Tuesday, August 27, 2013

Sunshine Act could cause 3rd degree sunburns

Check out an article in the August 2013 issue of MedAdNews entitled "Responding to Sunshine" (it isn't online yet as far as I can tell as of this writing).

Here's the scary part, which comes close to the end of the piece:

"Federal and state agencies will regularly consult the data to uncover investigation opportunities. The IRS may start auditing physician tax filings once they see the posted data. The DOJ will be looking for potential violations of the Ant--Kickback statute (AKS), where payments may be seen as inducements to prescribe products. And if a claim is submitted to a federal health care program for payment of items prescribed in violation of AKS, the False Claims Act could be implicated. We will see cases brought that link Sunshine to both of these laws."

So physicians will not just risk public exposure and embarrassment when they accept payments from pharma, they will be exposed to serious legal risks.

Clearly, the Sunshine Act is going to exert a powerful disincentive for physicians to provide any services or accept anything of value from the industry. There are clear downsides. Valuable industry-professional collaboration may cease to exist. Some industry business models may be vaporized, with a commensurate impact on sales.

However, there may be a silver lining to these clouds. Opportunities for new service businesses may arise to provide services previously rendered by physicians. Industry expenses may be reduced by enforcing rules that apply to every pharmaceutical company and physician, with stiff penalties for non-compliance. 

Only time will tell how these benefits and risks play out. But one thing is clear: physicians will be loathe to accept any money from pharmaceutical companies if the legal risks become clear as enforcement actions ensue.

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