Justin Lindhorst, MBA

Between 2010 and 2018, the rate of hepatitis C virus (HCV) infection in the United States more than quadrupled.

 More than 2 million Americans are estimated to be living with HCV, many unaware they are infected.

The latest viral hepatitis surveillance report from the CDC indicated that infections rose again during 2019. Hepatitis C is a leading cause of liver cancer and primary cause of liver transplants,

 and despite widely available curative, direct-acting antiviral treatments, it remains a major public health issue. Viral hepatitis costs the government, health systems, and patients billions of dollars every year.

 But the US Department of Health and Human Services (HHS) has a strategic plan to eliminate viral hepatitis in the United States, and 340Bs can play a role.

HHS has laid out a national strategic plan to eliminate viral hepatitis over the next 10 years. The plan has adopted the World Health Organization’s definition of elimination: a 90% reduction in acute infections and a 65% reduction in mortality compared with a 2015 baseline. The strategy provides an actionable framework and key performance indicators to eliminate viral hepatitis by 2030 in the United States.

HHS identifies several disproportionately affected populations and challenges related specifically to HCV. Populations at greater risk for HCV infection include American Indian/Alaskan Natives, Black individuals, non-Hispanic individuals, those who inject drugs or have HIV, and those born between 1945 and 1965. Challenges include access to and cost of HCV treatments, injection drug use, lack of awareness regarding infection status, lack of an HCV vaccine; perinatal transmission of HCV; and testing and linkage to care.

The strategy has 5 primary goals with supporting objectives to achieve elimination. These include achieving integrated coordinated efforts across stakeholder groups to collectively address the viral hepatitis epidemic, decreasing hepatitis disparities, establishing more comprehensive national viral hepatitis surveillance and data usage, improving viral hepatitis–related health outcomes, and reducing infections.

The plan identifies “high-impact settings,” in which large portions of at-risk populations receive care. Included in these settings are many 340B-eligible covered entities (CEs), such as community health centers, Federally Qualified Health Centers, Ryan White clinics, and sexually transmitted infection clinics. The proximity of these CEs to disproportionately affected communities makes the 340B program an extremely effective resource in the plan to eliminate viral hepatitis in the United States.

The National Alliance of State and Territorial AIDS Directors is a nonpartisan nonprofit agency representing a coalition of public health officials involved with the administration of HIV and viral hepatitis programs in the United States.

The organization affirms 340B as “an instrumental tool in ending the viral hepatitis epidemic, enabling viral hepatitis programs to expand and improve services, address health equity, and reduce health disparities.”

One of the challenges identified in the strategic plan is access to medication. On average, 340B health systems provide a higher number of medication access programs than non-340B hospitals.

 The cost savings generated by 340Bs provide critical funding for mission-driven organizations to expand health services and improve health outcomes. A 2019 peer-reviewed study conducted a budgetary impact analysis on a multidisciplinary primary care–based HCV treatment program. The findings showed that for every referral of a patient with HCV, the health system would lose $370 without the 340B program and gain $930 in cost savings with the program.

Across the country, CEs use 340B cost savings to expand resources, facilitate access to treatment, improve health outcomes for at-risk populations, and increase testing. In Philadelphia, Pennsylvania, a community health center used cost savings to significantly expand linkage to care for at-risk community members and testing.

 The United States faces a mounting shortage of health care workers,

 and data show that expanding the role of the clinical pharmacist can successfully fill the HCV provider gap and facilitate positive outcomes.

 340B cost savings are often used to integrate clinical pharmacists into care teams. After a significant increase in local HCV infections, a health system in Maine used 340B savings to create a pilot program integrating pharmacists alongside physicians to manage HCV by providing education, medication therapy management, monitoring, and ongoing follow-up. The program increased the number of patients starting treatment for HCV, and 100% of those enrolled in the program completed posttreatment laboratory tests compared with 58.8% of those without pharmacist involvement.

 Pharmacists have also been successful in extending the reach of rural clinics by providing HCV clinical services for disproportionately affected Alaskan Native and Native American populations.

Although the 340B program maintains bipartisan support, there are shortcomings. Critics contend that some health systems are not using cost savings generated through the program to increase care for at-risk or low-income populations.

 Sixteen drug manufacturers have moved to restrict discounts through 340B contract pharmacy arrangements with many health systems, citing lack of oversight in addition to an increase in duplicate discounts and diversion.

 Also, some CEs have come to rely on the cost savings generated through 340B programs to keep their doors open. As lower-cost generics enter the market, 340B cost savings decrease and leave many mission-driven entities at financial risk.

Program integrity has fallen on the shoulders of the CEs. Now more than ever, health systems must draw a clear line showing how 340B cost savings are applied to expand services, improve outcomes, and stretch resources. CEs should also consider financial contingency plans, as generics erode cost savings and leave overleveraged CEs at risk.

Working together with contract pharmacy partners, CEs should also be prepared to provide increased visibility and claims level data demonstrating program integrity to their manufacturer partners.

“Covered entities should critically evaluate and review the compliance processes in place with their contract pharmacy partners,” said Ted Traurig, BioMatrix vice president of specialty pharmacy operations. “Aggressive mock auditing, physically segregated inventories, separate wholesale accounts, and prospective identification of Medicaid claims can go a long way in helping CEs avoid duplicate discounts and diversion.”

The elimination of HCV will require engagement from a wide range of health stakeholders and organizations. The clinical pharmacist role continues to evolve in the health care environment, and pharmacists will play an increasingly active part in overcoming HCV. Although it is not perfect, the 340B program provides significant opportunities and resources to achieve many goals outlined in the HHS plan. Health systems in high-impact settings should critically review the action plan and consider how to best use 340B cost savings to help achieve the goal of eliminating HCV.

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

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7. Jones EA, Linas BP, Truong V, Burgess JF, Lasser KE. (Budgetary impact analysis of a primary care-based hepatitis C treatment program: effects of 340B drug pricing program. 

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8. Case study: how BioMatrix 340B services helped Philadelphia FIGHT increase HCV testing and linkage to care. BioMatrix Specialty Pharmacy. October 2020. Accessed April 26, 2022. https://static1.squarespace.com/static/58d944d2ebbd1aac620cfead/t/6025b182a95517221882cf0d/1613083010534/BMX057.2+%7C+340B+FIGHT+Case+Study+Case+Study-tk-v1.4.pdf

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Articles

Health systems should review HHS’ action plan and determine how to leverage cost savings to help eradicate HCV.

Explore the Role of 340B in Eliminating Hepatitis C

for oncology medications made up just 3% of total drug expenditures in the United States. In 2020, that number climbed to 15%. Oncology medication is now one of the single largest drivers of specialty spending—increasing on a net basis by an astonishing 316% since 2011. In the next 5 years alone, 100 new oncology medications are expected to reach the global market, culminating in over $300 billion in oncology drug spending by 2026.

Oncology treatment is rapidly evolving. So, too, are the needs of patients, prescribers, pharmaceutical manufacturers, and payors. As the health care industry in the United States pivots toward a value-based system, specialty pharmacies play an increasingly important role in advancing positive health outcomes, controlling costs, and providing real-world insights into the impact of specialty medications used to treat cancer. This article examines the evolution of specialty pharmacy to meet the needs of patients and other health care stakeholders in the oncology space.

A Brief History of the Rise of Specialty Pharmacy

Beginning in the late 1970s and early 1980s, treatment advancements and new therapies made home management for patients with rare or chronic health conditions possible. Despite these advancements, retail pharmacies were largely unequipped to serve patients with conditions such as cancer, HIV/AIDS, hemophilia, multiple sclerosis, or other rare diseases. Medications to treat these conditions were costly and clinically complex; they required specialized handling and/or administration routes. The therapies also posed an additional risk for traditional pharmacies—it was often difficult to obtain required timely third-party reimbursement, particularly when compared with the process for reimbursement for common therapies dispensed in a retail setting.

Specialty pharmacies emerged as a solution to these problems, facilitating medication access, easing the coordination of billing and reimbursement support, and providing the high-touch patient services required for effective home management of rare and chronic health conditions.

As specialty pharmacies began to form during the 1980s and 1990s, oncology treatment was experiencing an evolution that would establish the need for today’s oncology-focused specialty pharmacy. Treatment during this time still primarily consisted of surgery, radiation, intravenous chemotherapy, or some combination of the 3. These methods often destroyed healthy cells in addition to cancerous ones and relied on treatment primarily in the inpatient setting. Further, they were associated with a litany of challenging adverse effects. Scientific advancements during this time led to promising research and exploration of new treatments, including targeted therapies and immunotherapies.

In addition, the late 1990s and early 2000s saw the advent of oral chemotherapy, which significantly improved treatment convenience and ease of administration.

 At the same time, cancer survivorship was increasing, and the medical community began to focus on treating and managing cancer as a chronic health condition rather than an acute disease.

 These treatment advancements and the emerging view of cancer as a chronic condition contributed to the need for increasingly specialized, oncology-focused pharmacy services and support.

Today, oncologists are deploying highly targeted treatment plans tailored to the genomic composition of tumors. The growing field of precision medicine combines sophisticated cancer diagnostics with targeted specialty drugs to slow or halt cancer progression.

“The growing field of precision medicine, limited distribution drugs, combination therapies, and the push for value-based programs have created the need for additional pharmacy specialization,” said Marc Stranz, PharmD, chief clinical officer of BioMatrix Specialty Pharmacy. “Understanding distribution requirements, drug response, adverse events, compliance support, cost-containment strategies, data management, and patient assistance programs are just a few of the drivers influencing the ongoing evolution of oncology pharmacy.”

During the 1990s, fewer than 30 specialty drugs were on the market.

 Today, there are hundreds of specialty medications and a robust pipeline of new treatments for patients with chronic and rare diseases.

Although still focused primarily on providing medication access and clinical and other support services, the modern specialty pharmacy has evolved to better meet the needs of unique patient populations and their health care stakeholders, including prescribers, pharmaceutical manufacturers, and payors.

“With an increasing number of specialty medications and the advent of precision medicine [to treat] cancer, the importance of clinical support and interventions provided by oncology-experienced specialty pharmacists continues to grow,” said Royce Burruss, MBA, RPh, FASCP, corporate director of clinical services at BioMatrix Specialty Pharmacy. “We continue to focus on updating and enhancing our support services and drug treatment guidelines while leveraging our deep experience in oncology to effectively support the evolving needs of those we serve.”

Any state-licensed pharmacy can designate itself as a specialty pharmacy.

 As specialty pharmacies proliferated in the 2000s, accreditation became a critical means to validate competency, measure quality, and differentiate services. In 2015, 378 pharmacy locations in the United States held specialty pharmacy accreditation from leading health accreditation agencies, the Utilization Review Accreditation Commission (URAC) and/or the Accreditation Commission for Health Care (ACHC). Today, that number is over 1200.

Accreditation has quickly emerged as the gold standard of how specialty pharmacies demonstrate value to health care stakeholders. In addition to standard specialty pharmacy accreditation, organizations such as the URAC and the ACHC have established standards and best practices that allow pharmacies to demonstrate a deeper level of specialization in categories such as oncology and rare disease.

In addition to accreditation and as an answer to the evolving complexity of our health care system, forward-facing specialty pharmacies are centralizing their clinical and administrative expertise on creating centers of excellence (COEs) that focus on key therapeutic categories, such as oncology. Health care in the United States is fragmented, complex, and currently pivoting from a system focused on volume to a system focused on value. The COE model fundamentally aligns with value-based health care principles and allows specialty pharmacies to provide a consistent experience and meaningful support throughout the patient journey.

“As the function of specialty pharmacy has evolved, our oncology COE applies advanced clinical expertise with a focus on timely access to therapy, enhanced visibility, and exceptional communication,” said Joshua Stoneking, PharmD, vice president of oncology at BioMatrix Specialty Pharmacy. “The COE streamlines all pharmacy operational efforts. Patient outcomes are improved when therapy is accessed quickly, enhanced communication provides prescribers [with] confidence [that] their patients are not ‘falling through the cracks,’ and pharmaceutical manufacturers, providers, and payors benefit from visibility into real-world data demonstrating the impact of prescribed therapies.”

Additionally, through the combination of institutional and individual employee expertise, the COE model empowers staff to deploy customized solutions to modern health care challenges.

“Many of our oncology COE employees have over a decade of experience or specialized board certifications,” Stoneking explained. “These employees are extremely passionate about what they do—the COE model enables and empowers them to provide precision, custom solutions to navigate real-world, day-to-day challenges occurring within our health system.”

The specialization required to meet accreditation standards and establish an effective COE can also have a positive impact on employees and organizational culture. The COE model establishes clear performance indicators, unites employees under shared goals, and fosters a collective understanding of what constitutes value.

“A COE creates a pool of resources focused on very specific outcomes. That specificity engages staff, simplifies training, and promotes continuous process improvement,” Stranz explained.

By 2023, it is predicted that 65% of new drug launches will be specialty therapies treating cancer and other rare diseases.

 The push for value-based care, the ongoing pandemic, rising rates of cancer incidence, and a shortage of medical oncologists are among just a few of the factors that will continue to influence the need for and evolution of specialty pharmacy.

Currently, pharmacies primarily are meeting the changing needs and expectations of patients and health care stakeholders with accreditation and COE modeling. Effective specialty pharmacies will embrace this evolution, focusing their expertise on improving clinical and support services while providing solutions to existing and emerging health care challenges.

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

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Effective specialty pharmacies learn to meet the changing needs of patients and stakeholders.

The Evolution of the Oncology Pharmacy

the Commonwealth Fund puts the US health care system in last place compared with 11 other high-income countries.

Despite spending the highest proportion of its gross domestic product on health care, the United States performed the worst in terms of access to care, administrative efficiency, health equity, and outcomes.

 Although the performance of the US health system affects all Americans, certain populations are at greater risk for health disparities based on their age, disability, ethnicity, gender, race, sexual identity, and socioeconomic status.

 Health disparities include, but are not limited to, differences in access to care, disease burden, life expectancy, mental health, and mortality.

Health disparities have long been documented in the United States, evidenced by poorer outcomes for at-risk populations across a wide range of health conditions and indicators.

 Beyond the avoidable negative health outcomes, health disparities create an unnecessary financial burden on both the health care system and the patients. A study commissioned by the Joint Center for Political and Economic Studies and conducted by investigators at Johns Hopkins University and the University of Maryland examined the costs associated with health disparities over a 4-year period.

 The investigators analyzed economic burden across 3 measures: costs of premature death, direct medical cost of health inequalities, and indirect cost of health inequalities. The total direct and indirect costs over the 4-year period totaled $1.24 trillion.

The COVID-19 pandemic has brought health disparities into sharper focus. Health systems, nonprofit agencies, pharmacies, and the US government are working to promote health equity and reduce disparities.

“Health equity is achieved when everyone can attain their full potential for health and well-being,” according to the World Health Organization.

For qualified health systems, cost savings generated through the 340B pharmacy program provide significant opportunities to reduce health disparities.

The 340B program was designed to “stretch scarce federal resources as far as possible, reaching more eligible patients and providing more comprehensive services,” according to the Health Resources & Services Administration.

The program works by requiring drug manufacturers participating in Medicaid to provide outpatient drugs at a reduced price for qualified health care organizations. Eligible health organizations are referred to as covered entities (CEs). They are defined by statute and include certain health centers, hospitals, Ryan White HIV/AIDS program grantees, and specialized clinics that serve at-risk or vulnerable populations.

 The difference between what a CE pays for 340B drugs and what they are reimbursed by third-party payers generates cost savings that can be used to expand services, invest in community health initiatives, provide care for individuals who are underinsured or uninsured, and offer discounted or free medications.

CEs often care for low-income, minority, underserved, or vulnerable populations. 340B disproportionate share hospitals (DSHs) treat a significantly higher number of low-income and Medicaid patients than non-340B acute-care hospitals. Additionally, 340B DSHs are more likely to provide “essential community services” that are considered “low-margin” or not always reimbursed by third-party payers.

These services often focus on at-risk patients and include community health programs addressing behavioral health, health care access, and social determinants influencing health.

 In its 2021 340B Hospital Community Benefit Analysis, the American Hospital Association examined public tax records of tax-exempt 340B hospitals. The analysis shows that cost savings generated by the 340B program provided $67.9 billion in total community health benefits.

“340B savings are used to provide a wide range of support for underserved communities, including diagnostics, counseling, transportation, and translation services,” said Sabine Enright, PharmD, director of 340B services at BioMatrix Specialty Pharmacy. “These services are a critical resource helping to address disparities and promote health equity.”

In addition to making up for low-margin or nonreimbursable services, some hospitals rely on 340B cost savings to support staff salaries and, in some cases, keep their doors open.

Hemophilia treatment centers provide specialized support for patients with bleeding disorders. 340B cost savings provided up to 90% of funding for critical staff, including nurses, physical therapists, and social workers at these centers, according to a 2018 report.

Critical access hospitals (CAH) are 340B-eligible organizations serving rural populations, which often face health disparities such as less access to care and poorer outcomes.

 CAH provide essential support for at-risk communities, but they face significant financial challenges that often threaten their ability to remain open.

 In a survey of more than 500 hospitals that were 340B-eligible, three-fourths of CAH respondents indicated that the 340B program is essential to staying open.

340B cost savings allow CEs to enhance services and stretch resources. In addition to financing essential community support services, funding critical salaries, and keeping doors open, the support provided at the 340B pharmacy level can promote equity and reduce disparities. The 340B program permits CEs to use an in-house pharmacy, contract with external pharmacies, or use a combination of both to expand access and better serve unique patient communities. There is no cap to the number of contract pharmacy arrangements that a CE can deploy. This flexibility allows CEs the ability to maximize cost savings, better meeting the needs of the communities and patients they serve. CEs can leverage their 340B pharmacy staff members to enhance the clinical and support services provided to patients.

CEs often use cost savings to develop programs integrating pharmacists as central members of the care team.

 Deploying integrated pharmacy services has been shown to improve outcomes and patient satisfaction while reducing health care costs.

 340B hospitals have used cost savings to integrate members of the pharmacy team, increasing adherence, providing targeted services for unique patient populations, and reducing hospital readmissions.

 Many programs dispense specialty drugs for patients with chronic or difficult-to-treat health conditions.

“Contracting with a specialty pharmacy that has specific therapeutic experience can enhance clinical support, improve patient engagement, and assist with other critical aspects of care, such as timely medication access and connection to financial assistance programs,” Enright said. “Highly trained, culturally competent staff add an additional layer of support at the individual patient level, reducing disparities and enhancing the patient’s overall health care experience.”

Contract pharmacy arrangements help CEs extend the geographic reach of their programs. In urban areas, pharmacy deserts leave Black and Hispanic patients with fewer options to access medication.

 In rural areas, an increase in hospital closures threatens to place vulnerable communities at even greater risk.

 Contract pharmacy partnerships can help solve that problem.

“Contract pharmacy arrangements help extend program reach to benefit a larger population of patients, often whom reside in rural or economically challenged areas,” said Pete Pecoraro, national account manager for 340B program and client services at BioMatrix Specialty Pharmacy. “These partnerships are critical in expanding both medication access and clinical support for patients residing in at-risk and underserved communities.”

The 340B program is not without controversy. Recent research questions the amount of uncompensated care that some hospitals participating in the program provide.

Several drug manufacturers are pushing back against providing discounts for contract pharmacies.

 But organizations such as the American Hospital Association and 340B Health maintain that the program is working as intended.

 They cite the multitude of unique ways that hospitals use 340B funds to enhance services, expand access, support patients, and ultimately create healthier communities. The 340B program still has a high level of support. In February 2021, a large bipartisan group of lawmakers voiced their support for protecting the program.

 Debate continues but achieving health equity will require an all-hands-on-deck approach to identify and systematically address the health disparities negatively affecting US communities.

“There is no single program in existence today that does more to promote health equity than the 340B drug pricing program,” Pecoraro said. “Whether increasing access to care, expanding operations, or financing community services, 340B extends critical support to patients who would not have access to similar resources in the absence of the program.”

As the US moves toward a more equitable health care system, a broad coalition of community health workers, health systems, lawmakers, pharmacies, and professional health agencies agree that the 340B program will continue to play a critical role in promoting healthier communities and reducing health disparities.

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Drug manufacturers participating in Medicaid offer lower prices, stretching resources and providing comprehensive services to more patients.

340B Program Helps Reduce Health Care Disparities

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.

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340B drug discount program: oversight of the intersection with the Medicaid drug rebate program needs improvement. U.S. Government Accountability Office. January 21, 2020. Accessed June 22, 2021. 

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