Text of section effective on September 01, 2024
Sec. 439.102.  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).
Added by Acts 2023, 88th Leg., R.S., Ch. 244 (S.B. 241), Sec. 1, eff. September 1, 2024.