Specialty Pharmacy Core URAC Standards Overview

Core standards are important for any specialty pharmacy business. This overview not only provides helpful information for companies undergoing URAC accreditation, but also offers a refresher for currently accredited organizations.

In a past issue of Specialty Pharmacy Times, I discussed URAC accreditation. Here, I would like to get into a little more content with regard to the core standards. Some of these core standards will be relevant not only to URAC specialty pharmacy accreditation, but other URAC accreditations as well.

The URAC Specialty Pharmacy accreditation has more than 40 standards. The first couple of core standards are specific to the organizational structure and documents for the specialty pharmacy. This includes organizational structure, mission statements, framework for your specialty pharmacy program, population served, and the oversight and reporting of the specialty pharmacy program. Proof of meeting these standards can be met by preparing an org chart. Using titles instead of staff names is recommended and will help you avoid updating org charts when individual staff changes are made.

The Pharm Core 3 standard is one of the most time-consuming parts of the URAC accreditation preparation tasks for new entities. The creations of policy and procedures can take several hours. The maintenance, review, and approval processes are keys to meeting these standards. So make sure you have effective dates, review dates, and most recent revision dates on your policy and procedure format/template.

An approval process is also very important, and you will need to be able to demonstrate this to the auditors. An annual review is part of this standard and can take proper planning. I would recommend not trying to do this all at once. If you incorporate the review of your policy and procedures into your quarterly quality and clinical oversight meetings, it can help you manage this review more effectively.

The next standard, Pharm Core 4, is specific to regulatory compliance. This standard is looking for compliance with all applicable laws, including state pharmacy laws and federal laws. HIPAA is included in this regulatory compliance. URAC will be looking for you to provide a list of all your pharmacy licenses and proof of tracking applicable laws and regulations where you conduct business. They also want to see proof of compliance with these laws and regulations as well as response protocols to detected problems.

In addition, URAC will be looking for coordination of these changes into your organization. This leads us to the next standard, Pharm Core 5. Collaboration, coordination, and communication are part of this standard and is for all aspects of change in the organization (laws, regulations, policies, quality, etc). Some examples of how an organization can meet this standard include executive meetings, departmental/team meetings, newsletters, and quality meeting minutes.

The last standard I’ll be covering is delegation. URAC wants to know how you handle delegation of functions. Some of the pharmacies I have worked with claim that they don’t delegate any functions (PAs, customer service, dispensing, etc). I would agree in most cases, but if you look closely at the delegation standards, these standards include delegated functions such as document shredding. Since this pertains to HIPAA and most organizations have a document-shredding company, you would be required to meet the delegated function standards. URAC will be looking for current contracts with specific contract language (subcontracting, functions delegated, recourse, survey/inspection, etc). They will also be looking for the organization’s approval process and background checks for delegated function vendors. It is recommended that these contracts be reviewed on at least an annual basis.

I hope this information is helpful, not only for companies undergoing URAC accreditation, but as a refresher for currently accredited organizations. In the coming issues of Specialty Pharmacy Times, we’ll review more of the Pharm Core standards and the Specialty Pharmacy URAC standards.

About the Author

Prior to joining D2, Quintin Jessee was the vice president of mail order operations for BioScrip Pharmacy. He had responsibility for the management and oversight of the Columbus mail order facility, which was the central hub for a majority of the business products/disease segments. Other positions with BioScrip included serving as director of quality assurance, pharmacist-in-charge, and special projects manager. He implemented and managed the first medication therapy management (MTM) program at BioScrip and was in charge of facility accreditations and CQI program management. Mr. Jessee also obtained and managed the pharmacy and wholesale licenses for the facility. He oversaw the implementation and acquisition of DrugStore.com’s pharmacy business and redevelopment of the e-commerce site.Mr. Jessee specializes in accreditation support (URAC, ACHC, Joint Commission, VAWD, VIPPS, DMEPOS, etc), as well as specialty pharmacy management. He works with specialty pharmacies on buildout support and overall business needs. This includes access to specialty products, managed care strategies, MTM services, workflow management, staffing models, and policy development. Mr. Jessee attended Ohio Northern University and attained a bachelor’s degree in pharmacy. He has served on the faculty of The Ohio State University School of Pharmacy as a professor and also mentors pharmacy students there. He volunteers with the Franklin County Disaster Relief Team to assist with pandemics and other natural disaster relief. Mr. Jessee is a registered pharmacist in Ohio and Tennessee and currently resides in Columbus, Ohio.