On January 31, 2022, the Nevada Department of Health and Human Services (“DHHS”) released its annual drug lists in accordance with its Drug Transparency Reporting Program. DHHS published four drug lists: List #1 Essential Diabetes Drug Summary List; List #2 Essential Diabetes Drug List with WAC; List #3 Essential Diabetes Drug List (with Significant Price Increase); and List #4 Over $40 Drug List (with Significant Price Increase). (Nevada Drug Transparency Drug Lists 2023)
Drug manufacturers with drugs identified on Lists #2, #3, and/or #4 are required to submit reports to the Transparency Program on or before April 1, 2023. The reporting templates and instructions can be found here: Manufacturers. Do not wait until late March to prepare the reports because the information requested is detailed and will likely require input from multiple divisions or functions within a company. Examples of the information required to be reported include: total cost of producing the drug; total administrative expenditures related to the drug; profit manufacturer earned from the drug; percentage of manufacturer’s total profit attributed to drug during marketing period for drug; and, for lists #3 and #4, an explanation for the applicable drug’s price increase.
In addition, with its reporting, the manufacturer representative who completed the report must provide an Affirmation of Accuracy Form attesting that “all information provided in the attached report(s) is accurate to the best of my knowledge. This attestation is made under penalty of perjury.” (Affirmation of Accuracy Form) Finally, based on the examples of the information requested above, manufacturers most likely will want to submit a Request for Confidentiality form to protect confidential and proprietary information. (NVDHHS DT Request for Confidentiality)
Don’t Miss the Deadline: The key for manufacturers is to submit the required information on or before April 1. The Nevada Transparency Program can impose administrative penalties of up to $5,000 per day for untimely reporting and Nevada has imposed administrative penalties on manufacturers in the past.