March 1, 2013. Today, we continue to examine definitions pertaining to the HIPAA Privacy Rule, for which we shall begin to examine modifications next week. Today’s definition is marketing, as modified in the Final Rule: Modifications to the HIPAA Privacy, Security, Enforcement, and Breach Notification Rules Under the Health Information Technology for Economic and Clinical Health Act [HITECH Act] and the Genetic Information Nondiscrimination Act; Other Modifications of the HIPAA Rules, which was published in the Federal Register on January 25, 2013. The effective date of the Final Rule is March 26, 2013, and covered entities and business associates must comply by September 23, 2013.
Here are excerpts from the relatively lengthy discussion in the Final Rule at 78 Federal Register 5595-5597 related to the modifications to the definition of marketing from the Notice of Proposed Rule Making (NPRM), followed by the Final Rule definition of marketing:
“The final rule significantly modifies the proposed rule’s approach to marketing by requiring authorization for all treatment and health care operations communications where the covered entity receives financial remuneration for making the communications from a third party whose product or service is being marketed. … We acknowledge that the distinction between what constitutes a treatment versus a health care operations communication may be difficult to make with precision in all cases, placing covered entities at risk for violating the authorization requirement for marketing communications. We, therefore, believe that requiring authorizations for all subsidized communications that market a health related product or service is the best policy. Such a policy will ensure that all such communications are treated as marketing communications, instead of requiring covered entities to have two processes in place based on whether the communication provided to individuals is for a treatment or a health care operations purpose. …
“We adopt the term ‘‘financial remuneration’’ and its definition as proposed without modification in the final rule. Most commenters were generally satisfied with the proposed use of the term and its definition. There was, however, some confusion among commenters as to what constitutes direct or indirect payment from or on behalf of a third party. We clarify that under this provision direct payment means financial remuneration that flows from the third party whose product or service is being described directly to the covered entity. In contrast, indirect payment means financial remuneration that flows from an entity on behalf of the third party whose product or service is being described to a covered entity.
“We also clarify that where a business associate (including a subcontractor), as opposed to the covered entity itself, receives financial remuneration from a third party in exchange for making a communication about a product or service, such communication also requires prior authorization from the individual. … Thus, individual authorization also must be obtained if a business associate is to send these communications instead of the covered entity.
“We also confirm, in response to comments, that the term ‘‘financial remuneration’’ does not include non-financial benefits, such as in-kind benefits, provided to a covered entity in exchange for making a communication about a product or service. Rather, financial remuneration includes only payments made in exchange for making such communications. In addition, we continue to emphasize that the financial remuneration a covered entity receives from a third party must be for the purpose of making a communication and such communication must encourage individuals to purchase or use the third party’s product or service. If the financial remuneration received by the covered entity is for any purpose other than for making the communication, then this marketing provision does not apply. For example, if a third party provides financial remuneration to a covered entity to implement a program, such as a disease management program, the covered entity could provide individuals with communications about the program without obtaining individual authorization as long as the communications are about the covered entity’s program itself. There, the communications would only be encouraging individuals to participate in the covered entity’s disease management program and would not be encouraging individuals to use or purchase the third party’s product or service.
“Under the final rule, for marketing communications that involve financial remuneration, the covered entity must obtain a valid authorization from the individual before using or disclosing protected health information for such purposes, and such authorization must disclose the fact that the covered entity is receiving financial remuneration from a third party. The scope of the authorization need not be limited only to subsidized communications related to a single product or service or the products or services of one third party, but rather may apply more broadly to subsidized communications generally so long as the authorization adequately describes the intended purposes of the requested uses and disclosures (i.e., the scope of the authorization) and otherwise contains the elements and statements of a valid authorization under 45 CFR 164.508 [Uses and disclosures for which an authorization is required]. This includes making clear in the authorization that the individual may revoke the authorization at any time he or she wishes to stop receiving the marketing material. …
“[N]o authorization is required where a covered entity receives financial remuneration from a third party to make a treatment or health care operations communication (or other marketing communication), if the communication is made face-to-face by a covered entity to an individual or consists of a promotional gift of nominal value provided by the covered entity. For example, a health care provider could, in a face to face conversation with the individual, recommend, verbally or by handing the individual written materials such as a pamphlet, that the individual take a specific alternative medication, even if the provider is otherwise paid by a third party to make such communications. However, communications made over the phone (as well as all communications sent through the mail or via email) do not constitute face to face communications, and as such, these communications require individual authorization where the covered entity receives remuneration in exchange for making the communications.
“With respect to the exception for refill reminders or to otherwise communicate about a drug or biologic currently being prescribed to the individual, we adopt the exception as proposed. We continue to provide a stand-alone exception for refill reminders, given that the HITECH Act expressly does so. … At this time, we clarify that we consider communications about the generic equivalent of a drug being prescribed to an individual as well as adherence communications encouraging individuals to take their prescribed medication as directed fall within the scope of this exception. Additionally, we clarify that where an individual is prescribed a self-administered drug or biologic, communications regarding all aspects of a drug delivery system, including, for example, an insulin pump, fall under this exception. With respect to the array of other examples and suggestions provided by commenters as to what should fall within or outside of the exception, we intend to provide future guidance to address these questions.
“The proposed rule contained the Act’s limitation that the financial remuneration received in exchange for providing a refill reminder or to otherwise communicate about a drug or biologic currently being prescribed to the individual must be ‘‘reasonable in amount,’’ by providing that such remuneration must be reasonably related to the covered entity’s cost of making the communication for the exception from marketing to apply. We adopt this provision in the final rule. In response to comments regarding what types of costs fall within permissible remuneration, we clarify that we consider permissible costs for which a covered entity may receive remuneration under this exception are those which cover only the costs of labor, supplies, and postage to make the communication. …
“Finally, in addition to the communications that fall within the refill reminder exception, two other types of communications continue to be exempt from the marketing provisions. First, as explained in the NPRM, communications promoting health in general and that do not promote a product or service from a particular provider, such as communications promoting a healthy diet or encouraging individuals to get certain routine diagnostic tests, such as annual mammograms, do not constitute marketing and thus, do not require individual authorization.
“Second, communications about government and government-sponsored programs do not fall within the definition of ‘‘marketing’’ as there is no commercial component to communications about benefits through public programs. Therefore, a covered entity may use and disclose protected health information to communicate with individuals about eligibility for programs, such as Medicare, Medicaid, or the State Children’s Health Insurance Program (CHIP) without obtaining individual authorization.”
Here is the modified definition of marketing, 45 CFR 164.501, at 78 Federal Register 5696, which is effective March 26, 2013:
(1) Except as provided in paragraph (2) of this definition, marketing means to make a communication about a product or service that encourages recipients of the communication to purchase or use the product or service.
(2) Marketing does not include a communication made:
(i) To provide refill reminders or otherwise communicate about a drug or biologic that is currently being prescribed for the individual, only if any financial remuneration received by the covered entity in exchange for making the communication is reasonably related to the covered entity’s cost of making the communication.
(ii) For the following treatment and health care operations purposes, except where the covered entity receives financial remuneration in exchange for making the communication:
(A) For treatment of an individual by a health care provider, including case management or care coordination for the individual, or to direct or recommend alternative treatments, therapies, health care providers, or settings of care to the individual;
(B) To describe a health-related product or service (or payment for such product or service) that is provided by, or included in a plan of benefits of, the covered entity making the communication, including communications about: the entities participating in a health care provider network or health plan network; replacement of, or enhancements to, a health plan; and health-related products or services available only to a health plan enrollee that add value to, but are not part of, a plan of benefits; or
(C) For case management or care coordination, contacting of individuals with information about treatment alternatives, and related functions to the extent these activities do not fall within the definition of treatment.
(3) Financial remuneration means direct or indirect payment from or on behalf of a third party whose product or service is being described. Direct or indirect payment does not include any payment for treatment of an individual.
Next week, we examine modifications to HIPAA Privacy Rule provisions, starting with 45 CFR 164.502 (Uses and disclosures of protected health information: General Rules).