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UnitedHealthcareMedicaid · Coverage · Medical Policy · KY · Oncology, Hematology, PathologyHigh impact

FDA Cleared or Approved Companion Diagnostic Testing (for Kentucky Only)

Act
by Nov 1, 2026
Effective date
Nov 1, 2026
Identified
Oct 3, 2026

Summary

UnitedHealthcare Community Plan of Kentucky has revised its companion diagnostic (CDx) testing policy effective November 1, 2026, adding a requirement to first reference Kentucky Revised Statutes § 304.17A-263 for medical necessity determination, then apply the policy criteria if statutory criteria cannot determine necessity. The policy also updated applicable CPT codes to reflect quarterly edits, including addition of CPT 0648U. This affects coverage determinations for FDA-cleared/approved CDx tests used with specific oncology medications across multiple cancer types.

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What to do

by Nov 1, 2026 · 5 steps
01Billing and clinical staff must implement the two-tier medical necessity review process for all companion diagnostic test claims on Kentucky Medicaid patients.
02First, evaluate claims against Kentucky Revised Statutes § 304.17A-263 criteria; if medical necessity cannot be determined using statutory criteria, then apply the specific indication/drug pairings listed in the policy (FoundationOne CDx, FoundationOne Liquid CDx, Guardant360 CDx, MI Cancer Seek, Oncomine Dx Express/Target, oncoReveal CDx, TruSight Oncology Comprehensive, and xT CDx).
03Update billing system to reflect the new CPT code 0648U and ensure it routes through the revised approval workflow.
04Update prior authorization templates and denial protocols to reference the statutory criteria first.
05Train oncology and related specialty staff on the new hierarchy.
If missed: Failure to follow the statutory criteria-first approach may result in improper denials or approval of non-covered tests.

Original notice

FDA Cleared or Approved Companion Diagnostic Testing (for Kentucky Only)
uhcprovider.com · Always check the source before changing claims.
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UnitedHealthcare policiesKY policy changesOncologyHematologyPathology

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