Changes Coming in Specialty Pharmacy Accreditation
If you're not accredited with any of the major players, you could instantly lose out on future business growth opportunities.
If you recently filled out a request for proposal (RFP), you will see a question that comes up over and over again: “What accreditations does your organization have in place?”
If your organization is not accredited with any of the major players, you could instantly lose out on future business growth opportunities. Not only are RFPs asking for 1 accreditation, more are requiring 2 accreditations. I am also seeing some RFPs asking for Certified Specialty Pharmacist (CSP) certification for your pharmacists in order to join their network.
The landscape is changing in accreditation, and here are a few essential things you should know to help you be prepared. I recently moderated an accreditation panel at the National Association of Specialty Pharmacy conference. One good thing to note from the panel discussion is that both of the main accreditation organizations—URAC and the Accreditation Commission for Health Care (ACHC)—are working on aligning certain standards.
This will be helpful for organizations that currently have both URAC and ACHC accreditations. This alignment should make some of the compliance requirements for both accreditations more manageable. The discussion, which featured panelists from ACHC and URAC, focused on the following topics:
•recent accreditation standard updates
•accreditation opportunities (findings from recent surveys)
•financial benefits of accreditations
Recent Accreditation Standard Updates
URAC has added some new updates in version 3.0 of the specialty pharmacy standards that you need to be aware of for initial and reaccreditation purposes. Here is a list of the standards with a greater emphasis:
There are also some new URAC version 3.0 specialty pharmacy accreditation requirements that you will need to be prepared for to budget and implement a solution.
•drug use management reporting
•cold chain process validation
•telephone performance monitoring (eg, average blockage rate)
ACHC also has some new updates and requirements for their specialty pharmacy accreditation standards. Here are a few of the new updates and requirements:
•care plan enhancements
•new disease specific accreditation requirements (eg, oncology)
One key change is that specialty pharmacy accreditation clients have the ability to schedule their on-site survey. The caveat is that this change only applies if your organization does not require durable medical equipment (DME) accreditation as part of the specialty pharmacy accreditation. CMS has guidelines that require an accreditation organization to provide unannounced surveys.
If you do not need DME, then you can work with your ACHC accreditation account manager to schedule your on-site visit. I see this as a very helpful change because you can make sure you have the appropriate staff available and backup support staff (eg, pharmacist) scheduled.
The panel discussion included some recent findings that help the specialty pharmacy to prepare for compliance with the accreditation organization. The panelists shared their experiences with certain key areas where they are seeing compliance issues for specialty pharmacies. First, the panelists said some survey findings are specific to the lack of proper documentation.
For URAC, this includes patient management data (initial assessments and follow up assessments), coordination of care or care plan documentation, and demonstrating value through outcomes reporting. URAC also saw clients struggling to report clinical staff credentialing via primary source verification. Remember, this is not just an annual verification of licenses and certification prior to hiring.
Finally, documentation of cold chain validation has been a challenge for some organizations, as well as proper handling and removal of hazardous materials. The ACHC panelist also provided great feedback on audit challenges. The first was that some organizations purchase policy templates and then do not even take off the plastic wrap. This is a big red flag, because they know that the organization has not even read their policies.
ACHC is also seeing a lack of documentation specific to training records. There are several training requirements for staff in the specialty pharmacy standards that are required, such as ongoing training records and orientation training records. The other areas where documentation is lacking is specific to performance or quality improvement. This includes performance improvement project documentation, meeting minutes, and annual evaluations of the performance improvement program.
Financial Benefits of Accreditations
Accreditation has become a minimum requirement for specialty pharmacies to participate in networks with managed care organizations, pharmacy benefit managers (PBMs), and manufacturers. Justifying these additional expenses can be tough, but the panelists offered some ways to help explain these costs. One suggestion was to evaluate the loss and gain of contracted network volume.
I have seen some clients lose more than half of their business overnight by not having an accreditation. Others, who were able to meet the network contract requirements, gained from the losses of these organizations. Therefore, pay attention to the RFP requirements and be able to either prepare ahead of time or to quickly adapt to new changes.
New specialty pharmacies can benefit from an accreditation by using these standards to help build their infrastructure on a solid foundation for future success. Accreditation standards help guide an organization to implement industry best practices and solutions required for network contracts. When the time comes to report or justify your organization’s value, you can use outcome reporting and clinical management case studies to help position yourself to be part of specialty pharmacy networks, or to gain access to limited distribution products.
In conclusion, accreditation is no longer something you can ignore if you want to participate in specialty pharmacy. Current trends are requiring organizations to not only have 1 accreditation, but 2 accreditations. If you want to stay ahead of the curve before you get the RFP or letter requesting new requirements, I would recommend monitoring current trends—both industry-wide and specific to RFPs—and remaining cognizant of new programs, such as the ACHC disease-specific accreditations of distinction and CSP certifications.
These are likely the next wave of requirements that you may need to react to rather quickly. In 2016, some clients received a letter from a PBM stating that they needed 2 accreditations, and they were not given enough time to comply if they did not already have multiple accreditations. A recent letter went out to clients from another large PBM mandating accreditation. This PBM is also going to inspect specialty pharmacies for compliance to contractual requirements. I foresee some pharmacies being removed from networks if they do not do well during these inspections.
URAC, ACHC, and other accreditation organizations can help prepare you for these types of audits. I also predict that new measure reporting requirements are going to help new specialty pharmacies, and existing specialty pharmacies, in their marketing efforts and value prop development. Most RFPs have some sort of reporting requirements. Accreditation standards and requirements help organizations prepare for these type of RFP measure requirements.
The next time you attend a specialty pharmacy conference, check out the vendors who have booths. You are going to see new clinical management tools, operating systems, measure reporting solutions, and cold chain management validation organizations. The key is to stay current with industry trends by attending industry meetings and reading journals such as Specialty Pharmacy Times®. â—†
About the Author
Quintin Jessee, RPh, DPh is senior consultant, specialty and mail order operations, at D2 Consulting. Prior to joining D2, Quintin was the vice president of mail order operations for BioScrip Pharmacy. Also while at BioScrip, he was director of quality assurance, pharmacist-in-charge, and special projects manager. He implemented and managed the first medication therapy management program (MTM) at BioScrip and was in charge of facility accreditations and CQI program management.