Why Accreditation Makes Sense for Specialty Pharmacies
By Stefanie Gove |
Specialty pharmacies pursue accreditation to demonstrate value and consistency in delivery of quality clinical services in treatment of chronic, complex diseases. Overall, accreditation helps define the services, programs and capabilities that a specialty pharmacy has in place. It also verifies compliance with strict guidelines required by accrediting bodies.
Among its high-level deliverables, specialty pharmacy accreditation requires adoption of policies and procedures to ensure consumer access to appropriate drugs while adhering to safety protocols and a coordinated strategy for patient management.1
Roughly 500 unique U.S specialty pharmacy locations had achieved accreditation as of January 2017 from two primary bodies, Utilization Review Accreditation Commission (URAC) and Accreditation Commission for Health Care (ACHC). That signified a 32 percent increase in the number of unique, accredited specialty pharmacy locations compared to previous analyses conducted by industry researcher Drug Channels. The 2017 data showed 42 percent of specialty pharmacies having been accredited by URAC, 32 percent by ACHC, and the remainder by both URAC and ACHC.2
What’s Driving Specialty Accreditation Growth?
Specialty drugs, with nearly 700 therapies currently under development3 for treatment areas such as cancer, hepatitis C, HIV, autoimmune disorders and multiple sclerosis, are expected to claim 9 out of the top 10 spots among bestselling drugs in 2020.4
Specialty drug manufacturers and payers need to partner with pharmacies that can ensure a consistent patient experience, appropriate medication use and continuity of care.5
At the same time, prescribing physicians seek to optimize patient care by referring to specialty pharmacies that can provide effective medication therapy management and unfailingly meet the highest standards for improvement in patient outcomes.
And, to round out the specialty ecosystem, pharmacies need to work with manufacturers and payers to gain access to, respectively, limited distribution drugs and patients who may be subject to payer network or reimbursement restrictions.
Any specialty pharmacy looking to become accredited must first be in compliance with all state and local laws governing pharmacy operation. Pharmacies should check their Board of Pharmacy or Department of Health website for full details, which vary from state to state.6
Beyond those provisions, URAC and ACHC have established recognized standards that apply to key aspects of specialty pharmacy services and operations. For example, ACHC’s standards address the following areas:
- leadership and organizational structure of the company;
- rights and responsibilities, complaints, protected health information, cultural diversity, and compliance with fraud-and-abuse prevention laws;
- financial operations, including budgeting process, business practices and accounting procedures;
- all categories of organizational personnel, including requirements for recordkeeping such as skills assessments and competencies;
- patient record documentation and requirements;
- implementation of a performance improvement program, including responsibilities, activities monitored, data compilation and corrective measures; and
- risk management as it applies to surveillance, identification, prevention, control, and investigation of infections and safety risks.7
Pharmacies should examine the standards for each accrediting body, as well as requirements of individual manufacturers and payer networks, when determining which accreditation to pursue. In some cases, pharmacies may need accreditation from both URAC and ACHC in order to attain access to drugs and patients for specific disease states and treatments.
Action Plan for Accreditation
In general, accreditation demonstrates a specialty pharmacy’s commitment to quality because the process identifies organizational strengths and opportunities for improvement. Additionally, gaining accreditation can help differentiate a pharmacy from competitors through dedication to optimizing patient outcomes and safety.8
Nonetheless, accreditation shouldn’t be taken lightly. It requires a time commitment of six months to a year, along with an application fee (for more program details, see URAC FAQs or ACHC FAQs). Both accrediting bodies host workshops for pharmacies deciding whether to move forward with the process.
Assuming a pharmacy wants to proceed, here’s a recommended sequence of action:
- Select the accrediting body and register online.
- Pay the accreditation deposit fee.
- Obtain the accreditation standards.
- Perform a gap analysis, comparing what’s required by the standards and the pharmacy’s ability to comply with current resources.
- Establish a project team, with a representative from each pharmacy department (e.g., compliance, HR, finance, pharmacy management, onboarding, prior authorization, clinical follow-up, on-call nursing).
- Consider engaging an accreditation consultant if the process appears too onerous to handle with existing team members.
- Formulate a project plan with a timeline. Schedule weekly meetings to assess status, progress and outstanding items.
- Document policies and procedures needed for compliance with standards.
- Educate staff on the importance of accreditation, and incorporate policies and procedures into all day-to-day jobs and responsibilities.
- Submit documentation to the accrediting body for initial review.
- Evaluate feedback from the accrediting body and make changes to policies/ procedures as needed.
- Prepare a comprehensive manual, shareable throughout the pharmacy, comprised of documented policies/ procedures and clinical data reporting.
- Conduct a test — a mock survey — to prepare for an unannounced site audit by an accrediting body surveyor.
- At the time of the actual audit (about three months after application submission), make the compliance director available to assist the surveyor in obtaining required information and setting up interviews with staff members.
- If the audit is successful, the pharmacy will be accredited for a three-year term (subject to periodic audits in some cases).
- In the event of a failed audit, address deficiencies and prepare for a follow-up audit.
Specialty pharmacy accreditation may seem like a “heavy lift” at first glance; however, the process creates a gold standard for patient care. Establishing policies and procedures to ensure compliance with accreditation standards puts patients first in terms of optimizing health outcomes and guiding them through complicated therapy management.
What’s more, when manufacturers and payers want proof of meeting their requirements, data reporting — integral to accreditation — delivers the desired numbers. If they demand a performance improvement plan, it’s already established through accreditation standards.
In short, when accreditation is part of a pharmacy’s everyday activity, consistent and enhanced services naturally fall into place.
1. Utilization Review Accreditation Commission (URAC). Specialty Pharmacy Accreditation. https://www.urac.org/accreditation-and-measurement/accreditation-programs/all-programs/specialty-pharmacy/
2. Drug Channels. The State of Specialty Pharmacy Accreditation in 2017. http://www.drugchannels.net/2017/04/exclusive-update-state-of-specialty.html
3. IMS Health. Overview of the Specialty Pharmacy Drug Trend: Succeeding in the Rapidly Changing U.S. Specialty Pharmacy Market. http://docplayer.net/4230764-Overview-of-the-specialty pharmacyecialty-drug-trend.html
4. Pembroke Consulting and Drug Channels Institute. 2014-2015 Economic Report on Retail, Mail and Specialty Pharmacies.
5. AmerisourceBergen. Add Value to Your Specialty Strategy. https://www.amerisourcebergen.com/abcnew/Insights/Add-Value-to-Your-Specialty-Strategy
6. Acreditation Commission for Health Care (ACHC). ACHC Accreditation Guide to Success Workbook.
8. ACHC. Why Achieve Accreditation? https://www.achc.org/about-accreditation.html#what-is-accreditation