After several years, the Maine Board of Pharmacy issued its Notice of Agency Rule-making Proposal related to its gift ban law that was enacted in 2017. We have previously written about the law, and as a refresher the law essentially bans manufacturers or wholesalers, including its agents, from offering or giving a practitioner a cash gift in any amount, or a gift for which reciprocity is expected or implied.
There are exceptions, such as the provisions of prescription drug samples and educational items to practitioners, but the law also requires the Maine Board of Pharmacy to issue regulations for certain exceptions. Specifically, the law directs the Board Pharmacy to define “modest meals and refreshments,” “reasonable honoraria,” and “reasonable expenses” related to the honoraria. The following is the proposed language for each of the terms:
Modest Meals and Refreshments Proposed Definition: Food and beverage of minimal value provided to a practitioner in connection with a meeting or presentation about the benefits, risks, and appropriate uses of prescription drugs or medical devices, disease states, or other scientific information as long as the meeting or presentation occurs in a venue and manner conducive to informational communication. Such food and beverage must be of the type and quantity typically provided for conference attendees at the venue where the meeting or presentation occurs.
Reasonable Honoraria Proposed Definition: Cash and/or a gift given to a practitioner in return for the practitioner speaking at a professional or educational conference sponsored by a manufacturer or wholesaler. The aggregate value of all cash and gifts received by a practitioner for a particular speaking engagement may not exceed an annual limit of $250 in retail value.
Reasonable Expenses Proposed Definition: The reasonable and actual expenses for travel, lodging, and meals incurred by a practitioner and that are necessary in order for the practitioner to speak at a professional or educational conference sponsored by a manufacturer or wholesaler.
Commentary:
While the definition for “modest meals and refreshments” is mostly consistent with the PhRMA Code, it deviates by stating that food and beverage must be of “minimal value.” The term, “minimal value,” is referenced in the law, but it still remains vague and it is unclear what the term actually means. For example, under the PhRMA Code, items of minimal value include pens, note pads, and mugs. To avoid confusion, we would hope the final language aligns completely with the PhRMA Code. This would be similar to the approach Massachusetts took when implementing its final amendments (see p. 2) to the code of conduct regulations.
What is also unclear is how the Board of Pharmacy arrived at setting a $250 annual limit on honoraria. This annual limit would essentially ban practitioners from engaging in any speaking arrangements with manufacturers. In the context of the law/proposed regulation, honoraria would extend to consulting agreements for speaking engagements, as well as compensation for serving as faculty or as a speaker for an accredited/non-accredited or certified/noncertified. In reviewing Maine’s 2017 Open Payments data, approximately $1.45 million can be attributed to these nature of payments which amount to over 500 Maine physicians being impacted by this provision. The language around “for a particular speaking engagement may not exceed an annual limit of $250 in retail value” does not make sense, the state may need to clarify if this is a yearly limit or a limit per instance.
It should be noted that the law allows practitioners to receive reasonable honoraria for speaking at a professional or educational conference or meeting, but the proposed regulations limit the honoraria and related expenses to speaking at conferences.
The law gave no exceptions for consulting or research. In addition to education and meals, if this rule is enforced there is a question if clinical research or consulting can continue in Maine, neither of which was exempted in the law.
Next Steps:
A public hearing will be held on May 8, 2019, 8:00 a.m., 76 Northern Avenue, Gardiner, Maine 04333, Central Conference Room and comments to the proposal are due by May 19.
Comments are also being accepted and are due May 19, 2019 by 5:00 p.m., 76 Northern Avenue, Gardiner, Maine 04333, Central Conference Room.
Questions related to the proposed regulations can be directed to Geraldine Betts, Program Administrator, 35 State House Station, Augusta, ME 04333, Geraldine.L.Betts@maine.gov , (207) 624-8625, TTY users call Maine Relay 711.
When submitting comments and questions, use the subject line, “Pharmacy – Public Comment on Ch 12 Proposed Rule.”