Coverage Policy Manual
Policy #: 2014024
Category: Laboratory
Initiated: December 2014
Last Review: December 2023
  Procalcitonin
Description:
Procalcitonin (ProCT) is a 116 amino acid precursor of calcitonin (CT). During severe systemic inflammation the tissue specific control of CT-related peptides expression breaks down and ProCT is secreted in large quantities by many tissues. ProCT levels have been used to aid in the diagnosis of sepsis, bacteriemia and other inflammatory disorders in adults and children.
 
Policy/
Coverage:
Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria
 
Testing for procalcitonin levels to aid in the diagnosis of sepsis or serious bacterial infection or for any other indication does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness.
 
For members with contracts without primary coverage criteria, testing for procalcitonin levels to aid in the diagnosis of sepsis or serious bacterial infection or for any other indication is considered investigational. Investigational services are specific contract exclusions in most member benefit certificates of coverage.
Rationale:
Elevated serum procalcitonin levels have been widely associated with bacterial infection and sepsis. Despite this association, there is recent evidence that does not support the clinical utility of this testing (Tang, 2007; Stein, 2014; Shehabi, 2014; Wu, 2012; England, 2014; Clec’h; 2006).
 
A multicenter, randomized controlled trial investigated the effect of a low procalcitonin cut-off on antibiotic prescription in patients (N=400) with suspected bacterial infection or sepsis in intensive care units (Shehabi, 2014). A procalcitonin algorithm using a 0.1ng/ml cutoff, determined antibiotic cessation. The authors report the algorithm did not achieve a 25% reduction in duration of antibiotic treatment (Shehabi, 2014).
 
A meta-analysis of 18 studies found that procalcitonin doesn’t reliably differentiate sepsis from nonseptic systemic inflammation (Tang, 2007). The overall diagnostic performance of procalcitonin was low (sensitivity 71% and specificity 71%).  
 
In 2014, Stein and colleagues evaluated the usefulness of procalcitonin along with C-reactive protein and TREM-1 in identifying serious bacteria infection (SBI) in neonates (Stein, 2014). In this prospective study, 112 patients (19 with SBI and 93 with negative cultures) were evaluated. There was no statistical difference between the two groups regarding the different biomarkers.  The sensitivity and specificity of procalcitonin was 55% and 75%, respectively (Stein, 2014).
A systematic review comparing the clinical utility of procalcitonin levels with available clinical prediction rules found procalcitonin concentration inferior for identification of infants at risk for serious bacterial infection (England, 2014).
 
2016 Update
A literature search conducted through November 2016 did not reveal any new published literature that would prompt a change in the coverage statement. A multicenter, randomized, controlled trial assessing the diagnostic accuracy and cost-effectiveness of the use of procalcitonin in the treatment of emergency medicine patients with fever is ongoing and currently recruiting patients (van der Does, 2016). The trial began in August 2014 and is scheduled to enroll approximately 550 patients. The trial is sponsored by Erasmus Medical Center (Rotterdam, Netherlands) and is registered in the Dutch trial register as NTR4949.  
 
2017 Update
A literature search conducted using the MEDLINE database through October 2017 did not reveal any new information that would prompt a change in the coverage statement.
 
2018 Update
A literature search was conducted through November 2018.  There was no new information identified that would prompt a change in the coverage statement.  
 
2021 Update
Annual policy review completed with a literature search using the MEDLINE database through November 2021. No new literature was identified that would prompt a change in the coverage statement.
 
2022 Update
Annual policy review completed with a literature search using the MEDLINE database through November 2022. No new literature was identified that would prompt a change in the coverage statement.
 
2023 Update
Annual policy review completed with a literature search using the MEDLINE database through November 2023. No new literature was identified that would prompt a change in the coverage statement.
CPT/HCPCS:
84145Procalcitonin (PCT)
References: Clec'h C, Fosse JP, Karoubi P et al.(2006) Differential diagnostic value of procalcitonin in surgical and medical patients with septic shock. Crit Care Med. 2006;34(1):102.

England JT, Del Vecchio MT, Aronoff SC.(2014) Use of Serum Procalcitonin in Evaluation of Febrile Infants: A Meta-analysis of 2317 Patients. J Emerg Med. 2014 Dec;47(6):682-8. doi: 10.1016/j.jemermed.2014.07.034. Epub 2014 Oct 1.

Shehabi Y, Sterba M, Garrett PM et al.(2014) Procalcitonin algorithm in critically ill adults with undifferentiated infection or suspected sepsis. A randomized controlled trial. Am J Respir Crit Care Med. 2014 Nov;190(10):1102-10.

Stein M, Schachter-Davidov A, Babai I et al.(2014) The Accuracy of C-Reactive Protein, Procalcitonin, and s-TREM-1 in the Prediction of Serious Bacterial Infection in Neonates. Clin Pediatr (Phila). 2014 Oct 7. pii: 0009922814553435. [Epub ahead of print]

Tang BM, Eslick GD, Craig JC, McLean AS.(2007) Accuracy of procalcitonin for sepsis diagnosis in critically ill patients: systematic review and meta-analysis. Lancet Infect Dis. 2007;7(3):210.

Van der Does Y., Limper M., Schuit S., et al.(2016) Higher diagnostic accuracy and cost-effectiveness using procalcitonin in the treatment of emergency medicine patients with fever (The HiTEMP study): a multicenter randomized study. BMC Emergency Medicine. 2016 Apri 6;16:17.

Wu JY, Lee SH, Shen CJ et al.(2012) Use of serum procalcitonin to detect bacterial infection in patients with autoimmune diseases: a systematic review and meta-analysis. Arthritis Rheum. 2012 Sep;64(9):3034-42.
Group specific policy will supersede this policy when applicable. This policy does not apply to the Wal-Mart Associates Group Health Plan participants or to the Tyson Group Health Plan participants.
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