In 2017, specialty medications accounted for 46.5% ($210 billion) of the total $453 billion drug spend in the United States. To put this in perspective, a total of 5.8 billion prescriptions were dispensed in 2017, but only 1.9% (110 million) of those were attributed to specialty medications.
 
Although patients are utilizing savings programs for 42% of their specialty medications, employers and payers are extremely interested in containing costs and ensuring high quality results for services.1 In an attempt to address this concern, payers have started to require specialty pharmacies achieve accreditation in order to contract with them.
 
This has also been mirrored in the limited distribution market in which drug manufacturers may only contract with pharmacies they perceive as providing exceptional service to their patients.2 Thus, accreditation can be a critical component for payers and drug manufacturers when considering various pharmacy contracts.
 
In the last decade, 4 accreditation agencies have emerged for specialty pharmacy accreditation: URAC, Accreditation Commission for Health Care (ACHC), The Center for Pharmacy Practice Accreditation (CPPA), and the Joint Commission. URAC has become the gold standard for specialty accreditation and is the preferred accreditation body by two-thirds of payers.
 
However, the standard practice is headed towards specialty pharmacies possessing two separate accreditations. Drug Channels Institute reviewed specialty pharmacies with accreditations and
179 (24.5%) of the 729 specialty pharmacies hold multiple accreditations. This is likely underestimating the true rate of dual accreditation because the Joint Commission was not considered an option.3
 
As more specialty pharmacies achieve accreditation, secondary accreditation may become necessary to maintain competitiveness and insurance contracts. Pursing secondary accreditation is an individualized decision for each pharmacy but choosing which to apply for can be a daunting task.4
 
Although there are significant differences between accrediting agencies, some aspects of the accreditation process are similar. The process begins with an application requesting information that may include general organizational information, services offered, licensing information, and contractual relationships with other health care entities. In addition to the initial application, a deposit is usually required, although it is eventually credited to the accreditation fee once the organization is approved.
 
In the initial application, organizations submit the required documentation to demonstrate compliance with the agency’s standards, which may be followed by a request for clarification or additional documentation. Site visits are then scheduled to conduct staff interviews, observations of operations, auditing of various records, and review of quality management programs. With the exception of URAC, site visits to the pharmacy can be unannounced, unless being conducted in a corporate setting where visits are scheduled.
 
Post site visit, the process can vary but opportunities to rectify any outstanding items with regard to the agency’s standards are available. If accreditation is denied, there are policies in place for an appeal. Once attained, all agencies’ accreditation lasts for three years.

Brief Comparison of Accreditation Agencies



Thorough perusal of agency standards and accreditation process is essential prior to selecting the ultimate route; some thoughts may be relevant when beginning that process. Although the Joint Commission is included as a potential option, its accreditation is not tailored to specialty pharmacy like the other agencies.
 
Pharmacy, which includes specialty, infusion, long-term care, compounding, mail order, and other niches, falls under the Joint Commission’s Home Care accreditation option. Home Care accreditation serves as a designation for other areas of health care, such as hospice, personal health, and community-based palliative care. As such, many of the standards do not apply to specialty pharmacy.
 
Therefore, unless the specialty pharmacy is providing significant durable medical equipment to patients or part of a large health system, the Joint Commission is unlikely to be a first choice. Historically, the Joint Commission was the only accrediting body available, but as others have emerged and tailored their standards to specialty pharmacy, the Joint Commission may have even less favor with payers than it currently does.
 
As a result of the Joint Commission’s generalized accreditation role, URAC, ACHC, and CPPA offer a more rigorous accreditation process for specialty pharmacy than the Joint Commission. These 3 agencies target services most important to payers, including patient services and reporting. EMD Serono Specialty Digest’s 2018 survey of 59 commercial plans found 69% and 66% rated patient care services and reporting as valuable, respectively.5
 
In the same survey mentioned above, 71% of respondents also reported “managing oncology drugs and services” as their top challenge. Given this reported concern of payers, ACHC could be an appropriate consideration over the Joint Commission and CPPA due to the distinction in oncology it offers.
 
This could be seen as a competitive edge because 47% of plans reported > 1 specialty pharmacy in network and 54% of those plans with > 1 specialty pharmacy in network did so to provide patient access to limited distribution drugs. Although URAC is preferred by about 66% of plans, ACHC could serve as a secondary option, although CPPA may be more feasible with its less rigorous requirements.
 
Ultimately, selecting an accreditation agency should be determined by the local business environment and needs. Such time consuming and expensive efforts necessitate a thorough and targeted analysis of multiple aspects of the organization, including structure, budget, projected growth, patient populations, managed therapeutic categories, and more. An organization must balance its current capabilities with its limitations and the goals they are striving toward.
 
 Works Cited
 
1.   IQVIA Institute for Human Data Informatics. Medicines Use and Spending in the U.S. A Review of 2017 and Outlook to 2020. https://www.iqvia.com/-/media/iqvia/pdfs/institute- reports/medicine-use-and-spending-in-the-us-a-review-of-2017-and-outlook-to-
2022.pdf?=1535554382768
2.   Toman A. The Ins and Outs of Limited Distribution Specialty Drugs. Specialty Pharmacy Times.
2018. https://www.specialtypharmacytimes.com/news/the-ins-and-outs-of-limited-distribution- specialty-drugs.
3.   Pembroke Consulting, Inc., Drug Channels Institute “EXCLUSIVE: A Record Number of Specialty
Pharmacies Now Have Accreditation” (2018). https://www.drugchannels.net/2018/04/exclusive-record-number-of-specialty.html
4.   Commito K. Do You Need More than One Accreditation to Compete in Specialty Pharmacy?
Mediware Information Systems. 2017. https://www.mediware.com/home-care/blog/need-one- accreditation-compete-specialty-pharmacy/.
5.   EMD Serono. EMD Serono Specialty Digest, 14th Edition (2018). http://specialtydigest.emdserono.com/digest.aspx
6.   URAC. Specialty Pharmacy Standards, Version 3.0. 2015.
7.   ACHC. ACHC Accreditation Standards. 2018.
8.   ACHC. Accreditation Process. 2018.
9.   CPPA. Specialty Pharmacy Practice Standards, Version II. 2016.
10. Timeline. Specialty Pharmacy Practice Accreditation Program. Center for Pharmacy Practice Accreditation. https://www.pharmacypracticeaccredit.org/our-programs/specialty-pharmacy- practice-accreditation-program/timeline
11. Joint Commission. The Accreditation Process. 2016.