Accreditation has become an increasingly critical component for successful specialty pharmacy businesses. Many pharmaceutical manufacturers consider accreditation a prerequisite when either building their network or adding pharmacies to their network.

Payers are also frequently requiring some form of accreditation for specialty pharmacies to gain network access. According to the Drug Channels Institute, 911 specialty pharmacies had at least Accreditation Commission for Health Care (ACHC), Center for Pharmacy Practice Accreditation (CPPA), or URAC accreditation in 2018 compared with 729 at the end of 2017. Many pharmacies also continue to pursue multiple accreditations.

The number of specialty pharmacies with multiple accreditations increased 70% from 179 to 305 over the same period, according to Drug Channels. Although accrediting bodies all aim to provide an enhanced standard of patient care and advance the industry overall, each organization has a unique approach to accreditation, with widely different standards and requirements.

URAC, ACHC, CPPA, Digital Pharmacy Accreditation (formerly Verified Internet Pharmacy Practice Sites [VIPPS]), and The Joint Commission are examples of well-recognized accrediting organizations.

However, new accrediting bodies and new specialized distinctions continue to be added each year, advancing the industry’s overall quality of care and allowing the most advanced specialty pharmacies to be recognized for their elevated standards and continued innovation.

URAC is considered by some as the gold standard in specialty pharmacy accreditation. The organization has been operating for more than 25 years and offers approximately 50 unique types of accreditations, including multiple categories within pharmacy, health plan, health care management, health care operations, and telehealth.

For URAC’s specialty pharmacy accreditation, primary measurements of performance include drug interactions, call center performance, dispensing accuracy, distribution accuracy, and turnaround times for prescriptions. URAC uniquely monitors exploratory measures that are not required for accreditation but can help offset deficiencies in other areas. Examples of exploratory measures include proportion of days covered (PDC) and primary medication non-adherence.

ACHC is also among the most popular accreditations in specialty pharmacy and is particularly respected because of its status as a “deeming authority.”

ACHC started accreditation with health care organizations outside of specialty pharmacies. Examples of other health care organizations ACHC accredits include ambulatory care, renal dialysis facilities, and hospitals.

As a deeming authority, organizations such as hospitals are required to have ACHC accreditation in order to bill for Centers for Medicare and Medicaid Services (CMS). Although CMS does not have a specific specialty pharmacy designation, certain standards as a deeming authority do carry over for specialty pharmacies.

For example, ACHC is able to conduct inspections for any of their accreditations on any day without notice. This ensures that organizations such as hospitals and specialty pharmacies are actually adhering to their standards of care and are not just abiding by these standards during a scheduled audit.

Standards of specialty accreditation for ACHC are organized and measured across the categories of organizational and administration, program and service operation, fiscal management, human resources management, provision of care and record management, quality outcomes/performance improvement, and risk management and safety control. ACHC also uniquely accredits locations rather than accreditation at an organizational level. At the end of 2018, there were 761 specialty pharmacy locations with ACHC accreditation.

Although ACHC and URAC are perhaps the most widely known accrediting organizations in specialty pharmacy, new accrediting entities are growing in popularity.  

CPPA has become increasingly recognized with approximately 100 locations. This organization focuses specifically on pharmacy and does not offer accreditation for other types of health care organizations. CPPA currently offers accreditation programs for community pharmacy practice, specialty pharmacy practice, and telehealth pharmacy practice.

The American Pharmacists Association, American Society of Health-System Pharmacists, and National Association of Boards of Pharmacy (NABP) partnered to form CPPA in 2012. In its earlier days, CPPA grew quickly through its partnership with a retail-based pharmacy organization, Kloud Script.   

In 1999, NABP also created a VIPPS program/accreditation. This program was launched to help safe and legitimate pharmacies with an internet presence stand out against rogue websites. This is not a specialty-focused program, however, as many specialty pharmacies are pursuing this additional distinction.

This program verifies the internet legitimacy of pharmacies; however, it also has numerous pharmacy specific operational requirements that are unique from other accreditations. Some specialty pharmacies are also pursuing the NABP’s Verified-Accredited Wholesale Distributors (VAWD) accreditation. This accreditation is recognized by 24 US states. VAWD primarily focuses on wholesaler and drug storage standards.

The Joint Commission accreditation has also become increasingly popular within pharmacy, partially due to its status as a deeming authority. The Joint Commission is widely-recognized because of its popularity and necessity for hospitals.

This entity accredits many different types of health care entities including hospitals, physician offices, nursing homes, office-based surgery centers, behavioral health treatment facilities, and providers of home care services. Similar to VIPPS, this accreditation is not “specialty” pharmacy specific, but The Joint Commission is working on launching a specialty specific accreditation.

Some accrediting organizations are now pursuing new distinctions within specialty pharmacy. For example, ACHC currently has distinctions in nutrition support, hazardous drug handling, palliative care, infectious disease related to HIV, oncology, and behavioral health. 

Earlier this year ACHC additionally launched a distinction in rare diseases and orphan drugs.  This distinction monitors standards across areas such as specialized training of patients and pharmacy staff, manufacturer collaboration, supply-chain logistics, disaster preparation, risk evaluation and mitigation strategies, adverse event reporting, and analysis of patient outcomes.

Similarly, URAC is in the process of launching a rare disease distinction in 2020. URAC has organized an industry panel to develop these new standards, which includes entities such as PANTHERx Rare Pharmacy, Amber Pharmacy, National Organization for Rare Disorders, and other industry experts.

According to URAC’s press release, “Because of the sporadic nature of rare disease cases, it is challenging for professionals to diagnose, treat, and support people living with these diseases…The FDA drug development pipeline is dominated by orphan and ultra-orphan therapies to treat rare diseases, but a rare disease recognition program will assist in properly delivering these therapies to patients by developing standards for helping patients suffering with these devastating conditions.”

Although there has been great progress in developing new and specific standards for specialty pharmacy accreditation, specialty pharmacy hubs have made less progress with standardizing best practices through accreditation. Specialty pharmacy hubs have become more regularly used and are playing an increasingly important role in the continuum of care.

Hubs are generally used on behalf of a manufacturer to collect all referrals for a specific product and triage these referrals to the appropriate specialty pharmacy. Hubs are now taking on additional responsibilities to ensure a consistent patient experience and, in many cases, performing services that were historically performed at the specialty pharmacy.

Each program is built based on the specific needs of a manufacturer, product, and disease state. However, programs commonly include case management, reimbursement support, co-pay, financial assistance program management, nursing support, health care professional education, patient adherence and education, and noncommercial pharmacy dispensing.

Although there are numerous accreditations and special distinctions for specialty pharmacies, there seem to be no programs developed specifically for specialty pharmacy hubs. When going through a hub provider selection process, manufacturers frequently ask about hub accreditation. Unfortunately, there are few accreditations standards in the market which can accurately measure HUB specific performance.

URAC currently offers a health call center accreditation. This program is intended for a wide audience of health care organizations, including hospitals, triage and crisis lines, state agencies, pharmaceutical drug hotlines, health plans, health call centers, medical management companies, behavioral health care organizations, and disease management companies.

The accreditation requires policies for effective responses to health concerns of patients, measures adherence to defined thresholds for telephone performance, and requires around-the-clock access to clinical support in addition to many other requirements. Many specialty pharmacy hubs have pursued this or similar call center accreditations.

However, these programs may not be directly applicable to hub activities, as they do not focus on hub-specific metrics. Some may consider important hub metrics to include time to complete benefits investigations/verifications, time to complete prior authorizations, time to complete patient assistance program determinations, and non-commercial pharmacy time to dispense.  

These metrics can vary widely based on the therapeutic area, product type, and payer environment. A benefit investigation and prior authorization for a life-saving rare oncology treatment, for example, may be easier to process quickly than a non-devastating condition with less clinical efficacy.

It may also be difficult to define hub standards and measurements, as each program managed at a hub can provide services entirely different from other programs. For example, one hub could manage programs that use a “hub-lite” model, in which referrals are almost immediately triaged to specialty pharmacies, whereas others can have enhanced clinical, dispensing, and/or reimbursement activities.

Disease states, roles, and call types differ dramatically based on the program requirements. To make up for a general lack of relevant accreditation in the hub space, manufacturers may lean more heavily on experience in specific therapeutic areas and inquire on their own performance indicators during the hub selection process. Although no hub-specific accreditations exist currently, we may see accrediting organizations attempt to overcome these challenges and begin to enter this market.

Accreditation has become even more essential within specialty pharmacy. Payers are requiring multiple accreditations in order for specialty pharmacies to maintain contracts. Pharmaceutical manufacturers are requiring accreditation in order for specialty pharmacies to be considered in their networks.  

The bar continues to be raised within specialty pharmacy as new standards and quality measurements are added. Some accrediting organizations are creating even more stringent requirements for specialty pharmacies to earn specific distinctions. It will be interesting to see how accreditations continue to evolve and adapt to unique areas within specialty pharmacy and other increasingly relevant areas, such as hub services.

About the Author
Gannon Vanscoy is the Director of Specialty Markets at RareMed Solutions, the nation’s first rare disease focused specialty pharmacy HUB.  Gannon leads RareMed’s overall business development efforts and manages strategic partnerships across the company’s portfolio. Gannon began cultivating his expertise in rare and orphan disease states at PANTHERx Rare Pharmacy, where he participated in a rotational development program focused on hub services.  Prior to working at PANTHERx Rare, Gannon served as a leader at a number of large multi-national banks, both in internal and client-facing roles.

Gannon earned his Bachelor of Business Administration degree from the University of Miami and is currently pursuing a Master of Pharmacy Business Administration (MPBA) from the University of Pittsburgh, a 12-month, executive-style graduate education program designed for working professionals striving to be tomorrow’s leaders in the business of medicines.