SPAARx Questions Language in HIPAA Final Rule

In a recent letter to HHS, the Specialty Pharmacy Association of America expressed its concerns about the impact of the HIPAA Final Rule on remuneration for Medication Therapy Management and specialty pharmacy services and on interaction with patients through social media platforms.

The Specialty Pharmacy Association of America recently voiced its concerns in a letter to the Department of Health and Human Services (HHS) about the final revisions to HIPAA regulations as dictated under the Health Information Technology for Economic and Clinical Health Act (HI-TECH) that were released on January 25, 2013.

The industry trade group contends that the HI-TECH Law and the Omnibus Rule, which limit remuneration to specialty pharmacies for marketing materials to “the cost of making the communication,” do not adequately account for the cost of the additional services provided by clinicians who deliver medication therapy management to patients over the phone. The group argued in a recent article that the rules governing refill reminders are “potentially in conflict with the best practices of Medication Therapy Management developed and implemented by specialty pharmacies to enhance quality of patient care through proactive compliance programs.” In the article, SPAARx notes that costs related to refill reminders and all other ancillary communications associated with biologics should be allowable under the rule.

In addition, SPAARx asks in its letter that HHS review its restrictions “on the use of patient contact lists and other marketing using PHI [patient health information] especially as it relates to the use of mobile devices and social media.” Under the new rule, according to a webinar from Avalere and SPAARx held on June 18, 2013, a refill reminder could be considered a breach of privacy.

The Privacy Rule to the HIPAA Act prohibits covered entities (health plans, clearinghouses, and health care providers) from using or disclosing individually identifiable health information about a patient without his or her consent. In its letter, SPAARx requested clarification on the issue of patient authorization as it relates specifically to the use of social and mobile platforms for compliance messaging programs such as refill reminders and adherence reminders. The trade group also requested clarification about what penalties would be associated with violation of these rules.

According to information presented in the SPAARx/Avalere webinar, some covered entities (such as those connected to Hub programs) have already started cancelling industry-funded refill reminder programs—and although face-to-face interactions are exempt from this rule, SPAARx is concerned that specialty pharmacists will be prevented from having adequate direct access to patients to conduct these types of interventions.

“The Accountable Care Act was passed by Congress for a number of reasons including a proactive movement towards Medication Therapy Management,” the letter to HHS stated. “SPAARx asks that HHS adhere to and implement that Congressional intent.”