As previously reported, HHS announced earlier this month that it would be providing clarification on the HIPAA Privacy Rule as it relates to marketing and prescription refill reminder programs. On September 19, 2013, HHS made good on that promise when the Office for Civil Rights announced guidance on when refill reminders and other communications about drugs currently being prescribed for an individual do not constitute “marketing” and thus do not require prior patient authorization.
The announcement provides a test for when refill reminders will not be considered marketing (“refill reminder exception”). The test focuses on two questions: First, is the communication about a currently prescribed drug or biologic? Second, if there is remuneration for the communication, is it reasonable?
The announcement also contains the following guidance for applying the test and a number of FAQs dealing with specific situations:
1. Is the Communication about a Currently Prescribed Drug or Biologic?
WITHIN EXCEPTION:
Communications that are:
- Refill reminders;
- About a recently lapsed prescription (one that has lapsed within the last 90 calendar days);
- About generic equivalents of a drug being prescribed;
- Adherence communications encouraging individuals to take prescribed medicines as directed; or
- About all aspects of the drug delivery system for a prescribed a self-administered drug.
NOT WITHIN EXCEPTION:
Communications:
- About specific new formulations of a currently prescribed medicine;
- About specific adjunctive drugs related to the currently prescribed medicine; or
- Encouraging an individual to switch from a prescribed medicine to an alternative medicine.
2. Does the Communication Involve Financial Remuneration, and If So, Is It Reasonable?
WITHIN EXCEPTION:
Communications:
- That do not involve remuneration;
- Involving only non-financial or in-kind remuneration, such as supplies, computers, or other materials;
- Involving 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:
- Involving 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; or
- Involving 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.
As reported in the earlier post, HHS will not enforce the restrictions on remunerated refill reminders and other communications until November 7, 2013.