UnitedHealthcare PA: March 2026 — Explicit FDA‑Cleared Companion Diagnostics & Oncomine Updates

Effective March 1, 2026, UnitedHealthcare Pennsylvania updated CS373PA.E to explicitly list multiple FDA‑cleared/approved companion diagnostics and their specific drug–indication pairings, including expanded listings for the Oncomine™ Dx family (Target and Express tests). FoundationOne® CDx, MI Cancer Seek™, oncoReveal™ CDx, TruSight™ Oncology Comprehensive and others are enumerated as proven/medically necessary for defined tumor types (e.g., cholangiocarcinoma, NSCLC, astrocytoma, oligodendroglioma) linked to FDA‑approved therapies. The Oncomine™ Dx Target Test is detailed (gene/fusion content) and is now tied to specific therapy pairings such as pembrolizumab and sunvozertinib for NSCLC in the revision history. For ampullary adenocarcinoma the policy aligns with NCCN guidance, supporting FDA‑approved or validated NGS assays to detect actionable alterations (FGFR2, NTRK, MSI, BRCA, HER2, etc.) in advanced disease.

Ocaliva (obeticholic acid) withdrawn; prior PBC coverage criteria retained

UnitedHealthcare notes Intercept’s voluntary market withdrawal of Ocaliva (obeticholic acid) on Sept 11, 2025, following an FDA request. The policy retains historical coverage criteria that limited Ocaliva to patients with a documented diagnosis of primary biliary cholangitis who have failed or had an inadequate response to at least 12 consecutive months of ursodeoxycholic acid. Because the product is withdrawn, the stated approval pathway may no longer be operational or available for dispensing, creating a divergence between formal criteria and real‑world access. No alternative agents, replacement pathways, or updated prior authorization instructions are provided in this excerpt; the entry functions mainly as a record of prior criteria and the withdrawal notice.

Elevidys: Clarified hepatic thresholds and FDA‑aligned monitoring (Mar 2026)

UnitedHealthcare’s March 1, 2026 update to MDC 07 narrows hepatic exclusion criteria for Elevidys by defining preexisting hepatic impairment as GGT >2× the upper limit of normal or total bilirubin >ULN (unless due to Gilbert’s syndrome), and continues to exclude acute hepatic viral infection. Prescribers must attest to weekly GGT and total bilirubin testing and clinical exam for the first 3 months after administration, and weekly troponin‑I monitoring for the first month, with subsequent monitoring per FDA labeling. Eligibility remains limited to ambulatory patients aged 4–5 years with LVEF ≥40% and anti‑AAVrh74 titers <1:400; recent vaccination or active/recent infection within 4 weeks are additional exclusions. The revision aligns monitoring language with FDA labeling and archives the prior policy version.

Cigna 6/15/2026: Vitamin D Testing Criteria Added for Liver/Pancreas Conditions

Effective 6/15/2026, Cigna consolidated and clarified coverage criteria for serum vitamin D testing in Medical Coverage Policy 0526, separating total 25(OH)D testing (CPT 82306/0038U) from active 1,25(OH)2D testing (CPT 82652) with distinct indications for each assay. Hepatobiliary and pancreatic conditions — including hepatic failure, advanced hepatic fibrosis, chronic pancreatitis, exocrine pancreatic insufficiency, cystic fibrosis, Crohn’s disease, celiac disease, and related malabsorption codes — are explicitly listed as medically necessary indications for total 25(OH)D testing. The policy maps these clinical indications to specific ICD code ranges (e.g., K72.x, K74.02, K86.x, K90.x, E84.x, K50.x) to operationalize coverage. Specialty society guidance (ACG, AGA) is cited to support testing in chronic pancreatitis, primary sclerosing cholangitis, celiac disease, and exocrine pancreatic insufficiency.

UHC: Livdelzi (seladelpar) Coverage Criteria for PBC — ALP‑Based Authorization

UnitedHealthcare updated coverage criteria for Livdelzi (seladelpar) for adults with primary biliary cholangitis (PBC), reflecting its FDA accelerated approval based on ALP reduction and noting that clinical benefit on survival or prevention of decompensation is unconfirmed. Initial authorization requires documented PBC, absence of decompensated cirrhosis, and either inadequate biochemical response to at least 12 months of ursodeoxycholic acid (UDCA) defined as ALP ≥1.67×ULN or documented UDCA intolerance/contraindication. Continued approval may depend on confirmatory trials demonstrating clinical benefit. The policy aligns coverage to the FDA-approved population and ties approval to a measurable ALP threshold and prior UDCA use or intolerance.

UnitedHealthcare MMP076.16 (MDC 07): Hepatobiliary CPT Codes Listed (78226, 78227)

UnitedHealthcare’s March 1, 2026 radiologic diagnostic procedures policy (MMP076.16, MDC 07) formally lists applicable CPT and unlisted nuclear medicine codes for hepatobiliary system and pancreas imaging. Hepatobiliary-specific codes 78226 (hepatobiliary imaging, including gallbladder) and 78227 (with pharmacologic intervention and quantitative measurements) are explicitly included. The policy also includes cross-cutting 3D rendering codes 76376 and 76377 for tomographic postprocessing and a broad set of nuclear medicine codes and unlisted procedure codes that situate hepatobiliary studies within a wider nuclear medicine code framework. The excerpt does not specify which codes were changed from prior versions; it reflects the current coding set effective 2026-03-01.

Bevacizumab + Atezolizumab Coverage Clarified for Unresectable/Metastatic HCC

Anthem clarified coverage for bevacizumab in hepatocellular carcinoma (HCC) effective 2026-03-01, reaffirming use only in combination with atezolizumab for unresectable or metastatic HCC consistent with the FDA label. Coverage aligns with NCCN guidance, specifying eligibility for patients with Child-Pugh Class A or B liver function and ECOG performance status 0–2. The combination is supported as first-line therapy and may also be used as subsequent systemic therapy consistent with NCCN 2A designation, and bevacizumab may be continued until disease progression. The policy maps multiple bevacizumab products and biosimilars to the HCC indication to ensure consistent application across formulations.

UnitedHealthcare: IMRT Coverage Clarified for Liver, IHC, and Pancreas (MDC 07)

UnitedHealthcare’s revised IMRT policy for hepatobiliary and pancreatic tumors (effective 2026-03-01) explicitly lists IMRT as medically necessary for unresectable hepatocellular carcinoma, unresectable intrahepatic cholangiocarcinoma, and pancreatic cancer among other primary sites. The policy clarifies exception criteria allowing IMRT when non‑IMRT plans would cause clinically meaningful normal tissue toxicity based on comparative planning or when prior irradiation requires highly conformal re-treatment to respect cumulative organ tolerances. Cited evidence includes a 2023 meta-analysis and retrospective series showing favorable local control and acceptable hepatic toxicity for IMRT in HCC/IHC, and observational data and guidelines supporting IMRT for pancreas to reduce GI toxicity while enabling dose escalation. Providers should document comparative plan results or prior radiation history when requesting exceptions or re‑irradiation coverage under this policy.

Mar 2026: Expanded ICI Coverage, Biomarker Criteria & Site‑of‑Service Rules

Effective March 1, 2026, Premera updated coverage for multiple immune checkpoint inhibitors used in hepatobiliary and related cancers, adding new indications, clarifying regimen‑ and biomarker‑specific criteria, and applying site‑of‑service review designations. Key additions include durvalumab (Imfinzi) coverage for resectable gastric/gastroesophageal junction adenocarcinoma with perioperative FLOT and single‑agent adjuvant durvalumab, Imjudo (tremelimumab‑actl) plus Imfinzi and nivolumab/ipilimumab combinations for unresectable HCC, and numerous label‑driven expansions for agents such as Opdivo, Keytruda, Jemperli, and Tecentriq (including Hybreza). The policy emphasizes FDA‑approved biomarker requirements (PD‑L1, MSI‑H/dMMR, TMB‑H), regimen‑ and line‑of‑therapy specificity, and documents removal or modification of prior indications (e.g., an Opdivo HCC indication). Several IV/injection agents are now subject to site‑of‑service review and administration clarifications tied to FDA dosing and concurrent infusion exceptions.

Ocaliva Removed; Iqirvo/Livdelzi/Rezdiffra Combo Edits Updated (Mar 2026)

Effective March 1, 2026, Premera removed coverage criteria for Ocaliva (obeticholic acid) following product withdrawal for liver safety risks and eliminated prior combination-use exclusions that referenced Ocaliva for Iqirvo, Livdelzi, and Rezdiffra. Iqirvo (elafibranor) and Livdelzi (seladelpar) remain covered for adults with PBC (including compensated cirrhosis) after ≥1 year of UDCA with inadequate response or UDCA intolerance, with dose and prescriber limits and mutual exclusion of combined use. Rezdiffra (resmetirom) remains covered for adults with biopsy- or test-confirmed MASH and stage F2–F3 fibrosis, with specified alcohol limits, comorbidity control, prescriber requirements, and a 100 mg daily dose limit. Authorizations may be approved up to 12 months with reauthorization contingent on documented clinical benefit; safety warnings and ongoing confirmatory trial requirements are noted for these agents.