Policies And Procedures For 340b Drug Program Reporting And Audit And Compliance And Enforcement Provisions Of R.I. Gen. Laws Chapter 5-19.3.

130-RICR-00-00-2 ACTIVE RULE

My Page Title

2.1General

2.2Authority

2.3Definitions

2.4Purpose and Scope

2.5Reporting - Policies and Procedures

2.6Compliance, Audit, and Enforcement - Policies and Procedures


Title 130 Auditor General
Chapter 00 N/A
Subchapter 00 N/A
Part 2 Policies And Procedures For 340b Drug Program Reporting And Audit And Compliance And Enforcement Provisions Of R.I. Gen. Laws Chapter 5-19.3.
Type of Filing Adoption
Regulation Status Active
Effective 02/17/2026
Additional Information https://www.oag.ri.gov/rulemaking.html

Regulation Authority:

R.I. Gen. Laws § 5-19.3

Purpose and Reason:

R.I. Gen. Laws Chapter 5-19.3 entitled “Defending Affordable Prescription Drug Costs Act” mandates specific reporting requirements in R.I. Gen. Laws § 5-19.3-6 for covered entities of Rhode Island that participate in the federal 340B program.  Those reporting requirements mandate the submission to the Office of the Governor, the Speaker of the House, the President of the Senate, and the Auditor General a report that includes a minimum of the following information:
1. The aggregated acquisition cost for all prescription drugs that the 340B covered entity obtained through the 340B program during the previous calendar year;
2. The aggregated payment amount that the 340B covered entity received for drugs, under the 340B program and dispensed or administered to patients enrolled in commercial and Medicare Supplemental plans;
3. The aggregated payment amount that the 340B covered entity made:
a. To contract pharmacies to dispense drugs to its patients under the 340B program during the previous calendar year;
b. To any other outside vendor for managing, administering, or facilitating any aspect of the 340B covered entity's drug program during the previous calendar year; and
c. For all other expenses related to administering the 340B program, including staffing, operational, and administrative expenses, during the previous calendar year.
4. The names of all vendors, including split billing vendors, and contract pharmacies, with which the 340B covered entity contracted to provide services associated with the covered entity's 340B program participation during the previous calendar year;
5. The number of claims for all prescription drugs the 340B covered entity obtained through the 340B program during the previous calendar year, including the total number of claims and the number of claims reported by commercial and Medicare Supplemental plans;
6. A description of the ways in which the 340B entity uses savings from its participation in the 340B program to benefit patients and/or its community through programs, projects, and services funded in whole or in part by savings from the 340B program;
7. A description of any and all material breaches, changes in 340B eligibility status, and/or the U.S. Department of Health and Human Services, Health Resources and Services Administration's ("HRSA") 340B program or manufacturer audits during the previous calendar year;
8. A description of the 340B covered entity's self-audit and oversight of its participation in the 340B program in compliance with the HRSA 340B program rules and guidance; and
9. Such additional information as the General Assembly or Auditor General may request.

Rulemaking Documents are organized by document type and are part of this rule’s rulemaking record (R.I. Gen. Laws § 42-35-2.3). If multiple documents of the same type are listed below, each is a unique document. If there are multiple Public Notice of Proposed Rulemaking documents, view each document to identify the most recently amended version, as it may be amended at any point during the Public Comment Period.