Section 439.102 - [Effective 9/1/2024] Written Verification Required For Brand Name Insulin Drug Manufacturer(a) The manufacturer of a brand name insulin prescription drug for which a generic or biosimilar prescription drug is not available and that is included in the Medicaid vendor drug program formulary must submit to the Health and Human Services Commission a written verification stating whether or not the unavailability of the generic or biosimilar prescription drug is the result, wholly or partly, of: (1) a scheme by the manufacturer to pay a generic or biosimilar prescription drug manufacturer to delay manufacturing or marketing the generic or biosimilar drug;(2) a legal or business strategy to extend the life of a patent on the brand name prescription drug;(3) the manufacturer directly manipulating a patent on the brand name prescription drug; or(4) the manufacturer facilitating an action described by Subdivisions (1)-(3) on behalf of another entity.(b) The executive commissioner shall adopt rules prescribing the form and manner for submission of the written verification required under Subsection (a).Tex. Health and Safety Code § 439.102
Added by Acts 2023, Texas Acts of the 88th Leg.- Regular Session, ch. 244,Sec. 1, eff. 9/1/2024.