Current through Register Vol. XLI, No. 50, December 13, 2024
Section 114-99-1 - General1.1. Scope. -- The purpose of this rule is to provide for the regulation of pharmacy auditing entities and pharmacy benefit managers and to provide licensing, reporting and activity standards for pharmacy benefit managers. The rule also provides registration requirements for pharmacy auditing entities.1.2. Authority. -- W. Va. Code §§ 33-51-8, 33-51-9, 33-51-10, 33-51-12 and 33-2-10.1.3. Filing Date. - March 29, 20231.4. Effective Date. - April 1, 2023.1.5. Sunset provision. -- This rule shall terminate and have no further force or effect upon August 1, 2028.1.6. Applicability. -- This rule applies to pharmacy benefit managers (PBMs) and persons or companies that perform pharmacy audits, as provided in Article 51, Chapter 33 of the West Virginia Code. Certain regulatory sections of this rule may not apply to Medicare Part D plans or Medicare Advantage plans that offer prescription drug coverage because 42 U.S.C. § 1395w-26(b)(3) and 42 U.S.C. § 1395w-112(g) provide that standards established under 42 U.S.C. § 1395w-101et seq. and 42 U.S.C. § 1395w-21et seq. shall supersede any state law or regulation, other than state licensing laws or state laws relating to plan solvency. PBMs that perform pharmacy benefits management for Medicare Part D plans and Medicare Advantage plans in this state must be appropriately licensed. Additionally, certain sections of this rule may not be applicable to health benefit plans that are subject to the Employee Retirement Income Security Act of 1974 ("ERISA") if the subject provision of the rule is preempted by ERISA because it regulates a key facet or essential part of plan administration or design. However, certain sections of this rule that only affect costs, pricing or alter incentives for ERISA plans are not preempted by ERISA and may be applicable to PBMs providing pharmacy benefits management for ERISA plans. This section does not limit the applicability of other sections to PBMs providing pharmacy benefits management for ERISA plans should federal statutory or common law afford the state authority to regulate. PBMs that perform pharmacy benefits management for ERISA plans in this state must be appropriately licensed. This rule applies to PBMs that manage prescription drug coverage for workers' compensation insurers and employers who are self-insured for workers' compensation in this state because workers' compensation insurers and self-insured employers are "healthcare payors."W. Va. Code R. § 114-99-1