Proton Pump Inhibitors (PPIs) prior authorization
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Defines medical necessity and prior authorization requirements for specific proton pump inhibitor products for Arizona Complete Health (AzCH-CCP) members, including initial and continuation criteria, dose limits, and documentation expectations.
1Q 2025 annual review removed esomeprazole packets and lansoprazole ODT from preferred products and added instruction to refer to current AHCCCS Drug List for preferred products.
Removed reference to Care1st Health plan and logos and removed reference to retired off-label use policy; added AHCCCS FFS Prior Authorization Guideline for off-label non-FDA approved indications.
Converted document to a new template and updated references over multiple prior updates.
Coverage Criteria
Initial Therapy
Covered when ALL of the following are met:
Initial approval overall
- Indication: Prescribed for one of: symptomatic GERD (including heartburn or laryngopharyngeal reflux); esophageal complications of GERD (e.g., erosive esophagitis, esophageal stricture, Barrett's esophagus, Schatzki's ring); extra‑esophageal complications (e.g., laryngopharyngeal reflux, vocal cord damage/nodules, asthma, laryngitis, pharyngitis); peptic ulcer disease including gastric or duodenal ulcers, H. pylori infection, or Zollinger‑Ellison syndrome; or gastrointestinal bleed prophylaxis for NSAID use when the member meets at least one of: history of peptic ulcer disease, age ≥ 60 years, or concurrent anticoagulant or oral corticosteroid therapy.
- Age and formulation requirements: For AcipHex (rabeprazole) Sprinkle, member age ≥ 1 year. Non‑capsule/tablet formulations for members > 18 years may require prior authorization per formulary guidance (see provider actions).
- Step therapy / trials: Member meets at least one of: (a) Any‑age request for AcipHex Sprinkle or Prilosec packets after failure of esomeprazole packets, lansoprazole ODT, AND pantoprazole packets each at up to maximally indicated doses unless contraindicated; (b) Age > 18 years with G‑tube or significant dysphagia requesting packet/ODT formulations (esomeprazole packets, lansoprazole disintegrating tablets, pantoprazole packets); (c) Member on clopidogrel requesting Dexilant: failure of a ≥ 4‑week trial of lansoprazole capsules at up to maximally indicated doses unless contraindicated; (d) Request for any non‑preferred tablet or capsule (e.g., dexlansoprazole, esomeprazole strontium, certain esomeprazole products, omeprazole/sodium bicarbonate): documented failure of a minimum 4‑week trial of ALL preferred generic PPIs (omeprazole capsules, lansoprazole capsules, and pantoprazole tablets) at up to maximally indicated doses, unless contraindicated or clinically significant adverse effects have occurred (chart notes and/or claims required).
- Dosing limitation: Requested dose does not exceed the FDA‑approved maximum recommended dose for the agent (refer to dosing section).
Approval duration: 12 months.
Continuation Therapy
Covered when ALL of the following are met for continued therapy:
Approval duration: 12 months.
Coverage when matching labeled indications and dosing
Dosing and maximum-dose criteria vary by agent, indication, and age/weight; coverage should match labeled indications and dosing limits.
Prescribe within indicated maximum doses unless treating labeled pathological hypersecretory conditions where higher agent‑specific maxima apply.
Treat per labeled hypersecretory dosing.
Non-FDA approved indications that are not specifically addressed in this policy are not authorized unless the provider supplies sufficient documentation of efficacy and safety in accordance with the AHCCCS FFS Prior Authorization Guideline — Coverage of Off-Label Non-FDA Approved Indications. Approval for off-label uses requires documentation that meets the criteria set forth in that guideline.
Use of any proton pump inhibitor is contraindicated in individuals with a history of hypersensitivity to the specific PPI, to other PPIs, to substituted benzimidazoles, or to any component of the product formulation. Specific product-level contraindications (for example, coadministration restrictions) are listed in individual prescribing information and Appendix C.
Operational formulary updates from the 1Q 2025 annual review removed esomeprazole packets and lansoprazole ODT from the preferred products list. Providers should refer to the current AHCCCS Drug List for the up-to-date preferred PPI products when selecting alternatives or submitting prior authorization requests.
Long-term, high‑dose proton pump inhibitor therapy (for example, multiple daily doses or treatment durations of a year or longer) without an appropriate indication should be minimized. Observational data suggest an association between prolonged, high‑dose PPI use and increased risk of osteoporosis‑related fractures; therefore prescribe the lowest effective dose for the shortest duration appropriate to the condition and manage patients at risk for fracture according to established treatment guidelines.
Coding & Dose Limits
| NDC/Drug list | rabeprazole (AcipHex, AcipHex Sprinkle), dexlansoprazole (Dexilant), esomeprazole strontium (ES), esomeprazole (Nexium 24HR, Nexium 24HR ClearMinis), omeprazole (Prilosec Packets), omeprazole/sodium bicarbonate (Zegerid, Zegerid OTC) |
| Preferred agents | esomeprazole capsule (Nexium), lansoprazole capsule (Prevacid), omeprazole capsule (Prilosec), pantoprazole tablets (Protonix), pantoprazole sodium packets (Protonix Packets) |
Provider Actions & Requirements
Prior authorization required for listed PPIs
Prior authorization is required for the listed proton pump inhibitors and for non-capsule/tablet formulations in members >18 years; providers must document that the member meets all approval criteria when requesting PA for: rabeprazole (AcipHex, AcipHex Sprinkle), dexlansoprazole (Dexilant), esomeprazole strontium (ES), esomeprazole products (Nexium family), omeprazole packets (Prilosec Packets), and omeprazole/sodium bicarbonate (Zegerid/Zegerid OTC).
- PA applies to listed agents and to non-capsule/tablet formulations for members >18 years.
- Chart notes or claims demonstrating that approval criteria are met should be provided with the PA request.
Product/formulation may require PA — document indication and dosing
Prior authorization may be required for specific PPI products, formulations, and therapeutic alternatives; when submitting a PA, document the indication and the dosing regimen to support approval.
- Appendix B lists preferred therapeutic alternatives (see AHCCCS Drug List for current preferred products).
- Document the exact product formulation and dosing in the PA submission.
Refer to AHCCCS PA guideline and Drug List
Follow the AHCCCS FFS Prior Authorization Guideline and refer to the AHCCCS Drug List for current preferred products when determining PA requirements and coverage for off‑label non‑FDA indications.
- The policy instructs providers to refer to the AHCCCS Drug List for the complete list of preferred agents and current formulary status.
- Off‑label, non‑FDA approved indications are governed by the AHCCCS FFS Prior Authorization Guideline per the policy update.
Step‑therapy: 4‑week trial of preferred generics required
For non‑preferred agents, prior authorization requires documented failure of a minimum 4‑week trial of preferred generic PPIs (omeprazole capsules, lansoprazole capsules, and pantoprazole tablets) at maximally indicated doses unless contraindicated or adverse effects occurred.
- Chart notes and/or claims are required to demonstrate the 4‑week trials of all three preferred generics.
- Specific exceptions (e.g., contraindication or clinically significant adverse effect) must be documented.
Step‑up vs step‑down: justify clinical approach
Both step‑up and step‑down therapy approaches are discussed in the evidence base; neither approach has proven superiority, so the chosen strategy should be clinically justified and documented.
- Clinical models exist for both approaches; providers should document rationale for selected strategy in the medical record.
- When requesting non‑preferred agents, include clinical justification if deviating from standard step requirements.
Preferred product and step guidance updated — check AHCCCS list
Preferred alternatives were updated; for non‑preferred tablet/capsule requests, pantoprazole tablets were added as a preferred alternative when esomeprazole tablets were removed — providers should follow the AHCCCS Drug List for current preferred/step guidance.
- 1Q 2023 and subsequent reviews replaced esomeprazole tablets with pantoprazole tablets among preferred alternatives.
- 1Q 2025 review removed esomeprazole packets and lansoprazole ODT from preferred products and instructs referral to the AHCCCS Drug List.
Submit supportive clinical documentation with PA
Provider must submit supporting documentation (which may include office chart notes and laboratory results) demonstrating that the member meets all approval criteria when requesting or renewing therapy.
- Include relevant office notes, prior trial documentation, dosing regimen, and any lab results that support the indication and response.
- Chart notes may be used to demonstrate prior trials and clinical rationale.
Required clinical documentation: indication, dosing, duration
Document the clinical indication (for example: symptomatic GERD, erosive esophagitis, peptic ulcer disease including H. pylori therapy, NSAID ulcer prophylaxis, or pathological hypersecretory conditions), the dosing regimen, and duration; include pediatric age/weight when applicable.
- For NSAID ulcer prophylaxis, document at least one qualifying criterion (history of PUD, age ≥60 years, or concurrent anticoagulant/oral corticosteroid therapy).
- For AcipHex Sprinkle and pediatric requests, document age (AcipHex Sprinkle: age ≥1 year).
Documentation must support medical necessity and follow coverage terms
Documentation should support medical necessity in accordance with this clinical policy and applicable state Medicaid manual; coverage decisions remain subject to the evidence of coverage, policy terms, and state and federal requirements.
- Providers are expected to exercise professional medical judgment and to document medical necessity per the policy and applicable Medicaid rules.
- Discrepancies between this policy and legal/regulatory requirements are resolved in favor of law/regulation.
Denial risk if supporting documentation is not provided
Failure to submit documentation (such as office notes, chart notes, or laboratory results) demonstrating that the member meets all approval criteria may result in denial of the PA request.
- Ensure prior‑trial documentation, dosing details, and indication are included with the submission to avoid denial.
- Chart notes and/or claims may be required to verify step‑therapy trials.
Contraindications: hypersensitivity to PPIs or components
PPIs are contraindicated in patients with hypersensitivity to the specific agent, to substituted benzimidazoles, or to any component of the formulation; verify and document absence of such hypersensitivity before prescribing or requesting PA.
- Appendix C lists hypersensitivity to the drug or other PPIs and substituted benzimidazoles as contraindications for all agents.
- Document any known allergies in the member's chart and in the PA submission.
State Medicaid rules take precedence over this policy
For Medicaid members, state Medicaid coverage provisions take precedence over this clinical policy; providers must follow the state Medicaid manual when state rules conflict with the policy, as failure to follow state provisions may affect coverage.
- Refer to the state Medicaid manual for any coverage provisions pertaining to this clinical policy.
- When state provisions conflict with this policy, state Medicaid rules govern.
Background
Proton pump inhibitors are indicated for a range of acid‑related disorders, including gastroesophageal reflux disease (GERD) — both erosive and non‑erosive — and erosive esophagitis. PPIs are also indicated for treatment of peptic ulcer disease, as part of combination therapy for H. pylori eradication, for prevention and healing of NSAID‑associated ulcers, and for pathological hypersecretory conditions (for example, Zollinger‑Ellison syndrome) that may require substantially higher, agent‑specific dosing.
Definitions
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