TITLE 12. HEALTH

STATE BOARD OF HEALTH

Notice of Extension of Emergency Regulation

Title of Regulation: 12VAC5-219. Prescription Drug Price Transparency Regulation (adding 12VAC5-219-10 through 12VAC5-219-140).

Statutory Authority: §§ 32.1-12 and 32.1-23.4 of the Code of Virginia.

On April 8, 2024, the Governor approved Chapter 727 of the 2024 Acts of Assembly, extending the expiration date of the emergency regulation for 12VAC5-219 "until the promulgation of final regulations". Therefore, the emergency regulation is continued in effect. On January 17, 2022, emergency amendments to 12VAC5-219 went into effect to ensure that health carriers, pharmacy benefits managers, drug wholesale distributors, and drug manufacturers submit to the Virginia Department of Health (VDH) information regarding prescription drug prices, which VDH is required to make publicly available. The emergency regulation was promulgated pursuant to Chapter 304 of the 2021 Acts of Assembly, Special Session I. The proposed regulation is under review by the Secretary of Health and Human Resources (Day 482). Once it is approved by the Executive Branch, it will be submitted for publication in the Virginia Register of Regulations. Upon publication, a 60-day public comment period will begin. After that closes, VDH will develop and submit a final regulation to make the emergency regulation permanent. VDH is working to complete the standard regulatory process to make the regulation permanent as quickly as possible, but the regulatory process is not complete, and the emergency regulation expired January 15, 2024 (find the extension pursuant to § 2.2-4011 D of the Code of Virginia published 39:15 VA.R. 2065 March 13, 2024). The emergency regulation was published in 38:11 VA.R. 1000-1010 January 17, 2022.

Agency Contact: Michael Sarkissian, Director, Data and Quality, Virginia Department of Health, 109 Governor Street, Richmond, VA 23219, telephone (804) 864-7416, FAX (804) 864-7022, or email vdh_oim_regulations@vdh.virginia.gov.