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Health Law

: HealthBlawg

Massachusetts Code of Conduct finalized for Pharma, device manufacturers, health care providers

By David Harlow

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The code of conduct adopted in Massachusetts is the most restrictive set of rules in the nation, crows the Department of Public Health, and mutters the industry. The final MA pharma and medical device conflict of interest rule is posted on the DPH website, together with related comments, memos and presentations. In brief, the rule "sets out what is and is not permissible for pharmaceutical and medical device manufacturers with respect to providing meals, sponsoring continuing medical education and other conferences, and otherwise providing payments or other items of economic benefit to Massachusetts health care practitioners."

Some fear the new regulations will lead to a drop in medical conferences held in Massachusetts, further battering the local economy.

Some wonder whether they would have helped nip in the bud past medical research fraud (probably not).

So what do they do? They implement part of the Massachusetts health reform law, part 2, so much of the commentary ought to have been (and was) directed at the legislature a while back, before it took action, and not at DPH, which is essentially just implementing the legislation. The rules build on PhRMA and AdvaMed codes of conduct, but do go a wee bit further. In DPH legalese:

Chapter 111N and 105 CMR 970.000 regulate pharmaceutical and medical device manufacturer conduct in three ways, requiring pharmaceutical and medical device manufacturers to: (1) adopt and comply with a state-authored code of conduct, (2) provide compliance information to the Department, and (3) disclose sales and marketing related payments to covered recipients. Sections 970.006-970.008 of the Department?s proposed regulations set out what is and is not permissible for pharmaceutical and medical device manufacturers with respect to providing meals, sponsoring continuing medical education and other conferences, and otherwise providing payments or other items of economic benefit to Massachusetts health care practitioners. Additionally, the Department?s proposed regulation outlines the statutory compliance directives in Section 970.005 and interprets the contours of the disclosure requirements for pharmaceutical and medical device manufacturers in Section 970.009. Finally, the Department?s proposed regulation reiterates the penalties outlined in Chapter 111N and provides procedures for enforcing the code of conduct, compliance and disclosure requirements of 105 CMR 970.000. The Department?s proposed regulations seek to address potential undue influence in interactions between pharmaceutical or medical device manufacturing companies and health care practitioners, and increase transparency with respect to such relationships without compromising Massachusetts health care consumers? access to clinical trials and new discoveries and treatments arising from legitimate and beneficial industry interactions with health care practitioners.

See the final reg hotlink above for the full memo, FAQs, the full text of the regs, a presentation outlining the regs and comparing them with other states' regs, etc.

There's a lot to digest here. Bottom line: Massachusetts may be in the vanguard on this front, but the industry and the rest of the nation will be following right along, as the pendulum swings to the pro-regulatory mindset. There is less and less stomach in Washington and on Main Street for anything that even smells of financial impropriety, and the national imperative to get health care costs in check will likely fuel further action on this front.

David Harlow
The Harlow Group LLC
Health Care Law and Consulting

Full post as published by HealthBlawg on March 13, 2009 (boomark / email).