UnitedHealthcare (PA-only) revised its CDx policy effective March 1, 2026 to apply explicitly only to FDA cleared/approved companion diagnostic (CDx) tests and added numerous test–drug pairings across platforms for NSCLC and other solid tumors (examples: Tepmetko, Rozlytrek, Keytruda and multiple PARP combinations). The policy enumerates platform-level coverage determinations (e.g., FoundationOne CDx/Liquid CDx, Guardant360 CDx, Oncomine Dx, xT CDx) and lists specific indication–therapeutic pairings considered proven and medically necessary. It affirms criteria for other FDA-cleared/approved CDx tests to be covered, allows repeat CDx testing at progression or recurrence, and permits concurrent tissue and plasma CDx testing for stage IV NSCLC and stage IV breast cancer. The policy cites evidence and guideline support (Hayes assessments, prospective/retrospective studies, IASLC and NCCN guidance) and provides applicable CPT/HCPCS test codes for billing.
March 1, 2026 Revision: FDA CDx Applicability and Test–Drug Pairing Additions
The March 1, 2026 revision to UnitedHealthcare's Pennsylvania-only policy CS373PA.E clarifies that the policy now explicitly applies only to tests that have been granted approval as FDA cleared or approved Companion Diagnostic (CDx) tests. The Summary of Changes also lists several specific additions and updates to test–drug pairings across multiple FDA-cleared CDx platforms, including additions for Tepmetko® (tepotinib), prostate cancer PARP combinations (e.g., Akeega®, Lynparza®, Rubraca®), and multiple additions for solid tumor indications such as Rozlytrek® (entrectinib) and Keytruda® (pembrolizumab).
Revision notes in the policy history further document that coverage rationale language was revised to emphasize applicability to FDA-designated CDx tests. The policy history enumerates specific platform-level coverage determinations (e.g., Guardant360® CDx, FoundationOne® Liquid CDx, Oncomine™ Dx Target Test, xT CDx, MI Cancer Seek™, and others) and associated indication/drug pairings that were added or updated in this revision.
Covered FDA‑Cleared CDx Platforms and NSCLC Focus
This policy defines which FDA cleared or approved companion diagnostic tests are considered "proven and medically necessary" in Pennsylvania for the management of specific oncology indications, with a strong emphasis on Non‑Small Cell Lung Cancer (NSCLC). Multiple specific CDx platforms are listed with discrete indication/drug pairings considered covered. For example, FoundationOne® Liquid CDx and FoundationOne® CDx are listed as proven and medically necessary for NSCLC when used to inform management for agents including alectinib, encorafenib + binimetinib, gefitinib, lazertinib + amivantamab, capmatinib, osimertinib, and various EGFR/ALK/MET targeted agents.
Similarly, Guardant360® CDx is listed as proven and medically necessary for certain NSCLC targeted therapies including fam-trastuzumab deruxtecan-nxki (Enhertu), sotorasib (Lumakras), amivantamab (Rybrevant), and osimertinib (Tagrisso). Other platforms (e.g., Oncomine™ Dx Express/Target Test, xT CDx, TruSight™ Oncology Comprehensive, oncoReveal™ CDx, MI Cancer Seek™) have enumerated indication/drug pairings covering NSCLC and multiple other tumor types. The effect is a mapping of specific FDA-cleared CDx assays to the targeted therapeutics and indications for which UnitedHealthcare considers the test medically necessary.
Evidence Base and Guideline References Supporting Tissue and Liquid CDx Testing
The policy includes an evidence and guideline summary supporting use of tissue-based and liquid biopsy CDx testing. It cites studies and assessments for major platforms: FoundationOne (tissue and liquid), Guardant360 CDx (liquid), Oncomine Dx Target Test (tissue), and Tempus xT CDx (concurrent testing analysis). The document references Hayes molecular test assessments (FoundationOne Liquid CDx and Guardant360 CDx), prospective and retrospective cohort studies, and a randomized trial (Yang et al., 2023) showing that early liquid NGS can shorten time to treatment and that combined tissue and liquid testing can detect complementary actionable alterations.
Professional guidance is also noted: the International Association for the Study of Lung Cancer (IASLC) consensus recommends clinically validated NGS platforms over single-gene PCR, and recognizes plasma ctDNA as a valid genotyping tool for advanced NSCLC—either complementary to tissue or as an initial approach. The policy cites NCCN recommendations for biomarkers in NSCLC, noting NCCN's non-endorsement of any single commercial assay but providing biomarker testing guidance.
Coverage Criteria, Subsequent Use, and Concurrent Tissue/Liquid Testing Rules
UnitedHealthcare specifies criteria under which FDA cleared or approved CDx tests not explicitly listed are nevertheless considered proven and medically necessary. Two conditions must be met: 1) the test results will be used to inform the use of a targeted oncology therapeutic product or product group in an individual with the corresponding clinical indication; and 2) either the test appears in the FDA's Cleared or Approved Companion Diagnostic Devices Table for the intended therapeutic and indication, or the test has an FDA approval order designating it as an FDA cleared/approved CDx in the FDA Premarket Approval Database even if the FDA's CDx table has not yet been updated.
The policy also addresses subsequent testing and concurrent testing scenarios. Subsequent use of an FDA-cleared/approved CDx on a new specimen is medically necessary when the CDx criteria are met and the individual has disease recurrence or progression or did not respond to the most recent systemic therapy. Concurrent tissue-based and liquid biopsy-based CDx testing is considered proven and medically necessary for advanced or metastatic (stage IV) NSCLC and stage IV breast cancer when the CDx criteria are met. The policy explicitly states that other uses of the listed FDA cleared/approved CDx tests are unproven and not medically necessary.
Coding References and Platform‑Specific Evidence Summaries
The policy lists specific billing/applicable codes associated with CDx testing modalities. Notable CPT/HCPCS-like codes referenced include 0022U, 0037U, 0211U, 0239U, 0242U, 0473U, and 0523U, each described (for example, 0239U is a cell‑free DNA targeted genomic sequence analysis of 311+ genes). These codes are provided in the policy’s "Applicable Codes" section and align with the next‑generation sequencing and targeted genomic panels discussed throughout the document.
Additionally, the policy contains multiple platform‑specific summaries, FDA label references, and study citations in its references and history sections (e.g., FDA labels for TruSight™ Oncology Comprehensive, Oncomine Dx Express/Target Test, and peer‑reviewed studies), which the policy uses to substantiate platform‑level coverage determinations.
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