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    v1.0.28
    OpenPayerPolicy UpdatesPharmacy & Specialty DrugsViva Health Pyridoxine Injection Coverage | OpenPa…
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    CurrentViva Health PlanPolicy s-034

    Pyridoxine Hydrochloride Injection Coverage Criteria

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    Establishes medical necessity and utilization review requirements for pyridoxine hydrochloride injection for VIVA Medicare and VIVA Commercial members. Coverage is limited to FDA-approved indications and requires medical-record documentation supporting medical necessity.

    Policy Summary
    PayerViva Health Plan
    PolicyPyridoxine Hydrochloride Injection Coverage Criteria
    Policy CodePolicy s-034
    Change TypeNo material change
    Effective DateN/A
    Last ReviewSep 15, 2026
    Next Review DateN/A
    Key ActionSupport requests with an FDA-approved indication and documentation establishing medical necessity.
    SourceLink
    POLICY UPDATE CHANGES

    No material clinical or coverage changes in this revision.

    FDA-approved onlyCoverage basis
    2Indication categories
    Oral not feasibleParenteral restriction
    RequiredDocumentation
    Medicare + Commercial

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    Lines of business

    Pyridoxine Hydrochloride Injection Coverage

    Pyridoxine hydrochloride injection coverage

    Covered when all applicable requirements are met.

    Coverage requirements

    • FDA-approved indication

      • Inborn error of metabolism: The patient has an inborn error of metabolism resulting in secondary pyridoxine deficiency, including vitamin B6-dependent convulsions or vitamin B6-responsive anemia.
      • Nutritional deficiency: The patient has pyridoxine deficiency due to inadequate dietary intake.
      • Drug-induced deficiency: The patient has drug-induced pyridoxine deficiency, including deficiency associated with isoniazid (INH) or oral contraceptives.

    • Medical necessity and regulatory support

      • The utilization meets all other applicable Medicare statutory and regulatory requirements.
      • The medical record clearly documents the specific clinical circumstances supporting medical necessity.

    • Parenteral-use rationale when applicable

      • Oral administration is not feasible because of anorexia, nausea and vomiting, or preoperative or postoperative conditions.
      • Gastrointestinal absorption is impaired.

    Medical Necessity and Documentation

    Documentation Required

    Support FDA-Approved Use

    Requests for pyridoxine hydrochloride injection must be supported by an FDA-approved indication and documentation of the patient's specific clinical circumstances. The standard of medical practice must also meet all applicable Medicare statutory and regulatory requirements.

    Documentation Required

    Document Medical Necessity

    The patient's medical record must clearly document the specific clinical circumstances supporting medical necessity for pyridoxine hydrochloride injection, including the applicable diagnosis, deficiency or condition, and treatment rationale.

    Documentation Required

    Indication and Route Rationale

    Identify the FDA-approved indication and explain why parenteral administration is medically appropriate. The parenteral route is indicated when oral administration is not feasible, such as with anorexia, nausea and vomiting, or preoperative and postoperative conditions, and when gastrointestinal absorption is impaired.

    Clinical Background

    Pyridoxine hydrochloride injection is used for the acute and chronic treatment of pyridoxine deficiency and conditions associated with vitamin B6 deficiency. Covered clinical contexts include an inborn error of metabolism causing secondary deficiency, such as vitamin B6-dependent convulsions or vitamin B6-responsive anemia, as well as deficiency caused by inadequate dietary intake or drug exposure, including isoniazid (INH) or oral contraceptives. The injectable route is used when oral administration is not feasible—such as with anorexia, nausea and vomiting, or preoperative and postoperative conditions—or when gastrointestinal absorption is impaired.

    Route and Indication Definitions

    Parenteral route
    DefinitionAdministration by injection rather than by mouth.
    When oral administration is not feasibleUse the parenteral route when oral administration is not feasible because of anorexia, nausea and vomiting, or preoperative and postoperative conditions.
    Impaired absorptionThe parenteral route is also indicated when gastrointestinal absorption is impaired.
    Drug-induced pyridoxine deficiency
    DefinitionA pyridoxine deficiency caused by exposure to a medication.
    Isoniazid (INH)Isoniazid (INH) is a listed medication-associated cause of pyridoxine deficiency.

    Administration Setting and Route

    Note

    Support hospital outpatient injectable administration

    In the hospital outpatient setting, support injectable administration when oral administration is not feasible or gastrointestinal absorption is impaired.

    • Oral administration may not be feasible because of anorexia, nausea and vomiting, or preoperative and postoperative conditions.
    • The parenteral route is also indicated when gastrointestinal absorption is impaired.
    Policy Summary
    PayerViva Health Plan
    PolicyPyridoxine Hydrochloride Injection Coverage Criteria
    Policy CodePolicy s-034
    Change TypeNo material change
    Effective DateN/A
    Last ReviewSep 15, 2026
    Next Review DateN/A
    Key ActionSupport requests with an FDA-approved indication and documentation establishing medical necessity.
    SourceLink
    On This Page
    Pyridoxine Hydrochloride Injection CoverageMedical Necessity and DocumentationClinical BackgroundRoute and Indication DefinitionsAdministration Setting and Route
    Denial Risk

    Non-FDA-Approved Indication

    Coverage is denied when pyridoxine hydrochloride injection is requested for a non-FDA-approved indication.

    Denial Risk

    Insufficient Medical-Record Support

    Coverage is denied when the medical record does not provide sufficient support for the specific clinical circumstances and medical necessity of the requested services.

    Billing Rule

    Meet Medicare Requirements

    The standard of medical practice regarding utilization of pyridoxine hydrochloride injection must satisfy all other applicable Medicare statutory and regulatory requirements.

    Oral contraceptives
    Oral contraceptives are a listed medication-associated cause of pyridoxine deficiency.