Shedding Light on the Sunshine Act

On February 1, 2013, the Centers for Medicare and Medicaid Services (CMS) unveiled the final version of the Physician Payments Sunshine ACT (PPSA). The Act was created by Congress to ensure transparency in the interactions between physicians and the manufacturers of pharmaceutical, biotechnology, and medical device products.
An unintended side effect of PPSA is that it created a great deal of confusion concerning educational materials given to physicians by manufacturers. When PPSA was passed by Congress in 2010 it clearly exempted patient education materials. Regardless of the monetary value of educational materials covered by the act, they are exempt from reporting requirements. Examples of materials that are excluded from reporting include:

• Any material that benefits patients or is intended for use by patients
• Patient kits, even those containing samples
• Patient kits, even those containing samples
• Anatomical models that help physicians educate their patients
• A flash drive that contains patient education materials to be distributed to patients
• Overhead expenses, such as printing and time, are excluded as long as they’re directly related to developing materials that benefit patients or are intended for patient use

Confusion arose when CMS announced that it would be narrowly interpreting the exclusion requirements for educational materials. But after the initial confusion, CMS clarified what it meant by “narrowly interpreting,” explaining that “education materials, such as medical textbooks or journal reprints, that are educational to covered recipients but are not intended for patient use or directly beneficial to patients are not included in the exclusion.”
According to CMS, the litmus test for whether an educational material is excluded from reporting requirements is that it must directly benefit patients. The good news in that requirement is that Artcraft Health Education creates an amazing array of educational materials that meet that test. Our custom materials in digital and traditional media help manufacturers reach their key audiences while strictly complying with the PPSA. Call us today to learn more.
Key Upcoming Dates regarding the Physician Payments Sunshine Act

• August 1, 2013: Manufacturers begin collecting information on included payments to physicians
• December 31, 2013: First reporting period ends
• January 1, 2014: Second reporting period begins
• March 31, 2014: Manufacturers report all 2013 information to CMS
• September 30, 2014: CMS releases reports on a public website

Tom Savonick - Medical Writer