As Trumpcare emerges what will happen to the Sunshine Act and the healthcare transparency ecosystem?
President Barack Obama’s legacy legislation, the Patient Protection and Affordable Health Care Act (PPACA, a.k.a. ACA) is dominating the headlines again as members of Congress contemplate its future in the new Trump administration. Press coverage is focused on the insurance – pricing, pre-existing conditions and the age at which kids get cut off from their parent’s insurance. Yet, less has been said about the particulars of the Open Payments law aka the Sunshine Act.
First of all, it’s one of 27 acts included in the ACA’s comprehensive health care legislation, which was passed into law in 2010. The law requires pharmaceutical, bio-pharmaceutical, medical device, dental companies, and Group Purchasing Organizations (GPOs) to track and report all financial transactions. Payments or transfers of value” (ToVs) greater than $10, to any physician or teaching hospital must be reported. This includes modest meals, travel expenses, speaking fees, consulting fees, research payments, notepads, or gifts of stock made to health care providers or academic teaching institutions.
Although the ACA was under scrutiny by the Supreme Court for its constitutionality in 2012 the law was instituted. The rule making process took almost three years and was finally promulgated Feb. 1, 2013. Therefore, on or before March 31, 2017, about 1,800 life sciences manufacturers will submit reports identifying all payments and transfers of value made to physicians and teaching hospitals in 2016.
What happened to the Sunshine Act aka Open Payments and the healthcare transparency ecosystem?
As we enter the third year for Sunshine Act aka Open Payments reporting, it’s a good time to assess the effects of the “Sunshine Provisions.” I wrote a cover story, “Health Care Transparency Law Exposes Industry Relationships with Physicians,” for Healthcare Review North East Network in April 2012 about the public scrutiny that comes with the public disclosure of all payments and transfers of value made to physicians from life sciences manufacturers.
Since 2010 transparency laws have spread throughout the world. Most noteworthy, is the proliferation of transparency laws throughout the world with 38 countries now requiring transparency reporting and disclosure of ToVs to publicly available websites.
Scotland is likely to join its former EU countries as it’s considering legislation requiring life sciences companies to declare financial payments made to healthcare providers on a single, central, searchable register. In addition, Saudi Arabia’s Saudi Food & Drug Authority (SFDA) issued a draft initiative for transparency reporting by pharmaceutical companies. South Korea also amended the Korean Research-based Pharmaceutical Industry Association (KRPIA) Code of Conduct to include transparency reporting requirements.
The European Federation of Pharmaceutical Industries Association (EFPIA) requires its members to report ToVs in the country in which the physician’s primary practice resides. Currently there are 33 countries that report under the transparency provisions of EFPIA. In addition an other group to join the growing number of countries are Trade Associations, such as MedTech Europe, with transparency reporting obligations for member companies effective Jan. 1, 2017.
The Sunshine Act goes global
So it’s fair to say that the healthcare transparency ecosystem is going global. But what about the Open Payments law here in the United States? Will the new Trump administration repeal the ACA and along with it Open Payments? Will Trump be tough in principal and soft in practice? More on these topics in future blog posts “Trump and the FCPA: The future of life sciences investigations” and “Trumpcare and the future of the U.S. Open Payments program.”