After a year of rule-making, Maine’s Board of Pharmacy (the “Board”) finally adopted the gift ban rules at its May Public Board Meeting. These rules provide manufacturers and wholesalers clear direction on the state’s gift ban law. In a win for the industry, especially CME providers and Maine-licensed practitioners, the rule does not set a cap on speaker honoraria and associated expenses.
For a refresher, in June of 2017, Maine’s legislature enacted a controversial gift ban bill that became law without the governor’s signature. The law broadly prohibits manufacturers and wholesalers from offering or giving gifts to health care practitioners licensed by the state of Maine. There are several exceptions, such as providing practitioners educational materials, prescription drug samples, “modest meals and refreshments” in connection with a meeting or presentation, and “reasonable honoraria” and “reasonable expenses” associated with speaking engagements. The law also required the Board to establish rules to define “modest meals and refreshments,” “reasonable honoraria,” and “reasonable expenses.”
Proposed regulations issued in April of 2019 ambiguously defined “modest meals and refreshments” as food and beverage of “minimal value,” set a $250 annual cap on honoraria, and considered the “reasonable expenses” associated with honoraria to be “the reasonable and actual expenses for travel, lodging, and meals” that the speaker incurs. The Board did not provide clarity on the scope of the law, whether research-related payments were banned, and the law’s applicability to CME programs. Without clarity, the proposed regulations added to the chilling effect of the broad gift ban law.
The CME Coalition, a Washington-based organization comprised of CME providers, beneficiaries of CME, and supporters of CME, submitted comments highlighted the chilling effect and asked the Board to “[e]liminat[e] the proposed rule’s strict limitation on the provision of honoraria to faculty members participating in accredited CME activities [to] allow physicians to continue to participate in CME without the risk of conflict-of-interest Maine rightly [sought] to curtail.” Altogether the Board received 117 comments with a majority of the comments from individuals. Notable commenters represented AdvaMed, King & Spalding’s Ad Hoc Sunshine and State Law Compliance Group, Pfizer, BIO, the Insight Association, and Northern Light Health (an integrated health care system in Maine).
The Board clarified and addressed areas of ambiguity, such as the meaning of “minimal value” in relation to modest meals and refreshments, “reasonable honoraria,” the scope of the gift ban, and bona fide marketing research. The rules went into effect on Saturday, June 6. The following provides a high-level summary:
- Modest Meals and Refreshments: The Board clarified that “minimal value” in relation to modest meals and refreshments “means the cost of which is similar to that which a practitioner would pay when dining at his or her own expense as judged by local standards where the event is held.” No monetary limits were established by the Board.
- Reasonable Honoraria: While the Board disagreed on rescinding an annual cap altogether, the Board agreed to increase the cap to $500 annually. Importantly, the Board stated “honoraria is a gift or gratuity in recognition of the practitioner’s presentation and does not include fee for service paid to the practitioner for the presentation, travel or lodging reimbursement, or other expenses incurred.” Further, “[t]he Board agree[d] that if a manufacturer or wholesaler sponsors a conference or meeting event with a dollar donation, and the manufacturer or the wholesaler does not and is not a participant in the selection of the practitioner chosen for the speaking engagement, nor does it influence or pay the practitioner directly, the honoraria limitation does not apply to such professional or educational meeting or presentation events.”This means that speaker fees associated with CME and non-CME programs, along with associated expenses for travel, lodging, and meals, are not subject to the $500 annual cap. The only items subject to the cap are those above and beyond the speaker’s fees (e.g., a token or gift bag; see Northern Light Health’s comment that the Board highlighted on p. 9).
- Practitioners: The Board clarified that the term “practitioner” does not include pharmacists. The term “practitioner” is defined by statute and means “…an individual who is licensed, registered or otherwise authorized in the appropriate jurisdiction to prescribe and administer drugs in the course of professional practice.” Further, the gift ban applies to “Maine licensed practitioners and does not apply to practitioners licensed outside Maine.”
- Bona Fide Marketing Research: The Board recognized that the gift ban law did not specifically exempt research-related payments. It stated that although the Maine Legislature gave it limited authority (i.e., to define by rule “modest meals and refreshments” and “giving reasonable honoraria”), it “[did] not believe the law prohibits payment to a practitioner for services rendered and would not be a matter subject to Board action.”
The industry, along with Maine-licensed practitioners, should view the final rule as good news. These rules should not disrupt business operations—current modest meal and refreshment limits set by companies should suffice and giving items above and beyond speaker fees and associated expenses are not recommended (should companies choose to, then monitoring will need to be established). Given the Board’s limited authority for rule-making and its position on how it would not take action against companies for making bona fide marketing research payments, we believe this extends to other transfers of value such as all research-related payments and consulting fees.
More details on the Maine regulations will be provided in the July Issue of Policy and Medicine Compliance Update.