As the health care delivery system continues its transition to a value-based reimbursement model, pharmacies face many of the same market pressures as other health care providers to improve patient outcomes and patient experience while controlling costs. Because complex therapies and medications are expensive and require intense patient management strategies, payers rely on pharmacy benefit managers (PBMs) to manage utilization and reimbursement of specialty drugs. Many PBMs, in turn, seek out accredited specialty pharmacies (SPs) to provide an elevated degree of competency—one that focuses on medication adherence and patient outcomes. Accredited SPs are strategically poised to partner with these organizations and their provider networks to help patients realize improved outcomes.
The SP industry is simultaneously thriving and facing pressures, including copay accumulators and vertical integration. As the health care delivery system continues its transition to a value-based reimbursement model, pharmacies face many of the same market pressures as other health care providers to improve patient outcomes and patient experience while controlling costs.
The explosion of the specialty drug market has forced the pharmacy industry into a new era of heightened competition. Specialty drugs for individuals with chronic or complex diseases and disorders now comprise nearly one-third of the pharmacy industry’s revenue and are expected to account for up to 50% by 2020.1
This dramatic increase in the supply and demand for specialty drugs has attracted a wide range of organizations to the market. Organizations ranging from small, independent pharmacies to large, publicly traded retail pharmacy chains now dispense specialty drugs to patients in every state of the United States, resulting in a wide variation of quality and expertise among these providers. With the health care delivery system continuing to move toward value-based reimbursement, health plans, PBMs, practices, and hospitals are seeking to partner only with pharmacies that have a proven ability to deliver better care at a lower cost.
To successfully compete, SPs not only must improve their processes and create sustainable transformation, but they must also collect and share data that demonstrate their ability to improve patient adherence and outcomes.
Growth of the Industry
The past 3 years have seen “astounding growth” in the number of unique accredited SPs. In 2015, there were 381 unique SP locations, a number that grew to 499 in 2016 and 729 in 2017, as many SPs are now seeking accreditation from multiple bodies.1 The diversity of SPs has resulted in tremendous variability in all operational areas, including tracking adherence, educating patients, dispensing medications, and ensuring medication safety. The SP landscape is also shifting. For example, providers and health care systems now account for the fastest-growing SP segment (eg, ~70% of integrated delivery networks own an SP and >20% plan to add one over the next 12 to 18 months.2 Today, 6 of 10 oncology practices have their own dispensing pharmacies, and these provide up to 35% of a practice’s revenue. At the same time, hospitals and health systems are realizing the value of caring for patients throughout the course of treatment and the ability to enter into outcomes-based contracts.1
What’s Driving Specialty Accrediation Growth?
Specialty drugs, with nearly 700 therapies currently under development for treatment areas such as cancer, hepatitis C virus (HCV), HIV, autoimmune disorders, and multiple sclerosis, are expected to claim 9 of the top 10 spots among bestselling drugs in 2020.3 Specialty drug manufacturers and payers need to partner with pharmacies that can ensure a consistent patient experience, appropriate medication use, and continuity of care. At the same time, prescribing physicians seek to optimize patient care by referring to SPs that can provide effective medication therapy management and unfailingly meet the highest standards for improvement in patient outcomes. 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.
In our current health care landscape, it has become more important than ever for SPs to focus on quality and value-based care. The increased costs surrounding specialty medications, paired with the payer shift toward outcomes-based reimbursement models, have made tracking and reporting pharmacy data—as well as decreasing costs through quality and efficiency measures—critical to their success. To secure the payer and pharma contracts necessary for continued growth in the marketplace, SPs must continually improve operational procedures and invest in increasingly complex technology. With new SPs arriving on the scene and existing pharmacies continually evolving, how is it possible for payers and pharma to see each pharmacy’s “report card,” so to speak, to ensure that they are a viable partner? The answer, of course, is SP accreditation.
The Necessity of Accreditation
If a pharmacy wants to have access to limited-distribution products and payer coverage, accreditation is considered part of the cost of doing business. In order to show payers and pharmaceutical manufacturers that SPs are dedicated to quality, controlling costs, and documenting positive patient outcomes, accreditation is now all but mandatory (if not truly mandatory) when competing for contracts. Accreditation has become so commonplace in the current landscape that many contracts are now requiring not 1, but 2 SP accreditations.4 This industry-wide movement is cemented by the preference of payers that SPs achieve third-party accreditation to confirm their commitment to quality, cost-containment, and proper utilization of services. According to an EMD Serono survey, “Healthcare purchasers are increasingly requesting that a specialty pharmacy become accredited by an independent third-party organization to validate the pharmacy’s commitment to quality management, patient safety and monitoring, and prescriber and consumer communications.”5 These accrediting bodies are separate from other accrediting agencies that most pharmacies will have interacted with, such as VIPPS (Verified Internet Pharmacy Practice Sites) for the accreditation of online pharmacies and VAWD (Verified-Accredited Wholesale Distributors) for pharmacies that also participate in wholesale distribution practices.
There are many accrediting bodies for SPs, however, the Utilization Review Accreditation Commission’s (URAC’s) accreditation program is considered the program with the greatest longevity in the industry. Nevertheless, URAC is not the only game in town when it comes to SP accreditation. Additionally, SPs are considering seeking multiple accreditations from programs such as the Accreditation Commission for Health Care (ACHC), The Joint Commission, the Center for Pharmacy Practice Accreditation, and the Community Health Accreditation Program, which are also commonly utilized for accreditation by SPs. The accreditation process is extremely complex and each accrediting body has a slightly different focus and, thus, different expectations.
SPs pursue accreditation to demonstrate value and consistency in the delivery of quality clinical services in the treatment of chronic complex diseases. Overall, accreditation helps define the services, programs, and capabilities that an SP has in place. It also verifies compliance with strict guidelines required by accrediting bodies. Among its high-level deliverables, SP accreditation requires the adoption of policies and procedures to ensure consumer access to appropriate drugs while adhering to safety protocols and a coordinated strategy for patient management.6
As of January 2017, approximately 500 unique SP locations in the United States had achieved accreditation from 2 primary bodies: URAC and ACHC. This signifies a 32% increase in the number of unique, accredited SP locations compared with previous analyses conducted by industry researcher Drug Channels. The 2017 data show that 42% of SPs were accredited by URAC, 32% by ACHC, and the remainder by both URAC and ACHC.7
Accreditation Standards
Any SP looking to become accredited must first be in compliance with all state and local laws governing pharmacy operation. Beyond those provisions, URAC and ACHC have established recognized standards that apply to key aspects of SP services and operations. See Box 1 for examples of what the ACHC’s standards address.8
In general, accreditation demonstrates an SP’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 its dedication to optimizing patient outcomes and safety.9 Nonetheless, accreditation should not be taken lightly. It requires a time commitment of 6 months to a year, along with an application fee.
SP accreditation may seem cumbersome 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.
While therapies for “the big 3” disease states (ie, multiple sclerosis, cancer, and rheumatoid arthritis) will continue to account for a substantial share of specialty drug utilization, the next generation of “pharmaceutical blockbusters” may actually comprise orphan drugs—specialty drugs developed to treat diseases that affect smaller patient populations that often have substantially higher costs. This will further expand market opportunities for SP providers: As the clinical, logistical, and operational expertise necessary to help patients manage these therapies becomes more complex, the need for exceptional SPs will increase.10
SP Accreditation Benefits to Payers
SP accreditation establishing policies and procedures to ensure compliance with accreditation standards puts patients first in terms of optimizing health outcomes and guides them through complicated therapy management. In addition, 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 is 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.
There is a tremendous amount of interest because of the sheer dollars going into specialty drugs, and that trend is here to stay. With consolidation, there will be increasing sophistication in operations and care management, as payers will continue to seek the best of the best. Among their top strategic priorities: coordinating specialty drug management across pharmacy and medical benefits.
The growth of lower reimbursement models that penalize poor outcomes has drug manufacturers, health plans, and PBMs seeking SPs that can deliver quality care at a lower cost. Accordingly, most now require SPs to be accredited by a nationally recognized accrediting organization as a way to externally validate quality and competency.
The overarching goal of accreditation is to serve as a mechanism to drive best practices, which is inevitably going to be at the forefront of the health care evolution as the industry continues to focus on value-based care. In today’s value-based landscape, medication adherence and medication management not only drive outcomes, they are driving specialty drug payment.
The pharmacy market has a significant role to play in creating a more collaborative model of care, particularly in the types of high-touch therapies provided by SPs. Accredited, patient-centered SPs will be best positioned to win some of this lucrative business. Pharmacy practice is undergoing a transformation: from an operational focus to providing more value-based services (Box 2).
SP Accreditation Benefits and Considerations for Pharmaceutical and Biotechnology Manufacturers
Consider the new pressures physicians are facing. The value-based reimbursement established under MACRA (Medicare Access and CHIP Reauthorization Act of 2015) will fundamentally change how providers are paid by rewarding physicians for improving outcomes. Physicians are care team leaders under MACRA. If physicians benefit financially by partnering with top-performing pharmacies who help them improve quality, they will seek out such pharmacies. To demonstrate their value as a care team partner, SPs must measure and report performance. Some measures commonly tracked include medication possession ratio, portion of days covered, viral load, accuracy and turnaround time of dispensed prescriptions, and customer satisfaction. Pharmacists and pharmacies who can demonstrate their ability to manage medication and thus demonstrate their value will be recruited by accountable care organizations, clinically integrated networks, and patient-centered medical homes. Pharmacists will no longer play supporting roles; they will be vital leads.
Validating improvement through performance measurement is critical in today’s value-based market. To demonstrate value, SPs must have data that connect their interventions directly to patient outcomes. Perhaps no measure is more important than adherence. Countless studies have demonstrated its impact on outcomes and avoiding unnecessary hospitalizations and other expenses. A 2013 study, for example, found that patients were 60% more likely to achieve optimal adherence with their HCV drug therapy if they used an SP rather than a retail pharmacy.11
Patients with >1 chronic condition have the highest readmission rates. SPs, with their high touch points and strategic patient outreach, are uniquely poised to help break this trend. Unlike most traditional prescriptions, specialty medications require strategic care coordination between pharmacists, physicians, nurses, allied health professionals, the patient, and caregiver. From comprehensive teaching prior to beginning their drug therapy to continuous monitoring and outreach throughout the treatment, specialty pharmacists provide an essential drug management program for each patient.
Accredited SPs are strategically poised to partner with pharmaceutical and biotechnology manufacturers to help patients realize improved outcomes. As such, manufacturers could benefit from exploring collaborations and partnerships with accredited SPs in achieving mutually beneficial business objectives (Box 3).
As the health care delivery system continues its transition toward value-based care and reimbursement models, SPs face many of the same market pressures as other health care providers to improve patient outcomes and patient experience while controlling costs. Accreditation demonstrates an SP’s commitment to quality, and gaining accreditation can help differentiate an SP from competitors through its dedication to optimizing patient outcomes and safety. Accredited SPs are strategically poised to partner with multiple key stakeholder organizations to achieve common objectives of the Triple Aim.
References
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2. Health Industries Research Companies (HIRC). Integrated Delivery Networks Research: Market Landscape and Strategic Imperatives. Hirc.com website. https://www.hirc.com/integrated-delivery-networks-market-landscape-and-strategic-imperatives. Published May 2018. Accessed August 16, 2018.
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6. Fein AJ. Exclusive update: the state of specialty pharmacy accreditation in 2017. Drug Channels. Drugchannels.net website. https://www.drugchannels.net/2017/04/exclusive-update-state-of-specialty.html. Published April 13, 2017. Accessed August 16, 2018.
7. IQVIA (formerly IMS Health). Overview of the Specialty Pharmacy Drug Trend: Succeeding in the Rapidly Changing U.S. Specialty Pharmacy Market [video]. https://docplayer.net/4230764-Overview-of-the-specialty pharmacyecialty-drug-trend.html. Accessed August 16, 2018.
8. Maloziec R. Add value to your specialty strategy. AmerisourceBergen.com website. https://www.amerisourcebergen.com/abcnew/insights/add-value-to-your-specialty-strategy. Published July 20, 2017. Accessed August 16, 2018.
9. Accreditation Commission for Health Care (ACHC). ACHC Accreditation Guide to Success Workbook. Accreditationuniversity.com website. https://accreditationuniversity.com/media/95e5b5ef-89fb-4484-aa3f-4ba039a19942. Published 2014. Accessed August 16, 2018.
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11. Visaria J, Glave Frazee S. Role of pharmacy channel in adherence to hepatitis C regimens. Am J Pharm Benefits. 2013;5(1):17-24.
