Utah Code 31A-48-103. Manufacturer reports — Insurer report — Publication by department
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Terms Used In Utah Code 31A-48-103
- Department: means the Insurance Department. See Utah Code 31A-1-301
- Drug: means a substance that is:(1)(a)(i)(1)(a)(i)(A) intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in humans; and(1)(a)(i)(B) recognized in or in a supplement to the official United States Pharmacopoeia, the Homeopathic Pharmacopoeia of the United States, or the official National Formulary;(1)(a)(ii) required by an applicable federal or state law or rule to be dispensed by prescription only;(1)(a)(iii) restricted to administration by practitioners only;(1)(a)(iv) a substance other than food intended to affect the structure or a function of the human body; or(1)(a)(v) intended for use as a component of a substance described in Subsection (1)(a)(i), (ii), (iii), or (iv). See Utah Code 31A-48-102
- Form: means one of the following prepared for general use:
(74)(a)(i) a policy;(74)(a)(ii) a certificate;(74)(a)(iii) an application;(74)(a)(iv) an outline of coverage; or(74)(a)(v) an endorsement. See Utah Code 31A-1-301- Individual: means a natural person. See Utah Code 31A-1-301
- Insurer: means the same as that term is defined in Section 31A-22-634. See Utah Code 31A-48-102
- Manufacturer: means a person that is engaged in the manufacturing of a drug that is available for purchase by residents of the state. See Utah Code 31A-48-102
- State: when applied to the different parts of the United States, includes a state, district, or territory of the United States. See Utah Code 68-3-12.5
- United States: includes each state, district, and territory of the United States of America. See Utah Code 68-3-12.5
- Wholesale acquisition cost: means the same as that term is defined in Utah Code 31A-48-102
(1)(a) A manufacturer of a drug shall, beginning January 1, 2022, report to the department the information described in Subsection (1)(b) no more than 30 days after the day on which an increase to the wholesale acquisition cost of the drug results in an increase to the wholesale acquisition cost of the drug of:(1)(a)(i) greater than 16% over the preceding two calendar years; or(1)(a)(ii) greater than 10% over the preceding calendar year.(1)(b) The manufacturer shall report:(1)(b)(i)(1)(b)(i)(A) the name of the drug;(1)(b)(i)(B) the dosage form of the drug; and(1)(b)(i)(C) the strength of the drug;(1)(b)(ii) whether the drug is a brand name drug or a generic drug;(1)(b)(iii) the effective date of the increase in the wholesale acquisition cost of the drug;(1)(b)(iv) a written description, suitable for public release, of the factors that led to the increase in the wholesale acquisition cost of the drug and the significance of each factor;(1)(b)(v) the manufacturer’s aggregate company-wide research and development costs for the most recent year for which final audit data is available;(1)(b)(vi) the name of each of the manufacturer’s drugs approved by the United States Food and Drug Administration during the preceding three calendar years; and(1)(b)(vii) the names of drugs manufactured by the manufacturer that lost patent exclusivity in the United States during the preceding three calendar years.(1)(c) Subsection (1)(a) applies only to a drug with a wholesale acquisition cost of at least $100 for a 30-day supply before the effective date of the increase in the wholesale acquisition cost of the drug.(1)(d) The quality and types of information and data that a manufacturer submits under this Subsection (1) shall be consistent with the quality and types of information and data that the manufacturer includes in the manufacturer’s annual consolidated report on Securities and Exchange Commission Form 10-K or any other public disclosure.(1)(e) The department shall consult with representatives of manufacturers to establish a single, standardized format for reporting information under this section that minimizes the administrative burden of reporting for manufacturers and the state.(2) On or before August 1, 2021, and on or before August 1 of each year thereafter, an insurer shall report to the department in aggregate the following information for the preceding calendar year for health benefit plans offered by the insurer:(2)(a) for the 25 drugs for which spending by the insurer was the greatest, after adjusting for rebates:(2)(a)(i) the name of the drug;(2)(a)(ii) the dosage form of the drug; and(2)(a)(iii) the strength of the drug;(2)(b) the percentage increase over the previous year in net spending for all drugs, after adjusting for rebates;(2)(c) the percentage of the increase in premiums over the previous year attributable to all drugs; and(2)(d) the percentage of the increase in premiums over the previous year attributable to specialty drugs.(3) The department shall publish on the department’s website:(3)(a) no later than 60 days after receiving the information, information reported to the department under Subsection (1); and(3)(b) no later than December 1 of each year, information reported to the department under Subsection (2).(4)(4)(a) The department may not publish information under this section in a manner that:(4)(a)(i) allows the identity of an insurer to be determined;(4)(a)(ii) allows for the identification of an individual drug, a therapeutic class of drugs, or a manufacturer; or(4)(a)(iii) is likely to compromise the financial, competitive, or proprietary nature of the information.(4)(b) The commissioner shall classify each record submitted under this section as a protected record under Title 63G, Chapter 2, Government Records Access and Management Act.(5) The department shall make rules, as necessary, in accordance with Title 63G, Chapter 3, Utah Administrative Rulemaking Act, to promote comparability of information reported to the department under this chapter. - Form: means one of the following prepared for general use: