Health care partner Tom Bulleit (Washington, D.C.) was quoted in a Jan. 10 Law360 article on a lawsuit against the Office of the Inspector General for the U.S. Department of Health and Human Services challenging OIG’s authority to place restrictions on medication patient assistance programs and their communications with drug manufacturer donors. The lawsuit, filed by Patient Services Inc., a charity providing financial assistance to patients with high medication costs, alleges that restrictions placed by OIG in an advisory opinion on PSI’s communications with donors violates the First Amendment free speech rights of PSI and its donors.
Mr. Bulleit explains that the OIG will likely argue that the advisory opinion issued to a patient assistance program that helps cover drug copayments for low-income patients represents a “safe harbor” from potential anti-kickback law liability rather than restricting free-speech rights. He notes that a successful lawsuit against the OIG could help the drug industry’s ability to address objections to high drug prices through charitable support for patient assistance programs.
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