Specialty Pharmacy AccreditationSpecialty pharmacy accreditation continues to be both relevant and essential for specialty pharmacies who want to earn a “seat at the table” and gain access to payor networks and specialty medication manufacturers. When pursuing specialty pharmacy accreditation, here are some of the top things you need to know.

In 2017, specialty medications accounted for 46.5% ($210 billion) of the total $453 billion drug spend in the United States. Although patients are using savings programs for 42% of their specialty medications, key priorities for both employers and payors are containing costs and ensuring high-quality results for services. In an attempt to address this concern, payors require specialty pharmacies to achieve accreditation in order to contract with them, making accreditation a critical component for payors and drug manufacturers when considering different pharmacy contracts.

In the last decade, four accreditation agencies have emerged for specialty pharmacy accreditation: URAC, Accreditation Commission for Health Care (ACHC), The Center for Pharmacy Practice Accreditation (CPPA), and the Joint Commission.

Below, we break down the 5 most important things organizations, especially first-time applicants, need to know about specialty pharmacy accreditation, so they can best prepare for success.

1. Designate a Point Person to Take the Lead

It is essential to assign one individual to serve as a point of contact and oversee the accreditation process. Often, this can be a pharmacist in charge or a clinical pharmacist. However, in larger organizations, there may already be a dedicated person for quality and accreditation to manage the process.

Designating one person to take the lead on accreditation makes the process smoother, as enhanced coordination is needed among different departments. The point person will need to work in close coordination with the clinical and pharmacy operations teams, as well as other sections within the organization, including marketing, IT, and human resources.

The lead individual should have a general understanding of standards across all programs, whether it be clinical standards, patient management, or quality standards. They should be able to coordinate with the different departments of the organization, appropriately train staff, and operationalize various programs.

Specialty pharmacy accreditation is a very involved process that takes significant effort and coordination across the entire organization.

2. Strengthen Areas in Need

As a corporation actualizes the accreditation process, they may realize that improvements are needed within specific areas. Often, areas such as patient management or formal quality management programs need to be enhanced. Sometimes, particular aspects of those programs need to be developed from scratch.

Specialty pharmacies may be ill-prepared for quality management and patient management programs, which may be completely absent in some cases. These will need to be developed early on in the process, as they involve a significant amount of work.

Every pharmacy administers some patient counseling and education, and often, a lot of good clinical work is being done. However, there may be no structured program around those activities. The same holds with quality management programs. An organization may not have a formal way of tracking and analyzing errors. Therefore, those areas need to be developed, documented, and regular follow-ups should be conducted.

For each organization, certain areas will need more work than others. Some processes may need to be tweaked a little bit, and often, an organization will already have many things in place that simply need to be highlighted better.

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3. Develop Policies, Procedures, and Documentation

It is critical from the outset to develop policies and procedures around every aspect of what the specialty pharmacy does. These policies need to be revised on an ongoing basis to ensure that organizations have the most current and accurate document upon submission to the accrediting body.

Often, a pharmacy will accomplish a great deal of work, but little is documented. Therefore, an accrediting body may interpret it as a sign of variability in how different processes are done within the organization.

Beyond the pharmacy aspect, documentation is often lacking when it comes to departments such as HR, personnel files, and IT. Organizations need to make sure that all personnel requirements and qualifications are well-documented. Moreover, all required risk tests conducted by IT or other departments need to be cited and detailed as well.

These documents may be outdated or may not truly reflect what the organization is implementing. Sometimes, procedures have changed or new systems introduced, but the actual policy and procedure do not reflect the changes.

Occasionally, operational efficiencies are in place, but the policy and procedures have not been updated to reflect those improvements. Therefore, it is essential to take the time to ensure all documents, policies, and procedures are current and that all processes are sound and thoroughly vetted.

4. Plan Ahead

Organizations should start planning at least a year before the target date for accreditation. It’s important to familiarize oneself with the requirements of the accrediting body to understand what is needed to achieve accreditation. Attending a training session from the accreditor, whether it be a webinar or a live training session, can pay dividends down the road.

Most accrediting bodies have a multi-step process. The organization should establish the desired program for accreditation during the initial phase of contracting with the accrediting body.

Next, the organization should follow up by submitting documents that serve as evidence for meeting the required standards of the accreditation program. These documents include:

  • Policies
  • Procedures
  • Meeting minutes

Once the desktop review process is complete, the next phase involves a validation review, which can be comprised of a visit to the applicant’s pharmacy, the site, and a virtual review as well.

By keeping the multi-step process in mind, organizations can better determine their needs, especially when it comes to developing or tweaking specific programs, including patient and quality management.

5. Choose Your Consultant Wisely

If you are contemplating using a consultant to guide you through the accreditation process, it is critical to choose a highly-skilled consultant for the effort. Ideally, consultants should have extensive experience with the accreditation process and a deep understanding of accreditation requirements, standards, and the documentation that the accreditation agency provides.

There is often more involved to the accreditation standard than meets the eye, and there can be many ways to meet the requirements of an accreditation standard more efficiently. Pharmacies sometimes do not even realize that a certain standard can be achieved or is already being met.

Often, a process just needs to be tweaked, better documented, or the pharmacy may need to leverage the electronic medical record to satisfy many of the requirements for effective patient management. A skilled and experienced consultant can quickly identify these areas and help pharmacies hone their efficiencies to make the process smoother and ensure success.