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Blue Cross & Blue Shield of MississippiAll Plans · Coverage · Medical Policy · Gastroenterology, PharmacyMedium impact

Genetic Testing for Helicobacter Pylori Treatment

Effective date
Not stated in the notice
Identified
Jun 20, 2026

Summary

Genotyping to determine cytochrome P450 (CYP2C19) genetic polymorphisms is considered investigational for the purpose of managing the treatment of Helicobacter pylori infection. The policy exceptions state that the Federal Employee Program may dictate that all FDA-approved devices, drugs or biologics may not be considered investigational, so those devices may be assessed only on the basis of their medical necessity. The Roche AmpliChip Cytochrome P450 genotyping test has FDA approval as a class II medical device, but the use of CYP2C19 polymorphism information was not addressed as part of that approval process.

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What to do

Action · 4 steps
01Billing team: Do not bill CYP2C19 genotyping as a medically necessary service for managing H.
02pylori treatment, because the policy considers it investigational.
03For Federal Employee Program members, FDA-approved devices, drugs or biologics may not be considered investigational and may be assessed only on the basis of medical necessity.
04CPT 81225 (CYP2C19 gene analysis, common variants) is the investigational code listed in the code reference.

Codes mentioned

81225

Original notice

Genetic Testing for Helicobacter Pylori Treatment
bcbsms.com · Always check the source before changing claims.
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Related changes

See all Blue Cross & Blue Shield of Mississippi changes →
Pharmacogenetic Testing for Pain ManagementMediumNo effective date · Medical PolicyCytochrome P450 Genotype-Guided Treatment StrategyMediumNo effective date · Medical PolicyBrowse every Blue Cross & Blue Shield of Mississippi change in the policy list

Related policy hubs

Blue Cross & Blue Shield of Mississippi policiesGastroenterologyPharmacyCode 81225

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