The Office of Civil Rights recently released guidance related to the new HIPAA marketing requirements and refill reminders. The guidance includes several FAQs and examples to help navigate the new HIPAA marketing/refill reminder rules. In conjunction with the release of this guidance (and as a result of a lawsuit filed by Adheris, Inc.), HHS has decided to delay enforcement of the refill reminder requirements until November 7, 2013. This enforcement delay is only with regard to the refill reminder rules and does not apply to the rest of the HIPAA requirements which will be enforced starting September 23, 2013.
Pursuant to HIPAA, a covered entity or business associate must receive a patient’s written authorization before using or disclosing PHI to make a marketing communication to him/her – unless another exception otherwise applies. The new HIPAA marketing definition includes a generally common sense definition of marketing, with certain limited exceptions. The new marketing rule creates an explicit exception “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 for making the communication.” The focus of the guidance is on two key phrases within the definition: (1) whether the drug is “currently being prescribed” and (2) whether there is financial remuneration and if so if it is “reasonably related to the covered entity’s cost of making the communication”.
The guidance identifies the following as satisfying the first requirement that the drug is currently being prescribed:
• Refill reminders.
• Communications about generic equivalents of a drug being prescribed.
• Communications about a recently lapsed prescription (one that has lapsed within the last 90 calendar days).
• Adherence communications encouraging individuals to take prescribed medicines as directed.
• Where an individual is prescribed a self-administered drug, communications regarding all aspects of a drug delivery system.
NOT WITHIN EXCEPTION
• Communications about specific new formulations of a currently prescribed medicine.
• Communications about specific adjunctive drugs related to the currently prescribed medicine.
• Communications encouraging an individual to switch from a prescribed medicine to an alternative medicine.
With regard to the second prong, whether there is financial remuneration and if so whether it is related to the cost of making the communication, HHS provides the following information:
• Communication does not involve remuneration.
• Communication involves only non-financial or in-kind remuneration, such as supplies, computers, or other materials.
• Communication involves only payment from a party other than the third party (or other than on behalf of the third party) whose product or service is being described in the communication, such as payment from a health plan.
• Remuneration involves payments to the covered entity by a pharmaceutical manufacturer or other third party whose product is being described that cover the reasonable direct and indirect costs related to the refill reminder or medication adherence program, or other excepted communications, including labor, materials, and supplies, as well as capital and overhead costs.
• Remuneration involves payments to a business associate assisting a covered entity in carrying out a refill reminder or medication adherence program, or to make other excepted communications, up to the fair market value of the business associate’s services. The payments may be made by a third party whose product is being described directly to the business associate or through the covered entity to the business associate.
NOT WITHIN EXCEPTION
• Communication involves financial remuneration other than as described above.
The guidance then provides a series of examples and FAQs that are quite helpful in explaining what is and what is not permissible under the refill reminder exception to the marketing rule. Though refill reminders are permitted, a covered entity should be careful to ensure that it is following the exception requirements or it should request patient authorization for such communications. For more information about HIPAA and the marketing rule specifically please contact Elana Zana.