Section 4551 - Scope of enforcement authority(a) Scope.--The department may investigate and enforce the provisions of this act only insofar as the actions or inactions being investigated relate to prescription drug coverage under a health benefit plan. (b)[Repealed by 2024 Amendment.](b.1) Examination and access to records.--The following apply:(1)(i) The department may order a PBM, a health insurer and a PBM's affiliates to produce records, books or other information as reasonably necessary to ascertain compliance with this act.(ii) The department may retain an expert or experts as reasonably necessary to assist the department to conduct an analysis of PBM business practices under this paragraph. The reasonable and necessary costs for the expert services shall be paid by the PBM, payable within 30 days of the PBM's receipt of a bill for the services. Analysis under this section shall include:(A) The impact of steering and spread pricing on the cost of prescription drugs to consumers in this Commonwealth and pharmacy access.(B) The impact to consumers and pharmacies in this Commonwealth by requiring a health benefit plan or PBM contracting with a health benefit plan to reimburse a pharmacy utilizing the national average drug acquisition cost and a professional dispensing fee of $10.49.(2) The department may examine or audit the books and records of a PBM, a health insurer and a PBM's affiliates to ascertain compliance with this act. The examination shall be conducted in accordance with article IX of the act of May 17, 1921 (P.L.789, No.285), known as the Insurance Department Act of 1921.(c) Review of specialty drugs.--The department shall establish an efficient process by which a pharmacy may refer designation of a prescription drug under a health benefit plan, by a PBM contracting with a health benefit plan, or a health insurer as a specialty drug which fails to meet the criteria under section 103. No later than 60 days following the effective date of this subsection, the department shall publish guidance to effectuate this subsection, including the list of prescription drugs classified as a specialty drug under the medical assistance fee-for-service program. The list under this subsection shall not be considered exclusive for the purposes of review by the department under this section. The department shall update guidance under this section to reflect changes in specialty drugs under the medical assistance fee-for-service program for each plan year.(d)Penalties.--Upon the determination, after notice and hearing, that this act has been violated, the commissioner may impose the following penalties: (1) Suspension or revocation of the licensee or registrant's license, authorization to operate or registration.(2) Refusal to issue or renew a license, authorization to operate or registration.(3) A cease and desist order.(4) Order reimbursement to an insured, pharmacy or dispenser that has incurred a monetary loss as a result of a violation of this act.(5) For each violation of this act that a licensee or registrant knew or reasonably should have known was a violation, a penalty of not more than $100,000, not to exceed an aggregate penalty of $1,000,000 in a single calendar year.(6) For each violation of this act that a licensee or registrant did not know nor reasonably should have known was a violation, a penalty of not more than $50,000, not to exceed an aggregate penalty of $500,000 in a single calendar year.(e) Additional remedies.--The enforcement remedies imposed under this section are in addition to any other remedies or penalties that may be imposed under any other applicable law of this Commonwealth, including the act of July 22, 1974 (P.L.589, No.205), known as the Unfair Insurance Practices Act. A violation of this act shall be deemed to be an unfair method of competition and an unfair or deceptive act or practice under the Unfair Insurance Practices Act.(f)Administrative procedure.--The administrative provisions of this section shall be subject to 2 Pa.C.S. Ch. 5 subch. A (relating to practice and procedure of Commonwealth agencies). A party against whom penalties are assessed in an administrative action may appeal to Commonwealth court as provided in 2 Pa.C.S. Ch. 7 subch. A (relating to judicial review of Commonwealth agency action).Amended by P.L. (number not assigned at time of publication) 2024 No. 77,§ 10, eff. 11/14/2024.Added by P.L. TBD 2016 No. 169, § 901, eff. 2/19/2017.