The Department of Health and Human Services (HHS) has responded to requests from the Specialty Pharmacy Association of America (SPAARx) for clarifications on 2013 regulations under the HIPAA HITECH Act.


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HHS acts on specialty Rx group's HITECH Act concerns

September 24th, 2013

FLORHAM PARK, N.J. – The Department of Health and Human Services (HHS) has responded to requests from the Specialty Pharmacy Association of America (SPAARx) for clarifications on 2013 regulations under the HIPAA HITECH Act.

SPAARx said Tuesday that it wrote a letter to HHS in late July to inquire about unresolved issues regarding patient adherence and refill reminders under the act, compliance for which was Sept. 23, 2013.

Specifically, the association expressed concern that certain language in the final rule regarding the statutory exception for "refill reminders" could be misinterpreted and negatively impact medication adherence programs.

SPAARx also sought HHS clarification on the definition of marketing as it pertains to refill reminders and called for a broader range of cost remuneration, noting that compensation is narrowly focused on print communications and doesn't recognized expenses incurred by clinicians and staff delivering therapy management via telephone. The group, too, requested that HHS employ fair market value as the formula for remuneration.

In response, HHS provided revised guidance on remuneration for refill reminders and other similar communications, SPAARx said. The prior HHS guidelines permitted covered entities to be compensated for reasonable direct costs — including labor, materials and supplies — and now the new guidelines will also include indirect costs, such as capital and overhead.

Also, pharmacy professionals will now be remunerated based on the fair market value for patient adherence and refill reminder services, according to SPAARx, which noted that this clarification "will continue to permit patient adherence and refill reminders to properly and positively impact the lives of millions of patients across the continuum of health care."

"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. 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," Kevin Alder, chief operating officer of SPAARx, said in a statement. "SPAARx will continue to lobby for additional improvements that are still needed to optimize patient care."

In the letter, SPAARx also had requested further clarification of how penalties will be assessed and urged HHS to review restrictions on the use of patient contact lists and other marketing using personal health information, particularly with 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 integral in new best practices," the association stated in the letter.

The Health Information Technology for Economic and Clinical Health Act (HITECH), enacted as part of the American Recovery and Reinvestment Act of 2009, became law in February 2009 and was designed to promote the adoption and meaningful use of health information technology. Subtitle D of the act addresses the privacy and security concerns related to the electronic transmission of health information. 

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