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PA Bulletin, Doc. No. 96-2189



Medical Exception Process; Generic Drug Substitution

[26 Pa.B. 6192]


   Act 134-96, the State Lottery Law, requires publication and dissemination of the medical exception process used by the Department of Aging for the Pharmaceutical Assistance Contract for the Elderly (PACE) and for the Pharmaceutical Assistance Contract for the Elderly Needs Enhancement Tier (PACENET). Specifically, the legislation addresses the medical exception process with regard to generic substitution when an A-rated therapeutically equivalent medication is available. The law further requires that the Department of Aging distribute the medical exception process to providers and recipients in the Program.

The Medical Exception Process

   Through the online claims processing system, the PACE/PACENET Program provides prospective therapeutic review of prescriptions before the pharmacist dispenses the medication to the cardholder. The review checks for potential drug interactions, duplicative therapies, over-utilization, under-utilization and other misutilization. The Department of Aging, of course, recognizes the possibility of exceptional circumstances in connection with the application of therapeutic criteria and reimbursement edits. A medical exception will be considered by the Program when the cardholder's physician indicates the diagnosis, medical rationale, anticipated therapeutic outcomes, the expected length of exception therapy, and the last trial at alternative therapy.

   Act 134-96 requires a pharmacist to dispense the A-rated, therapeutically equivalent, generic drug to the cardholder if they have a prescription for a multisource brand product. If a cardholder seeks an exception to this mandate, a pharmacist may request a short term medical exception at the time of dispensing by calling 1 (800) 835-4080. The PACE Program may grant a 30-day medical exception if requested. Immediately following approval of the exception, the Program sends a follow-up letter to the cardholder's prescribing physician. This let- ter serves as notice that the Program granted a temporary medical exception to the mandatory substitution requirement. The letter seeks the therapeutic rationale for continuing the medical exception. The Program allows 30 days for the return of the written medical exception request from the prescriber. If the Program does not receive written documentation, the short term medical exception will expire. If the prescriber does respond to the letter and provides appropriate information, the Program may grant a longer medical exception period. The cardholder may continue to obtain the brand medication without paying the extra cost of a generic differential.

   The Program may refer a request to a physician consultant or to a therapeutics committee for special review and consideration. The cardholder will receive a short term medical exception until completion of the review process.

   If the Program denies a request for a medical exception to the mandatory generic requirement, the cardholder may opt to continue using the brand multisource product and, then, pay the generic differential. If this occurs, the pharmacist must collect the copay for the brand name product plus 70% of the average wholesale price of the brand name product from the cardholder.

   Please direct questions regarding the implementation of the medical exception process to 1 (800) 835-4080 or in writing to Thomas M. Snedden, Director, Bureau of Phar- maceutical Assistance, Pennsylvania Department of Aging, 400 Market Street, 6th Floor, Harrisburg, PA 17101.


[Pa.B. Doc. No. 96-2189. Filed for public inspection December 27, 1996, 9:00 a.m.]

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