Justin Lindhorst, MBA

Hemophilia treatment centers (HTCs) represent the medical standard of care for individuals living with a bleeding disorder. Using a highly specialized, multidisciplinary team, HTCs provide focused medical care proven to reduce hospitalizations, mortality, and other complications.

 HTCs are federally funded and organized into 10 regions across the country. Federal funding for HTCs has declined over the years. Individual HTCs receive an average of just $35,000 in government funding annually.

Many HTCs incorporate 340B pharmacy programs to reduce reliance on limited federal funding and expand their comprehensive model of care. Approximately 71% of federally funded HTCs participate in the Health Resources and Services Administration’s (HRSA) 340B program, according to the National Hemophilia Foundation.

HTCs use cost savings generated from their 340B programs to fund salaries for critical staff, including nurses, physical therapists, and social workers. Cost savings also help cover nonbillable services, such as telephone triage encounters and other care coordination activities.

Under HRSA guidelines, covered entities (CEs), such as HTCs, are permitted to use contract, in-house, or combination arrangements to facilitate access to 340B drugs. There is no limit to the number of contract pharmacy arrangements a CE can use.

 Many HTCs use a combination of contracted and in-house pharmacy services to manage their 340B programs. Contract pharmacy arrangements can help HTCs with existing or new 340B programs maintain regulatory compliance, maximize cost savings, and promote patient engagement, improving outcomes.

Adherence to prescribed therapy is a common challenge for invididuals with bleeding disorders. One study surveyed the perceptions of HTC clinicians regarding patients’ adherence. Just 42% thought their patients were adequately adherent, and 34% cited concerns about nonadherence influ- encing their prescribing patterns.

For HTCs that contract some or all of their 340B pharmacy services, specialty pharmacy partnerships can enhance patient engagement, promote adherence, and reinforce standards of care. Research indicates that patients who use a specialty pharmacy are more adherent to prescribed therapy than patients who use a retail option.

 Some contract pharmacy arrange- ments include dedicated staff members who provide patient navigation services for those served through the 340B programs. These navigators have been effective in helping patients with bleeding disorders attend appointments, maintain insurance coverage, and obtain medication refills.

Jeff Johnson is a patient with hemo- philia who is a regional care coordinator serving an HTC 340B program in the Northwest. “My role is to enhance the efforts of the HTC and support the patients served through the 340B program. The relationships I form are based on trust and shared experience as a fellow community member,” Johnson said.

“Coordinating every step with HTC and our pharmacy team, I help patients effectively navigate common coverage or insurance challenges, access programs reducing financial burden, reinforce the importance of care standards, and coordinate accurate and timely refill support,” he said. “I feel our efforts help improve adherence, continuity, and overall connectivity with the comprehensive care team.”

The intent of the 340B program is enabling CEs “to stretch scarce federal resources as far as possible, reaching more eligible patients and providing more comprehensive services,” according to HRSA.

 The cost savings generated through 340B programs supports up to 90% of critical HTC staff.

 Whether the HTC uses a contract or in-house pharmacy or a combination, adding a new program partner can increase cost savings.

Pharmacy partnerships influence cost savings for HTCs through cash flow services, fee structures, inventory management, manufacturer purchasing contracts, and the pharmacy’s payer network. These factors vary across pharmacy partnerships, and HTCs should strategically analyze their options to maximize the cost savings generated by their 340B programs.

Patricia Holliday, national 340B manager, hemophilia, at BioMatrix Specialty Pharmacy, has worked with individuals who have bleeding disorders supporting HTCs and their 340B pharmacy programs for 25 years. “Having a pharmacy partner willing to tailor the program to the specific needs of the HTC and their patient population is important. A partner with bleeding disorder experience and a degree of flexibility in program design and implementation can [affect] cost savings generated through the program in a number of ways,” Holliday said.

“Clotting factor and other drugs used to treat bleeding disorders are among the most expensive specialty medications, so innovative inventory management is a must,” she said. “Additionally, companies with a service-oriented approach provide value-add support that can go a long way in terms of patient retention and growing the program within the local community.”

HTCs are designed to provide comprehensive medical care for patients with bleeding disorders, not to decipher complicated 340B regulations. Increasing scrutiny around 340B program compliance makes navigating these challenges of critical importance. US Government Accountability Office reports in 2018 and 2020 recommended increased oversight of auditing procedures, including the avoidance of duplicate discounts.

 Estimates indicate that drug manufacturers pay hundreds of millions of dollars in noncompliant Medicaid discounts every year.

 As a result, drug manufacturers are aggressively auditing CEs to recuperate lost revenue as government agencies consider options to tighten compliance. CEs are liable to refund noncompliant discounts, and HRSA audit failure may result in program termination.

Much like factors influencing cost savings, regulatory compliance and related support services vary by program partner. Contract pharmacy services can help HTCs maintain regulatory compliance and stand prepared for any HRSA- or manufacturer-related audit. Identifying patient eligibility and aligning billing, shipping, and inventory replenishment systems are fundamental for successful 340B program management. Some contract pharmacies offer staff members who are certified in 340B compliance to monitor, oversee, and interface with HTC partners to institute robust compliance processes. Others require use of third-party agencies to identify patient eligibility and review claims.

Regina Valenzuela is an intake specialist at BioMatrix Specialty Pharmacy. She holds a 340B certification from Apexus and has nearly a decade of experience working with HTC 340B programs.

“Compliance is of critical importance for covered entities,” Valenzuela said. “Pharmacies providing robust compliance processes, a variety of reporting tools, and a proactive, hands-on approach for matters such as patient eligibility and inventory management [ensure] audit preparedness and ongoing program integrity.”

Individuals living with hemophilia and other rare bleeding disorders are best served by a multidisciplinary team. HTCs have been improving outcomes for individuals with bleeding disorders since the mid-1970s. Federal funding is not enough to sustain the HTC model. Whether using a contract or in-house pharmacy or a combination, the 340B program helps HTCs support and expand the tested and proven comprehensive model of care.

is marketing director/regional care coordinator at BioMatrix Specialty Pharmacy in Plantation, Florida.

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Articles

Many HTCs use these drug pricing arrangements to reduce reliance on limited federal funding.

340B Programs Help Hemophilia Treatment Centers Promote Care

The era of fee-for-service health care is nearing an end. In its place, value-based initiatives seek to improve patient outcomes, reduce cost, and increase transparency in health care. These changes represent significant opportunity for specialty pharmacies to demonstrate their ability to create sustainable value across the health care continuum.       

The United States spends more per capita on health care than any other developed nation.

 According to the CMS, National Health Expenditures (NHE) in the US are predicted to outpace the growth of GDP through 2027 when health spending is predicted to exceed $6 trillion.

Despite spending the most, the US falls behind other developed countries in several key health indicators. The US has the highest incidence of chronic disease burden, the highest rates of obesity, and among the largest numbers of both preventable hospitalizations and avoidable deaths.

 Coupled with an aging population, rapidly expanding drug portfolios, and a fragmented health care system that tends to promote volume over outcomes, it’s clear why there is a push for change.

Michael Porter is a Harvard Business School professor whose extensive work in economics, strategy, and social causes has earned worldwide recognition.

 Porter and Elizabeth Teisberg wrote the book 

, providing a widely accepted framework for a value-based health care system. They define value in health care as “The measured improvement in a patient’s health outcomes for the cost of achieving that improvement.”

In addition to defining value in health care, Porter describes a “paradox” in the US health care system which focuses on shifting cost and increasing bargaining power while restricting patient choice—none of which ultimately create value for the patient. Porter proposed a set of principles focused on high-quality, less costly care, improving value for patients, advancing unrestricted competition based on results, focusing on the full cycle of care, and value that is driven by provider experience, regional and national competition, transparency, and strongly rewarding innovation.

Journal of the Association of American Medical Colleges

, Teisberg et. al provide a strategic framework for implementing value-based health care. The framework includes 5 broad imperatives for value: understanding shared health needs of patients, designing comprehensive solutions to improve health outcomes, integrating learning teams, measuring health outcomes and costs, and expanding partnerships. These 5 imperatives have significant implications for health care delivery and defines a space where specialty pharmacy has opportunity to act as a driver of value within the broader health care system.

Specialty pharmacies are uniquely positioned to thrive in the era of value-based health care. Working with patients, caregivers, prescribers, payers, and pharmaceutical drug manufacturers, specialty pharmacies promote value by coordinating care for complex health conditions across a diverse range of stakeholders and uniting patient touchpoints within a fragmented health care system. Driving positive patient outcomes and managing costs are at the core of specialty pharmacy services.

As the Medicare Access and CHIP Reauthorization Act of 2015 and other federal legislation seeks to fundamentally change health care delivery and payment for health care services, specialty pharmacies are successful because of their proven ability to drive value in spite of the existing health “paradox” as described by Porter. Independently owned specialty pharmacies in particular are in a unique position in the current shift to value-based care because they are already organized around the imperatives as outlined by Teisberg while functioning outside of health systems and third-party payer organizations more closely tied to the fee-for-service system.

Specialty pharmacies align under Teisberg’s 5-point framework as follows:

Imperative 1: Understanding Shared Health Needs of Patients    

Specialty pharmacies understand the unique clinical needs of patients with complex, often chronic health conditions and the drugs used to treat them. Specialty pharmacies build clinical programs with clinicians and staff who have extensive training and experience with specific disease states, drug classes, and comorbid conditions. Specialty pharmacists take the time to understand the unique clinical, psychosocial, and financial needs of the patient groups they serve, promoting continuity and establishing relationships based on trust and mutual understanding. Understanding the broad needs associated with a particular condition such as hemophilia or drug class such as IV/SC-Ig allows experienced clinicians to deliver targeted, individualized care to a specific group or groups of patients. 

Imperative 2: Designing Comprehensive Solutions to Improve Health Outcomes 

Specialty pharmacies use medication therapy management (MTM) to coordinate comprehensive care for patients and improve health outcomes. MTM employs a range of clinical tools to improve outcomes and promote value, including therapeutically focused clinical assessments, validated quality of life measures, detailed medication reconciliation, monitoring adverse effects, connecting patients to educational resources, peer-based support programs, and access to need-based financial resources reducing barriers to care. Specialty pharmacies provide patient level support reducing health system and therapy complexity by explaining benefits and coverage, coordinating the best site of care for injected or infused medication, providing drug administration training, adherence support, and resources empowering patients to independently manage complex, persistent treatment plans.   

Imperative 3: Integrating Learning Teams 

Specialty pharmacies leverage highly experienced, multi-disciplinary teams to promote value. By integrating clinical teams with intake, billing and care coordination specialists, specialty pharmacies speed access to care, remove barriers to treatment, and reduce therapy abandonment. Integrating clinical and nonclinical teams create synergies that do more than promote access and positive outcomes for patients. Aligning teams around shared goals creates a workplace culture focused on process improvement, cross-functional learning, and organizational efficiency.     

Imperative 4: Measuring Health Outcomes and Costs 

Specialty pharmacies have long been required to demonstrate their ability to improve outcomes and reduce cost to be included in payer networks, earn referrals from prescribers, and obtain Limited Drug Distribution agreements from pharmaceutical manufacturers. Specialty pharmacies are also required to measure outcomes to maintain accreditation from leading health care accreditation agencies. Specialty pharmacies employ sophisticated software and tools to track response to therapy, monitor dosing, utilization, and adverse effects while tracking costs. These tools allow pharmacists to deliver data-driven interventions, reducing unnecessary hospitalizations or adverse events.

Data collected by specialty pharmacies drive value across stakeholder groups: patients better understand the benefits and outcomes of their treatment plan, prescribers receive a complete picture of response to therapy for a patient or group of patients, pharmaceutical manufacturers discern insights into the efficacy of their product, and payers develop deep insight into cost and cost drivers for high-dollar health conditions.   

Specialty pharmacies work with an array of stakeholders across the health care continuum to drive value. In a fragmented health care system, specialty pharmacies use these partnerships to promote continuity and facilitate a better understanding of patient-level needs and experiences across stakeholder groups. By expanding partnerships with each of the traditional health care stakeholders and developing relationships in new areas, including patient advocacy groups, government organizations, and a growing digital health industry, specialty pharmacies have significant opportunity to improve patient care, scale operations, and reduce complexity in the health care system.  

Porter affirms, “Value in health care is determined in addressing the patient’s particular medical condition over the full cycle of care, from monitoring and prevention to treatment to ongoing disease management.”

Specialty pharmacies will thrive in the era of value-based health care because their business model is already firmly centered in creating value. As health systems, independent physician practices, payers, pharmaceutical manufacturers, and patients navigate this new environment, specialty pharmacies are uniquely positioned to lead as a valued, experienced member of a multi-disciplinary, multi-stakeholder team facilitating a shift to a paradox free, value-based healthcare system.    

, is marketing director and senior regional care coordinator at BioMatrix Specialty Pharmacy.

U.S. health care from a global perspective, 2019: Higher spending, worse outcomes?

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Specialty pharmacies are uniquely positioned to thrive in the era of value-based health care.       

How Specialty Pharmacy Will Thrive in the Value Era

SPECIALTY PHARMACIES ARE improving health and creating value in the oncology space. Study results have demonstrated that pharmacists are effective partners in improving care, reducing cost, and avoiding drug complications for patients with cancer.

Yet what does excellence in oncology pharmacy look like? For any specialty pharmacy program to reach excellence, it must be patient centric, outcomes focused, collaborative, and future oriented. 

This year, an estimated 1,806,590 individuals will receive a cancer diagnosis in the United States.

 By 2030, worldwide cancer incidence is expected to reach 3.6 million new cases per year.

 As incidence increases, so, too, does the need for medical professionals experienced in cancer treatment. The annual growth rate for medical oncologists is 5%, though a rate of 40% is needed to meet the rising number of cancer cases.

 A strong specialty pharmacy partnership can help medical oncologists spread resources while providing effective, high-level care. 

In addition to rising incidence rates, the past decade has seen a record number of new cancer treatments. Over the next several years, 65% of new drug approvals will be for specialty medications targeting cancer or rare disease.

 Specialty pharmacies are experienced in the management of complex, high-dollar medications. As new and innovative cancer treatments are approved, specialty pharmacies will continue to play an important role in medication distribution and support services. 

The site of care for cancer treatment is changing. Up to 80% of patients with cancer now receive care in the outpatient setting.

 The emergence of coronavirus disease 2019 (COVID-19) will influence this trend for the foreseeable future. The pandemic will result in an ongoing push for more home-based treatment options, furthering the need for oncology-focused specialty pharmacy services. Pharmacists play an important role in helping to manage and monitor treatment in outpatient and home environments. Research shows both patient and treatment center benefit from a strong specialty pharmacy partnership.

The cost of cancer treatment is trending upward. In 2001, $57 billion was spent on treating cancer in the United States. Estimates from the National Cancer Institute predict that cost will rise to $173 billion this year.

 Specialty pharmacies drive down the cost of care in a variety of ways, by promoting adherence to therapy, identifying utilization or dosing mistakes, and helping to avoid unnecessary hospitalizations, for example. Research has proved that specialty pharmacies can reduce costs and improve patient satisfaction.

Cancer is a devastating diagnosis for patients and their families and other loved ones. A strong relationship between patient and health care provider can positively affect the patient’s ability to cope.

 Patients value working with pharmacists to help manage their treatment. Research conducted at an outpatient clinic in Texas demonstrated that 86% of patients felt it important to discuss their cancer treatment with a pharmacist. Seventy-six percent requested a pharmacy follow-up at their future visit.

One of the primary pillars of an excellent specialty pharmacy program is patient-centric care. In a large study, patients who perceived their health care providers as “knowing them as a person” had higher rates of treatment adherence, more positive beliefs about the effectiveness of their therapy, fewer missed doctor appointments, and a higher quality of life.

 Every patient with cancer faces unique challenges that affect their day-to-day treatment, from psychosocial to financial issues. Pharmacists who earn the trust and get to know the individual needs, challenges, and preferences of their patients are better able to support, educate, and empower those they serve. 

From timely access to medication and support services to interventions promoting safety and adherence, outcomes-focused services make oncology specialty pharmacies the best they can be. Patients with cancer typically have 3 additional comorbid conditions and take an average of 9 different medications.

 Preexisting conditions, polypharmacy, and the complexity and toxicity of cancer treatment contribute to significant drug-related challenges that pharmacists can help patients avoid. In one study, investigators analyzed more than 4000 oncology prescriptions. Pharmacists found drug-related problems in more than 1% of the prescriptions. Subsequent interventions led to treatment discontinuation, dosing adjustments, alternate administration routes, and other modifications.

Specialty pharmacies affect outcomes through highly coordinated medication therapy management (MTM) programs. Strong MTM programs improve adherence and quality of life.

 MTM programs incorporate validated, diagnosis-specific clinical assessments, patient-reported outcomes, and quality-of-life measures. MTM allows the pharmacy to deploy targeted, data-driven interventions, identify drug-related challenges, and promote individual health goals. 

Study results show that when continuity of care is high, patient outcomes improve.

 Achieving continuity requires a high level of collaboration across health care disciplines. Patients can easily feel lost or confused when coordinating care across a complex health care environment, especially when dealing with a diagnosis such as cancer. Specialty pharmacies can ease that burden by fostering collaboration among patients, health care providers, payers, pharmaceutical manufacturers, community-based organizations, and peer-to-peer support networks. Highly coordinated, collaborative care positively affects the patient journey by promoting the development of a multidisciplinary support system and providing ongoing resources throughout the patient’s course of therapy and recovery. 

By working with a range of health care stakeholders, specialty pharmacies can affect more than just the individual patient journey. Analyzing pharmacy data and sharing appropriate information can help identify trends, areas for improvement, cost savings, and other opportunities to promote safer, more effective care. Manufacturer partnerships and limited distribution drug programs provide specialty medication and support for patients with extremely rare or complicated conditions. Clinical trial and research programs help advance research, leading to new and improved therapies, and 340B partnerships extend care to uninsured and underinsured populations while providing additional revenue to eligible treatment centers. Support for community-based 501(c)(3) organizations promotes research, peer-to-peer support, and the availability of emergency financial assistance for patients in times of need. 

To best serve patients, specialty pharmacies need to be future oriented. Health care lags behind other industries in digital maturity.

 Patient expectations regarding the digital capabilities of their health care providers have increased significantly.

 In addition to patient expectations, COVID-19 is accelerating the requirement for specialty pharmacies to leverage technology in new ways. Future-facing specialty pharmacies are prepared to meet these requirements and use digital tools to engage patients, promote adherence, encourage healthy behaviors, and monitor health. 

Accreditation from leading health agencies is another important component for specialty pharmacies to remain forward facing. To maintain accreditation, health care organizations must meet rigorous standards while implementing continuous process improvement plans. Accreditation establishes a culture focused on excellence and ongoing organizational growth. 

The number of cancer survivors in the United States is increasing. The 5-year relative survival rate for cancer has reached 67.4%.

 By 2026, a predicted 0.3 million cancer survivors will be living in the United States.

 Thousands of dedicated health care professionals are working hard every day to help patients manage, treat, and eventually cure cancer. Specialty pharmacies and the staff they employ are among them. 

New treatments, expanding site-of-care options, rising costs, and the need for oncology-focused medical professionals will increase demand for strong specialty pharmacy partnerships. Specialty pharmacies providing patient-centric, outcomes-focused, collaborative, and future-oriented care will emerge as powerful allies throughout the patient journey—helping to ease burden, slow progression, and speed recovery for those facing cancer. 

, is marketing director and senior regional care coordinator at BioMatrix Specialty Pharmacy; 

, is director of pharmacy services at BioMatrix Specialty Pharmacy. 

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Study results have demonstrated that pharmacists are effective partners in improving care, reducing cost, and avoiding drug complications for patients with cancer.

What Does Excellence in Oncology Pharmacy Look Like?

The clinical assessment has long been a cornerstone of patient-centric specialty pharmacy care. As the health care industry focuses on outcomes, accountability, and cost control, a demand is growing for increasingly sophisticated clinical assessment instruments. Numerous concomitant variables are associated with this demand, including more advanced, complex, and very expensive drug therapies, as well as growing requirements from payers and pharmaceutical manufacturers for greater quantity and quality of patient-specific data. In the current health care environment, specialty pharmacies are tasked more than ever to provide specific data to qualify for in-network status with payers and secure access to limited-distribution medications.

The patient management standards of accreditation agencies appear to be changing in concert with payer and manufacturer requirements, thereby increasing the need to monitor, assess, intervene, and accurately report outcomes to obtain and maintain specialty pharmacy accreditation. The resulting emerging expectation is for specialty pharmacies to use validated, disease-specific, health quality survey instruments to capture detailed pharmacy interventions and related outcomes. Clinical assessments—also referred to as patient questionnaires, survey instruments, survey tools, and health quality assessments&mdash;are a primary component of every patient-centered care model. Specialty pharmacy assessments are designed to capture data necessary for patient-centric pharmaceutical care that is safe, efficacious, and individually tailored. Traditionally, clinicians administer specialty pharmacy assessments at the start of care and repeat them at timely intervals, with the frequency of reassessments determined by patient need, disease state/medical condition, and medication regimen.

In general, specialty pharmacy assessments are designed to monitor adverse effects, drug interactions, and patient-reported adherence to prescribed drug therapy. The requirements of the modern health care system are challenging specialty pharmacies to rethink traditional assessments, and those ahead of the curve are using increasingly sophisticated instruments to engage patients, capture data, and implement interventions.

Disease- and medication-specific assessments provide a more complete picture of patient response to therapy, allowing the clinician to deliver focused care plans for patients and quality data for manufacturers, medical providers, and payers.

Specialty pharmacies are also incorporating validated survey instruments to demonstrate outcomes and the quality of their care. Sequence is a proprietary, web-based data management and analytics program that can help specialty pharmacies effectively collect and share data before and after patients undergo solid organ transplant. This includes a transplant-specific, weighted clinical assessment tool that helps identify patient adherence and lifestyle or other challenges that may disrupt therapy. The platform combines pharmacy assessments, dispensation, and therapy interventions with transplant center, home nursing, and laboratory data.

The result is a comprehensive picture of therapeutic impact and efficacy at the individual patient and aggregate transplant center levels. A study published in the Journal of Managed Care Pharmacy found that transplant patients followed by a specialty pharmacy with a specific transplant program had higher adherence rates and lower overall medical costs than patients followed by a traditional retail pharmacy.

 Provision of transplant-specific assessments and singular access to multiple patient touch points are helping specialty pharmacies and transplant professionals work together to improve adherence, speed time to transplant, and reduce the risk of organ rejection.

Specialty pharmacies are also using new ways to encourage patients to share self-reported data. Mobile, digital health, and business intelligence tools are changing the way patients record and share information with their specialty pharmacy. These data are particularly valuable in complex, high-cost therapies. According to a 2017 Express Scripts report, patients with hemophilia can have an annual prescription drug cost of more than $700,000.

 Patients with severe hemophilia typically self-infuse medication in their home. With more than 20 factor products, a new subcutaneous treatment option, and gene therapy preparing to enter the market, tracking infusions and recording bleeding episodes will become increasingly important.

Health care technology company Audaire Health focuses on facilitating transparency and accountability among payer, provider, pharmacy, and patient. Audaire has partnered with the National Hemophilia Foundation and several leading specialty pharmacies to provide patients with hemophilia a near passive platform to record and instantly share drug utilization information. The system also provides a nearly passive data input solution designed to ease reporting burden for both patients and pharmacy providers.

The platform captures multiple data points, including prescription, dispensation, pharmacy/clinic touch points, reported bleeds, and other medication administration information. Utilization is recorded and shared instantly, providing the opportunity for early interventions, preventing costly emergency department visits or hospitalizations, and identifying trends in bleeding episodes. This type of dynamic, real-time reporting allows the pharmacy clinician to step beyond static assessments to track utilization, pinpoint adherence or other therapy issues, and provide resources to help patients experience better outcomes.

The specialty pharmacy industry has and will continue to face increasing challenges associated with capturing, analyzing, and reporting greater amounts of patient-reported data, including interventions and outcomes. The future of specialty pharmacy as an industry is contingent on clinical data capture, analysis, interpretation, and reporting on both the patient-specific and aggregate bases to better meet patient-centric needs as well as to respond to the growing demands from payers, manufacturers, and health care accreditation agencies.

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		Super spending U.S. trends in high cost medication use. Express Scripts website. 

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The clinical assessment has long been a cornerstone of patient-centric specialty pharmacy care.