On January 17th, the Nevada Department of Health and Human Services (DHHS) released a revised draft template for its disclosure law.
You may access the template here. The template includes new disclosure requirements related to the following categories:
- Prescription Drug Manufacturers
- Pharmacy Benefit Managers
- Pharmaceutical Sales Representatives
For prescription drugs posted on the DHHS website, the “Prescription Drug Manufacturers” disclosure section requires the reporting of, for example, the cost of producing the drug, the profit earned from the drug, and the total amount of financial assistance provided through patient prescription assistance programs. For prescription drugs posted on the DHHS website, the “Pharmacy Benefit Managers” disclosure section requires the reporting of, for example, the total amount of rebates negotiated with manufacturers.
The third disclosure section, “Pharmaceutical Sales Representatives”, most closely aligns with traditional transparency reporting requirements and will be the focus of this update.
The Pharmaceutical Sales Representative section includes two primary disclosure areas:
- HCP/HCO Compensation
- Sample Distribution Information
The HCP/HCO Compensation section requires pharmaceutical manufacturers to report a list of healthcare providers or facilities to whom (1) any type of compensation exceeded $10 USD in value or (2) the total compensation exceeded $100 USD in the aggregate. The Sample Distribution Information section requires the “name and manufacturer of each prescription drug for which the pharmaceutical sales representative provided a free sample to a provider…” of health care licensed, certified or registered in Nevada, a pharmacy, or an employee of a medical facility or a person licensed or certified under the provisions of title 57 of the NRS. Additionally, it requires the name of each person who received a free sample. This report must be submitted to email@example.com.
There are a number of questions still outstanding with respect to these disclosure requirements, including report formatting and the expected submission date. While the draft template states that reports must be submitted to DHHS by March 1st for the previous calendar year, there was initially no specification of whether this requirement started March 1, 2018, or March 1, 2019. New guidance released one day after the draft template was published indicates that 2017 will be the first reporting period (meaning that the first report is due March 1, 2018). The reportable period of time for this first year will be October 1, 2017-December 31, 2017. For the 2018 and all future reporting periods, the reporting period will be the calendar year.
The Polaris legal team is working closely with Nevada regulators to gain further clarity related to this update and will communicate findings as soon as possible upon confirmation.