SPAARx heralds revised regulations to HIPAA HITECH Act

Specialty organization, other industry groups lobbied HHS for changes

FLORHAM PARK, N.J. — A decision by the Department of Health and Human Services to resolve conflicts that arose when it issued regulations under a law that establishes privacy rules for health information technology has drawn applause from a specialty pharmacy organization.

The Specialty Pharmacy Association of America said that it received a "positive response" from HHS to concerns it expressed to the department about 2013 regulations under the HIPAA HITECH Act. According to SPAARx, a number of questions related to patient adherence and refill reminders under the regulations were left unresolved, resulting in conflict with healthcare practices for compliance and persistency programs developed by specialty pharmacies.

In response to lobbying by SPAARx and other industry groups, HHS provided revised guidance on remuneration for refill reminders and other similar communications. The previous guidelines allowed covered entities to be compensated for direct costs like labor, materials and supplies, while the new ones also include indirect costs like capital and overhead. In addition, business associates will be compensated based on the fair market value for patient adherence and refill reminder services.

"We are encouraged that the Department of Health and Human Services has responded to many of the clarifications that SPAARx and our specialty pharmacy members requested over the past several months," SPAARx CEO Kevin Alder said. "The clarifications they made are improvements to the rules governing the ability of specialty pharmacies to continue to advance the necessary patient-care to achieve positive patient health outcomes."


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