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42 U.S. Code § 17936. Conditions on certain contacts as part of health care operations
(a) Marketing
(1) In general
A communication by a covered entity or business associate that is about a product or service and that encourages recipients of the communication to purchase or use the product or service shall not be considered a health care operation for purposes of subpart E of part 164 of title 45, Code of Federal Regulations, unless the communication is made as described in subparagraph (i), (ii), or (iii) of paragraph (1) of the definition of marketing in section 164.501 of such title.
(2) Payment for certain communicationsA communication by a covered entity or business associate that is described in subparagraph (i), (ii), or (iii) of paragraph (1) of the definition of marketing in section 164.501 of title 45, Code of Federal Regulations, shall not be considered a health care operation for purposes of subpart E of part 164 of title 45, Code of Federal Regulations if the covered entity receives or has received direct or indirect payment in exchange for making such communication, except where—
(A)
(i)
such communication describes only a drug or biologic that is currently being prescribed for the recipient of the communication; and
(ii)
any payment received by such covered entity in exchange for making a communication described in clause (i) is reasonable in amount;
(B) each of the following conditions apply—
(i)
the communication is made by the covered entity; and
(ii)
the covered entity making such communication obtains from the recipient of the communication, in accordance with section 164.508 of title 45, Code of Federal Regulations, a valid authorization (as described in paragraph (b) of such section) with respect to such communication; or
(C) each of the following conditions apply—
(i)
the communication is made by a business associate on behalf of the covered entity; and
(ii)
the communication is consistent with the written contract (or other written arrangement described in section 164.502(e)(2) of such title) between such business associate and covered entity.