If you sell to doctors in Massachusetts, say goodbye to the promotional pen.
A state agency finalized the nation’s toughest rules governing gifts by medical device manufacturers and pharmaceutical firms to physicians.
The regulations, enacted as part of a healthcare reform measure passed last summer, contain sweeping limits and outright bans on gifts to physicians, including meals, tickets and even pens.
The rules, unanimously approved by the Massachusetts Public Health Council March 11, also mandate stringent public reporting standards that detail how much companies gave, when they gave it and to whom. The rules go into effect July 1, 2009, with the first reports coming out July 1 the following year.
One provision bars companies from doling out tickets to sporting or entertainment events; another rules out cash payments of any kind except for “bona fide services.”
And get your hands on as many brand-bearing pens while you can: Gifts of all promotional items, including pens, calendars and coffee mugs, are against the law as of July 9.
Companies must report any gift-giving of more than $50 to the Mass. Dept. of Public Health, which will make the filings available to the public, searchable by physician and company, on its website.
The rules make the Commonwealth the only state to require companies to adopt a government-mandated code of conduct and to require fully transparent gift disclosure by pharma and med. device makers. They also make the Bay State’s definition of “sales and marketing” the broadest of any state’s.
There are a few exceptions in the rules. For example, device manufacturers can still provide gratis demo and evaluation models to doctors and other providers, and charitable donations are still allowed.
And while they ban financial support of interns, residents or other healthcare providers-in-training, there are allowances for meals.
Companies can feed attendees of training or educational sessions, as long as the meals are “modest” (stick to the unassuming $15 Cabernet) and as long as they occur inside a hospital or doctor’s office (whoops, there goes that nice Cabernet).
And the doctor’s spouse will have to brown-bag it: “Meals to spouses or other guests are prohibited.”
Industry-funded research projects and clinical trials are still kosher, but companies must disclose how much they pay for so-called “seeding trials” aimed at promoting a particular device or drug. The funding behind pure research projects and trials need not be disclosed.
Rebates, discounts and other price concessions (including prescription drugs “provided solely and exclusively for patient’s use”) are also legal.