NOTICES
DEPARTMENT OF
HUMAN SERVICES
Pharmacy Prior Authorization
[53 Pa.B. 3653]
[Saturday, July 8, 2023]The Department of Human Services (Department) announces it will add Amyloid-Targeted Monoclonal Antibodies and the following drugs that are not included on the Statewide Preferred Drug List to the Medical Assistance (MA) Program's list of services and items requiring prior authorization: gene therapy drugs, chimeric antigen receptor T-cell (CAR-T) drugs, drugs approved by the United States Food and Drug Administration (FDA) through the Accelerated Approval, Priority Review, Breakthrough Therapy or Fast Track programs, drugs classified as orphan drugs by the FDA, Tzield (teplizumab) and Vuity (pilocarpine).
Section 443.6(b)(7) of the Human Services Code (62 P.S. § 443.6(b)(7)) authorizes the Department to add items and services to the list of services requiring prior authorization by publication of notice in the Pennsylvania Bulletin.
The MA Program will require prior authorization of all prescriptions for Amyloid-Targeted Monoclonal Antibodies and the following drugs that are not included on the Statewide Preferred Drug List: gene therapy drugs, CAR-T drugs, drugs approved by the FDA through the Accelerated Approval, Priority Review, Breakthrough Therapy or Fast Track programs, drugs classified as orphan drugs by the FDA, Tzield (teplizumab) and Vuity (pilocarpine). These prior authorization requirements apply to prescriptions dispensed on or after July 10, 2023.
The Department will issue MA Bulletins to providers enrolled in the MA Program specifying the procedures for obtaining prior authorization of prescriptions for Amyloid-Targeted Monoclonal Antibodies and the following drugs that are not included on the Statewide Preferred Drug List: gene therapy drugs, CAR-T drugs, drugs approved by the FDA through the Accelerated Approval, Priority Review, Breakthrough Therapy or Fast Track programs, drugs classified as orphan drugs by the FDA, Tzield (teplizumab) and Vuity (pilocarpine).
Fiscal Impact
These changes are estimated to result in minimal savings in the MA Fee-for-Service Program.
Public Comment
Interested persons are invited to submit written comments regarding this notice to the Department of Human Services, Office of Medical Assistance Programs, c/o Regulations Coordinator, Room 515, Health and Welfare Building, Harrisburg, PA 17120. Comments received within 30 days will be reviewed and considered for any subsequent revisions to these prior authorization requirements.
Persons with a disability who require an auxiliary aid or service may submit comments using the Pennsylvania Hamilton Relay Service at (800) 654-5984 (TDD users) or (800) 654-5988 (voice users).
VALERIE A. ARKOOSH,
SecretaryFiscal Note: 14-NOT-1587. No fiscal impact; recommends adoption.
[Pa.B. Doc. No. 23-900. Filed for public inspection July 7, 2023, 9:00 a.m.]
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