42 U.S.C. § 17936 — Conditions on certain contacts as part of health care operations

(a) Marketing. (1) In general. A communication from a covered entity or business associate that promotes a product or service and encourages people to buy or use it does not count as a "health care operation" under subpart E of part 164 of title 45, Code of Federal Regulations, unless the communication fits one of three specific categories in the definition of "marketing" in section 164.501 of that title. (2) Payment for certain communications. A communication that fits one of those three categories also stops counting as a health care operation if the covered entity got, or is getting, payment in exchange for making it, except when: (A)(i) the communication only describes a drug or biologic currently prescribed for the recipient, and (ii) any payment received for it is reasonable in amount; (B) the communication is made by the covered entity itself, and the covered entity gets a valid authorization from the recipient under section 164.508 of that title; or (C) the communication is made by a business associate for the covered entity, consistent with their written contract or arrangement under section 164.502(e)(2) of that title. (3) Reasonable in amount defined. The Secretary defines "reasonable in amount" by regulation. (4) Direct or indirect payment. This term does not include payment for treating an individual, as "treatment" is defined in section 164.501 of that title. (b) Opportunity to opt out of fundraising. The Secretary must make a rule requiring that any written fundraising communication that counts as a health care operation under section 164.501 of that title clearly and obviously let the recipient choose not to get any more such communications. If someone makes that choice, it counts as revoking their authorization under section 164.508 of that title. (c) Effective date. This section applies to written communications happening on or after the effective date set under section 13423.