Prior Authorization Required

Prior Authorization (PA) is required for products that are flagged 'PA' in the formulary. Providers must complete and submit the payer's Prior Authorization form and supply clinical documentation supporting medical necessity (diagnosis, indication, prior therapies tried, patient age when an age limit applies, and the requested quantity/days supply). Urgent PA requests will be responded to within 24 hours of receipt of all necessary information; non-urgent requests will be responded to within 72 hours unless state law requires a faster response. If a request is disapproved or incomplete, the notice will state specific reasons for denial or identify the missing information required to complete the request.

• Complete the Centene/Payer Prior Authorization form and include clinical justification (indication, prior treatment, labs or diagnostic info as applicable).
• Indicate patient's age when AL (age limit) is listed and the specific quantity/days requested when QL (quantity limit) applies.
• Allowable PA response times: urgent = 24 hours; non-urgent = 72 hours (subject to state law).
• Denial notices will explain specific reasons or missing information.

PA for Specialty, Biologic, Antineoplastic, Pulmonary Hypertension, and Antiviral Agents

Many specialty, biologic, oncology, pulmonary hypertension, antiviral, insulin, and other high-cost or specialty agents are designated as requiring PA and/or specialty (SP) processing. Requests for these drugs commonly require submission of prior therapy history, dosing regimen, and anticipated duration. Non-FDA uses (off-label) also generally require PA documentation.

• Biologics and biosimilars listed with 'PA' require prior authorization; examples throughout the formulary include adalimumab products, monoclonal antibodies, and oncology agents (many of which are also SP).
• Antineoplastics and adjunctive cancer therapies flagged 'SP; PA' require specialty-channel processing plus PA.
• Pulmonary hypertension therapies and prostacyclin agents (e.g., treprostinil, epoprostenol, riociguat, bosentan-related entries) are often SP and PA.
• Select antivirals and hepatitis/HIV agents may have QL, refill-frequency limits, and PA; e.g., tenofovir products and certain combination antiviral regimens are flagged SP; PA or PA with limits.
• Non-FDA (off-label) uses require PA.

PA and Quantity Limits for Opioids

Opioid products frequently carry both PA and quantity limits. New starts for many opioid formulations are limited to a 7-day supply unless documented justification for an exception is provided. Requests that exceed quantity limits or do not have required PA documentation may be denied.

• New starts limited to 7-day supply for many immediate-release opioid liquid and tablet products — document rationale for exceptions.
• Common opioid QL examples: hydrocodone and hydromorphone entries include daily QLs (e.g., QL(2 EA daily)) and may require PA.
• Requests exceeding the stated QL (quantity limit) or without an approved PA are at high risk for denial—provide documentation to support medical necessity for amounts beyond the QL.
• Naloxone and certain opioid antidotes have specific per-fill and per-period QLs and may be Rx/OTC noted; some naloxone presentations also list PA for certain uses.

Quantity, Age, and Fill/Package Limit Requirements

Quantity limits (QL), age limits (AL), fill/package frequency limits, and specialty (SP) designations are applied across the formulary. When a product lists a QL, AL, or refill frequency limit (for example, 1 max fill per 90 days or package limits per 180 days), the provider must document the clinical justification for exception requests. Exceeding those limits without supporting documentation or required PA may result in a denial.

• Document intended days supply, units per day, and reason for exceeding the QL when requesting an exception.
• Fill/package limits: several products list limits per 30/90/180/365 days — verify the product entry and include requested frequency in PA.
• Requests that exceed QL/AL/packaging limits without sufficient clinical justification or an approved PA are likely to be denied.

PA for Select Insulin and Specialty Diabetes Agents

Certain insulin and specialty diabetes agents are designated as PA and/or have quantity limits. For these products, clinical documentation should include prior therapies tried (including formulary insulins), current A1c or relevant glucose data, and the specific insulin product/dosing requested.

• Select insulin products (e.g., concentrated U-500, pen/cartridge systems, long-acting/high-cost pens) may require PA (see formulary entries like HUMULIN R U-500, REZVOGLAR, TRESIBA FlexTouch entries).
• Combination/extended-release antidiabetic products may have QL and PA requirements (e.g., TRIJARDY, SYNJARDY XR, XULTOPHY).
• Include glycemic control data, prior agent trials, and quantity/dosing when submitting PA for insulin or specialty diabetes agents.

Step Therapy (ST) Requirements

Some formulary entries list Step Therapy (ST) requirements, while others do not enumerate explicit step sequences in the excerpt. Where ST is indicated, providers must document trials of required preferred agents before requesting the non-preferred or step-exempt product.

• Examples in the formulary show ST flags for certain topical and combination products; follow the plan's ST process when present.
• When ST is not detailed in the formulary excerpt, contact the payer for the required prior agent(s) or review the plan's step-therapy matrix.
• Site-of-care or specialty program indicators (SP) may interact with ST; for example, some injectables require SP processing even if ST is applicable.

Specialty Injectables — PA/SP Risk

Specialty injectables and high-cost biologics commonly require both PA and specialty dispensing (SP). These products have heightened denial risk if SP or PA requirements are not satisfied.

• Examples include antineoplastics, monoclonal antibodies, growth hormones, ACTHAR GEL, teriparatide, zoledronic acid, and many biosimilars marked 'PA' or 'SP; PA'.
• Confirm specialty channel availability and include provider/site enrollment info if required by the specialty program when submitting PA.
• Failure to meet SP contracting/dispensing requirements or to obtain PA may result in claim denial or coverage refusal.

PA Required for Specific Products

Certain individual products are specifically flagged with PA in the formulary (examples include SPRAVATO, select antifungals/antivirals, XIFAXAN, select antidiabetics, and many biologics). Providers should check the formulary entry before prescribing and initiate PA when indicated.

• SPRAVATO (56 mg and 84 mg doses) is listed with PA; the 84 mg dose also lists a QL (1 EA daily) plus PA — include dosing frequency and treatment setting in the PA.
• Antifungals like itraconazole, posaconazole, voriconazole include QL/PA entries — include indication and prior therapy in PA.
• XIFAXAN (200 mg and 550 mg) lists age limits and PA — document age and indication.
• Many biologic agents (adalimumab variants, et al.) list PA and package/180-day fill limits; include prior biologic exposure and rationale.

PA Documentation Expectations

Documentation that should accompany PA requests includes: indication/diagnosis, relevant lab or imaging data, prior medication trials (and why they failed or were not tolerated), patient age for AL rules, and the exact quantity/days supply requested. This documentation supports approval and any exception to QL/AL limits.

• Suggested documentation elements: diagnosis/indication, prior therapy history (dates, doses, response), objective measures (A1c, viral load, etc.), patient age if AL applies, and requested quantity/days supply.
• For quantity exceptions, provide clinical rationale tied to dosing needs (weight-based dosing, titration, or extended supplies).
• If requesting coverage for non-FDA or off-label uses, include literature support and treating specialist documentation.

Denial Risk and Explanation

Requests that exceed quantity limits, age limits, or that lack required PA or specialty processing may be denied. Denial notices will specify reasons and identify missing documentation when applicable. Providers should include follow-up contact info and be prepared to submit peer-to-peer or appeal information per payer processes.

• Denials commonly cite lack of PA, exceeding QL, age outside AL, missing prior therapy trials (ST), or missing clinical information.
• If a request is incomplete, the denial/explanation will identify exactly what additional information is required to complete the PA.
• Providers may be given next steps for appeal or resubmission — include clear clinical justification on re-submission to address stated denial reasons.

Prior Authorization Triggers — Operational Reminder

Operational/billing triggers — prior authorization must be obtained before dispensing for listed drugs; PA and QL indicators in the formulary constitute triggers for prior authorization submission.

• Check formulary entries for the 'PA', 'QL', 'AL', 'SP', and 'ST' flags prior to prescribing/dispensing.
• When a product is labeled 'PA' in the formulary, do not assume auto-coverage — submit PA prior to claim submission to avoid denial.
• Some products additionally list refill frequency limits (e.g., 1 max fill per 90 days); adhere to these operational limits or secure PA with justification.