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    Pharmacy Benefit Reform Act (Act 77)

    Specialty Drug Designation Referral Process

    Guidance on submitting a specialty drug designation referral, as required by the Pharmacy Benefit Reform Act (Act 77). 

    Submit a Specialty Drug Referral
    Guidance on Specialty Drug List

    Overview

    Section 901(c) of the Pharmacy Benefit Reform Act requires that the Pennsylvania Insurance Department (PID) "publish guidance to effectuate … an efficient process by which a pharmacy may refer designation of a prescription drug under a health benefit plan." The guidance will include a list of prescription drugs classified as specialty drugs. That list will include "the list of prescription drugs classified as a specialty drug under the Medical Assistance (MA) fee-for-service program," but that (MA) list is "not to be considered exclusive."

    The list in the guidance is published to facilitate PID's review of rates and forms for individual, small group, student health, and large group health benefit plans. The listing of prescription drugs not on the MA list is preliminary, tentative, and nonbinding for purposes of that review process.

    View Section 901(c) Guidance on Specialty Drug List

    Submitting a Section 901(c) Referral

    A pharmacy may refer pharmacy benefit manager's (PBM's) or health insurer's designation of a particular drug as a specialty drug to PID if, but only if, the designation was made by a PBM or a health insurer relating to prescription drug coverage under a health benefit plan (i.e., a fully-insured plan).

    The pharmacy should submit the referral to our Bureau of Consumer Services through the form linked below. PID will evaluate whether the request is eligible for review.

    Supporting Information

    Please note that you will be asked to include supporting information in the form.

    For example, you will need to provide:

    • the name of the covered individual
    • contact information for the PBM
    • identification of the referred drug, including RXCUI

    Additionally, you'll be asked for any other documents that confirm the covered individual is provided pharmacy benefits by a commercial (not self-funded, Medicare, or Medicaid) health benefit plan either directly or pursuant to a contract administered by a PBM.

    Submit a Specialty Drug Referral

    Section 901(c) Review Process

    1. 1

      Step 1

      Pharmacy files a referral with PID’s Bureau of Consumer Services

    2. 2

      Step 2

      PID determines if the referral is eligible.

      • If PID establishes that the request is ineligible for review or we are unable to confirm jurisdiction over the referral, PID will notify both the pharmacy and the PBM identified by the pharmacy by letter and electronic mail.
      • If PID's evaluation concludes that the pharmacy’s request is eligible for review, we will forward the referral to our Administrative Hearings Office (AHO) for the opportunity for an administrative hearing.
    3. 3

      Step 3

      PID forwards the referral to the AHO.

      • The request for review and any supporting documentation will be sent to PID's Administrative Hearings Office (AHO), copying both the pharmacy and the PBM on the transmittal letter.
    4. 4

      Step 4

      AHO conducts a hearing between the pharmacy and the PBM.

      • At the hearing, both parties will have the opportunity to present witness testimony, offer documentary exhibits, and cross-examine the other party’s witnesses.
      • At the conclusion of the hearing, the parties are afforded the opportunity to file written arguments in support of their position.
    5. 5

      Step 5

      The Pennsylvania Insurance Commissioner issues a determination identifying whether the drug subject to the hearing is consistent with the statutory definition of “specialty drug.”

      • Following the receipt of all evidence, the Insurance Commissioner will issue a determination through the AHO identifying whether the drug subject to the hearing is consistent with the statutory definition of “specialty drug” in section 103 of Act 77 of 2024.
    6. 6

      Step 6

      After the determination, either party has the right to request reconsideration and/or file an appeal with the Commonwealth Court.

      • The request for reconsideration must be filed within fifteen (15) days of the determination.
      • The appeal with the Commonwealth Court must be filed within thirty (30) days of the determination.
      • Filing a request for reconsideration does not add time to the deadline for filing an appeal with the Commonwealth Court.
      • PID's 901(c) adjudications will be made available online.
      • Additionally, PID will update the list of specialty drugs in accordance with any determinations made.

    Questions?

    Contact our Consumer Services Bureau for questions about the Specialty Drug Designation Referral Process.