While reporting requirements under the Sunshine Act have yet to kick in, the payment transparency program is already facing allegations that a specific provision may violate the First Amendment. The Washington Legal Foundation sent a letter to CMS May 15 arguing that requiring drug and device manufacturers to report gifted medical textbooks "would constitute a serious infringement on the First Amendment rights of pharmaceutical companies to disseminate medical texts and the First Amendment rights of doctors to receive such information."

WLF says medical textbooks constitute free speech and that a reporting requirement could lead to harassment and investigations for both manufacturers and physicians. Furthermore, WLF says the U.S. Supreme Court has already ruled that pharmaceutical company speech to physicians, even if only for the purpose of selling a product, is protected by the First Amendment. (Sorrell v. IMS Health Inc., 131 S. Ct. 2653, 2672 (2011))

The Sunshine Act, officially known as the National Physician Payment Transparency Program, was created by Section 6002 of the Affordable Care Act, and requires manufacturers of drugs, devices, and other medical supplies and group purchasing organizations to report certain payments or transfers of value to physicians or teaching hospitals. While the program includes a reporting requirement exclusion for educational materials that directly benefit patients, medical textbooks do not qualify.