What makes specialty pharmaceuticals ‘special’? Other than cost (the primary criterion), it is often the tangled combination of patients’ health and personal situations, comorbidities, and complex forms of drug delivery (often, infusion). This, in turn, calls for a greater number of pharmacy services; thus, the specialty pharmacy.
But what makes a specialty pharmacy ‘special’? Besides the reality of being able to deliver the personalized follow-on services, the acknowledged way of signifying those capabilities is for the pharmacy to obtain accreditation from one or more accrediting bodies. These organizations define both baseline expectations and aspirational goals, by establishing standards, processes and protocols, based on updated clinical evidence and industry best practices. Such third-party accreditation has become more important than ever, as both the number of specialty medications and the number of players in the specialty pharmacy channel continues to grow.
Today, the primary players in specialty pharmacy accreditation are:
* The Center for Pharmacy Practice Accreditation (CPPA; https://www.pharmacypracticeaccredit.org ); CPPA is a nonprofit organization established through partnership of the American Pharmacists Association (APhA), the National Association of Boards of Pharmacy (NABP) and the American Society of Health-System Pharmacists (ASHP)
* URAC; (www.urac.org)
* Accreditation Commission for Health Care (ACHC; www.achc.org)
* The Joint Commission (TJC; https://www.jointcommission.org)
“Manufacturers of these high-cost therapies have a vested interest in making sure their specialty drug is working for patients, and manufacturers know that the drug has a better chance of success if they can be assured their specialty pharmacy partner is providing the highest level and greatest consistency of care, including the many patient-support programs that are needed,” says Heather Bonome, PharmD, Director of Pharmacy for URAC.
Today’s accreditation standards are written “to provide a baseline of quality of performance and to challenge an organization to stretch to perform to the highest level of industry best practices,” says Karen Saunders, Director of Quality Management & Accreditations for Express Scripts.
According to the Drug Channels Institute’s 2018 update on the accreditation of specialty pharmacies,  the number of specialty pharmacies with accreditation expanded again from 2017 values. “We identified 729 unique pharmacy locations that by the end of 2017 had achieved accreditation from the three major independent accreditation organizations, ACHC, CPPA and URAC,” says Adam Fein, Ph.D., president of Pembroke Consulting, which also operates the Drug Channels Institute. “The 2017 figure is almost double what it was in 2015.” He adds that pharmacy locations owned by healthcare providers—hospitals, health systems, physician practices, and providers’ group purchasing organizations—were the fastest-growing category.
“The accreditation process involves a comprehensive review of all the many processes that support quality patient care and promote patient safety, with an emphasis on ongoing performance measurement and validation,” says Rob Osborne, Vice President, Pharma Trade Relations, for Express Scripts. “Achieving one or more accreditation awards is a key benchmark that reflects not only the specialty pharmacy’s capabilities, but its commitment to ongoing improvement of services, as well.”
For instance, because specialty medications are often biologics that require complex dosing regimens and self-injection, specialty pharmacies often provide a full slate of educational programs to help patients understand their disease and their medication, understand and avoid potential drug-drug interactions, manage the complex drug-administration requirements prior to initiation of therapy and more. By providing continuous monitoring and periodic outreach to patients (using pharmacists or nurses), and reporting agreed-upon metrics back to the drug maker, specialty pharmacists provide the critical connective tissue needed to ensure optimal drug utilization over time for each patient.
The program-specific data and analysis the specialty pharmacy can provide helps drug makers track drug utilization and patient outcomes over time, and use the detailed insight to make ongoing program enhancements over time.
Meanwhile, many of today’s specialty medications have potential toxicity issues that trigger complex handling and reporting requirements under the drug’s FDA-mandated Risk Evaluation and Mitigation Strategies (REMS) program. Specialty pharmacies are in a good position to institutionalize the type of rigorous operational framework to manage REMS and comparable regulatory requirements.
“When we perform an onsite visit, we’ll look at individual patient records and profiles to see if the specialty pharmacy is meeting its requirements with regard to REMS,” says Lynnae Mahaney, B.S., Pharm., M.B.A., FASHP, ASHP Director of Pharmacy Accreditation, providing comment on behalf of CPPA, a joint initiative with APhA (American Pharmacists Association) and NABP (National Association of Boards of Pharmacy) and ASHP (American Society of Health-Systems Pharmacists). CPPA accreditation programs are administered by ASHP and NABP.
Oral oncology medications fall under the purview of specialty pharmacy because they often have a unique set of dosing and administration requirements to encourage optimal clinical outcomes, and a toxicity profile that must be closely managed. Unlike traditional infused oncology medications, which are administered in a clinical care setting and billed through the physician practice’s buy-and-bill program, oral oncology medications are typically dispensed by the specialty pharmacy directly to the patient to self-administer at home.
When it comes to oral oncoloytics, small deviations from ideal dispensing and dosing can have enormous consequences. For instance, “in chronic myeloid leukemia, as little as one week off of the prescribed oral oncology medication can cause the disease to relapse, so patients must take a pill without fail, every day, for the rest of their lives,” explains Ann Steagall, BSN, RN, OCN, Director, Clinical Policy for Biologics, Inc., McKesson’s specialty pharmacy. ‘That’s a lot to ask of patients—especially when you consider the potential financial implications or side effects they may be facing—but there’s so much at stake if they fall off therapy. High-touch support programs that involve regular outreach from a nurse help to not only encourage patient compliance, but provide a mechanism to quickly recognize the emergence of contributing factors such as pill fatigue, financial impediments and other lifestyle or health issues that may arise, so that rapid intervention from a nurse or pharmacist can be provided.”
“Meanwhile, as the cancer-treatment paradigm moves from infused therapies toward oral medications, oncology practices often lose money with that prescribing choice (as the oral oncolytics are not administered onsite nor billed through the practice’s buy-and-bill model). As a result, many oncology practices do not invest a lot in the extra programs or personnel to carry out high-touch patient support — rather, that tends to be relegated to the drugmaker-sponsored specialty pharmacy,” continues Steagall.
Voluntary versus compulsory
When the specialty pharmacy accreditation movement really began to gain traction several years ago, first movers were able to tout their hard-won accreditation status as a differentiator to set them apart from others competing for the same lucrative contracts with specialty drug manufacturers. However, as specialty drug makers, payers and pharmacy-benefit managers (PBMs) are increasingly urging — if not outright requiring — third-party accreditation from one or more of the leading accreditation bodies, this once-voluntary undertaking now feels more like a de facto requirement than ever for specialty pharmacy.
“Of course, specialty pharmacies should recognize that gaining accreditation benefits their practice and their patients,” says Bonome of URAC. “But we also see that many pharmacies come to us because a given drug maker or payer has made accreditation a requirement to do business within their limited-distribution network.”
Payers, in particular, have a lot of skin in the game whenever it comes reimbursing for high-cost specialty medications, which can easily cost $100,000/year or more. “When these therapies are administered and used properly, they can provide critical relief of symptoms, or even a cure, for patients, and that justifies the cost,” says Bonome. “Payers are also aware the improper use of these medications can lead to a worsening of the condition, which could lead to hospitalization and other high-cost interventions.”
“Importantly, the accreditation award reduces the burden of oversight by payers themselves, because it establishes specific, rigorous performance standards and then provides a consistent level of assurance (by the third-party accreditation organization) that the quality of services provided specialty pharmacy meets them,” says Osborne of Express Scripts, who adds that increasingly, accreditation is also required to meet regulatory requirements for government payers such as Medicare and Medicaid.
Meanwhile, in this era of value-based care, payers are also working with specialty pharmacies to create payment models that reward those specialty pharmacies that are able to demonstrate consistent patient outcomes and other performance metrics. While simply having accreditation no longer provides the degree of competitive differentiation it once did, the ability to deliver world-class programs and to develop the metrics needed to prove it can continue to give accredited specialty pharmacies a competitive advantage.
“Fortunately, any additional expenses and effort associated to gain and maintain accreditation can be justified by the potential to win or lose contracted work based on being able to demonstrate the accreditation status,” says Quintin Jessee, RPh, DPh, an executive at D2 Consulting, adding: “Today, if your organization is not accredited with any of the major players, you could instantly lose out on future business-growth opportunities.”
“Of course if you don’t have your house in order, you won’t be able to deliver the highest-quality care for patients with these complex illnesses, and you won’t be able to compete against those specialty pharmacies that do,” adds Mahaney on behalf of CPPA, who also served as the Executive Director of CPPA until late 2016. “Accreditation helps ensure both.”
Balancing customization and standardization
Accreditation criteria involve standardized protocols, processes, data-gathering, documentation and reporting requirements for patient care related to:
* Securing insurance approval for the patient
* Improving time to first fill of the prescription
* Investigating options that may be available to reduce the cost of the medication
* Managing patient data (from initial assessments through ongoing follow-up assessments)
* Coordinating care and documenting the care plan
* Reconciling medications (to avoid potential drug-drug interactions)
* Reporting clinical outcomes, side effects and adverse events
* Validating cold-chain processes
* Ensuring proper handling of hazardous waste
* Carrying out staff credentialing and training (with proper documentation)
* Monitoring the performance of incoming and outgoing telephone-based interactions with patients (looking, at for instance, speed to answer calls, longest wait times, how many calls are abandoned and so on)
* Providing seamless access to nurses, disease specialists and behavioral coaches who can increase patient understanding and support the optimal use of the medication.
Keeping an eye on the silver lining
Jessee of D2 Consulting notes that emerging specialty pharmacies can benefit from the accreditation process by using these standards to both level the playing field with existing players in the space, but to also build a solid infrastructure, with rigorous, durable processes, right from the outset, which will establish a pathway for successful growth over time.
Toward that end, specialty pharmacies should look at the data gathering and reporting requirements not as a burden but as a tool for continuous improvement, adds Bonome. “If you are required to track and report multiple metrics, you should use these to identify negative trends that arise and respond quickly with a corrective-action plan,” she says.
It is important for specialty pharmacies “to have a commitment to ongoing innovation and improvement,” says Mahaney of ASHP. “If you’re going to just check the box, you’re missing the greater point here.”
“As our CPPA surveyors are working with specialty pharmacies to gain or maintain accreditation, they will not only make specific recommendations in writing how the pharmacy can become compliant, but they will also document the specialty pharmacy’s own best practice or points of excellence,” says Mahaney. “CPPA-accredited specialty pharmacies can then publicize these findings to differentiate themselves from their competitors as they work to gain access to the specialty manufacturer distribution channels.”
In that same vein, when a specialty pharmacy is able to develop a strong, data-driven story to demonstrate strong patient outcomes related to the optimal use of the therapy, it can also leverage that accomplishment to demonstrate the high quality of its service offering, says Bonome.
By way of example, Jessee of D2 Consulting, says: “Several pharmacies have carried out case studies that demonstrate that their management of therapies and patient outcomes are saving the overall healthcare system money, through proper formulary management for PBMs, prevention of side effects, reduction of hospital readmissions and more.”
Maintaining some freedom to customize the offerings
The various accreditation organizations are quick to point out that while they establish rigorous performance standards based on clinical evidence and industry best practices, the opportunity for a certain amount of flexibility and customization is always baked into the different frameworks. Consider, for example, the inherent variability among complex illnesses — from hepatitis C and HIV to hemophilia and cancer — and the landscape of specialty therapy options that are available to treat them. To develop and administer the most meaningful wraparound programs, accredited specialty pharmacies want some degree of latitude, to work closely with the drug manufacturer to decide which types of data and metrics are most relevant.
“URAC’s accreditation programs allow for innovation and encourage customization by empowering organizations to develop drug- or disease-specific workflows that align with their business model and patient needs, while still meeting accreditation standards,” notes Bonome.
Is opting out still an option?
Despite the benefits, and the overwhelming peer and professional pressure to seek accreditation, some pharmacies do still choose to forego accreditation. “I see this all the time,” says Jessee of D2 Consulting. “The fees are often the biggest obstacle for smaller pharmacies, and the financial and administrative burden can be hard to justify if the return on investment is not obvious.”
The added costs are both internal ones (to provide the required patient services and reporting adequately) and external (the fees for initial and renewal inspections and audits), notes Express Scripts’ Saunders. “For some specialty pharmacies, the cost of a particular required accreditation may simply outweigh the potential benefits of participating in a given network, based on the payer’s reimbursement schedule,” she says.
Is consolidation inevitable?
The proliferation of competing accreditation bodies in recent years begs two important questions — Is there enough differentiation among them to justify so many players in the space? And why must today’s specialty pharmacies endure the added cost, parallel effort and potentially redundant burden required to achieve accreditation with multiple organizations, and manage so many sets of rigorous process and protocols to maintain ongoing accreditation?
While there are certainly overlaps in the philosophy and requirements of each of the competing specialty pharmacy accreditation bodies, many stakeholders agree that there’s still room at the table for all of them. “Some of these groups focus on specific portions of the overall specialty pharmacy offering, by offering specific accreditation requirements for Home Infusion, Sterile and Non-Sterile Compounding, Wholesaling, Durable Medical Equipment, Prosthetics, Orthotics and Supplies (DMEPOS),” explains Jessee of D2 Consulting.
He adds: “ACHC and URAC don’t offer any accreditation for wholesaling operations, but NABP offers such an accreditation (called Verified-Accredited Wholesale Distributors; VAWD). In order to get a state wholesale license in Indiana, Wyoming and North Dakota you have to have a VAWD accreditation.” He adds: ACHC has something similar with Compounding and it is required by states, so you must gain that accreditation if you do any compounding operations, in order to obtain a state pharmacy license.” On the other hand, the State of Michigan recently mandated Joint Commission accreditation for compounding pharmacies in that state.
“There are differences in survey requirements, survey processes, customer focus and support, costs, reputation and industry standing, along with the rigor of their individual accreditation processes that would impact the choice between accrediting organizations and ultimately define the competitive landscape,” adds Saunders of Express Scripts.
Battle-ready for audits
“Many PBMs carry out periodic audits of specialty pharmacies to ensure compliance with contractual requirements. Fortunately, most of the common audit topics are already effectively addressed within the rigorous standards imposed by the third-party accreditation organizations,” says Jessee. He notes that if the specialty pharmacies are not staying compliant with their accreditation standards, they will likely not do well with these audits.
As for the reporting requirements set forth in the various accreditation standards, they are generally two-fold:
(1) Reporting to any to external stakeholders (such as the specialty drug manufacturer, various payers and PBMs), and
(2) Reporting to the accreditation agency, to both demonstrate ongoing compliance and help the accreditation body to develop performance-related metrics of its own.
For example, the various accreditation agencies require accredited specialty pharmacies to track and report, on an annual basis, specific metrics such as:
* Adherence rates
* Percentage of days covered
* Pharmacist interventions
* Patient and healthcare provider satisfaction
* Drug-drug interactions
* Call center performance
* Dispensing accuracy
* Distribution accuracy
* Prescription turnaround time
* Quality-related events and medication errors
* Active patient volume being maintained according to patient-case-management protocols, by disease state
* Proportion of days covered
* Fulfillment of promise to delivery
* Primary medication non-adherence.
From the drug maker’s standpoint, one of the most important metrics relates to patient adherence to drug therapy, as this is the ultimate bellwether of how all of the various program elements are working. “The pharmacy is in a unique position to track key indicators, such as side effects, adverse events and adherence. Consistent, periodic monitoring can identify patients who are struggling with adherence to medication, and provide timely, targeted interventions that will help to keep the patient on the regimen as long as it is clinically appropriate,” says Bonome. “Evaluating how pharmacies are tracking and documenting individual patient adherence is something that we review regularly, by pulling individual patient files, whenever we conduct an accreditation review,” she adds.
1 Drug Channels Institute, 2018 Economic Report on U.S. Pharmacies and Pharmacy Benefit Managers, available at: