SPAARx protests rules on refill reminders, marketing

August 12, 2013

The Specialty Pharmacy Association of America is concerned about the language involving refill reminders and marketing in the U.S. Department of Health and Human Services’ newly released revisions to HIPAA concerning the HITECH Act.

The Specialty Pharmacy Association of America (SPAARx) is concerned about the language involving refill reminders and marketing in the U.S. Department of Health and Human Services’ (HHS) newly released revisions to HIPAA concerning the HITECH Act.

“The Accountable Care Act was passed by Congress for a number of reasons, including a proactive movement towards medication therapy management. Unfortunately, the current interpretation of HITECH….restricts and adversely conflicts these potential benefits,” said Bill Sullivan, executive director of SPAARx. Sullivan requested a meeting with the HHS’ Office for Civil Rights after sending a letter to Susan McAndrew, deputy director for Health Information Privacy at the OCR, outlining SPAARx’s concerns.

Language in the HITECH final rule, set to be implemented September 23, 2013, includes a statutory exemption for refill reminders. The exemption “will be misinterpreted and could seriously impede medication adherence programs with no substantive benefits to patient privacy,” according to a statement from SPAARx. “As such, SPAARx seeks that OCR clarify these issues in guidance of FAQs,” SPAARx stated.

“Costs related to delivering enhanced therapy management services should be allowable for a broad range of refill reminders and related communications about a drug or biologic currently prescribed or expired,” SPAARx stated. HHS is limiting remuneration to the specific direct cost of making the communication (such as printing and mailing), which SPAARx believes does not fairly recognize the additional expenses of clinicians and staff that delivery therapy management, typically by phone.

SPAARx also wants HHS to review its restrictions on the use of patient contact lists and other marketing using protected health information, especially as it relates to mobile devices and social media. “The current language is inconsistent with emerging methods of physician-pharmacy-patient communication that is designed to enhance the care team concept,” SPAARx stated.