The policy text and CPT/ICD crosswalk identify specific ICD‑10 codes that are noted as not covered for CPB‑listed indications. Examples listed in the policy include A15.0–A15.9 (respiratory tuberculosis), B37.0–B37.9 (candidiasis), and C73 (malignant neoplasm of thyroid gland / medullary thyroid carcinoma). The ICD‑10 list in the document also annotates certain respiratory codes (e.g., J00‑J06.9, J20.0‑J21.9) as not covered for evaluation of suspected lower respiratory tract infection or sepsis in the ambulatory/ED setting and for use as a biomarker for rhino‑sinusitis.

The provided evidence summaries do not state formal coverage exclusions in the cited sections. Instead, systematic reviews and guideline reviews conclude that PCT should not be relied upon alone to rule in or rule out conditions such as sepsis or infective endocarditis because pooled diagnostic performance is limited and clinical algorithms based solely on PCT did not consistently affect mortality outcomes.

The document does not list explicit test‑level exclusions (e.g., specific assay names or methods excluded). Rather, multiple reviews noted insufficient or inconsistent evidence for routine diagnostic use of PCT across many indications (for example neonatal sepsis and other settings), implying limited utility but not enunciating test‑specific exclusions.

A systematic review found that although PCT values are generally lower in candidemia than bacteremia, the evidence is heterogeneous and of low quality; the authors concluded that PCT should not be used as a stand‑alone tool to differentiate bacteremia from candidemia and that PCT alone is insufficient to guide antifungal therapy.

The portions of the policy containing policy history and administrative information do not provide explicit coverage exclusions; they record review dates, effective date, and next review but do not add additional exclusion language for clinical indications.

The policy lists numerous indications in the Experimental and Investigational section and states that measurement of PCT for these listed uses is considered experimental/investigational. As such, PCT use for the enumerated indications (for example neonatal bacterial infection, rhino‑sinusitis, bacterial meningitis, ventilator‑associated pneumonia, differential diagnoses such as bacteremia vs candidemia, and many others) is regarded in the policy as not proven and therefore not medically necessary for those purposes.

Meta‑analyses and reviews cited in the policy indicate that PCT alone does not provide sufficient diagnostic accuracy to definitively diagnose severe sepsis or septic shock. One pooled analysis reported sensitivity and specificity near 71% each, and guideline summaries emphasize there is no single laboratory test that confirms severe sepsis or septic shock, so reliance on PCT as a single definitive diagnostic test is not supported.

A Cochrane review of diagnostic tests for pancreatic necrosis found only three studies (242 participants) with variable sensitivities and specificities and wide confidence intervals; the authors concluded that CRP, PCT, and LDH were not sufficiently accurate to support clinical use for diagnosing pancreatic necrosis given the paucity and methodological limitations of the evidence.

For both pancreatic necrosis and for distinguishing bacterial versus viral community‑acquired pneumonia, the policy cites evidence showing limited diagnostic performance. The Cochrane review and CAP meta‑analyses conclude that current data do not demonstrate that PCT is sufficiently accurate to guide routine clinical management for these diagnostic purposes.

The cited administrative and policy history sections do not include explicit 'not medically necessary' statements beyond those already provided elsewhere in the policy; they record review dates and versioning without adding new clinical determination language.

Consistent with the Experimental and Investigational listing, the policy indicates that PCT testing for the many listed indications is not covered because the clinical effectiveness has not been established. Examples included among the investigational/not covered group are neonatal bacterial infection, rhino‑sinusitis, suspected appendicitis, diagnosis of pancreatic necrosis, ventilator‑associated pneumonia, and multiple prognostic and diagnostic uses enumerated in the policy.

While some document sections do not assert formal non‑coverage lists, the evidence discussion emphasizes that PCT does not add clinically relevant diagnostic information in certain outpatient presentations (for example acute cough/presumed pneumonia in primary care) and that routine use is not supported by the cited literature; therefore many indications remain unsupported by sufficient evidence even if not explicitly enumerated as denied in those chunks.

Because diagnostic studies for pancreatic necrosis were few and had wide confidence intervals for sensitivity and specificity, the policy concludes that PCT is not supported for diagnosis of pancreatic necrosis and therefore is not recommended for clinical use in that indication.

The policy highlights that PCT should not be used as a sole diagnostic test to rule out conditions such as peri‑prosthetic joint infection, pancreatic necrosis, candidemia versus bacteremia, or bacterial versus viral community‑acquired pneumonia because current evidence demonstrates inadequate sensitivity and/or specificity for standalone decision‑making.

The administrative portions of the policy do not present a separate explicit list of denied tests or indications beyond the investigational/experimental section; policy history and review notes are provided without additional denials in the cited chunks.

Procalcitonin (PCT) is the pro‑peptide precursor of the hormone calcitonin that rises rapidly in response to bacterial infection and often correlates with severity of systemic infection. FDA‑cleared quantitative assays (e.g., BRAHMS KRYPTOR, VIDAS BRAHMS PCT, BRAHMS PCT LIA) are intended to aid assessment of risk progression to severe sepsis and to support antibiotic stewardship strategies when interpreted alongside clinical assessment and other laboratory data.