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SPAARx Issues Industry Letter to Office of Civil Rights (HHS) Requesting Clarifications to HIPAA HI-TECH Regulations

Aug 6 2013 12:00AM



FLORHAM PARK, NJ -- (Marketwired) -- 08/06/13 -- The Specialty Pharmacy Association of America (SPAARx), the largest national association representing the broad interests of the specialty pharmacy industry, today announced the Association's position relating to issues associated with the U.S. Department of Health and Human Services' (HHS) newly released revisions to HIPAA regulations that implement the HITECH Act. [78 Fed. Reg. 5566 (Jan. 25, 20l3) ("final rule")]. The Association has sent a letter to the Office for Civil Rights at the Department of Health and Human Services requesting clarification and or revision of several key elements of the regulations that will adversely impact the well-established Standards of Care at specialty pharmacies nationally.

In the letter to Ms. Susan McAndrew, Deputy Director for Health Information Privacy at the OCR, SPAARx affirmed HHS's intent to strengthen consumer privacy and data security protections, and enhancing enforcement for HIPAA violations by covered entities and their business associates. However, SPAARx posed a number of questions that were left unresolved and potentially conflict with the best healthcare practices for compliance and persistency programs developed and implemented by specialty pharmacies to enhance quality of patient care through proactive compliance programs.

"The Accountable Care Act was passed by Congress for a number of reasons including a proactive movement towards Medication Therapy Management," said Bill Sullivan, Executive Director of SPAARx. Sullivan continued, "Congress clearly sought to protect and enhance public health benefits that accrue to patients through adherence and compliance messaging programs. Unfortunately, the current interpretation of HI-TECH through the HIPAA Omnibus rule restricts and adversely conflicts these potential benefits. We welcome an opportunity to discuss the issues with OCR in the very near future to reach resolution before the September 23, 2013 deadline for implementation."

SPAARx expressed concern that certain language in the final rule regarding the statutory exception for "refill reminders." will be misinterpreted and could seriously impede medication adherence programs with no substantive benefits to patient privacy. As such, SPAARx seeks that OCR clarify these issues in guidance or FAQs. Given that the revisions will go into effect in less than ninety (90) days, SPAARx encouraged the Department to act swiftly to address these concerns.

Specifically, SPAARx seeks to have the Department clarify its position on the definition of marketing to resolve instances where the covered entity receives direct or indirect remuneration in exchange for making communications with patients, specifically compliance and persistency services including refill reminders as referenced in the Omnibus Rule. Additionally, 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. As currently defined, the Department is limiting remuneration to the specific direct cost of making the communication (e.g., drafting, printing, mailing), which does not fairly recognize the additional expenses of clinicians and staff that deliver therapy management, traditionally telephonically.

SPAARx suggests that the Department consider using 'Fair Market Value' as a guideline for remuneration. Fair Market Value provides a consistent and uniform measure as expressed by HHS's Office of Inspector General which has previously recognized that sponsored programs of healthcare providers are generally not of anti-kickback enforcement concern provided that the payments do not exceed Fair Market Value of any legitimate service rendered to the sponsor. Not only would the use of a Fair Market Value as a standard to determine the "reasonableness" of the remuneration allow for the healthcare improvements available through better adherence and compliance of patients, it also permits alignment of healthcare provider's compliance programs to ensure that compliance with the Privacy Rule does not create non-compliance with anti-kickback obligations.

Further, SPAARx encouraged the Department to review its restrictions on the use of patient contact lists and other marketing using PHI especially as it relates to the use of 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, an emerging and integral component of new best practices.

About Specialty Pharmacy Association of America (SPAARx)
SPAARx is the largest national Association solely dedicated to the interests of all individuals in the specialty pharmacy segment of healthcare. SPAARx is managed and governed by a board of directors comprised of executives from a diverse group of specialty pharmacies. This association is vendor-neutral and fully-aligned with the interests of all industry stakeholders. SPAARx is setting the standards, leading in advocacy and promoting the value of specialty pharmacy. The association's goal is to protect and promote common industry interests along with fostering professional growth within specialty pharmacy. To learn more about SPAARx or join today, please visit

Bill Sullivan
Interim Executive Director
Specialty Pharmacy Association of America (SPAARx)
100 Campus Drive
Florham Park, NJ 07932

Source: Marketwire

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