PURPOSE:
The purpose of this bulletin is to issue updated handbook pages that include the requirements for prior authorization and the type of information needed to evaluate the medical necessity of prescriptions for Antibiotics, GI and Related Agents, Antidepressants, Other submitted for prior authorization.
SCOPE:
This bulletin applies to all licensed pharmacies and prescribers enrolled in the Medical Assistance (MA) Program. The guidelines to determine the medical necessity of Antibiotics, GI and Related Agents, Antidepressants, Other will be utilized in the fee-for-service and managed care delivery systems. Providers rendering services to MA beneficiaries in the managed care delivery system should address any questions related to the prior authorization of Antidepressants, Other to the appropriate managed care organization.
BACKGROUND:
The Department of Human Services (Department) is updating the medical necessity guidelines for Antibiotics, GI and Related Agents to remove the guidelines related to Xifaxan (rifaximin) and Zinplava (bezlotoxumab). Medicaid covers drugs approved by the U.S. Food and Drug Administration when the manufacturer participates in the Medicaid Drug Rebate Program (MDRP). The manufacturer of Xifaxan (rifaximin) is no longer participating in the MDRP. Xifaxan (rifaximin) is no longer a Medicaid-covered drug. Zinplava (bezlotoxumab) was discontinued by the manufacturer in January 2025.
The revisions to the guidelines to determine medical necessity of prescriptions for Antibiotics, GI and Related Agents were subject to public review and comment and subsequently approved for implementation by the Department.
The Department of Human Services’ (Department) Pharmacy and Therapeutics (P&T) Committee reviews published peer-reviewed medical literature and recommends the following:
Preferred or non-preferred status for new drugs and products in therapeutic classes already included on the Statewide Preferred Drug List (PDL).
DISCUSSION:
During the September 24, 2025, meeting, the P&T Committee recommended revisions to the medical necessity guidelines for Antidepressants, Other to remove the guideline that Spravato (esketamine) is prescribed in conjunction with a therapeutic dose of an oral antidepressant.
The revisions to the guidelines to determine medical necessity of prescriptions for Antidepressants, Other submitted for prior authorization, as recommended by the P&T Committee, were subject to public review and comment and subsequently approved for implementation by the Department.
PROCEDURE:
The procedures for prescribers to request prior authorization of Antibiotics, GI and Related Agents are located in SECTION I of the Prior Authorization of Pharmaceutical Services Handbook. The Department will take into account the elements specified in the clinical review guidelines (which are included in the provider handbook pages in the SECTION II chapter related to Antibiotics, GI and Related Agents) when reviewing the prior authorization request to determine medical necessity.
As set forth in 55 Pa. Code § 1101.67(a), the procedures described in the handbook pages must be followed to ensure appropriate and timely processing of prior authorization requests for drugs and products that require prior authorization.
The procedures for prescribers to request prior authorization of Antidepressants, Other are located in SECTION I of the Prior Authorization of Pharmaceutical Services Handbook. The Department will take into account the elements specified in the clinical review guidelines (which are included in the provider handbook pages in the SECTION II chapter related to Antidepressants, Other) when reviewing the prior authorization request to determine medical necessity.
As set forth in 55 Pa. Code § 1101.67(a), the procedures described in the handbook pages must be followed to ensure appropriate and timely processing of prior authorization requests for drugs and products that require prior authorization.
RESOURCES:
Prior Authorization of Pharmaceutical Services Handbook – SECTION I
Pharmacy Prior Authorization General Requirements
https://www.pa.gov/en/agencies/dhs/resources/pharmacy-services/pharmacy-prior-authorization-general-requirements.html
Prior Authorization of Pharmaceutical Services Handbook – SECTION II
Pharmacy Prior Authorization Guidelines
https://www.pa.gov/en/agencies/dhs/resources/pharmacy-services/clinical-guidelines.html
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