Prior Authorization of Anti-Allergens, Oral - Pharmacy Services
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Governs prior authorization requirements and medical necessity criteria for oral anti-allergen prescriptions for providers and pharmacies participating in Pennsylvania Medical Assistance fee-for-service.
Medical necessity guidelines for Anti-Allergens, Oral were updated to include age-appropriate and dose consistent with FDA-approved labeling, compendia, or peer-reviewed literature and allow renewals up to four months.
Coverage and Medical Necessity Criteria
Initial Therapy
Covered when ALL of the following are met
If the beneficiary does not meet the clinical review guidelines listed above but, in the professional judgment of the physician reviewer, the services are medically necessary to meet the medical needs of the beneficiary, the request for prior authorization will be approved
Continuation / Renewal Therapy
Renewal approval requires ALL of the following
Renewals may be approved for up to 4 months; if the beneficiary does not meet the clinical review guidelines listed above but, in the professional judgment of the physician reviewer, the services are medically necessary to meet the medical needs of the beneficiary, the request for prior authorization will be approved
Concomitant receipt of allergen immunotherapy disqualifies approval. The clinical review checklist explicitly requires that the beneficiary will not be receiving concomitant allergen immunotherapy as a condition of medical necessity for an oral anti-allergen prior authorization.
Requests that do not meet the clinical guidelines in Section B will be referred to a physician reviewer. Such referrals may be denied unless the physician reviewer, using professional judgment, documents that the requested service is medically necessary and approves the prior authorization.
Provider Requirements, Prior Auth, and Denial Triggers
Prior authorization required for all oral anti-allergens
All prescriptions for oral anti-allergens must have prior authorization. When clinical criteria are met, initial and renewal approvals may be granted for up to four months.
- All prescriptions for Anti-Allergens, Oral must be prior authorized.
- Initial and renewal requests will be approved for up to 4 months when clinical guidelines are met.
Step therapy — document failure/intolerance of listed first-line therapies
The request must document therapeutic failure, contraindication, or intolerance to the listed first-line therapies before an oral anti-allergen will meet the clinical review criteria.
- Document failure, contraindication, or intolerance of intranasal glucocorticoids.
- Document failure, contraindication, or intolerance of intranasal or oral antihistamines.
- Document failure, contraindication, or intolerance of montelukast.
- Document failure, contraindication, or intolerance of intranasal or ophthalmic cromolyn sodium.
- Document failure, contraindication, or intolerance of antihistamine eye drops when conjunctivitis is present.
- Document failure, contraindication, or intolerance of subcutaneous immunotherapy.
Required submission procedures and supporting clinical documentation
Follow the procedures in SECTION I of the Prior Authorization of Pharmaceutical Services Handbook and supply clinical documentation consistent with the clinical review guidelines in SECTION II for Anti-Allergens, Oral.
- Use the handbook procedures (SECTION I) to submit prior authorization requests as required by 55 Pa. Code § 1101.67(a).
- Provide clinical documentation that addresses the Section B clinical review criteria (indication, age, dose/duration, specialist involvement, contraindications, asthma status, concomitant immunotherapy, and documented prior trials).
Denial risk when clinical criteria are not met
If the submitted documentation does not meet the clinical guidelines, the request will be referred to a physician reviewer and may be denied if the physician does not find the service medically necessary.
- Requests failing to meet the clinical review guidelines will be referred to a physician reviewer for a medical necessity determination.
- A physician reviewer may deny the prior authorization if, in professional judgment, the service is not medically necessary.
Policy Background and Rationale
This bulletin updates the medical necessity guidelines for oral anti-allergens to align age, dose, duration, and indications with FDA-approved package labeling and nationally recognized compendia or peer-reviewed literature. The policy standardizes the prior authorization review process by specifying age-appropriate use, dose and timing consistency with authoritative sources, required specialist involvement, contraindication and asthma exclusions, and required documentation of prior therapeutic failures. Prior authorization personnel apply these clinical guidelines; if criteria are met the prescription is authorized, and if not the request is escalated to a physician reviewer for a medical necessity determination.
Key Definitions
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