A path forward: Corporate Integrity Agreement sheds light on manufacturer interactions with independent charitable foundations

Manufacturers of pharmaceuticals and biologics have been closely watching the industry-wide investigation by the Boston U.S. Attorney's Office into manufacturer support of independent charitable foundations that assist financially needy patients, including federal healthcare program beneficiaries, obtain access to drugs and other items and services vital to treating their chronic diseases, most often in the form of copayment assistance.

The government's multi-year investigation has forced the industry to consider how manufacturers can continue to support these programs that provide an important safety net for many patients. A recently announced settlement and Corporate Integrity Agreement (CIA) provides the most direct articulation of the controls and policies the government will expect manufacturers to implement when donating to and interacting with independent charitable foundations.

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