URAC Director of Pharmacy Heather Bonome, PharmD and URAC Reviewer Jennifer Richards, PharmD, JD, co-presented at the 2018 Asembia Specialty Pharmacy Summit at the Wynn & Encore Las Vegas. URAC is the premier accrediting organization in the U.S. pharmacy industry.
Bonome and Richards offered insights into the URAC accreditation review process, as well as lessons learned from pharmacies they have reviewed. Richards shared results of a survey completed by URAC Review staff identifying the challenges and opportunities faced by URAC specialty pharmacy clients.
“We believe one of the reasons URAC is considered the ‘Gold Standard’ in pharmacy accreditation is because we leverage our full-time clinicians to conduct validation reviews,” says Bonome. “Pharmacies that pursue URAC Specialty Pharmacy Accreditation benefit from the Reviewers’ years of training and experience through ongoing interaction with this team throughout the review process. URAC’s Pharmacy Reviewers have experience with all models of practice settings – from local community practices to large national organizations – giving URAC the unique opportunity to share best practices.”
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URAC Specialty Pharmacy Accreditation: Advice from the Review Team
1. URAC Specialty Pharmacy Accreditation:
Advice from the Review Team
Heather Bonome, PharmD
Director of Pharmacy, URAC
Jennifer Richards, PharmD, JD
Pharmacy Accreditation Reviewer, URAC
2. Agenda
• URAC Overview
• Our Approach to Accreditation
• Accreditation Process
• Specialty Pharmacy Standards
• Advice from the Review Team
• Questions
3. URAC was founded in 1990 as an independent,
third party validator of the quality in healthcare
using best practices
4.
5. URAC’S Unique Approach to Accreditation
Unifies Diverse Stakeholders
Balance
views of
stakeholders
from across
healthcare
Utilize the
best
practices of
market
leaders in
quality
6. URAC Volunteer Peer Committees
• Advise URAC staff on quality best practices
• Support standard updates and periodic reviews
• Draft standards released for public comment
• Submit final standards to URAC’s Board of Directors for approval
Standards Advisory Committees
• Volunteer peers review Applicant scores
• Render accreditation and certification decisions
Accreditation Committee
7. URAC Accreditation Offers
• Rigorous, evidence-based standards
• Thought leadership
• Independent validation of quality
• Platform for continuous quality improvement
Industry stakeholders have recognized URAC Specialty Pharmacy
accreditation as a key differentiator and an independent validation of quality
9. Five Phases of Accreditation
Submit Application
Desktop
Review
Validation
Review
Accreditation
Committee
Review
Ongoing
Compliance
The accreditation process takes approximately 10-12 months.
10. Specialty Pharmacy Accreditation, Version 3.0
• Pharmacy Core, Version 3.1
• Organizational Structure
• Policies and Procedures
• Regulatory Compliance
• Inter-departmental Coordination
• Oversight of Delegated Functions
• Marketing and Sales Communications
• Business Relationships
• Information Management
• Quality Management
• Staff Qualifications
• Staff Management
• Clinical Staff Credentialing and Oversight Role
• Health Care System Coordination
• Consumer Protection and Empowerment
• Customer Service,
Communications, and Disclosure
• Specialty Drug Management
• Pharmacy Operations
• Patient Management
• Measures Reporting
Learn more:
https://www.urac.org/standards-
and-measures-glance
11. Survey: Advice from the Review Team
Where are pharmacies
most successful?
Where do pharmacies
struggle the most during
the DTR?
Where do pharmacies
struggle the most during
the VR?
What are the attributes of
the most successful
Applicants?
What are the biggest
differences btw new and
reaccreditation
Applicants?
What advice would you
offer Applicants working
with consultants?
What advice would you
offer consultants working
with Applicants?
What do you most want
Applicants to know about
the review process?
12. • Dispensing Practices +++
• Policy and Procedure Management
• Quality Management Committee
• Business Continuity
Most Successful OverallSurvey Categories
PnP Management
Quality Management Committee
Quality Improvement Projects
Business Continuity
HR Documentation
Telephone Metrics
Dispensing Practices
Cold Chain Management
PM for All Patients
PM Assessment Documentation
PM by Clinician
Care Plan Documentation
13. • Quality Improvement Projects
• Telephone Metrics
• Cold Chain Management
• PM by Clinician
Struggle on DesktopSurvey Categories
PnP Management
Quality Management Committee
Quality Improvement Projects
Business Continuity
HR Documentation
Telephone Metrics
Dispensing Practices
Cold Chain Management
PM for All Patients
PM Assessment Documentation
PM by Clinician
Care Plan Documentation
14. • HR Documentation
• PM Assessment Documentation
• PM by Clinician
• Care Plan Documentation
Struggle on Validation ReviewSurvey Categories
PnP Management
Quality Management Committee
Quality Improvement Projects
Business Continuity
HR Documentation
Telephone Metrics
Dispensing Practices
Cold Chain Management
PM for All Patients
PM Assessment Documentation
PM by Clinician
Care Plan Documentation
15. Rank the Attributes that Lead to Success
Clear Overall PnP URAC
Workshop/Webinar
Clear Process for
Clinical Doc
Sr Leadership
Support
Engage Reviewers Structured QMC
16. New vs. Reaccreditation Applicants
New Applicants generally need more guidance and education.
New Applicants tend to struggle more with the process of Patient Management assessments. When
clinical assessments are completed, they don’t always document everything they do.
Reaccreditation Applicants sometimes struggle with maintaining compliance throughout the 3-year cycle
and adapting to new standards.
Reaccreditation Applicants tend to struggle more with the documentation of Core elements (HR File
review, QMC meeting minutes, QIPs, etc.)
Reaccreditation Applicants must maintain documentation for the 3-year cycle – such as QMC meeting
minutes and evidence of Primary Source Verification.
Reaccreditation Applicants are more aware of the process, and typically adapt easier to Request-For-
Information requests and recommendations. However, the overall success rate is not significantly higher.
17. Applicants Working with Accreditation Consultants
Consultants can be a great resource, but it is important to own your policies and to ensure that the policies
and procedures you write are reasonable and attainable.
Review any template policies and procedures provided by the consultant and modify to match your
practice while maintaining compliance with the standards.
Not all consultants offer the same services or have the same success rate. Consider the different services
offered.
Consultants can be very helpful if used as a resource. Applicants who work with their consultants to help
them create their own policies and procedures or refine their processes to meet the intent of the standards
tend to be the most successful. Those who rely on their consultant to provide policies and procedures
without working through their processes and ensuring their practices meet those policies tend to struggle
significantly throughout all Accreditation phases.
18. Accreditation Consultants Working with Applicants
Consult with your clients, but do not write policies for them. Encourage the applicant to create policies and
procedures that mean something to the organization, and are attainable for the staff.
Simply providing Applicants all the policies and procedures sometimes leaves them unprepared for the review.
Make sure the applicant, and not just the consultant, are familiar with the standards and requirements of the
accreditation process.
Conduct mock reviews to identify gaps in standard compliance so action plans can be implemented prior to the
validation review. Also work with applicants to customize template policies and procedures to match the pharmacy
practice.
Provide best practices for the organization to excel in performance and not just template policies and procedures.
19. What do Reviewers want Applicants to know?
Understand, implement, and
know your policies and
procedures.
Be sure to clearly cite Desktop
Review documentation for each
standard element.
Take the time to read and
understand the issues and
recommendations provided
during Request For
Information. If you need
clarification, please ask.
During the Validation Review,
be prepared for the review of
30 case files for compliance
with Patient Management
standards.
Maintain your HR
documentation (Primary
Source Verification,
Background Checks, Drug
Screening).
Attend a workshop or webinar
and review the SP Guide before
submitting your application.
20. Coming Soon….
• Community Pharmacy Program, v2.0 will be released in May 2018
• Webinar introducing the new version on June 12, 2018
• Specialty Pharmacy Program, v3.1 will be released in July 2018
• Replaces Core v3.1 with Core v4.0
• Core v4.0 webinar on June 19, 2018
• 2-day workshop focusing on the Specialty Pharmacy and Mail Service Pharmacy programs
to be held in Washington, DC in September 2018
See the Events & Webinars webpage for upcoming events and to register:
https://www.urac.org/events-webinars
21. More Information Available on urac.org
Standards and Measures at a Glance
Accreditation Process
Insights & Ideas
Trend Watch
Events & Webinars
Directory of Accredited Organizations
https://www.urac.org