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Maine Proposes Cap on Honoraria Paid to Practitioners by Medical Device and Pharmaceutical Manufacturers and Wholesalers

Alert
05.01.2019
By Tricia Kaufman

On April 17, 2019, the Maine Department of Professional and Financial Regulation published notice of a proposed rule, Exception to Prohibition Against Gifts to Practitioners, that would clarify the meaning of “modest meals and refreshments,” “reasonable honoraria” and “reasonable” travel expenses under Maine's gift ban laws, which are applicable to transfers of value to practitioners by medical device and pharmaceutical manufacturers and wholesalers.  

Honoraria

The most significant impact of the rule is that it sets an explicit limit on honoraria provided by manufacturers and wholesalers to practitioners who speak at manufacturer- or wholesaler-sponsored professional and educational conferences, though exactly how the amount is being capped is somewhat vague. The rule states that:

"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." (emphasis added)

Imposing an annual limit on a single speaking engagement seems somewhat odd. As written, the rule appears to anticipate that practitioners will receive cash and gifts for the same speaking engagement over a period of more than one year. It is unclear if, instead, the rule is meant to impose either a $250 limit for each speaking engagement or an annual $250 maximum from a single manufacturer or wholesaler per practitioner for all speaking engagements during a single year.

As an interesting comparison, although Maine legislators may not accept gifts intended to influence their decisions, with respect to non-prohibited gifts the Maine Governmental Ethics and Election Practices requires only that legislators disclose gifts with a value over $300, and the Maine statutes require legislators only to disclose honoraria of $2,000 or more.     

Meals and Travel Costs

Of less interest are the definitions of “modest meals and refreshments” and "reasonable expenses" in the context of travel and lodging, which appear to have been modeled after industry codes. While no specific cap is defined in the proposed rule for meals and travel costs in the proposed definitions, “modest meals and refreshments” must be: 

  • Of “minimal value” 
  • Provided in connection with a meeting or presentation
  • Typical of what a conference attendee would receive at the same venue  

Similar to the AdvaMed and PhRMA Codes, the venue for meals must be conducive to informational exchange, and discussions must be about the safe and effective use of the manufacturer’s products, disease states or other scientific topics.   

Payment of “reasonable expenses” for travel and lodging, which is permissible when a practitioner speaks at a manufacturer or wholesaler-sponsored professional or educational conference, means the actual, necessary and reasonable costs incurred. 

If you would like to comment on the proposed rule, a public hearing will be held at the Maine Department of Professional & Financial Regulation Office of Professional and Occupational Regulation on May 8, 2019 at 8 a.m. Eastern time. Alternatively, you may submit written comments until May 19 at 5 p.m. Eastern time.

Related Resources

Bureau of Corporations, Elections & Commissions for the State of Maine: Weekly Notices of State Rule-making for April 17, 2019

Department of Professional and Financial Regulation, Office of Professional Occupational Regulation, Maine Board of Pharmacy's Notice of Agency Rule-making Proposal

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