Dec. 22, 2011 – As industry groups focus on the details of last week’s proposals from HHS to implement the Sunshine Act provisions of the Affordable Care Act, veteran journalist Cole Werble in PrevisionPolicy recently made a set of predictions on how Sunshine may change the marketing spend of the medicines industry.
Among several predictions, Werble states that “the added burdens and specific rules of the disclosure provisions will continue to nudge pharma budgets away from the broad dispersal of speaking and research funds for practitioners and towards other forms of spending.”
The article highlights key provisions in the proposed regulations that will have an impact on pharma marketing and calls out pitfalls in the proposal.
Meanwhile, the Coalition for Healthcare Communication and other industry groups are sharing information and coordinating efforts to provide robust comments to HHS on many of the details in the Notice of Proposed Rulemaking published
Dec. 19 in the Federal Register.
“While HHS wisely decided to postpone implementation, there are several devilish details in the proposed rules,” explains Coalition Executive Director John Kamp. “For example, the proposed rules inappropriately expand the scope of the statute, sweeping in activities not intended by Congress. In particular, many indirect payments to doctors for REMS and certified CME should not be included.”
Many of the relevant details in the proposal are outlined in the Medical Policy Blog published by Thomas Sullivan of Rockpointe Communication: http://www.policymed.com.
For more information on the proposed rule and to join the industry discussion on how to effectively participate in the HHS rulemaking process, contact John Kamp at email@example.com. Comments must be sent to the Centers for Medicare & Medicaid Services by Feb. 17, 2012.