Overview
Section 901(c) of the Pharmacy Benefit Reform Act, as amended by Act 77 of 2024, requires that the Department “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, identifying drugs by medication name (Column A) and classification (Column B). That list will include “the list of prescription drugs classified as a specialty drug under the Medical Assistance (MA) fee-for-service program” (as shown in Column C ), but that MA list is “not to be considered exclusive.” Drugs not on the Medical Assistance list may be referred for review under the section 901(c) process, where the designation of the drug as a specialty drug by a PBM contracting with a health benefit plan or a health insurer relates to prescription drug coverage under a health benefit plan.
To facilitate the Department’s review of policy forms pursuant to the Accident & Health Filing Reform Act, the Department is identifying, a preliminary, tentative, and nonbinding list of additional drugs, shown in Column C as “Non-Binding: Formulary Review”, to which the Department has no plans to object during its form review process if an insurer identifies them as specialty drugs in the formulary filed as part of a form filing. The presence of a drug so designated does not foreclose either:
- the right of a PBM contracting with a health benefit plan or a health insurer, to designate another drug or drugs as specialty under a health benefit plan
- the right of a pharmacy to refer the drug for consideration of the designation as a specialty drug under the process contemplated by section 901(c)
- the right of the Department to amend this list; nor
- the right of the Department to object during its form review process.
Rather, the identification of drugs as preliminary, tentative, and non-binding (i.e., as “Non-Binding: Formulary Review” in Column C) is merely to allow an efficient form review process and to facilitate efficiency in the section 901(c) process.
Finally, if a “Non-Binding Formulary Review” drug is referred for consideration of a designation of the drug as a specialty drug: after it has been adjudicated, the designation will be modified to show the result of the adjudication: Column C will show as “Designation Referred” with Column D showing either “Removed” or “Confirmed” and Column E will show the date the drug designation was updated as a result of the adjudication decision.