Coalition Calls for Substantial Revisions to Sunshine Act Proposed Rules

Feb. 16, 2012 – Further notice and comment are necessary for the implementation of Section 6002 of the Affordable Care Act – known as the “Sunshine Act” – to ensure that the data submitted under the Act are accurate and are placed in the proper context for public understanding, according to the Coalition for Healthcare Communication Sunshine Act Comment submitted to the Department of Health & Human Services (HHS).

“Although the Coalition understands the importance of  transparency, there are numerous issues that need to be resolved – and further commented on by all stakeholders – if the rule is to fulfill its intended purpose,” said Coalition Executive Director John Kamp. “To get transparency right, the HHS must do a further notice on accuracy and context,” he asserted.

The Coalition is concerned that the current proposal would have a chilling effect on important collaborations between industry and healthcare providers, lead to unnecessary and significant complexities, increase costs and create public perception issues. These concerns “must be addressed fully before final rules are adopted,” according to the Coalition comment.

“Rubber-stamping the proposal as written would be a huge mistake that, ultimately, would hurt, rather than protect, patients,” Kamp noted, adding that the public perception issues are particularly important.

“It”s time for the press and some politicians to stop treating every reported payment as a newly uncovered scandal,” he said. “The real scandal is the demonization of collaborations between industry, academia and government. Collaboration has enabled the great medical breakthroughs that have added 10 years to the average American life in just a generation.”

In addition to the call for a further notice on accuracy and context, the Coalition’s comments focus on several areas needing additional refinement and review, and make the following recommendations:

  • HHS should hone the rules to more accurately reflect the legislative intent and the specific language of the statute, and “narrow its burdens and reach” accordingly. The Coalition cites indirect payments and vital prescriber education as examples of how HHS has expanded its purview under the proposed rule.
  • HHS should take a closer look at the costs associated with the proposal, including the significant cost of industry and provider compliance. The Coalition believes that HHS has underestimated the direct compliance costs and largely ignored the indirect “intangible costs of possibly misleading patients, caregivers and professionals regarding the nature and value of these relationships.”
  • HHS should clarify explicitly in the final statement of the rule that  commercially supported meetings and educational enduring materials are not intended to be covered by the statute and are not subject to any reporting requirement.

Further, because many details of the proposed rule are unknown, the Coalition is concerned that entities involved in the medicines industry will simply avoid many collaborative programs that provide healthcare providers with valuable professional education. Such a result “would harm, not help, patients,” Kamp said. “There is a lot more work to be done.”