DIGEST The digest printed below was prepared by House Legislative Services. It constitutes no part of the legislative instrument. The keyword, one-liner, abstract, and digest do not constitute part of the law or proof or indicia of legislative intent. [R.S. 1:13(B) and 24:177(E)] HB 538 Engrossed 2019 Regular Session LeBas Abstract: Provides relative to conditions and procedures for pharmacy record audits. Present law provides criteria for auditing of pharmacy records, including a protocol for onsite audits, by the following entities: (1)Managed care companies. (2)Insurance companies. (3)Third-party payors. (4)Representatives of managed care companies including pharmacy benefit managers, insurance companies, and third-party payors. Proposed law repeals all provisions relative to onsite audits of pharmacy records by these entities. Present law requires that any audit involving clinical judgment be conducted by or in consultation with a licensed pharmacist. Proposed law revises present law to require that such audits be conducted by or in consultation with a pharmacist who is licensed in this state. Present law provides that no pharmacy shall be subject to recoupment of any portion of the reimbursement for the dispensed product of a prescription unless certain conditions are met. Proposed law revises present law to require that these conditions occur at the point of adjudication in order for the pharmacy to be subject to recoupment. Proposed law stipulates that if any entity determines that the processed or adjudicated pharmacy claim qualifies for recoupment based upon the use of a manufacturer coupon or copay card, then the recoupment shall come from the beneficiary of the reduction if the product is approved by the U.S. Food and Drug Administration through the new drug application process or abbreviated new drug application, or is an investigational drug which is a biological product as defined in present law. Proposed law repeals present law relative to pharmacy record audits providing that present law shall not apply to any federally funded activity specifically preempted by law or rule, or to any audit conducted pursuant to the participation of a pharmacy in the La. Medicaid program. (Amends R.S. 22:1856.1(B)(intro. para.), (2), (3), (7)(b), and (8), (D)(1)(intro. para.) and (2)(intro. para.), and (F); Adds R.S. 22:1856.1(D)(3); Repeals 22:1856.1(G)(3) and (4)) Summary of Amendments Adopted by House The Committee Amendments Proposed by House Committee on Health and Welfare to the original bill: 1. Delete proposed law providing that any audit of a pharmacy with its principal place of business in this state shall be conducted by a pharmacist licensed in Louisiana. Provide instead that any audit which involves clinical judgment shall be conducted by or in consultation with a pharmacist licensed in Louisiana. 2. Provide that proposed law relative to recoupment based upon the use of a manufacturer coupon or copay card shall apply only if the product is approved by the U.S. Food and Drug Administration through the new drug application process or abbreviated new drug application, or is an investigational drug which is a biological product as defined in present law.