Us Code § 17936 - Conditions on certain contacts as part of health care operations
Full text of Us Code United States Code § 17936 — Conditions on certain contacts as part of health care operations, with citation guidance and answers to common questions.
§ 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 communications
A 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.
(3) Reasonable in amount defined
For purposes of paragraph (2), the term "reasonable in amount" shall have the meaning given such term by the Secretary by regulation.
(4) Direct or indirect payment
For purposes of paragraph (2), the term "direct or indirect payment" shall not include any payment for treatment (as defined in section 164.501 of title 45, Code of Federal Regulations) of an individual.
(b) Opportunity to opt out of fundraising
The Secretary shall by rule provide that any written fundraising communication that is a healthcare operation as defined under section 164.501 of title 45, Code of Federal Regulations, shall, in a clear and conspicuous manner, provide an opportunity for the recipient of the communications to elect not to receive any further such communication. When an individual elects not to receive any further such communication, such election shall be treated as a revocation of authorization under section 164.508 of title 45, Code of Federal Regulations.
(c) Effective date
This section shall apply to written communications occurring on or after the effective date specified under section 13423.1
(Pub. L. 111–5, div. A, title XIII, §13406, Feb. 17, 2009, 123 Stat. 268.)
Editorial Notes
References in Text
Section 13423, referred to in subsec. (c), means section 13423 of div. A of Pub. L. 111–5, which is set out as an Effective Date note under section 17931 of this title.
Statutory Notes and Related Subsidiaries
Effective Date
Section effective 12 months after Feb. 17, 2009, except as otherwise specifically provided, see section 13423 of Pub. L. 111–5, set out as a note under section 17931 of this title.
About This Section
42 U.S.C. § 17936 is part of Title 42 of the United States Code. The United States Code is the official codification of federal statutes maintained by the Office of the Law Revision Counsel of the U.S. House of Representatives. Congress amends the Code through new public laws, which are eventually incorporated into the relevant title.
This section may be cited in legal writing as 42 U.S.C. § 17936. For the most current official text, including any recent amendments, use the official source links below. Do not rely on this page as the sole authority for legal citation or litigation.
How to Read This Statute
Statutes are organized by title, chapter, section, and subsection. Pay attention to words like "shall," "may," "and," and "or," because they determine whether a requirement is mandatory or permissive and whether multiple conditions must all be met. Historical notes and amendments often appear at the end of a section.
Using This Page
This page is intended for research and educational use. Lawyers, students, journalists, and compliance professionals can use it as a starting point, but should always verify the current text through an official government source before relying on it for legal advice, filings, or compliance decisions.