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2026-04-30 - CMS & FDA Announce RAPID Coverage Pathway to Accelerate Patient Access to Life-Changing Medical Devices

Medicare/CMS·Coverage
Effective date
May 1, 2026
We identified it
Apr 30, 2026
Days to comply

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.

Action Required

Action needed
By May 1, 2026: Clinical diagnostic laboratories must report HCPCS codes, private payor rates, and volume data for January-June 2025 period using CMS Data Collection System. By 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. Immediately: 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. Update billing system with new ICD-10 diagnosis codes for abdominal aortic aneurysm screening.

Affected Billing Codes

G0136
Z13.6
Z87.891
F17.210
F17.211
F17.213
F17.218
F17.219
Z84.89
2026-04-30 - CMS & FDA Announce RAPID Coverage Pathway to Accelerate Patient Access to Life-Changing Medical Devices | Medicare/CMS | PolicyChanges.app