The Sunshine Act: Unintended consequences

March 07, 2014

There have been a lot of news stories lately on the impact that the Sunshine Act is having on health care companies. The Sunshine Act is a component of the Affordable Care Act (Obamacare) that requires manufacturers of drugs or medical devices report payments or gifts given to physicians and teaching hospitals.

The objective of the act is certainly well-intentioned — payments to doctors can create conflicts of interest and compromise objectivity in a way that patients are often ill-suited to sort out. With much of the conventional marketing most of us encounter in our daily lives, we are generally pretty well equipped to filter and discount as appropriate. When the toothpaste promises us a brilliantly white smile or the soft drink implies we’ll be profoundly more hip and attractive - most of us can recognize and contextualize the hyperbole. Healthcare is of course different. The stakes are higher and our level of understanding and intuition are often far lower. The need for trust is supreme. When our doctor tells us to take a particular medication or undergo a particular procedure, most of us simply do so (as an aside, that’s something that probably needs to change). Even well-intentioned doctors could be subtly influenced by their economic ties to a specific treatment. So the government has stepped in and now requires healthcare companies to fully disclose any payments to doctors in the interest of making the potential conflict a lot more visible. Makes sense.

One interesting and unintended consequence of the Sunshine Act has hit our business specifically. We do a lot of innovation work in the healthcare and medical device markets and a key element of our design methodology is ‘immersing’ ourselves with the ‘users’ of medical products and pharmaceuticals. That’s how we can design and develop tomorrow’s healthcare —by studying today’s healthcare and looking for opportunities, paint points, mistakes and shortcomings.

When doing this type of work it is customary to pay a modest honorarium to doctors for a few hours of their time — compensating them for the interruption as they allow us to interview them or observe them as they work.

Our research certainly isn’t intended to sway doctors into prescribing or using any particular device — we’re trying to study behavior and determine habits, needs, features or functions that would improve care. The flow of information in these interviews and observations is almost entirely from the doctors to us — not vice versa. And of course most of our research pertains to drugs, products and services that aren’t even on the market yet. There’d be nothing for the doctors to promote even if they wanted to.

When the toothpaste promises us a brilliantly white smile most of us can recognize the hyperbole. Healthcare is, of course, different. The need for trust is supreme.

But the Sunshine Act can’t (understandably) make any distinction between our research to help design new products and experiences - and payments to doctors that might create a conflict of interest with prescribing current treatments. So our research gets trapped up in the Sunshine Act. Our clients grapple with how to make sure they are fully complying with the intent — and the letter of the agreement. Seemingly simple tasks get layered with complexity, forms, policies, procedures and confusion. And our design firm ends up needing to painstakingly and exhaustively document any payments to doctors for our clients. It’s not terrible — we’ve actually gotten pretty good at it – but it’s laborious, time-consuming, expensive and inefficient. Exactly the types of things that the affordable care act was designed to combat. Hmmm.

And it’s getting a bit more challenging to find doctors to agree to talk with us. They’re busy and it’s becoming a pain. They need to fill out W9s and sign scary forms. Increasingly they realize they’ll end up in a database and might one day have to explain a payment that could be construed by someone with an axe to grind as a conflict of interest. So many of them are figuring it’s just not worth it. This is a real shame since there’s no better way to design solutions to the huge problems facing modern healthcare than to actively involve doctors. Probably not what the people drafting the Sunshine Act had in mind.

Will the benefits of the Sunshine Act outweigh any unintended consequences? Only time will tell.