What did you do last year? The District of Columbia and the State of Maine want to know by July 1

By: Judy Fox, CIS Senior Compliance Manager
judyfox@cis-partners.com

On July 1, pharmaceutical manufacturers are required to disclose their expenditures on Healthcare Practitioners (HCPs) to the State of Maine and the District of Columbia (DC). If you haven’t looked at a calendar lately, July 1 is right around the corner. Scrambling for the correct reportable expenditures? The following is a snapshot of the Maine and DC requirements. Are you ready?

In DC, the reporting requirements apply to manufacturers and labelers of prescription drugs dispensed in the District that employ, direct or utilize marketing representatives in the District. Not only is the report due by July 1, but it must be accompanied by a fee to support, and help offset the cost of, the work of the Department. The content of the annual report is to include a report of the value, nature, purpose and recipient of the expenses for marketing prescription drugs in the District that includes:

o All expenses associated with advertising, marketing and direct promotion of prescription drugs through radio, television, magazines, newspapers, direct mail and telephone communications as they pertain to District residents.
o The aggregate cost of all employees or contractors who engage in advertising or promotional activities including all forms of payment to those employees as it pertains to the District, or to the recipients who are residents or are employed in the District.
o All expenses with regard to any licensed Healthcare Provider or person employed by a Healthcare provider in DC including:

• All expenses associated with educational or informational programs, materials, seminars and the remuneration for promoting or participating in the programs, regardless of whether the manufacturer provides the program or materials.
• All expenses associated with food, entertainment, or gifts for more than $25 or anything provided to an HCP for less than market value. 1

Maine requires an annual report that includes the following information as it pertains to marketing activities conducted within the State in a format that provides the value, nature, purpose and recipient of the expense including:

o All expenses associated with advertising, marketing and direct promotion of prescription drugs through radio, television, magazines, newspapers, direct mail and telephone communications as they pertain to residents of Maine. (Expenses associated with advertising for a regional or national market that includes Maine are excluded).
o The following information for all persons or entities licensed to provide healthcare in the state, including anyone employed by a licensed HCP, health plan and benefits managers, pharmacies, hospitals, nursing facilities and clinics:

• All expenses associated with educational or informational programs, materials, seminars and the remuneration for promoting or participating in the programs, regardless of whether the manufacturer provides the program or materials,
• All expenses associated with food, entertainment, gifts valued at more than $25 and anything provided to a healthcare professional for less than market value,
• All expenses associated with trips and travel,
• All expenses associated with product samples, with the exception of samples that are distributed free of charge to patients,
• The aggregate cost of all employees or contractors of the manufacturer or labeler who engage in the advertising or promotional activities, including all forms of payment to the employees. The cost reported must reflect only the portion of payment to employees or contractors that pertains to activities within Maine or to the recipients of the advertising or promotional activities who are residents of or are employed in the State. 2

On the surface, the reporting requirements may seem straightforward; they can be if a manufacturer has been collecting and recording the required information in a manner that flows easily into an annual report. However, more often than not, that is not the case. The various departments and systems used to handle the collection of information can prove to be challenging when relying on the information to flow accurately into a report.

If you aren’t ready yet, it is time to get busy identifying where and how the necessary information is going to be collected into the July 1 report.

1. DC ST § 48-833.02 and § 48-833.03
2. 22 M.R.S.A.§2698-A