As the Obama era comes to close, and with huge uncertainty, fear and loathing about almost all aspects of the upcoming Presidential, House and Senate elections, forecasting the regulatory environment is a crap shoot. So, why not take a look at one of the regulations we already have, and see if it’s lived up to its promises?
As a provider of employee reporting software, our customers in the healthcare sector look to us for guidance on the Sunshine Act, aka Open Payments, enacted in 2010. In a nutshell, this law requires medical product manufacturers to disclose any payments, gifts, honoraria, travel or other transfers of value made to physicians or teaching hospitals.. So, how’s it working out?
Not so good, according to independent analysts. Compliance professionals must prepare for and comply with complex tracking and reporting requirements. A recent article by Jeanne Lenzer, in the BMJ, a scholarly medical journal published in the UK, suggests that the Sunshine Act has done little in achieving its stated objective of protecting the healthcare system from undue industry influence.
A Major Reason
A major reason is loopholes. According to Lenzer, 12 types of payments are exempt from the reporting requirement, including “payments for specific types of continuing medical education, receipt of product samples, and discounts and rebates.”
What about transparency?
Lenzer writes that it is “unclear whether transparency has led to a substantive change in biased prescribing practices.” But…so what? While the ultimate aim of the law was to lessen industry influence, it’s clear that manufacturers and providers can be fully compliant while conducting business as usual.
The future of the Sunshine Law is certainly cloudy, with poor visibility. After failure to become law, it was finally passed as part of the Affordable Care Act. What will happen the ACA in the next administration? And do consumers really know, or care, enough about transparency to provide popular support for giving it more teeth?
There’s one thing that’s certain. The Sunshine Act won’t go away. Even with our current legislative log jam, almost 600 bills were passed into law this year? How many laws on the books were repealed? Few to none.
In addition, the Sunshine Act (Open Payments), like most regulations, is now under the care and feeding of the unelected federal bureaucracy. While these folks can’t amend or change the law, they surely will do their bureaucratic best to enforce the law with new and creative administrative requirements. In other words, the burden of compliance will increase, no matter who sits in the Oval Office.
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