The size and scope of specialty pharmacy accreditation criteria has grown throughout the years.
Accreditation has never been more important for specialty pharmacies than it is today.
With the unprecedented growth in the specialty pharmacy space, accreditation by various accrediting bodies serves as a stamp of approval for the pharmacy that has undergone review. Accreditors serve as independent third parties to review the policies, procedures, firm organizational structure, and observe day-to-day operations.
Full accreditation granted by the reviewing entity demonstrates that the pharmacy meets all standards required for accreditation. It signifies to manufacturers, payers, prescribers, and state boards of pharmacy that the participating pharmacy has high levels of customer service and quality standards. As the specialty pharmacy market has continued to grow, the number of accrediting bodies has also grown.
Each institution has its own specific set of criteria required for accreditation, and the size and scope of criteria required has grown throughout the years. Below I examine some of the most commonly used accrediting bodies.
Perhaps the most commonly sought after accreditation for specialty pharmacy, URAC, is for specialty pharmacies that are duly licensed pharmacies with both an intake processing site and a dispensing location through mail carrier. Pharmacies seeking URAC accreditation must serve patients who utilize drugs for chronic conditions, acute events, or fertility.
Pharmacies must provide patient education, counseling, 24/7 access to pharmacists, as well as drug utilization and comprehensive patient management programs. For pharmacies that are seeking URAC accreditation, it is recommended to anticipate about 8 to 10 months to complete the review process.
The review process takes place in a 2-step process. First, URAC performs a desktop audit where an in depth review of the company's standard operating procedures takes place. Second, there is a scheduled on site visit by URAC representatives who conduct employee interviews and perform a physical inspection of the facilities.
Specialty pharmacy standards for URAC accreditation are divided into several key areas. First are the pharmacy's core standards criteria, which includes evaluation regarding standard operating procedures, proper job descriptions, and a defined organizational structure.
Customer service, communications, and proper disclosure practices are also an important part of the evaluation. Additionally, URAC reviews pharmacy operations and specialty drug management programs.
Evaluation also includes call center performance, dispensing and distribution accuracy, and time to fill for prescription referrals. URAC is specifically looking for pharmacies that have commitment to safe patient outcomes that can help mitigate the economic and patient cost of poor quality.
Once obtained, URAC accreditation is valid for 3 years. Following the 3-year period, pharmacies must apply for reaccreditation.
Accreditation Commission for Healthcare (ACHC)
ACHC has several focus areas that coincide with URAC accreditation; however, there are several key differences and benefits to having ACHC accreditation. Providers seeking to bill Medicare for the services they provide must obtain a Medicare provider number.
To do so, an initial Medicare certification survey must be conducted by either the state authority or through an accreditation organization that has deeming authority granted by the US Centers for Medicare and Medicaid Services (CMS). ACHC qualifies as a deeming authority. As such, pharmacies that obtain ACHC accreditation are able to bill Medicare for qualified products and services.
Pharmacies undergoing ACHC accreditation also must provide information on their organizational and administrative structure, in addition to fiscal and human resources management. Also reviewed are the patient provision of care records, quality of outcomes, and risk management and safety controls.
Center for Pharmacy Practice Accreditation (CPPA)
In comparison to URAC and ACHC, the CPPA certification focuses primarily on clinical product offering by the specialty pharmacy, ensuring patients receive the highest quality of care. CPPA accreditation is awarded to pharmacies that offer advanced levels of patient care services, quality and safety. Providers, patients, and payers can feel confident in the pharmacy's ability to have a consistently high level of service, and ultimately improve patient outcomes.
The Joint Commission (JCO)
The joint commission accredits and certifies more more than 20,000 health care organizations and programs in the United States. It is recognized throughout the country as an indication of quality that relates to the pharmacy’s ability to meet an array of performance standards.
The standards are developed by a multidisciplinary team, including providers, subject matter experts, and government agencies such as CMS. The standards must relate to patient safety and quality of care, as well as meet or surpass all laws or regulations.
The implemented standards must be accurately and readily measurable. The Joint Commission is also a deeming authority, therefore, pharmacies with JCO accreditation may bill Medicare for qualifying products and services provided.
The Verified Internet Pharmacy Practice Sites (VIPPS)
VIPPS accreditation is granted by the National Association of Boards of Pharmacy (NABP). It accredits online pharmacies that dispense prescription drugs. In order for a pharmacy to receive VIPPS accreditation, it must comply with the standards of privacy, authentication, and security of prescriptions.
It must also adhere to quality assurance policies, and provide meaningful consultation between patients and pharmacists. VIPPS serves as a means to legitimize an internet pharmacy from the thousands of rogue sites that are illegally selling prescription drugs.
VIPPS pharmacies may have application fees waived for the .pharmacy Top-Level Domain (TLD) program. It allows pharmacies to use the .pharmacy TLD for any websites that have been approved through the VIPPS accreditation process.
The pharmacy domain is regarded as trustworthy where consumers know that the medications they buy will be safe.
Verified Accredited Wholesaler Distributers (VAWD)
The VAWD accreditation is for wholesale distribution facilities and granted by NABP. It plays a vital role in preventing counterfeit drugs from entering the drug supply chain.
VAWD ensures that wholesalers and others in the supply chain are licensed in good standing, employing security and best practices for the distribution of prescription drugs.
The value of accreditation by the bodies mentioned above are numerous. However, the greatest values of accreditation are that they drive patient care, encourage proper and safe pharmacy operations, and serve as an objective third party method to perform specialty pharmacy valuation.
The most successful specialty pharmacies in the future will comply with, and receive accreditation from these accrediting bodies. In doing so, specialty pharmacies will demonstrate their commitment to safety and quality patient care.
Links to the accrediting bodies discussed in this post are found below.
About the Author
Justin Smerker earned his PharmD degree from the University of Pittsburgh in 2009. He is currently a clinical pharmacist for PANTHERx Specialty Pharmacy. He has experience in the implementation and delivery of high-touch patient care services as well as in clinical management, persistency, and adherence programs. Justin also has participated in assisting with the successful launch of newly FDA approved medications. He has served as an adjunct clinical instructor for experiential education at Duquesne University. Prior to working in the specialty pharmacy sector, Justin successfully managed high volume retail pharmacies. Justin is currently enrolled in the Masters of Science in Pharmacy Business Administration at the University of Pittsburgh.