Life science trade associations PhRMA, Advamed, and BIO have sent a letter to the Centers for Medicare and Medicaid Services (CMS) voicing concerns about the Sunshine Act public database, set to go live on September 30. The associations request CMS to engage in open communication about the contextual information the agency will provide.
“[F]or implementation of the Sunshine Act to be successful and for the data to be meaningful to patients and the public, the CMS Open Payments program public website must provide clear background information and context regarding such industry relationships,” state the associations. “Such background ensures the reported data is helpful in patient decision-making.”
“Further, providing context for reported payments and other transfers of value is critical to ensuring patients do not form mistaken impressions that all payments to physicians are suspect.” The associations note that they have “repeatedly encouraged CMS to engage all stakeholders in a public process to develop this important context, consistent with the statutory requirement that CMS consult with affected industry and other stakeholders to ensure that the information made available to the public is presented in the appropriate overall context.”
However, with only a number of days before the system goes live, the associations state that they “have not been given an opportunity to review how CMS intends to present this crucial contextual information or to consult with CMS on its content.”
The associations are “hopeful that this situation can be addressed before the first expected release of Sunshine data September 30.” They believe “the need for context is even more critical where CMS intends to post only a portion of manufacturer-submitted data.” We have followed this issue extensively.
“It is not clear why this volume of data is being withheld. We are hopeful that this issue can be resolved expeditiously so that the data that is made available to the public is accurate, useful and complete,” the letter states.
Speaking to the importance of context, the associations note:
“Our constant innovation leads to the introduction of new and improved treatments that prevent illness, allow earlier detection of diseases, and improve patient outcomes. As industry representatives, we believe it is important that collaboration with physicians and other health care providers continues and thrives. These interactions help encourage R&D as well as physician education and training, and benefit patients.”
View the letter here: PhRMA Advamed BIO Letter to CMS
We will be interested to follow the countdown to the public database, and whether CMS engages with stakeholders about how the agency will display its data.