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.

The Governor has approved the request of the State Board of Health to extend the expiration date of the emergency regulation for 12VAC5-219 for six months as provided for in § 2.2-4011 D of the Code of Virginia. Therefore, the emergency regulation is continued in effect through January 15, 2024.

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. These emergency regulations were promulgated pursuant to Chapter 304 of the 2021 Acts of Assembly, Special Session I, and are set to expire on July 16, 2023. The proposed regulation is being developed and is currently under review by the Department of Planning and Budget. Once it is approved by the Executive Branch, it will be submitted for publication in the Virginia Register of Regulations. Upon publication, a public comment 60 days will open, after that closes, VDH will develop and submit a final regulation to make the emergency regulations permanent. VDH is working to complete the standard regulatory process to make these regulations permanent as quickly as possible, but there is the potential that the regulatory process will not be complete before the emergency regulations expire. The State Board of Health, which approves each stage in a regulatory action and officially promulgates the regulations, only meets once per quarter. VDH needs time to collect and consider public comment and meet with and reach consensus with relevant stakeholders, including Virginia Health Information, the nonprofit data services organization with which VDH contracts pursuant to the Code of Virginia. These delays could potentially prevent the permanent regulations from becoming effective before the expiration date of the emergency regulations. As a result, it is necessary to extend the expiration date to ensure the emergency regulations do not expire before they are made permanent, which would leave VDH and the State Board of Health out of compliance with the legislative mandate and ultimately cause confusion for the public and the regulated community. The emergency regulation was published in 38:11 VA.R. 1000-1010 January 17, 2022.

Effective Date Extended Through: January 15, 2024.

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.