American Society of Hematology

Implementation of Sunshine Act Delayed

Published on: May 07, 2012

Included in the Patient Protection and Affordable Care Act (PPACA) is a provision that will require drug and medical device companies to begin recording any physician payments that are worth more than $10 in 2012 and to report and make public on the Web. This includes stock options, research grants, knickknacks, consulting fees and travel to medical conferences. The measure is based on a bill that was introduced more than two years ago by Senators Charles Grassley (R-IA) and Herb Kohl (D-WI). The senators believe that physicians who receive benefits from drug and device makers are more inclined to prescribe the priciest products. The provision, known as the Physician Payments Sunshine Act, was originally to be implemented in 2012, but the Centers for Medicare and Medicaid Services (CMS) has announced a delay until 2013 in order to provide time to address stakeholder concerns.

CMS will not require companies to collect transparency data before January 1, 2013. The new timeline is a delay from the original Physician Payments Sunshine Act, which required HHS to come up with final reporting procedures by October 1, 2011. Instead, draft regulations were released in December of 2011; during the following 60-day comment period, CMS was bombarded with more than 300 comments from stakeholders. ASH's comments strongly urged a delay in implementation.

In a press statement Senator Grassley called the delay disappointing. "The process has dragged on long past the statutory deadline for implementation. Consumers need to know more about the financial relationships between their doctors and drug companies sooner rather than later." Last April, Senators Grassley and Koh wrote a letter to CMS Acting Administrator Marilyn Tavenner, requesting that the final rule be released no later than June, to allow for partial data collection for 2012. Tavenner responded that given the flood of stakeholder comments, "CMS does not believe it is feasible to address all of the remaining issues in such a short time period."

While the new federal law stops short of banning gifts, it does promise to increase the public's understanding of how companies interact with physicians. Rather than simply listing names and dollar amounts, a new federal database that will be launched in September 2013 will include explanations of what services the physicians provided in return for the payments. Drop-down menus will make it simple for patients to parse the data by name, type of gift received, and other specifics.

The final rule for the Sunshine Act is expected to be promulgated later this year.

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