Device and pharmaceutical makers who market products in the Commonwealth of Massachusetts are going to face an even greater degree of scrutiny when it comes to reporting gifts and contributions to physicians starting July 1.

The new state law cuts deeply for some – asking companies to report on financial interactions with healthcare providers and identify compliance officers responsible for such, have a marketing code of conduct and train employees on the program and establish policies and procedures for investigation and corrective action.

The move was approved back March by the Massachusetts Public Health Council (Medical Device Daily, March 18, 2009).

For nearly two hours on Thursday, med-tech companies took part in an audio conference titled "Massachusetts Pharmaceutical & Medical Device Conduct Law: Practical Advice on How to Comply," hosted by the Advanced Medical Technology Association (Advamed; Washington).

The conference discussed the law in depth and how companies could best be in compliance with it.

"I'd say a practical component for companies is to get ahead of the curve and explain to their customers what's going on and what they can expect," said Roger Louis, chief compliance officer with Genzyme (Cambridge, Massachusetts) and a panelist.

The code that starts in two weeks will require reporting contributions to the Massachusetts Department of Public Health for the last six months of 2009 and submitted to the department by July 1, 2010. The new law would require reporting of all payments or economic benefit over $50 and not aggregated.

Other key factors in the law include:

• Payment for entertainment or recreation is prohibited, such as tickets to a sporting event, passes to a museum, etc.

• Payments in cash or cash equivalents to healthcare providers, either directly or indirectly, are prohibited, except as compensation for bona fide services.

• Financial support by manufacturers to healthcare practitioners in training.

• Complimentary items such as pens, mugs, and calendars are banned.

• Meals are restricted and in some instances prohibited. For example, any meals given to healthcare providers must be modest, and only provided at a training or educational event. They generally cannot be provided or paid for when they occur outside of a healthcare provider's office or the hospital setting. Meals to spouses or other guests are prohibited.

The rules allow for industry to sponsor conferences and professional meetings at hotels and convention centers.

The meals section seemed to draw a bit of frustration and ire from members of the audience. One caller in particular vented at the strictness of the law, saying that it was borderline ridiculous.

"So I can't even invite them into my office for a sandwich," the caller asked. "We're struggling with not even being able to buy them a sandwich?"

The law even reaches outside of the state and is focused on any Massachusetts resident, in whatever part of the country they're in.

"If you can't feed them in Massachusetts, you can't feed them outside of the state either," Louis said describing how the law applies to Massachusetts doctors visiting other states.

He added that people unhappy with such provisions should get use to it, because more states are sure to follow, according to Louis. Already communication has been severely limited between doctors and med-tech companies.

"Go back to the desperation these folks (from med-tech companies) are feeling right now," Louis said. "They can't get 10 minutes with doctors anymore. Imagine the temptation they must feel to pull these doctors aside and say let's get a drink and let me tell you about what my company is working on now. But people from the compliance department of that company should tell them this isn't OK."

The audio conference comes on a political landscape laden with transparency policies. The biggest attention-getter so far is the Physician Payments Sunshine Act, which was drafted by U.S. Sens. Chuck Grassley (R-Iowa) and Max Baucus (D-Montana).

With the Sunshine Act struggling to come into being, states could take a page out of Massachusetts' book and adopt such strong statewide policies.

Just last month several groups – the American College of Radiology (ACR; Reston, Virginia), American College of Emergency Physicians, (Irving, Texas), American College of Cardiology (Washington), American College of Rheumatology (Atlanta) and American Society of Plastic Surgeons (Arlington Heights, Illinois) issued a statement that said each would be hard-pressed to extensively sever economic ties with these med-tech companies since the economy has gone south (MDD, May 4, 2009).

But with transparency on the horizon, Louis said Massachusetts could become the "gold standard" for states and that there would probably be more policies on the way.

He warned that "This is probably just the beginning."