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Pharma companies are still struggling with how to comply with Open Payments, formerly known as the Sunshine Act section of the Patient Protection and Affordable Care Act. Here are some practical suggestions that will help.
The Open Payments—formerly known as the Sunshine Act—section of the U.S. healthcare reform law requires certain manufacturers of covered drugs, devices, biologicals, and medical supplies to report payments or other transfers of value they make to physicians and teaching hospitals to the Centers of Medicare and Medicaid, or CMS.
This is easier said than done, as companies continue to struggle with interpreting the rules and making changes to internal business processes to accommodate the requirements. Here are some best practices that Melissa LaFrain, senior manager, corporate compliance, Wright Medical Technology, shared with the audience at the 2014 Pharma Forum, held in March in Orlando and co-organized by MeetingsNet and CBI.
1. Develop an “Assumptions” Document
The assumptions document explains the reasonable assumptions made and methodologies used as part of a company’s good-faith effort to interpret and implement its tracking and reporting obligations under Open Payments. The document should explain your interpretations of the law and how the information will be derived from the different business areas. “While CMS does not require companies to submit an assumptions document, it will help support your methodology if someone comes knocking on your door. Be sure to have the document reviewed by outside counsel,” said LaFrain.