This text of New Mexico § 59A-59A-3 (Prescription drug manufacturer price and price increase) is published on Counsel Stack Legal Research, covering New Mexico primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.
reporting requirements. A. By May 1, 2025, and annually thereafter, each manufacturer shall submit data to the superintendent, in a form and manner prescribed by the superintendent, that includes the name and national drug code for each prescription drug product that has a wholesale acquisition cost of four hundred dollars ($400) or more for a thirty-day supply or for a course of treatment that is less than thirty days and is a:
(1)brand name drug that has increased in wholesale acquisition cost by ten percent or more in the previous calendar year;
(2)brand name drug that has increased in wholesale acquisition cost by sixteen percent or more over the course of the previous two calendar years; or (3) generic drug or biosimilar product that has increased in wholesale acquisition cost by th
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reporting requirements. A. By May 1, 2025, and annually thereafter, each manufacturer shall submit data to the superintendent, in a form and manner prescribed by the superintendent, that includes the name and national drug code for each prescription drug product that has a wholesale acquisition cost of four hundred dollars ($400) or more for a thirty-day supply or for a course of treatment that is less than thirty days and is a: (1) brand name drug that has increased in wholesale acquisition cost by ten percent or more in the previous calendar year; (2) brand name drug that has increased in wholesale acquisition cost by sixteen percent or more over the course of the previous two calendar years; or (3) generic drug or biosimilar product that has increased in wholesale acquisition cost by thirty percent or more in the previous calendar year. B. For each prescription drug product that is reported to the superintendent, the manufacturer shall provide the following information that shall be verified, whenever possible, by the superintendent through the use of independent third-party resources: (1) the introductory wholesale acquisition cost of the prescription drug product when the prescription drug product was approved for marketing by the federal food and drug administration; (2) the annual increase in the prescription drug product's wholesale acquisition cost over the previous five calendar years; (3) the direct costs associated with manufacturing, marketing and distributing the prescription drug product; (4) the total revenue from the prescription drug product over the previous calendar year; (5) the net profit attributable to the prescription drug product over the previous calendar year; (6) the patent expiration date for the prescription drug product; (7) the ten highest government-negotiated prices of the prescription drug product in European Union countries and the United Kingdom; (8) any agreement between the manufacturer and another entity that involves a delay in marketing a generic version of the prescription drug product; (9) the names and prices of any generic equivalents of the prescription drug product; (10) the total amount of manufacturer-supported financial assistance provided to consumers of the prescription drug product; and (11) other information requested by the superintendent. C. When a new brand name drug is introduced in the United States and has a price that is higher than the medicare part D specialty-tier threshold, the manufacturer of the brand name drug shall report the name of the drug to the superintendent within three days of the brand name drug's introduction. D. When a new generic drug or biosimilar product is introduced in the United States with a price that is higher than the medicare part D specialty-tier threshold and a price that is not at least fifteen percent lower than the price of the brand name drug or biological product that the generic drug or biosimilar product is based on, the manufacturer of the generic drug or biosimilar product shall report the name of the generic drug or biosimilar product to the superintendent within three days of the generic drug or biosimilar product's introduction. E. A manufacturer of a prescription drug product that is increasing in price enough to meet the reporting requirements of Subsection A of this section shall notify the superintendent on the price increase in writing no later than the date that the price increase becomes effective. The notice shall include: (1) the date of the price increase; (2) the current wholesale acquisition cost of the prescription drug product; (3) the dollar amount of any known future increase of the wholesale acquisition cost of the prescription drug product; and (4) a statement regarding whether a change or improvement in the prescription drug product necessitates the price increase, and if so, the manufacturer shall describe the change or improvement. F. Except for the superintendent's reporting requirements in Section 7 [59A-59A-7 NMSA 1978] of the Prescription Drug Price Transparency Act, the superintendent and a person acting on behalf of the superintendent, including staff and third-party contractors, shall keep confidential all of the information provided pursuant to this section, and the information shall not be subject to the requirements of the Inspection of Public Records Act [Chapter 14, Article 2 NMSA 1978]. The superintendent shall include in every contract for services related to the Prescription Drug Price Transparency Act a requirement that contractors and subcontractors do not disclose confidential information to any persons other than the superintendent or a person acting on behalf of the superintendent.