By now, you’ve heard that to be considered a player in specialty pharmacy, you must hold multiple pharmacy accreditations. In a competitive market in which so many pipeline drugs are being launched, it’s no wonder that pharmaceutical manufacturers are looking for a way to narrow the potential pharmacies to be included in their specialty network offering.

Accreditation becomes that key differentiator in many cases.

As a specialty pharmacy manager, you may be wondering where to start. After all, it seems as though there is a new accrediting body available every other day during this heat wave of pharmacy accreditations. If you find yourself in this situation, you may want to consider starting with what many consider to be the big three: URAC, The Joint Commission (TJC), and the Accreditation Commission for Health Care (ACHC). 

URAC
Originally incorporated under the name Utilization Review Accreditation Commission, URAC is an independent, nonprofit accreditation entity with a stated mission to “advance health care quality through leadership, accreditation, measurement and innovation.” The organization was founded in 1990 and is based in Washington, DC. Its original name was shortened to the acronym URAC in 1996 when the association began accrediting other types of organizations such as health plans, pharmacies, and provider organizations. 

The following outlines the basic beliefs held by the organization:
  • The patient is at the center of everything we do.
  • The provider’s voice must be heard.
  • The best approach to care delivery is through physician-led teams.
  • Health care solutions must be local to be sustainable.
  • Continuous improvement is achieved through performance measurement.
The standards developed by URAC “promote industry best practices, encourage quality improvement, and protect and empower consumers.” Their programs and services follow continuous improvement aligning with the principles of Lean Six Sigma. 

The organization takes a learning approach to the accreditation process. They are not interested in “checking off a list of requirements,” but rather the promotion of continuous improvement and innovation for the client.

Accreditation through URAC usually takes approximately 10 to 12 months to complete and involves a 5-step process.
  1. Two-Part Application Process: Clients are assigned an account manager to aid in the application process. First, the organization is required to obtain approval from URAC as an applicant. The second part involves uploading required information to the URAC web portal. The timeline of the application process ranges from 6 to 9 months. 
  1. Desktop Review: In this phase of the process, uploaded information is reviewed to ensure compliance with URAC standards. The organization will have an opportunity to address any deficiencies noted through a request for information. Completion of the desktop review takes somewhere between 30 to 45 days.
  1. Validation Review: The validation review involves a member of the URAC team visiting the organization. During the visit, leadership and staff members are interviewed and systems, work processes, and policies and procedures outlined in the desktop review are validated. The surveyor will provide information regarding any findings at the end of the review and a score will be generated outlining the organization’s compliance level.
  1. Committee Review: During this phase of the process, a formal assessment of the organization is completed by URAC’s Accreditation Committee. The committee is comprised of experts in health care fields relevant to the specialty pharmacy accreditation. Validation review findings and score will be considered to determine the application status. Notification of the results are normally received within a week of the committee decision.
The URAC-accredited specialty pharmacy:
  • Has policies and procedures in place to ensure consumers have access to appropriate drugs/medications.
  • Maintains methods to measure customer satisfaction.
  • Protects consumer health information.
  • Has policies and procedures that ensure adherence to drug safety protocols.
  • Follows a logical blueprint for quality management, maintenance, and reporting.
  • Meets rigorous performance measures for accuracy and turnaround time of dispensed prescriptions.
  • Has a patient-centered strategy for its patient management program that includes coordination of care, communication and education, patient rights and responsibilities.
  • Ensures the timeliness and performance of customer service center operations, including time to answer telephone inquiries.
  • Reports mandatory performance measures to URAC.
  1. Monitoring: Once accreditation is received, monitoring is required to ensure sustainability of the programs covered by the accreditation. Requirements may include collection and annual reporting of quality measures. A mid-cycle onsite review to confirm ongoing compliance may be conducted by URAC with 14 days-notice to your organization. Specialty pharmacy accreditation is awarded for a period of 3 years, at which time another visit to your organization will be completed by a member of the URAC team.
TJC
Founded in 1951, The Joint Commission on Accreditation of Healthcare Organizations (now known as TJC) is the nation’s oldest and largest standards-setting and accrediting body in health care. It is an independent, not-for-profit organization, evaluating more than 21,000 health care organizations and programs in the United States. 

Its accreditation is recognized as a symbol of quality that reflects an organization’s commitment to meeting performance standards. Their mission is “to continuously improve health care for the public, in collaboration with other stakeholders, by evaluating health care organizations and inspiring them to excel in providing safe and effective care of the highest quality and value.” 

Their vision statement outlines the goals of health care providers nationwide: “All people always experience the safest, highest quality, best-value health care across all settings.”

At this time, TJC does not have a separate accreditation for specialty pharmacy.  Specialty pharmacies wishing to obtain accreditation through TJC must comply with the standards that fall under the Home Care designation. Focus areas include:
  • comprehensive patient assessment
  • all-inclusive admission procedures
  • ongoing monitoring – patient and drug interaction
  • procedures for compounding and distribution of sterile infusion products
  • medication reconciliation
  • timeliness of therapy delivery
  • patient-level documentation
  • performance improvement measures for quality, access and patient satisfaction
The commission’s accreditation process primarily focuses on operational systems critical to the safety and quality of patient care. Pharmacies can expect an on-site survey during their initial accreditation and subsequent visits within 18 to 36 months.  The objectives of the on-site surveys are to:
  • Evaluate the organization using standards and elements of performance (for deemed organizations, many standards cross walk to the Centers for Medicare & Medicaid Services’ Conditions of Participation).
  • Provide education and “good practice” guidance that will help staff continually improve the organization’s performance.
 
The surveyors include professionals with at least 5 years of experience in home care, including registered nurses, pharmacists, respiratory therapists, rehabilitation technologists, orthotists, prosthetists, and medical equipment experts. Surveys are usually unannounced and have the following agenda:
  • survey-planning session
  • opening conference and orientation to the organization
  • leadership session
  • tracer methodology using actual patients, residents or individuals served to assess standards compliance
  • individual tracers following the experience of care for individuals through the health care process, including safety culture assessment
  • system tracers evaluating the integration of related processes and the coordination and communication among disciplines and departments 
  • competence assessment process
  • medical staff credentialing and privileging (hospitals only) and optional medical staff session
  • environment of care session, including a building tour 
  • exit conference, including a written summary of the survey findings 
 After the survey, a report of ‘findings’ is posted on the Joint Commission extranet.  The accreditation decision becomes official at the time the summary report is available, effective the day after survey completion.  Accredited organizations receive TJC’s Gold Seal of Approval®.   If the organization received any requirements for improvement, the accreditation decision is made after submission of evidence of standards compliance. 

ACHC
ACHC is a nonprofit accreditation organization known for value, integrity, and the industry’s best customer service. It has been a symbol of quality and excellence since 1986, with a mission “to deliver the best possible accreditation experience.”
ACHC outlines the benefits of receiving their accreditations with the following:
  • Dedicated account advisors who are committed to delivering quality customer service.
  • Service-specific standards that are relevant, realistic and easy to understand
  • Industry expert surveyors who take an educational approach.
  • Committed to education with program-specific resources available through Accreditation University, ACHC’s educational division.
  • CMS deeming authority for home health, hospice and Durable Medical Equipment, Prosthetics, Orthotics, and Supplies and national recognition from third-party payers.
  • Transition program that helps guide providers through the process of switching to ACHC.
The accreditation process can be outlined in 6 steps:
Step 1:  Create a Customer Central account/download standards.
Step 2:  Submit application and deposit.
Step 3:  Sign accreditation agreement.
Step 4:  Submit PER Checklist indicating your readiness.
Step 5:  Participate in an on-site survey.
Step 6:  Receive your accreditation decision.
 
The ACHC team offers support before, during, and after an organization’s on-site survey. Preparing for the visit provides an opportunity for the organization to identify any gaps in compliance and make the necessary adjustments needed to receive accreditation. 

After initial accreditation is received, on-site surveys are conducted every 3 years. During the renewal survey, a comprehensive review process will be performed that analyzes organizational structure, policies and procedures, and compliance with state and federal laws. Surveys are completed by licensed pharmacists, which is just one of the reasons that ACHC is a recognized leader in pharmacy compliance.

Although the steps towards pharmacy accreditation may seem a bit cumbersome, the reward is much greater. Along with an official accreditation by any of these highly recognized organizations, you can rest assured that your pharmacy is performing to the best of its abilities, focusing on patient safety, quality, and care, with continuous improvement along the way.
 
References

1. Jointcommission.org, www.jointcommission.org/.
2. “ACHC | Home.” ACHC | Accreditation Process, www.achc.org/.
3. “URAC.” URAC, www.urac.org/.

About the Author
Michelle Byrne earned her Doctor of Pharmacy degree from Duquesne University and earned her Master of Science in Pharmacy Business Administration (MSPBA) program at 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. Michelle has worked in the specialty pharmacy industry for the past 9 years, starting as a clinical pharmacist and working in leadership roles within her organization. Michelle’s current role is Pharmacy Manager, Quality & Regulatory and Pharmacist-in-Charge for her site within the Specialty Operations division of her organization.