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, purchase, or use a product or service as part of the treatment of the individual or for case management or care coordination of that individual, such communication by a health care professional may violate the anti-kickback statute.
Similar examples of pharmacist communications with patients relating to the marketing of products on behalf of pharmaceutical companies were identified by the Office of the Inspector General (OIG) as problematic in a 1994 Special Fraud Alert (December 19, 1994, 59 FR 65372). Other violations have involved home health nurses and physical therapists acting as marketers for durable medical equipment companies. Although a particular communication under the Privacy Rule may not require patient authorization because it is not “marketing,” or may require patient authorization because it is “marketing” as the Rule defines it, the arrangement may nevertheless violate other statutes and regulations administered by the Department of Health and Human Services, Department of Justice, or other Federal or State agencies.