pathway to Accelerate Patient Access to Life-Changing Medical Devices
Act
by May 1, 2026
Effective date
May 1, 2026
Identified
Apr 30, 2026
Summary
CMS released multiple updates including a new RAPID coverage pathway for breakthrough medical devices, mandatory clinical lab data reporting starting May 1, required third-party vendor enrollment by May 11, new physical activity risk assessment code G0136, and updated abdominal aortic aneurysm screening codes.
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01Clinical diagnostic laboratories must report HCPCS codes, private payor rates, and volume data for January-June 2025 period using CMS Data Collection System.
02By May 11, 2026: Enroll all third-party vendors for HIPAA Eligibility Transaction System access by linking vendor unique IDs to your NPI to prevent service disruptions.
03Immediately: Begin using new HCPCS code G0136 for physical activity and nutrition risk assessments as add-on to E/M visits every 6 months or Annual Wellness Visits.
04Update billing system with new ICD-10 diagnosis codes for abdominal aortic aneurysm screening.
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