R590. Insurance, Administration.R590-287. Manufacturer Data Reporting.
R590-287-1. Authority.
This rule is promulgated by the commissioner pursuant to Sections 31A-2-201 and 31A-48-103.
R590-287-2. Purpose and Scope.
(1) The purpose of this rule is to establish the:
(a) method for reporting information, and
(b) information required to promote comparability of the information reported to the department.
(2) This rule applies to a manufacturer.
R590-287-3. Definitions.
Terms used in this rule are defined in Sections 31A-1-301 and 31A-48-102. Additional terms are defined as follows:
(1) "Drug product" means the finished dosage form of a drug that contains a drug substance, in association with other active or inactive ingredients, and that has a unique NDC.
(2) "FDA" means the United States Food and Drug Administration.
(3) "National Drug Code" or "NDC" means a three-segment code maintained by the FDA that is converted to an 11-digit format and includes a:
(a) labeler code;
(b) product code; and
(c) package code.
(4) "WAC" means wholesale acquisition cost.
R590-287-4. Manufacturer Reporting and Submission.
(1) For each drug product that experiences a wholesale acquisition cost increase, a manufacturer shall submit the following information to the department:
(a) WAC history;
(b) approval history; and
(c) patent history.
(2) The reported information shall comply with the instructions provided by the Utah Insurance Department Pharmacy Web Portal User Guide available at https://insurance.utah.gov/consumer/other/pharmacy.
(3) The information required under this rule and Subsection 31A-48-103(1) shall be submitted electronically at https://pharma.utah.gov/.
R590-287-5. WAC History.
The reported WAC history shall include the following information:
(1) the name of the manufacturer;
(2) the drug product's NDC;
(3) a description of the drug product that includes the;
(a) name;
(b) strength;
(c) dosage form; and
(d) package size;
(4) the FDA classification of the drug product as brand or generic;
(5) the effective date of the WAC increase for the drug product;
(6) the amount of the WAC increase for the drug product;
(7) the WAC resulting from the reported cost increase for the drug product;
(8) the WAC one calendar year prior to the effective date of the reported cost increase of the drug product;
(9) the WAC two calendar years prior to the effective date of the reported cost increase of the drug product;
(10) a written description, suitable for public release, of the factors that led to the increase in the WAC of the drug product and the significance of each factor; and
(11) the manufacturer's aggregate company-wide research and development costs for the most recent year for which final audit data is available.
R590-287-6. Approval History.
The reported approval history shall include the following information for a manufacturer's drug that was approved by the FDA during the three calendar years prior to the effective date of the reported cost increase for the drug product reported in Section R590-287-5:
(1) the name of the drug; and
(2) the date when the drug was approved by the FDA.
R590-287-7. Patent History.
