340B Programs Help Hemophilia Treatment Centers Promote Care

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.¹ 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.²

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.²

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.³

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.⁴ 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.⁵

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.⁶ 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.⁵

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.”

Increase Cost Savings

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.⁷ The cost savings generated through 340B programs supports up to 90% of critical HTC staff.³ 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.⁸

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.”

Promote Program Integrity

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.^9,10 Estimates indicate that drug manufacturers pay hundreds of millions of dollars in noncompliant Medicaid discounts every year.¹¹ 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.¹²

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.”

Comprehensive Care, Proven Outcomes

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.

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

REFERENCES

1. Hemophilia treatment centers (HTCs). CDC. Updated July 17, 2020. Accessed June 22, 202 https://www.cdc.gov/ncbddd/hemophilia/htc.html[RP1]
2. NHF policy statement hemophilia: treatment center participation in the 340B drug discount program. National Hemophilia Foundation. Accessed June 22, 2021. https://www.hemophilia.org/sites/default/files/document/files/NHF-Position-Statement-Regarding-Hemophilia-Treatment-Center-Participation-in-the-340B-Drug-Discount-Program.pdf[RP2]
3. Malouin RA, Mckernan L, Forsberg A, et al. Impact of the 340B pharmacy program on services and supports for persons served by hemophilia treatment centers in the United States. Matern Child Health J. 2018;22(9):1240-1246. doi:10.1007/s10995-018-2545-7
4. Notice regarding 340B drug pricing program—contract pharmacy services. Federal Register. 2010;75(43):10272-10279. Accessed June 22, 2021. https://www.govinfo.gov/content/pkg/FR-2010-03-05/pdf/2010-4755.pdf[RP3]
5. Thornburg CD, Duncan NA. Treatment adherence in hemophilia. Patient Prefer Adherence. 2017;11:1677-1686. doi:10.2147/PPA.S139851
6. Kale HP, Patel AM, Carroll NV. A comparison of pharmacy dispensing channel use and adherence to specialty drugs among Medicare Part B beneficiaries. J Manag Care Spec Pharm. 2018;24(4):317-326. doi:10.18553/jmcp.2018.24.4.317
7. 340B drug pricing program. Health Resources & Services Administration. Updated May 2021. Accessed June 22, 2021. https://www.hrsa.gov/opa/index.html[RP4]
8. How the right pharmacy partner can increase cost-savings and value creation. BioMatrix Specialty Pharmacy. Accessed June 22, 2021. https://www.biomatrixsprx.com/340b-program-management [RP5]
9. Drug discount program: federal oversight of compliance at 340B contract pharmacies needs improvement. U.S. Government Accountability Office. June 21, 2018. Accessed June 22, 2021. https://www.gao.gov/products/gao-18-480[RP6]
10. 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. https://www.gao.gov/products/gao-20-212[RP7]
11. Bringing clarity to the world of duplicate discounts. Kalderos. August 13, 2020. Accessed June 23, 2021. https://resources.kalderos.com/library/whitepapers/bringing-clarity-to-duplicate-discounts[RP8]
12. Program integrity. Health Resources & Services Administration. Updated May 2021. Accessed June 23, 2021. https://www.hrsa.gov/opa/program-integrity/index.html[RP9]