Kyle Skiermont, PharmD

	Each year, more health systems and academic medical centers implement in-house specialty pharmacy programs. According to the 2016 American Society of Health-System Pharmacists (ASHP) survey of hospital pharmacy practice, a specialty pharmacy operation is in place in 47.1% of hospitals with 600 or more staffed beds. The percentage declines with hospital size, down to 1.6% of hospitals with fewer than 50 beds.

	Whether a hospital is a community hospital, part of a larger health system, or the flagship of an academic medical center, it should address the issue of specialty pharmacy in all its operational and economic complexity. However, just 8.7% of all hospitals surveyed operate a specialty pharmacy.

	When planning for a specialty pharmacy within a health system, 3 business models should be considered: build, partner, and outsource. A fourth model—doing nothing or delaying a decision&mdash;becomes, by default, a fragmented, reactive outsourcing program with individual patient risk managed as it arises. And it is bound to arise.

	As specialty drugs carve out a greater slice of the pharmaceutical landscape, delaying a decision leaves the health system at a disadvantage in terms of managing the cost of care, maintaining continuity of care, managing medical records, delivering a high-quality experience for patients and their families, and retaining pharmacy revenue.

	A brief description of each model follows. Organizations should consider the business case for and against each one: What are its advantages and disadvantages? What is the risk involved in following or not following this pathway? What resources would be required?

	A health system is best positioned to successfully implement an in-house specialty pharmacy operation if it has 3 things:

		Existing ambulatory pharmacy capabilities

	The largest health systems and those with many specialty patients, such as academic medical centers, will see the clearest potential from building their own capabilities. The build model’s greatest benefit is the ability to manage care and transitions of care seamlessly, so that complex patients continue to receive their medications. The deciding factor in getting in or staying out is likely to be economic. Many health systems may choose to enter the space, regardless of the economic return, to align pharmacy services with their institutional mission and values.

	An existing ambulatory pharmacy operation reduces the risk of issues during care transitions and provides a head start in terms of infrastructure and expertise. However, specialty pharmacy operations differ from traditional ambulatory pharmacy in many ways. Technology platforms, strict storage and dispensing capabilities, call center capabilities, and shipping capabilities will likely need to be developed.

	Building a specialty pharmacy program can be approached incrementally or all at once. Either way, it is important to recognize that a capability intended to serve as much of the organization as possible from inception may still have to accommodate payers and products to which the organization does not have access. Any related concerns about access to product and access to patient lives should not, however, delay implementation. As an organization’s specialty pharmacy grows, develops, and consistently meets patient, manufacturer, and prescriber expectations, it will become more likely to gain access to these contracts.

	Another option that can permit health systems to retain some of the advantages of controlling their own specialty pharmacy function, depending on the choices made, is the partner model.

	Midsize health systems or those with a lower concentration of specialty patients may be best served by developing some functions in-house and finding partners to assist with the rest.

	Partnerships allow health systems to tap into expertise, technology, and manufacturer relationships that could be prohibitively difficult to develop on their own. As the business plan is reevaluated every few years, the decision can be made to pivot to an in-house operation. Avera Health System in South Dakota, for example, subcontracted call center services to Fairview Specialty Pharmacy while building its own specialty pharmacy. 

	If a health system sees compelling reasons to offer a full range of specialty pharmacy services, it may also see value in partnering or contracting with an outside resource or resources to provide certain services and perhaps accelerate speed to market. Partners are available to manage call centers, run prior authorization and patient assistance programs, provide staff training and education on the latest therapies, and take on many other aspects of the operation. Personnel needs will be less than in a full build-out, an advantage to organizations that have limited resources to acquire staff or that struggle with finding qualified employees. 

	The partner model allows the health system to leverage its strengths and bring in aligned resources to fill out its capabilities. Assembling the pieces involves considerable complexity, but a number of organizations have done so successfully. 

	With the outsource model, an organization contracts out all or most of the services, including fulfillment or patient care, that an in-house specialty pharmacy (or partner) would otherwise provide. Wholesaler subsidiaries and group purchasing organizations may offer the solutions a health system needs to put this model into place. Multiple vendors may be required to cover a range of specialty pharmaceuticals, or the selected vendor may have collaborative arrangements with other companies. Vendors frequently offer co-branding opportunities, placing the health system’s name and logo on prescription labels and promotional materials. 

	The outsource model makes continuity of care challenging; therefore, health systems should develop processes that help coordinate care as much as possible. 

Opportunities inside and outside health systems

	In the larger specialty pharmacy marketplace, businesses such as Shields Health Solutions, Trellis Rx, and Acentrus Specialty, as well as organizations such as Excelera, have emerged to help health systems negotiate the complexities of planning, funding, building, and operating successful specialty pharmacies. Large specialty pharmacies such as Diplomat, among others, also provide a variety of services to help fill partnership or outsourcing needs.

	For manufacturers, payers, large specialty pharmacies, technology providers, and others, conversations that recognize the mission-driven nature of health systems and acknowledge the often-challenging economic realities they face can be the first step toward effective collaboration, whichever model a health system seeks to implement. 

	Many of the largest health systems and major academic medical centers recognize the significant clinical and economic benefits of pursuing the specialty pharmacy build model. Other health systems generally fall into 2 categories: 

		Leadership has decided to pursue specialty pharmacy through a partnership or outsourcing agreement, a path that usually makes sense for mid-size health systems.

		Leadership is focused on other pressing issues, with specialty pharmacy planning falling to the bottom of a long list of concerns. 

	For those who have failed to engage with the topic, the time to do so is now. An excellent resource for further information is the ASHP Specialty Pharmacy Resource Guide, available for download at 

		Pederson, Craig A et al. ASHP national survey of pharmacy practice in hospital settings: Prescribing and transcribing — 2016. 

Articles

When planning for a specialty pharmacy within a health system, 3 business models should be considered: build, partner, and outsource.

Indecision Is Not an Option: Understanding the Range of Business Models for Health-System Specialty Pharmacy

 away from fee-for-service (FFS) reimbursement into a brave new world of payment models that may involve risk sharing, reward sharing, capitation, and other mechanisms across various periods of time for certain patient populations. These new payment models offer opportunities for the health system-based specialty pharmacy.

The American Hospital Association Committee on Research defines 2 fundamental alternatives to FFS: bundled-based payment and population-based payment.

 Optum defines 4 value-based reimbursement models—pay-for-performance, the patient-centered medical home, bundled payment, and shared savings/accountable care organizations (ACOs)&mdash;and 5 payment methods&mdash;pay-for-reporting, pay-for-adoption, prospective payment, warranty services, and gainsharing.

 Quality assessments are often part of the formula, as are risk adjustments based on teaching status, the types of patients served, and other factors. The variables and data requirements are complex.

FFS is still dominant, but its days are numbered. Even drug companies are publicly discussing the idea of “going at risk” with payers through value-based pricing that focuses on outcomes.3 To some degree, the impetus to reform payment models has come from the top down, as with the Centers for Medicare & Medicaid Services and its designation of ACOs. The market is also demanding payment model reform, both to control costs and to achieve the other elements of the triple aim: improve population health and the patient experience. Innovation has been emerging through the joint efforts of payers and providers in negotiating contracts. Health systems must manage these contracts proactively to make sure that they are allowed to effectively care for their patients while sustaining the viability of the organization.

Specialty pharmacy must actively engage with the new payment models. The sheer numbers involved demand it. According to Express Scripts, less than 1% of all prescriptions written in 2014 were for specialty drugs even though they accounted for about 32% of total drug expenditures.

 In 2015, that number jumped to 37.7% of the overall drug spend.

 Outsourcing pharmacy—or being cut out of pharmacy&mdash;for this tiny fraction of the overall patient population can result in significant challenges for the health system when trying to meet the requirements of these payment models. Health systems cannot assume the financial risk for these complex and very expensive patients without the ability to manage all aspects of their care.

How Specialty Pharmacy Is Already Shaping New Payment Models 

At Fairview Health Services, which includes the University of Minnesota Medical Center, more than 300,000 lives are covered by innovative value-based payment models. Based on the nature of these payment models, Fairview Specialty Pharmacy has been able to fill prescriptions for many specialty patients at its hospitals and clinics, including some who might be required to use a remote, for-profit pharmacy if they become patients at a different health system. In negotiating these contracts, Fairview, like other health systems with integrated specialty pharmacy capabilities, can make a strong case for the patient care advantages and efficiency of care team integration and access to electronic medical records (EMRs). Because Fairview is responsible for the outcomes and total cost of care for these patients, it is imperative that the health system be allowed to provide its specialty prescriptions for the duration of their care.

It is not just Fairview that is providing these services. Ochsner Health System has also seen the importance of managing its own specialty pharmacy patients. “To provide coordinated care to our patients, we found we needed to provide the specialty medication and manage the care within our system,” said Deborah Simonson, vice president of pharmacy at Ochsner Health System. “This enables us to provide an integrated team approach that manages cost, outcomes, and the patient experience. Carving the system out of that process disrupts workflow, decreases communication, and adds unnecessary roadblocks for the provider and patient.”

Expansion of the Specialty Drug Sector Demands Continuous Attention From Health Systems 

Properly managing reimbursement for this small percentage of patients is critical to managing costs and outcomes in the evolving payment environment, especially as the specialty drug sector continues to grow. A report from the Pew Charitable Trusts suggests that specialty’s spend will total $400 billion by 2020, which is more than 9% overall of national health spending.

 Drugs in the approval pipeline are heavily weighted toward specialty products.

Furthermore, traditional therapeutic categories are edging into the specialty class. The treatment of high cholesterol, for example, became potentially more complex with the approval in 2015 of alirocumab and evolocumab. Although payers have placed boundaries on their coverage of these drugs, their use is growing rapidly.

 It is precisely this type of drug for a chronic condition that presents a large risk to health systems when they are financially accountable for the cost of care, but are excluded from the specialty pharmacy benefit.

Yale New Haven Health System also entered the specialty pharmacy market, in part to manage the cost of its complex patients. “Today’s changes in health care require all models to rethink the best way to care for our patients,” said Lorraine Lee, vice president and chief pharmacy officer at Yale New Haven Health. “As health systems, we historically focused on acute care episodes of treatment. Now, with the move to value-based care and population health, ensuring our patients are cared for after they leave the hospital setting is critical to patients’ long term health.”

Yale New Haven saw that some of its most complex patients were being sent home to care for medication needs on their own, leading to noncompliance, readmissions, and seeking higher levels of care. Having its own specialty pharmacy enables the system to provide better care for these patients. “Our specialty pharmacy services allow better communication to all members of the team, including the patient, in the discussions,” Lee said. “This has shown to improve outcomes through improved compliance and closer management of side effects and other issues encountered by patients. We also have access to the EMR and can document this care, so that when a patient interfaces with their physician in the future, there is better information to make decisions.”

To remain viable in an outcomes-based payment environment, health systems must address specialty pharmacy. If health systems are responsible for the health outcomes of specialty patients, they must be allowed to manage these patients, including dispensing their specialty prescriptions. In addition, as health systems continue to take on more financial risk, it is imperative that they be able to affect one of the fastest growing expenses in health care: the prevalence and utilization of specialty medications.&ensp;

Properly managing reimbursement is critical to managing costs and outcomes in an evolving payment environment.


Brave New World: What the Trend Away From Fee-for-Service Means for Health-System Specialty Pharmacy

THE BENEFITS OF INTEGRATED clinical care are undeniable. In a specialty context, pharmacy integration acquires additional meaning and urgency for its impact on individual patient health, population health, and organizational efficiency. The ASHP Specialty Pharmacy Resource Guide notes these factors as contributing to successful clinical integration:

• Complete and timely information about the patient and the services they are receiving

• Access to the electronic medical record (EMR)

• Adequate resources for patient education and self-management support

• The ability to measure and report on the quality of care

• A culture of teamwork among staff and physicians

Health systems and their in-house specialty pharmacies are uniquely positioned to leverage these factors, whether the pharmacy staff is located within specialty clinics or a centralized approach is used. The specialty pharmacy can help deliver a seamless patient experience,reduce the administrative workload on clinics, and collaborate with physicians to develop and refine treatment protocols. Specialty pharmacies also provide comprehensive counseling, follow-up, and intervention that can improve patient outcomes.

Specialty Pharmacy Integration in the Care Process 

Specialty pharmacy integration relies on communication among providers and the inclusion of pharmacists and other pharmacy staff on the care team. In an integrated system, the pharmacist—often board-certified and residency-trained&mdash;has access to the EMR and the ability to review diagnoses, lab results, discharge notes, and other information.

The pharmacist can recommend treatment and document interventions in the EMR, so that the physician and other providers can stay up-to-date without relying on the patient to communicate information accurately. Under ideal circumstances, the pharmacist and pharmacy technicians are embedded in the process.

Vanderbilt University Medical Center (VUMC) has been a pioneer in embedding pharmacy staff inside specialty clinics. Currently, Vanderbilt Specialty Pharmacy (VSP) has 26 pharmacists rooted in 20 specialty clinics across the enterprise.

“We feel that the hands-on, team-based approach to specialty pharmacy care within the clinic is providing a superior service, patent experience, and outcomes, and allowing us to really leverage our position as an integrated delivery network,” said Jerry Buller, DPh, director of specialty pharmacy services at VUMC.

The clinic-based Vanderbilt pharmacy team conducts specialty benefits investigations, obtains prior authorizations (PAs), and handles any manufacturer-funded co-pay assistance upstream in the clinic. They also work with providers to draft appeals and letters of medical necessity.

“The fact that clinical pharmacists are steps away from the physician and communicating instantly within their EMR ensures patient care issues can be addressed real time,” Buller said. “We bring the clinic to the patient.”

According to Buller, 60% to 65% of patients typically are qualified to use VSP, and most choose to have the pharmacy fill their medications. For patients whose insurance requires them to use an outside specialty pharmacy, Vanderbilt still performs initial assessments, patient education, and injection training, and obtains the PA in an effort to increase the speed to therapy.

Even patients who are required to use an outside specialty pharmacy receive the benefit fostered by this clinic-based model. These patients experience a significantly reduced time to therapy compared with that experienced at a typical outside specialty pharmacy. VSP’s average time to process a clean claim is 1.01 days, according to Buller.

Clinical metrics are also bolstered by Vanderbilt’s in-house pharmacy model, as shown in patients receiving hepatitis C virus (HCV) therapy. A recent poster presented at last year’s National Association of Specialty Pharmacy annual meeting2 demonstrated that every HCV patient referred to VSP was able to start therapy. Additionally, a statistically significant number of those patients completed their entire course of HCV therapy compared with an outside pharmacy (97% vs 93%; P = .02).

Issues that Arise in Traditional or Coordinated Care Processes 

Clinically integrated care, such as Vanderbilt’s, stands in contrast to traditional, or coordinated, care. In a traditional care process, patients receive their specialty medications from a pharmacy that is not linked to their hospital or clinic. Reimbursement assistance, adverse effect (AE) management protocols, and patient education are fragmented or lacking, so that patients fall between the cracks of the system, sometimes failing to begin therapy and rarely being adequately monitored.

Although an individual patient may have a good experience if there is a close relationship between the prescriber, the pharmacist, and the patient, all parties must perform their due diligence. The payer must be willing to authorize a charge and the patient must be able to afford the medication; however, traditional care is still fraught with obstacles for most specialty patients. The lack of integration in the traditional care process is compounded, as manufacturers limit distribution of new specialty pharmaceuticals.

In a coordinated care process, pharmacies with extensive specialty business, such as large mail order pharmacies, provide more comprehensive services. Depending on the pharmacy, reimbursement specialists, patient care coordinators, and pharmacists provide PA assistance, standardized case management, patient education, ongoing monitoring, and other support.

However, much of the administrative burden still falls on physicians to provide letters of medical necessity and other paperwork, and pharmacists must rely on patient-reported information because they do not have access to the EMR. Abandonment of therapy is often not reported to the physician.

Implementing Specialty Pharmacy Integration 

Simply having an in-house specialty pharmacy, of course, does not guarantee clinical integration within a health system. Establishing workflow and building trust can be a slow process. Clinics may already be receiving competent, coordinated support from outside specialty pharmacies, but it is impossible for this type of support to be fully clinically integrated and collaborative.

An outside pharmacy cannot match the advantage of a shared EMR for clinicians and local convenience for patients. A single point of referral also makes staff workflows more efficient.

In conversations with clinics, questions about what the specialty clinic is struggling with can uncover the most urgent integration needs. If PAs and other administrative tasks are burdensome, as they often are, the pharmacy can offer a staff member to take on these tasks, perhaps operating as an on-site liaison. These staffers can also advise patients on the value of using the in-house pharmacy, if a patient’s insurance allows it.

Taking on the task of follow-up phone calls is also a common way to increase integration; formally instituting a therapy management protocol for each specialty is a best practice. The clinic and pharmacy work together to develop protocols and improve them over time. Specific steps and staff vary, but typically, a specialty pharmacist counsels patients before or upon initiation of therapy and a pharmacist or nurse follows up at defined intervals. Patients build rapport with their care team, facilitating proactive problem solving that may prevent therapy abandonment and hospitalizations.

At Fairview Health Services, all specialty clinics have been integrated with Fairview’s specialty pharmacy. In the oral oncology program, for example, pharmacists who specialize in oncology medicines monitor patients’ lab values to ensure they are in the normal range, determine whether drug therapy is appropriate, help manage AEs, and adjust the dosage of the oncology drug or other medications, if needed. For example, an elderly diabetic patient was taking the oral chemotherapy drug palbociclib (Ibrance) to treat metastatic breast cancer.

The therapy management program meant that the pharmacist was aware the patient was taking metformin for her diabetes. With access to the patient’s labs, the pharmacist noticed that the patient’s creatinine level had risen precipitously over the course of 7 days, indicating severe renal impairment.

The oncologist was informed immediately and a decision was made to hold the metformin. The patient was given intravenous fluids, her primary care provider was informed, and the metformin was stopped permanently. Communicating stories like this is helpful in expanding specialty pharmacy integration to more clinics within the health system.

While having high-level buy-in at the senior level, such as the medical director, can be useful, it is usually more effective to work directly with the providers at the clinic. Along with sharing individual stories, sharing metrics is also important, and if these metrics can be communicated by providers, all the better.

If the persistency rate has increased at the cystic fibrosis clinic as a result of therapy management, those physicians might be enlisted to contact doctors at the rheumatology clinic to discuss the improvement, along with other benefits, of greater integration.

Reducing waste while improving the odds of successful treatment is also a persuasive point for clinicians. When counseling occurs before initiation of therapy, the pharmacy can uncover factors that might call for a delay. This could be as simple as waiting until after a patient’s upcoming vacation or as challenging as addressing mental health issues. Either of these factors could cause interruptions in therapy that would not only have a clinical impact, but would result in the waste of thousands of dollars of medication.

Fairview’s HCV patient onboarding process considers short-term concerns such as surgery, vacation, moving, and changing jobs or insurance. Also considered are factors such as confusion or cognitive impairment, previous history of nonadherence, and missing appointments, as noted in the medical record. The onboarding process team includes a patient financial advocate, a specialty care coordinator, and an HCV-trained clinical pharmacist.

Some nursing staff and physician assistants may be skeptical of integration initiatives, but the benefits become clear when integration provides them with more time for hands-on patient care, frees them from administrative burdens, improves medication adherence and AE management, and enhances the overall patient experience.

A specialty pharmacy that operates in a bubble within the health system is not reaching its full potential. The pharmacy needs to become fully integrated with the health system and its specialty clinicians to compete in the marketplace and benefit from optimal patient outcomes and operational efficiencies. Clinical integration is important and achievable in this era of health care disruption and transformation. 

Specialty pharmacy integration relies on communication among providers and the inclusion of pharmacists and other staff on the care team.

Breaking Out of Isolation: The Value of Clinical Integration in Health System Specialty Pharmacy

In the data- and outcomes-driven paradigm that is shaping health care today, access to the electronic medical record (EMR) is a key factor that distinguishes health-system specialty pharmacies from their nonintegrated competitors.

This access is critical to managing the specialty patient population. For health systems, it means greater efficiency and better patient care. For individual patients, it means more integrated, responsive care.

In the aggregate, a seamless set of EMR data offers the opportunity to discover which therapies provide the best long-term outcomes. As part of the care team, the health-system pharmacist can gain immediate EMR access to all relevant patient data, including laboratory test values, progress notes, and clinic appointments.

The pharmacist can also add information to the EMR, as appropriate, and can communicate with the rest of the care team more easily and quickly than an outside pharmacist. Ideally, the record becomes seamless and the entire care team can access and learn from the data.

Unfortunately, when a health system has not implemented its own specialty pharmacy program—or the health system’s pharmacy does not have access to the drug, or the payer has carved out the benefit to a for-profit specialty pharmacy&mdash;the prescription is filled outside the health system by a remote specialty pharmacy without connectivity to the health system’s EMR.

The resulting EMR gap means the care team can lose sight of where and when a drug was dispensed. They might even be unaware of an adverse event unless that event results in hospitalization, for which the health system, in an accountable care environment, is responsible.

From the moment a physician prescribes a specialty drug, the pharmacist’s access to the EMR matters in terms of speed, accuracy, responsiveness, adherence, waste reduction, and the availability of data for determining long-term costs and outcomes. The telephone and the fax machine seem to be state-of-the-art technology where PAs are concerned.

Communication between providers, payers, patients, and pharmacies can feel like a step back to a time before today’s sophisticated EMR software existed. With access to the EMR, health-system specialty pharmacists can deal with PAs in the most efficient way possible, not only making life easier for providers and patients, but minimizing the potential for errors, omissions, and confusion. When a payer requires PA with each renewal, the time savings become substantial.

By speeding the process of requesting authorization, the health-system specialty pharmacy does all it can to minimize approval time and initiate therapy as quickly as possible. When access to the EMR is available, pharmacy staff can research all questions, attach appropriate clinic notes and lab data, and submit the information to the payer the same day the prescription is received. For example, for a patient with psoriasis, all previously tried and failed therapies—including topical, OTC remedies, nonbiologic, biologic, and phototherapy&mdash;can be retrieved and submitted.

This substantially reduces the time to first fill, allowing the patient to initiate therapy much more quickly. Remote specialty pharmacies operate with a built-in lag time. Communicating with them to reduce dosage, increase dosage, or change medication takes time. By the time the communication has passed through, an incorrect refill may already have been shipped.

In a specialty pharmacy operated by the health system, pharmacists can see lab results in the EMR and supply the correct dose, eliminating the possibility of a wasted refill. An example of the benefits of EMR integration can be found at The Johns Hopkins Hospital Sidney Kimmel Comprehensive Cancer Center, where clinical pharmacy specialists have been embedded into multidisciplinary ambulatory oncology teams.

Pharmacy specialists are involved in the design of comprehensive treatment plans, including adjunctive and supportive therapies, patient education, adherence support, and ongoing safety and efficacy monitoring. These specialists utilize the EMR extensively to coordinate care, monitor patients, and document all components of the treatment course. Access to critical information, such as laboratory values, appointment schedules, changes in level of care, and treatment history, allows these pharmacists to make decisions based on the most up-to-date and accurate clinical data.

In one case, a pharmacist prevented a likely hospital admission for febrile neutropenia by identifying a patient with a low absolute neutrophil count and coordinating discontinuation of therapy until counts recovered. In another case, a pharmacist identified the benefit that additional lab monitoring would provide in managing a patient receiving a second cycle of oral capecitabine.

In this scenario, the pharmacist was able to facilitate the ordering of appropriate labs, which led to the identification of significant renal impairment requiring dose adjustment. Without this information, the patient would have been at high risk for additional health care exposure related to toxicities from overdosing. Pharmacists interact with patients and families in ways that bring out important information—from something with serious treatment implications, such as excessive alcohol consumption, to something that is simply a matter of logistics, such as an upcoming vacation.

Pharmacists are in a strong position to learn about potential barriers to adherence that a patient might not share with a prescriber, such as lifestyle preferences, financial hardship, or medication side effects.

Health-system specialty pharmacists can easily communicate such critical information to the rest of the care team and enter it in the EMR if appropriate. Pharmacists often uncover important information even when it is not directly or intentionally stated by the patient. In a white paper published in 2015, health-system specialty pharmacy network Excelera cites an example of a health-system pharmacist whose first interaction with a patient with hepatitis C, prescribed $100,000 in drug therapy, raised red flags regarding the patient’s mental health.

With access to the EMR, this attentive pharmacist could, without delay, communicate with the care team regarding the concern. Thus, the patient’s underlying mental health issues could be addressed prior to the hepatitis C therapy, thereby minimizing the risk of noncompliance and unnecessary drug expense.

The health-system pharmacist’s ability to document communications with the patient in the EMR can be especially important if the patient has stopped taking medication because of serious side effects or drug interactions.

Although nonintegrated specialty pharmacies may do their best to support patients with therapy management programs and help lines, that support may be insufficient, impersonal, or delayed. Certainly, the ability of these pharmacies to track and measure adherence, compliance, and outcomes is limited. There is extraordinary potential for the EMR to be a rich source of data for measuring true health outcomes and the total cost of care.

At Fairview Health Services, several initiatives are underway to tap into this information. One project will measure the outcomes of patients with cystic fibrosis (CF) treated in the health system compared with industry clinical trial data and outcomes data from the national CF registry. Another will seek to quantify the extent to which pharmacist interventions with patients at the health system’s oncology clinics lead to better identification and management of adverse events.

To sum up, access to the EMR is important because it provides:

		a full view of the medication record, including current and previous medications

		a full view of the medical history, including allergies, access to clinic notes, hospitalizations, and historic lab values

		the ability to process insurance PAs more quickly because of access to all the data

		the ability to communicate logistics and fill information to the provider and have a record in the EMR

		the ability to communicate clinical information and assessment data to the provider and have the record of that communication in the EMR

		the ability to report response to a medication, as well as its dispensing information

		the ability to measure true health outcomes, including mortality, quality of life, and functional years

		the ability to measure total cost of care 

Among the practical, clinical, and financial reasons for hospitals and health systems to implement their own specialty pharmacy programs, access to the EMR stands out as a key differentiator. Health-system decision makers can point to this key differentiator to support implementation of their own specialty pharmacy programs. 

 is the Chief Operating Officer for Fairview Pharmacy Services, a leading health system based pharmacy organization in Minneapolis, MN. He received his PharmD from the University of Nebraska Medical Center College of Pharmacy. As COO, Kyle is responsible for strategy and overall operations of Fairview Pharmacy’s specialty pharmacy, retail, mail order, long-term care, compounding, home infusion, and community infusion business units.

Access to electronic medical records is a key factor that distinguishes health-system specialty pharmacies from their nonintegrated competitors.

Minding the Gap: Why Access to Electronic Medical Records Matters in Specialty Pharmacy

AS HEALTH CARE PAYMENT MODELS SHIFT TOWARD RISK-SHARING

, pay-for-performance, and accountable care organizations (ACO), hospitals and health systems are waking up to the realization that decisions they make regarding specialty pharmacy could affect clinical outcomes, color the patient experience, and impact the bottom line for years to come.

While not every hospital or health system has the population base or infrastructure to build in-house specialty pharmacy capability, every large integrated delivery network and academic medical center with specialty clinics and existing ambulatory pharmacy infrastructure should, in fact, must, consider the possibility. Every hospital and health system should look at the issues and act decisively, whether the decision is ultimately to build internally, partner with a regional or national specialty pharmacy, or continue in the current environment controlled by payers and manufacturers.

A number of health systems have already awakened to the impact and opportunity of specialty pharmacy, and have seized control of their destiny in the rapidly evolving specialty environment. Their successes and challenges will reshape the landscape of this segment of health care, and perhaps, redefine what the industry considers to be the preferred model. Certainly, there is plenty of specialty pharmacy spending to go around.

Pharmacy revenues from specialty drugs may have reached $98 billion in 2015.

 But, a study of 7 academic medical centers indicated that, on average, each center captured less than 15% of the more than $200 million in prescriptions that it wrote annually.

Only 10.6% of accredited specialty pharmacy locations in 2015 were owned by health care providers, a figure that includes physician practices, as well as hospitals, health systems, and provider group purchasing associations.

But the trend is growing. In October 2015, more than 2 dozen health system pharmacies were in the process of seeking specialty accreditation from URAC, which, if completed successfully, would triple the number awarded this designation.

Health systems are actively reaching out for support as they develop their specialty pharmacy functions. Specialty pharmacy networks that provide services and support to health system pharmacies have emerged: UHC, the consortium of academic medical centers, added a specialty pharmacy program in 2014; Excelera, a network exclusively dedicated to specialty pharmacy that launched in 2011; along with 15 academic health systems and medical centers are members.

These early adopters have determined that health systems not only can match, but can improve upon, the set of services typically provided by the dominant for-profit specialty pharmacies. Very briefly, here are some points to consider as the sleeping giant awakens:

Access to the electronic medical record is critical to managing the specialty patient population. As part of the care team, the pharmacist can gain immediate access to all relevant patient data, including laboratory test values, progress notes, and clinic appointments. Pharmacists can also communicate with the rest of the care team regarding compliance, financial hardship, or adverse drug events. When an outside pharmacy dispenses the drug, there is a gap in the EMR, and the care team becomes blind to where and when the drug was dispensed or whether there was an adverse event, unless the event results in hospitalization, for which the health system then becomes responsible in an accountable care environment.

•Clinical integration and point-of-care access

Ideally, specialty pharmacy should not be an isolated bubble in the health system. Clinically, health systems have a unique opportunity to serve as the central hub for patient care and research into complex illnesses. In practical terms, a specialty program run by the health system can create ease and efficiency by, for example, assuming management of activities that the system’s clinics may struggle with, such as managing benefit investigations, obtaining prior authorizations, completing reimbursement hub forms, and preparing letters of medical necessity.

•Payment model changes and the specialty market

Retaining and effectively managing the care of specialty patients is critical to managing costs and outcomes in the evolving payment environment. In a further layer of complexity, more health systems are merging with health plans and specialty physician practices. The significant financial challenges posed by the cost of specialty drugs and the structure of the remote, for-profit specialty payment model weigh heavily on both the provider and payer sides of the equation as they try to serve their patients and employer-customers effectively.

Global payment models put health systems at risk for the cost of care, while health plans must increase value for their customers; just as payers with integrated pharmacy benefit managers (PBM) may argue for the benefits of that arrangement in terms of access to spending and utilization data. Therefore, health systems with integrated specialty pharmacies can point to the advantages of access to the EMR and care team integration, as well as the benefits to the financial health of the enterprise, especially in an accountable care context.

Health systems that develop specialty pharmacy programs are in a unique position to provide data reporting and analysis that payers and the pharmaceutical industry require for ongoing partnership. Health systems can provide a complete picture surrounding a drug’s real-world use, while outside specialty pharmacies generate retroactive claims reports that create more questions than answers. Without access to the EMR, they cannot provide a clear, seamless picture of what is happening at the point of care.

Clinically, these health systems have the opportunity to develop innovative programs, such as the cystic fibrosis (CF) therapy management program at Fairview Specialty Pharmacy. As part of an integrated health system, Fairview goes beyond refill reminder phone calls to address the root causes of non-adherence. The program screens and refers patients with depression, for example.

It also helps college students transition to managing their own health and medications, at a time when many lack daily parental oversight and are far away from their childhood CF treatment centers. The development of data on patient outcomes in the context of health system specialty pharmacy is in its early stages, but progressing quickly. The leading health system specialty pharmacies and networks are making substantial investments in clinical data analysis and financial tracking, considering it essential to supporting overall operations and long-term program viability, as the payer marketplace shifts to outcomes-based measures.

Patients appreciate the convenience and continuity of care that health system specialty pharmacy provides. In conversations with pharmacy directors from health systems across the county, I’ve heard dozens of stories about patients who thanked their health system pharmacists for cutting through paperwork, keeping refills order on track, helping patients find ways to reduce side effects, and helping them understand the value of their complicated drug regimens.

Conversely, I’ve heard numerous cautionary tales about patients who experienced a breakdown in their medication therapies upon leaving the health system and becoming reliant on non-affiliated, remote specialty pharmacies that had no direct stake in the patient’s health and outcomes. As last July’s article on specialty pharmacy in the New York Times made evident to a wide readership, the structure of the dominant specialty pharmacy model can lead to inconvenience and dissatisfaction.

The business case for health system specialty pharmacy The financial case is compelling. In the current climate, health systems are becoming more responsible for the cost of care, while being forced to bridge the gap in continuity of care and the diversion of revenue, as payers carve out the specialty pharmacy benefit. The missed gross profit opportunity is estimated to be as much as $14.87 million per 1 million patients served. The financial benefits to for-profit PBMs and specialty pharmacies accrue to their shareholders and not to the entities, often non-profits that are providing patient care.

Furthermore, health systems can focus and scale their specialty pharmacy services to those disease states and specialties they serve most. Transplant and HIV drugs are relatively easy to access, and thus, an ideal entry point into specialty pharmacy if the patient population is appropriate. Drugs for these conditions may not be classified as “specialty” from a payer perspective, but present similar requirements and challenges.

Fairview Health Services, which includes the University of Minnesota Medical Center, ventured into the specialty arena with transplant drugs. It has since become one of the most robust health system pharmacies in the nation, dispensing drugs for nearly every specialty condition. Once a foothold has been established, it is important for a health system specialty pharmacy to expand its access to specialty medications, without getting too discouraged in the process. Keep in mind that no pharmacy, including the largest national players such as CVS Caremark, Accredo, and Walgreens, provides, or has access to, every possible medication that can be classified as a specialty drug.

Despite the barriers to entry, from competing priorities to drug access issues to payer contracts to limited specialty experience, many health systems have natural points of entry to leverage into the specialty space, and the benefits in terms of patient care and cost can be substantial. With appropriate planning and resourcing, and assistance from pharmacy networks, many health systems can be operational with specialty pharmacy in a matter of months, not years.

Should a health system choose to build, there are special considerations to maintain service levels. Being competitive in the market requires capital investment for financial management (including both budgeting and accounts receivable management), systems personnel (for diversification of roles, including patient management and drug dispensing), and facility space (including refrigerated product and shipping supply storage). Integrated health systems and academic medical centers are the most likely candidates for building a specialty pharmacy function.

Small-to-moderate size hospitals with limited specialty populations may find that helping their specialty physicians find a specialty pharmacy partner or hub service is a sufficient solution. One such option may be a joint venture with a regional or national specialty pharmacy to private-label the hospital’s specialty prescriptions.

Clarifying their approach to specialty pharmacy must be a strategic priority for health systems. The role of health systems in specialty pharmacy is important for everyone in the industry to consider—payers, manufacturers, PBMs, and competing specialty pharmacies, no less than health systems themselves.

		Pembroke Consulting research and estimates cited in the Drug Channels Institute’s 

2016 Economic Report on Retail, Mail, and Specialty Pharmacies.

		Unpublished UHC data, 2012, cited in the 

		Pembroke Consulting, cited in Drug Channels Institute report.

		Motz J. Health Systems: Discovering Specialty Pharmacy. 

 website. http://www.specialtypharmacytimes.com/publications/specialty-pharmacy-times/2015/october-2015/health-systems-discovering-specialty-pharmacy. Accessed February 15, 2016.

		Thomas K and Pollack A. Specialty Pharmacies Proliferate, Along With Questions. 

 Published July 15, 2015. ExceleraRx, Corp., Integrating Specialty Pharmacy, Impacting Outcomes, May, 2015.

 is the Chief Operating Officer for Fairview Pharmacy Services, a leading health system based pharmacy organization in Minneapolis, MN. He received his PharmD from the University of Nebraska Medical Center College of Pharmacy. As COO, Kyle is responsible for strategy and overall operations of Fairview Pharmacy’s specialty pharmacy, retail, mail order, long term care, compounding, home infusion and community infusion business units. Kyle has spent 19 years in pharmacy including traditional retail, clinic based retail, outpatient pharmacy at an academic health center, community and home infusion, specialty, and mail order. In addition, he is a frequent media and professional spokesperson on a variety of pharmacy topics.

Large integrated delivery networks and academic medical centers with specialty clinics and infrastructure should consider building in-house specialty pharmacy capability.