What effect do the “marketing” provisions of the HIPAA Privacy Rule have on Federal or State fraud and abuse statutes?
The Privacy Rule makes it clear that nothing in the marketing provisions of the Privacy Rule are to be construed as amending, modifying, or changing any rule or requirement related to any other Federal or State statutes or regulations, including specifically anti-kickback, fraud and abuse, or self-referral statutes or regulations, or to authorize or permit any activity or transaction currently proscribed by such statutes and regulations. Examples of such laws include the anti-kickback statute (section 1128B(b) of the Social Security Act), safe harbor regulations (42 CFR Parts 411 and 424), and HIPAA statute on self-referral (section 1128C of the Social Security Act). The definition of “marketing” is applicable solely to the Privacy Rule and the permissions granted by the Rule are only for a covered entity’s use or disclosure of protected health information. In particular, although the Privacy Rule defines the term “marketing” to exclude communications to an individual to recommend, pur
